Protective Stoma Research Articles

Factors associated with leakage after reversal of protective stoma in patients with locally advanced rectal cancer following curative resection and anastomosis

IntroductionAnastomotic leakage (AL) is a significant complication in colorectal surgery with numerous general and specific risk factors. The determinants of colorectal AL following the reversal of a protective defunctioning ileostomy remain unclear and warrant further investigation. Material and methodsData from April 2008 to December 2014 were collected and retrospectively reviewed for 361 consecutive patients who underwent protective ileostomy reversal following curative resection with anastomosis for rectal cancer. The baseline, treatment, and oncological variables of patients associated with post-reversal AL were evaluated using univariate and multivariate logistic regression analysis. The impact of AL on long-term survival outcomes was assessed using Kaplan-Meier survival analyses. ResultsIn a study of 361 patients, 52 (14.4 %) experienced leakage following stoma reversal, manifesting at a median of 5.7 months. Multivariable logistic regression analysis revealed that an anastomosis located less than 7 cm from the anal verge (OR 2.82, p = 0.008), a side-to-end anastomotic configuration (OR 2.02, p = 0.036), involvement of the circumferential resection margin (OR 6.46, p = 0.043), and adjuvant radiotherapy (OR 4.69, p = 0.003) significantly predicted post-reversal AL. Notably, five-year overall survival (63.4 % vs. 90.3 %, p < 0.0001) and disease-free survival (46.9 % vs. 71.1 %, p = 0.001) were significantly lower in patients with post-reversal AL. ConclusionsOur analysis identified several clinicopathological factors associated with post-reversal AL, which is linked to a significant decrease in long-term survival and oncological outcomes. Alleviating these adverse effects necessitates ensuring early detection and effective management of leaks among high-risk patients.

Long-Term Functional Outcome After Early vs. Late Stoma Closure in Rectal Cancer Surgery: Sub-analysis of the Multicenter FORCE Trial

PurposeThe aim of this study was to assess the effect of early stoma closure on bowel function after low anterior resection (LAR) for rectal cancer.MethodsPatients participating in the FORCE trial who underwent LAR with protective stoma were included in this study. Patients were subdivided into an early closure group (< 3 months) and late closure group (> 3 months). Endpoints of this study were the Wexner Incontinence, low anterior resection syndrome (LARS), EORTC QLQ-CR29, and fecal incontinence quality of life (FIQL) scores at 1 year.ResultsBetween 2017 and 2020, 38 patients had received a diverting stoma after LAR for rectal cancer and could be included. There was no significant difference in LARS (31 vs. 30, p = 0.63) and Wexner score (6.2 vs. 5.8, p = 0.77) between the early and late closure groups. Time to stoma closure in days was not a predictor for LARS (R2 = 0.001, F (1,36) = 0.049, p = 0.83) or Wexner score (R2 = 0.008, F (1,36) = 0.287, p = 0.60) after restored continuity. There was no significant difference between any of the FIQL domains of lifestyle, coping, depression, and embarrassment. In the EORTC QLQ-29, body image scored higher in the late closure group (21.3 vs. 1.6, p = 0.004).ConclusionTiming of stoma closure does not appear to affect long-term bowel function and quality of life, except for body image. To improve functional outcome, attention should be focused on other contributing factors.

Total neoadjuvant therapy with split-course hypofraction radiotherapy combined with CAPOX and envafolimab followed by local excision for locally advanced very low rectal cancer (TRACE-LE): An open-label, single-arm, multicenter, phase II trial.

TPS3647 Background: In the treatment of patients with locally advanced very low rectal cancer, neoadjuvant chemoradiotherapy followed by total mesorectal excision (TME) is considered a standard therapeutic approach. Short-course hypofractionated radiotherapy, in combination with subsequent chemotherapy, has been shown to be comparable to long-term chemoradiotherapy in terms of neoadjuvant therapy effects in rectal cancer. Additionally, it has been observed that hypofractionated radiotherapy, when combined with programmed death L-1 (PD-L1) blockade, can enhance the immune response. This study aims to investigate efficacy and safety of organ preservation in patients with locally advanced very low rectal cancer by utilizing total neoadjuvant therapy involving split-course hypofraction radiotherapy in conjunction with CAPOX and Envafolimab (a humanized single-domain anti-PD-L1 antibody fused to an Fc fragment). Methods: TheTRACE-LE trail is an open-label, single-arm, multicenter, phase II trial. The target sample is 72 participants. Key eligibility criteria include individuals aged 18-75, confirmed rectal adenocarcinoma, cT3-4N0/cT1-4N1-2 with lower margin ≤ 2cm from anorectal ring's upper edge (MRI) and ECOG performance status of 0-2. The treatment protocol include preoperative split-course hypofractionated radiotherapy (5×7Gy), in conjunction with 6 cycles of CAPOX chemotherapy and Enverolimab (300 mg subcutaneous injections) administered in a 3-week treatment cycle. The primary outcome measure is organ preservation, specifically the rectum intact, owing to no radical total mesorectal excision (TME), no locoregional regrowth unless amenable to limited, curative (R0) salvage surgery by local excision (LE) and no permanent stoma (including a never reversed protective stoma, or a stoma owing to toxicities and/or poor functional outcomes). The secondary outcome measures encompass ypT0-1 rate, pathological complete response (pCR) rate, acute and late toxicity as per NCICTCAE V.5.0, local recurrence rate, local regional recurrence rate, disease-free survival, quality of life, and anorectal function. Clinical trial information: NCT05970900 .

Low rectal resection for low rectal endometriosis and rectal adenocarcinoma: Are we discussing the same risks?

To evaluate the rate and risk factors for anastomosis leakage in patients undergoing colorectal resection with low anastomosis for rectal endometriosis and rectal adenocarcinoma. A retrospective cohort study evaluating prospectively collected data was conducted. Patients undergoing colorectal resection for rectal endometriosis and rectal adenocarcinoma with low anastomosis (<7 cm from the anal verge [AV]) from September 2018 to January 2023 were included in the analysis. The main outcome was the rate of anastomosis leakage. A multivariate logistic regression was conducted to evaluate risk factors for anastomosis leakage in both groups. A total of 159 patients underwent colorectal resection with low anastomosis due to rectal endometriosis (n = 99) and rectal adenocarcinoma (n = 60). Patients with endometriosis were significantly younger than those with adenocarcinoma (35.7 ± 5.1 vs 63.7 ± 12.6; P = 0.001). The leakage rate was similar between the endometriosis (n = 12, 12.1%) and adenocarcinoma (n = 9, 15.0%) patients (P = 0.621). The anastomosis height less than 5 cm from the AV (adjusted odds ratio [aOR] 12.12, 95% confidence interval [CI] 2.24-23.54) was significantly associated with the anastomosis leakage. Protective stoma was associated with the decrease of the leakage risk (aOR 0.12, 95% CI 0.01-0.72). The type of disease (rectal endometriosis or adenocarcinoma) was not associated with the anastomosis leakage (aOR 2.87, 95% CI 0.34-21.23). Despite the different pathogenesis, the risk of anastomotic leakage was found to be similar between patients with low rectal endometriosis and those with rectal adenocarcinoma. These results must be considered by the gynecologist and colorectal surgeon to deliver proper information before rectal surgery for endometriosis.

Comparison of purse-string technique vs linear suture for skin closure after ileostomy reversal. A randomized controlled trial.

Protective stoma after rectal surgery has been associated with important complications. The most common is surgical site infection (SSI) high rates after stoma reversal reported in literature. Our study compared the rate of SSI of two skin closure techniques, linear closure, and purse string closure. We carried out a single center, prospective, randomized controlled trial in the Department of Colorectal Surgery of Fondazione Policlinico Campus Bio-Medico of Rome between January 2018 through December 2021, to compare LC vs PS closure of ileostomy sites. A total of 117 patients (53.84% male) with a mean age of 65.68 ± 14.33years were finally evaluated in the study. 58 patients were included in the PS group and 59 patients in the LC one. There was a marked difference in the SSI rate between the two arms of the study: 3 of 58 patients in the purse-string arm versus 11 of 59 in the control arm (p = 0.043). The outcome of cosmesis was also higher in PS, with a statistical significance (mean ± DS 4,01 ± 0,73 for PS group vs mean ± DS 2,38 ± 0,72 for LC group, p < 0,001). Our study demonstrated that the PS technique had a significantly lower incidence of stoma site SSI compared with LC technique. Our findings are in line with other randomized studies and suggest that PS closure could be considered as standard of care for wound closure after ileostomy reversal.

The value of transitory protective stomas during primary debulking surgery for advanced epithelial ovarian cancer-- a retrospective cohort study

Objectives: Limited data are available on patients with advanced-stage epithelial ovarian cancer (OC) who require ostomy during primary cytoreductive surgery. This study aimed to investigate the application of postoperative and long-term oncological results from transitory protective stoma (TPS) formation during primary debulking surgery (PDS) for OC. Methods: This is a retrospective cohort study with a single center. We identified patients with stage III-IV OC who underwent colon resection and anastomosis. Depending on the methods used after colorectal anastomosis and the outcomes of surgical resection, the patients were stratified into three groups: resection and end-to-end anastomosis, resection and ostomy, or R1 resection. Demographic and clinical data were analyzed. Results: 84 patients underwent colorectal resection during cytoreduction for FIGO stage III-IV OC. Patients undergoing ostomy were more likely to have a longer mean operative time (266 vs. 283 vs. 236 min; P=0.003) and to undergo rectosigmoid resection at the time of cytoreductive surgery (56.0% vs. 22.7%, P=0.007). Their postoperative feeding (7 vs. 1 vs. 3 d, P&lt;0.001) and exhaustion (6 vs. 3 vs. 3, P&lt;0.001) times were similar to those of patients with R1 resection and much earlier than those of patients with intestinal anastomosis. The first normal time (35 d) and half-life (14.68 d) of CA125 after surgery were significantly better in patients with TPS group. The overall incidence of complications was the same, and there was no significant difference in the 30-day readmission rate. The overall quality of life assessment was significantly lower in the R1 resection group. Conclusions: TPSs can accelerate postoperative recovery and the initiation of postoperative chemotherapy, reduce the risk of mortality and disease progression and limit the incidence of complications.

Application value of laparoscopic double stapler firings and double stapling technique combined with rectal eversion and total extra-abdominal resection in the sphincter-preserving resection of low rectal cancer

Objectives: To investigate the application value of laparoscopic double stapler firings and double stapling technique combined with rectal eversion and total extra-abdominal resection (LDER) in the anal preservation treatment of low rectal cancer. Methods: Inclusion criteria: (1) age was 18-70; (2) the distance of the lower tumor edge from the anal verge was 4-5 cm; (3) primary tumor with a diameter ≤3 cm; (4) preoperative staging of T1~2N1~2M0; (5) "difficult pelvis", defined as ischial tuberosity diameter<10 cm or body mass index>25 kg/m2; (6) patients with strong intention for sphincter preservation; (7) no preoperative treatment (e.g., chemotherapy, radiotherapy, molecular targeted therapy, or immunotherapy); (8) no lateral lymph node enlargement; (9) no previous anorectal surgery; (10) patients with good basic condition who could tolerate surgery. Exclusion criteria: (1) previously suffered from malignant tumors of the digestive tract or currently suffering from malignant tumors out of the digestive tract; (2) patients with preoperative anal dysfunction (Wexner score ≥ 10), or fecal incontinence. The specific surgical steps are as follows: the distal end of the rectum was dissected to the level of the interspace between internal and external sphincters of anal canal. Five centimeters proximal to the tumor, the mesorectum was ligated, and a liner stapler was used to transect the rectum. The distal rectum with the tumor were then everted and extracted through the anus. The rectum was transected 0.5-1.0 cm distal to the tumor with a linear stapler. Full thickness suture was used to reinforce the stump of the rectum, which was then brought back into the pelvic cavity. Finally, an end-to-end anastomosis between the colon and the rectum was performed. A retrospective descriptive study was performed of the clinical and pathological data of 12 patients with T1-T2 stage low rectal cancer treated with LDER at Henan Provincial People's Hospital from January 2020 to December 2022. Results: All 12 patients successfully completed LDER with sphincter preservation, without conversion to open surgery or changes in surgical approach. The median surgical time was 272 (155-320) minutes, with a median bleeding volume of 100 (50-200) mL. No protective stoma was performed, and all patients received R0 resection. The average hospital stay was 9 (7-15) days. There were no postoperative anastomotic leakage or perioperative deaths. All 12 patients received postoperative follow-up, with a median follow-up of 12 months (6-36 months) and a Wexner score of 8 (5-14) at 6 months postoperatively. There was no tumor recurrence or metastasis during the follow-up period. Conclusions: LDER is safe and effective for the treatment of low rectal cancer.

Ileostomy: Early and Late Complications

Abstract Introduction Ileostomy formation is performed for multiple purposes related to intestinal pathology, such as obstructive malignant or benign tumors, inflammatory bowel diseases, intestinal ischemia, and, for the most part, as a protective stoma in high-risk anastomosis. The creation of this surgical opening, despite being considered a simple procedure, is undoubtedly followed by complications in certain cases. Materials and Methods We conducted an electronic literature search in the MEDLINE database using the PubMed search engine. A total of 43 articles were included in the present review. Results/Discussion Over the course of the present work, we were able to explore different types of complications that can arise in patients with an ileostomy. High-output stomas were found to be associated with dehydration and electrolyte imbalance. Skin-related morbidity was shown to be present in a great percentage of patients. More severe complications, such as peristomal pyoderma gangrenosum and necrosis, are less frequent and require urgent management. Several risk factors were identified in cases of retraction, obstruction, prolapse, and parastomal herniation. Conclusion Even though ileostomies may present numerous benefits in certain patients, they are also associated with many complications, which should be avoided and quickly managed, because they can severely affect the quality of life of the patients. Surveillance and follow-up by a multidisciplinary team is strongly advisable, bearing in mind that a good performance on the part of the responsible surgeon is also a key factor.

Discoid excision for colorectal endometriosis associated infertility: A balance between fertility outcomes and complication rates

ObjectiveThe objective of our study was to study the impact of discoid excision for deep endometriosis (DE) with colorectal involvement on fertility outcomes. Methods49 patients with a desire for pregnancy treated with discoid excision for colorectal endometriosis in our endometriosis expert center between January 2015 and August 2020 were selected from our prospectively maintained database. Indications for surgery were either infertility and / or pelvic pain. Postoperative complications were graded according to the Clavien-Dindo classification. Fertility outcomes, both spontaneous and post-ART pregnancies, were analyzed. ResultsAmong the 49 patients who underwent discoid excision exclusively (no other digestive resection) with a desire to conceive, 25 had a pregnancy after surgery and 24 did not. Double discoid excision was performed in 6.1 % of the cases (3/49). A colpectomy was performed in 12.2 % of the patients (6/49), and a protective stoma in 12.2 % (6/49). Fenestration of endometriomas was performed in 28.6 % of the patients (14/49), and parametrectomy in 40.8 % (20/49). The postoperative complication rate was 24.5 % (12/49) including 10.2 % (5/49) grade I, 12.2 % (6/49) grade II, and 2 % (1/49) grade III. Prior to surgery, 28 (57.1 %) patients had infertility including 13 (52 %) that successfully conceived following surgery and 15 (62.5 %) that remain infertile. Spontaneous pregnancy was achieved in 60 % (15/25) of infertile patients’ prior surgery. The live-birth rate in patients conceiving spontaneously was 75 % (12/16). ConclusionOur results support that discoid excision is safe and associated with good fertility outcomes. Whether first-line surgery using discoid excision is superior to first-line ART remains to be determined.

Primena transanalnog drena nakon prednje resekcije rektuma - uticaj na prevenciju nastanka "Ahilove tetive" kolorektalne hirurgije

Aim: The aim of our study was to investigate the potential reduction in the likelihood of anastomotic leakage occurrence in patients undergoing open anterior resection of the rectum without a protective stoma for stage III adenocarcinoma, by employing a transanal tube after performing stapled colorectal anastomosis. Results: Considering the influence of all included risk factors, male gender (p=0.032; OR=2.873) and patients with type 2 diabetes mellitus (p=0.033; OR=2.873) demonstrated an increased likelihood of anastomotic leakage, while the presence of a transanal tube (p=0.043; OR=0.349; 95% CI: 0.126, 0.966) was associated with a statistically significant reduction in the likelihood of anastomotic leakage. T-test revealed that patients with anastomotic leakage without a placed tube had a statistically significantly longer mean postoperative hospitalization (20.94 days) compared to those with a transanal tube (19.43 days) (t=2.375; p=0.025). Kaplan-Meier analysis didn't show a statistically significant difference in the average estimated time to the occurrence of anastomotic leakage between patients without (3.86 days) and with a transanal tube (4.58 days) (p=0.057). Conclusion: Our study found that the placement of a transanal tube after colorectal anastomosis may be associated with a reduced likelihood of anastomotic leakage and shorter hospitalization in case leakage occurs. Additionally, although no statistically significant difference was found in the effect of the tube on the occurrence of anastomotic leakage depending on the presence of type 2 diabetes mellitus, the indication for its use in patients with type 2 diabetes mellitus may be of particular benefit.

Short-term and long-term efficacy in robot-assisted treatment for mid and low rectal cancer: a systematic review and meta-analysis

ObjectiveThis study aims to conduct a meta-analysis to evaluate the short-term and long-term therapeutic effects of robot-assisted laparoscopic treatment in patients with mid and low rectal cancer.MethodsA comprehensive search strategy was employed to retrieve relevant literature from PubMed, NCBI, Medline, and Springer databases, spanning the database inception until August 2023. The focus of this systematic review was on controlled studies that compared the treatment outcomes of robot-assisted (Rob) and conventional laparoscopy (Lap) in the context of mid and low rectal cancer. Data extraction and literature review were meticulously conducted by two independent researchers (HMW and RKG). The synthesized data underwent rigorous analysis utilizing RevMan 5.4 software, adhering to established methodological standards in systematic reviews. The primary outcomes encompass perioperative outcomes and oncological outcomes. Secondary outcomes include long-term outcomes.ResultA total of 11 studies involving 2239 patients with mid and low rectal cancer were included (3 RCTs and 8 NRCTs); the Rob group consisted of 1111 cases, while the Lap group included 1128 cases. The Rob group exhibited less intraoperative bleeding (MD = −40.01, 95% CI: −57.61 to −22.42, P < 0.00001), a lower conversion rate to open surgery (OR = 0.27, 95% CI: 0.09 to 0.82, P = 0.02), a higher number of harvested lymph nodes (MD = 1.97, 95% CI: 0.77 to 3.18, P = 0.001), and a lower CRM positive rate (OR = 0.46, 95% CI: 0.23 to 0.95, P = 0.04). Additionally, the Rob group had lower postoperative morbidity rate (OR = 0.66, 95% CI: 0.53 to 0.82, P < 0.0001) and a lower occurrence rate of complications with Clavien–Dindo grade ≥ 3 (OR = 0.60, 95% CI: 0.39 to 0.90, P = 0.02). Further subgroup analysis revealed a lower anastomotic leakage rate (OR = 0.66, 95% CI: 0.45 to 0.97, P = 0.04). No significant differences were observed between the two groups in the analysis of operation time (P = 0.42), occurrence rates of protective stoma (P = 0.81), PRM (P = 0.92), and DRM (P = 0.23), time to flatus (P = 0.18), time to liquid diet (P = 0.65), total hospital stay (P = 0.35), 3-year overall survival rate (P = 0.67), and 3-year disease-free survival rate (P = 0.42).ConclusionRobot-assisted laparoscopic treatment for mid and low rectal cancer yields favorable outcomes, demonstrating both efficacy and safety. In comparison to conventional laparoscopy, patients experience reduced intraoperative bleeding and a lower incidence of complications. Notably, the method achieves comparable short-term and long-term treatment results to those of conventional laparoscopic surgery, thus justifying its consideration for widespread clinical application.

Role and Morbidity of Protective Ileostomy after Anterior Resection for Rectal Cancer: One Centre Experience and Review of Literature

The creation of a protective stoma is considered a valid life-saving tool, significantly reducing the effects of anastomotic leakage in terms of related morbidity, mortality, and reoperation rate. The aim of this study was to evaluate the impact of a protective loop ileostomy in terms of short- and long-term postoperative morbidity, quantifying the stoma-related complications arising after stoma creation and stoma closure and the risk of permanent stoma. From January 2009 to January 2020, 149 patients with rectal cancer treated by anterior resection and protective ileostomy were enrolled in the study. A total of 113 (75.84%) patients were preoperatively treated with neoadjuvant radiochemotherapy. A clinically relevant anastomotic leak occurred in two patients (1.34%). The postoperative stoma complication rate was 6%. According to the Clavien classification, the stoma-related complication grade was I in seven patients (4.7%) and II in two patients (1.3%). A late stoma-related parastomal hernia occurred in one patient (0.67%). In 129 patients (86.57%), it was possible to close the stoma. Postoperative complications of stoma closure occurred in 12 patients (9.3%). The stoma closure complication grade was I in seven cases (5.43%), II in two cases (1.55%), and ≥3 in three cases (2.33%). Incisional hernia was the only late complication recorded in seven cases (5.42%). The permanent stoma rate was 13.43%. A protective ileostomy has a nonnegligible complication rate, but the rate of severe complications is low. Every effort should be made to clearly identify patients in whom the risk of anastomotic leakage justifies the stoma.

Novel stent-assisted ileal bypass is applied to avoid protective stoma and prevent anastomotic leakage for rectal cancer.

This study aimed to investigate the safety and feasibility of a novel stent-assisted ileal bypass for rectal cancer patients who received sphincter-preserving surgery. Patients who were diagnosed with rectal cancer and received sphincter-preserving surgery plus a novel stent-assisted ileal bypass were respectively included from January 2022 to January 2023. Biofragmentable ileal stent with diaphragm sheet in the cavity was placed in the terminal ileum using absorbable sutures after anastomosis. At the proximal end of the stent, an intestinal diversion tube was placed in the prefabricated purse-string, through which faeces were drained. The stent completely disintegrated in the body after 3-4 weeks, which protected the anastomosis after surgery and avoided protective stoma. Clinical characteristics and surgical outcomes were collected. Eleven patients who successfully received surgery were included. There were seven (63.6%) males and four (36.4%) females. The tumour size was 3.2 ± 1.7 cm and the lower verge of tumour to anal verge was 6.8 ± 1.3 cm. As for surgical outcomes, operation time was 216.4 ± 54.1 min, blood loss was 43.6 ± 64.6 mL, time to first flatus via intestinal diversion tube was 3.2 ± 1.1 days, time to discharge stent was 22.8 ± 3.0 days, and postoperative hospital stay was 21.0 ± 5.4 days. Two patients suffered from postoperative complications including pneumonia and incision infection. This novel stent-assisted ileal bypass is safe and feasible, it provides a new choice for rectal cancer patients to avoid protective stoma and secondary surgery.

Risk factors, quality of life, and oncological effects of refractory anastomotic leakage for laparoscopic intersphincteric resection.

Refractory anastomotic leakage (RAL) after intersphincteric resection (ISR) usually leads to failure of protective stoma reversal in ultralow rectal cancers. The aim of this study is to assess the risk factors and oncological outcomes of both anastomotic leakage (AL) and RAL, and quality of life (QoL) of RAL after laparoscopic ISR (LsISR). A total of 371 ultralow rectal cancer patients with LsISR were enrolled from a tertiary colorectal surgery referral center. Risk factors for AL and RAL were identified by logistic regression. Three-year disease-free survival (DFS) of AL and RAL was analyzed by the Cox regression. QoL of RAL group (compared with non-RAL group) was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-CR29 questionnaires. The rates of AL and RAL after LsISR accounted for 8.4% (31/371) and 4.6% (17/371) in this cohort, respectively. Non-left colic artery preservation (odds ratio [OR]=3.491, P=0.009), neoadjuvant chemoradiotherapy (nCRT) (OR=6.038, P<0.001), and lower anastomosis height (OR=5.271, P=0.010) were independent risk factors for AL, while nCRT (OR=11.602, P<0.001) was the only independent risk factor for RAL. Male (hazard ratio [HR]=1.989, P=0.014), age>60years (HR=1.877, P=0.018), and lymph node metastasis (HR=2.125, P=0.005) were independent risk factors of poor 3-year DFS, but not RAL (P=0.646). RAL patients have significantly worse global health status, worse emotional and social function scores at the late postoperative stage, and worse urinary and sexual function at the early postoperative stage (all P<0.05). Neoadjuvant chemoradiotherapy was an independent risk factor for RAL after LsISR. RAL shows similar oncological outcomes, but with poor QoL.

Anastomotic leakage following bowel resection in radical cytoreductive surgery for ovarian cancer: A subgroup analysis of the prospective AGO-OVAR.OP3/LION.

5566 Background: Anastomotic leakage (AL) is an important and severe complication following bowel resection in cytoreductive surgery (CRS) for ovarian cancer (OC). Identifying patients (pts) at risk for AL could improve clinical management and reduce frequency and severity of complications. Methods: AGO-OVAR.OP3/LION intraoperatively randomized 647 pts with advanced OC (FIGO IIB-IV) following complete cytoreduction with unsuspicious lymph nodes to either undergo systematic pelvic and paraaortic lymphadenectomy (LNE) or not. All pts who underwent bowel resection were included in this analysis. Potential prognostic impact of AL was analyzed by Kaplan-Meier method and log-rank tests regarding progression-free (PFS) and overall survival (OS). Risk factors for AL in a subset of clinicopathological parameters were evaluated by calculating odds ratio (OR) with 95% confidence interval (CI) in univariate and multivariate logistic regression models. A stepwise variable selection algorithm using the Akaike Information Criteria (AIC) for identification of the final logistic regression model was applied. P values presented were two-tailed, and P&lt;0.05 was considered as statistically significant. Results: Among all 647 randomized pts, AL was noted in 24 (3.7 %) pts. The AL rate of the 336 pts with bowel surgery during CRS (median age 61.3 years; 316 large bowel, 94 small bowel resections) was 7.1% (24/336 pts). Pts following stoma formation had an AL rate of 5.5% (3/55 pts) compared to 7.5% (21/281 pts) in pts without stoma. Median PFS was 18 months in pts with AL versus 19 months in the no-AL-group (hazard ratio (HR) 0.86; 95% CI 0.5 to 1.4, P=0.53), median OS was 31 months in the AL group and 58 months in the no-AL-group (HR 0.69; 95% CI 0.4 to 1.2, P=0.17). The clinicopathological characteristics “volume of blood loss” (OR 1.05 per 100cc; 95% CI 1.01-1.10) and “LNE vs non-LNE” (OR 4.10; 95% CI 1.60-12.62) were identified as factors potentially predictive for AL in univariate analysis, and both factors (volume of blood loss [OR 1.04 per 100cc, 95% CI 1.0001-1.09], LNE vs non-LNE [OR 3.67, 95% CI 1.41-11.39]) remained a significant independent factor in multivariate analysis. Conclusions: Considering the high surgical complexity in this large prospective surgical trial, the overall rate of AL following bowel surgery was relatively low and had no significant impact on PFS or OS. While protective stoma formation was not identified as protective factor in this cohort, volume of blood loss and LNE procedure were clinical parameters associated with higher risk of AL. Being potential surrogates for extensive surgery, these factors should be considered in perioperative management in pts with advanced OC. Further specific factors predicting AL were not identified. Clinical trial information: NCT00712218 .

The status of low anterior resection syndrome: data from a single-center in China

AimThe incidence and risk factors of low anterior resection syndrome (LARS) largely variate in different studies. In addition, there is lack of study on how patients evaluate the therapeutic effect of LARS. This single-center retrospective study aims to investigate the status of LARS in Chinese patients undergoing laparoscopic low anterior resection (LAR).MethodsConsequent patients undergoing laparoscopic LAR and free from disease recurrence from January 2015 to May 2021 were issued with both LARS questionnaire and satisfaction survey. Related data were collected and analyzed.ResultsBoth LARS questionnaires and self-made satisfaction survey were received from 261 eligible patients. The overall incidence of LARS was 47.1% (minor in 19.5%, major in 27.6%), decreased with the passage of postoperative time (64.7% within 12 months, and 41.7% within 12–36 months), and became stable 36 months later (39.7%). The most common symptoms were defecation clustering (n = 107/261, 41.0%) and defecation urgency (n = 101/261, 38.7%). According to the multivariable regression analysis, risk factors of major LARS were: 1 year increase in age (OR 1.035, 95% CI 1.004–1.068), protective stoma (OR 2.656, 95% CI 1.233–5.724) and T3 − 4 stage (OR 2.449, 95% CI 1.137–5.273). Most patients complained defecation disorder (87.3%) to doctors and 84.5% got suggestions or treatments for it. However, only 36.8% patients thought the treatments worked for them.ConclusionsLARS frequently occurs after laparoscopic LAR, while the therapeutic effect is not satisfying. Elder, advanced T-stage and protective stoma were risk factors for postoperative major LARS.

Application and evaluation of transitory protective stoma in ovarian cancer surgery.

Ovarian cancer is the most fatal of all female reproductive cancers. The fatality rate of OC is the highest among gynecological malignant tumors, and cytoreductive surgery is a common surgical procedure for patients with advanced ovarian cancer. To achieve satisfactory tumor reduction, intraoperative bowel surgery is often involved. Intestinal anastomosis is the traditional way to restore intestinal continuity, but the higher rate of postoperative complications still cannot be ignored. Transitory protective stoma can reduce the severity of postoperative complications and traumatic stress reaction and provide the opportunity for conservative treatment. But there are also many problems, such as stoma-related complications and the impact on social psychology. Therefore, it is essential to select appropriate patients according to the indications for the transitory protective stoma, and a customized postoperative care plan is needed specifically for the stoma population.

Functional outcomes after transanal total mesorectal excision (TaTME): a random forest analysis to predict patients' outcomes.

Anorectal, sexual, and urinary dysfunction are common issues after rectal cancer surgery, although seldom explored. The primary aim of this study was to investigate postoperative anorectal functional results. Patients with mid/low-rectal cancer treated with transanal TME (TaTME) with primary anastomosis with/without diverting stoma between 2015 and 2020 were reviewed and selected if they had a minimum follow-up of 6months (from the primary procedure or stoma reversal). Patients were interviewed using validated questionnaires and the primary outcome was bowel function based on Low Anterior Resection Syndrome (LARS) scores. Statistical analyses were performed to identify clinical/operative variables correlated with worse outcomes. A random forest (RF) algorithm was computed to classify patients at a greater risk of minor/major LARS. Ninety-seven patients were selected out of 154 TaTME performed. Overall, 88.7% of the patients had a protective stoma and 25.8% reported major LARS at mean follow-up of 19.0months. Statistical analyses documented that age, operative time, and interval to stoma reversal correlated with LARS outcomes. The RF analysis disclosed worse LARS symptoms in patients with longer operative time (> 295min) and stoma reversal interval (> 5.6months). If the interval ranged between 3 and 5.6months, older patients (> 65years) reported worse outcomes. Finally, no statistical difference was documented when comparing the rate of minor/major LARS in the first 27 cases versus others. One-quarter of the patients developed major LARS after TaTME. An algorithm based on clinical/operative variables, such as age, operative time, and time to stoma reversal, was developed to identify categories at risk for LARS symptoms.

The economic impact of anastomotic leak after colorectal cancer surgery

ObjectiveTo determine the economic impact of the incremental consumption of resources for the diagnosis and treatment of anastomotic leak (AL) in patients after resection with anastomosis for colorectal cancer compared to patients without AL on the Spanish health system.MethodThis study included a literature review with parameters validated by experts and the development of a cost analysis model to estimate the incremental resource consumption of patients with AL versus those without. The patients were divided into three groups: 1) colon cancer (CC) with resection, anastomosis and AL; 2) rectal cancer (RC) with resection, anastomosis without protective stoma and AL; and 3) RC with resection, anastomosis with protective stoma and AL.ResultsThe average total incremental cost per patient was €38,819 and €32,599 for CC and RC, respectively. The cost of AL diagnosis per patient was €1018 (CC) and €1030 (RC). The cost of AL treatment per patient in Group 1 ranged from €13,753 (type B) to €44,985 (type C + stoma), that in Group 2 ranged from €7348 (type A) to €44,398 (type C + stoma), and that in Group 3 ranged from €6197 (type A) to €34,414 (type C). Hospital stays represented the highest cost for all groups. In RC, protective stoma was found to minimize the economic consequences of AL.ConclusionsThe appearance of AL generates a considerable increase in the consumption of health resources, mainly due to an increase in hospital stays. The more complex the AL, the higher the cost associated with its treatment.Interest of the studyit is the first cost-analysis study of AL after CR surgery based on prospective, observational and multicenter studies, with a clear, accepted and uniform definition of AL and estimated over a period of 30 days.

P759 Perianal Crohn’s disease – therapeutic response and anal cancer risk - a single centre retrospective cohort

Abstract Background Perianal manifestations of Crohn’s disease (CD) occur in up to 43% of CD patients, and are strongly associated with colonic and rectal involvement. They have negative effects on patients’ quality of life and the risk of anal cancer (AC) is two to three times higher than the general population. The management of perianal disease (pCD) often includes a local approach but also a systemic therapeutic escalation. Methods Aim: to evaluate the response to therapy and the incidence of AC in patients with pCD. Retrospective single-centre study, recruiting all adult patients with pCD. We analysed the population demography, extraintestinal manifestations, the presence of perianal disease at diagnosis, the subtype of pCD, PDAI score, baseline treatment and the need for readjustment. We evaluated the clinical and MRI response atsix months, further therapeutic changes required, the incidence of anal and rectal cancer and the status at last follow-up. Results 174 patients with CD, 50 with pCD (29%) – from these: 59% Male; Age 22-77 (median 51); Extraintestinal manifestations 16 (31%); pCD at the diagnosis of CD 29 (57%). pCD characterization: fistula 46 (92%) (simple 6; complex 40); abscess 27 (54%); fissure 12 (24%). PDAI score: 1-17 (median 7,5). Approach: fistulotomy 25 (49%); seton placement 13 (25%); protective stoma 5 (9,8%). Antibiotics in 43 (86%). Therapeutic change 40 (84%) -started: corticosteroid course 9 (18%) (all with rectal disease activity), anti-TNF 28 (55%), thiopurine 23 (45%) 13 of them in monotherapy. At 6 months: global clinical improvement 41 (81%); healed PD 18 (35%). Follow up 2-49 years (mean 20); Subsequent treatment change during follow up: 28 (55%). At last follow-up: luminal CD in clinical remission 44 (86%); pCD improvement 43 (84%) and deep remission in 32 (64%). By univariate analysis there was no significant association between starting anti-TNF therapy or monotherapy with thiopurine and clinical response at 6 months, or at last follow up, with MRI improvement. During follow up, 3 patients (6%) develop AC (2 perianal fistula-related cancer; 1 adenocarcinoma). There was no significant association with the use of anti-TNF (p 0,356) or thiopurine (p 0,312) but there was an association with absence of clinical response at 6 months (p 0,050) and lack of MRI improvement (p 0,057). There were no rectal cancer cases. Conclusion Most patients with pCD required therapeutic changes, the majority of them initiating anti-TNF – this resulted in luminal disease remission and at least pCD improvement in more than 80% of patients. The small sample size limited our results, but AC seemed to be more common in patients with chronically active pCD.