Creation Of Ileostomy Research Articles

Prediction model and web-based risk calculator for postoperative ileus after loop ileostomy closure.

Postoperative ileus (POI) is a significant complication after loop ileostomy closure given both its frequency and impact on the patient. The purpose of this study was to develop and externally validate a prediction model for POI after loop ileostomy closure. The model was developed and validated according to the TRIPOD checklist for prediction model development and validation. The development cohort included consecutive patients who underwent loop ileostomy closure in two teaching hospitals in Montreal, Canada. Candidate variables considered for inclusion in the model were chosen a priori based on subject knowledge. The final prediction model, which modelled the 30-day cumulative incidence of POI using logistic regression, was selected using the highest area under the receiver operating characteristic curve (AUC) criterion. Model calibration was assessed using the Hosmer-Lemeshow goodness-of-fit test. The model was then validated externally in an independent cohort of similar patients from the University of British Columbia. The development cohort included 531 patients, in whom the incidence of POI was 16·8 per cent. The final model included five variables: age, ASA fitness grade, underlying pathology/treatment, interval between ileostomy creation and closure, and duration of surgery for ileostomy closure (AUC 0·68, 95 per cent c.i. 0·61 to 0·74). The model demonstrated good calibration (P= 0·142). The validation cohort consisted of 216 patients, and the incidence of POI was 15·7 per cent. On external validation, the model maintained good discrimination (AUC 0·72, 0·63 to 0·81) and calibration (P= 0·538). A prediction model was developed for POI after loop ileostomy closure and included five variables. The model maintained good performance on external validation.

Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study

Efficacy and Application of the Alfred SmartBag System After Ileostomy Creation in Colorectal Surgery: A Pilot Study

Incidence and predictors of postoperative ileus after loop ileostomy closure: a systematic review and meta-analysis.

Postoperative ileus (POI) is regarded as the most clinically significant morbidity following loop ileostomy closure; however, its incidence remains poorly understood. Our objective was therefore to determine the pooled incidence of POI after loop ileostomy closure and identify risk factors associated with its development. We systematically searched MEDLINE (via Ovid and PubMed), Embase, the Cochrane Library, Biosis Previews, and Scopus to identify studies reporting the incidence of POI in patients who underwent loop ileostomy closure. Two independent reviewers extracted data and appraised study quality. Cumulative incidence proportions were pooled across studies using a random-effects meta-analytic model. Sixty-seven studies, including 9528 patients, met our inclusion criteria. The pooled estimate of POI was 8.0% (95% CI 6.9-9.3%; I2 = 74%). The estimated incidence varied by POI definition: studies with a robust definition of POI (n = 8) demonstrated the highest estimate of POI (12.4%, 95% CI 9.2-16.5%; I2 = 79%) while studies that did not report an explicit POI definition (n = 38) demonstrated the lowest estimate (6.7%, 95% CI 5.3-8.3%; I2 = 61%). Small bowel anastomosis technique (hand-sewn) and interval time from ileostomy creation to closure (longer time) were the factors most commonly associated with POI after loop ileostomy closure. However, most comparative studies were not powered to examine risk factors for POI. POI is an important complication after loop ileostomy closure, and its incidence is dependent on its definition. More research aimed at studying this complication is required to better understand risk factors for POI after loop ileostomy closure.

How temporary is temporary ileostomy: variables delaying reversal of an ileostomy

Background: Temporary diversion ileostomy are done to protect distal bowel anastomosis giving adequate time for the bowel repair to heal. Here we studied the reversal time for different temporary ileostomy done and found the factors causing delay in reversal of ileostomy.Methods: In a retrospective cohort of patients, data was collected from the MRD and the operating registry of department of general surgery from January 2013 to December 2017. Parameters like reversal time interval between creation to closure, type of ileostomy, timing of stoma creation, ostomy created with primary index surgery or subsequently, primary etiology that led to creation of ileostomy, ileostomy done on elective list or as an emergency and postoperative complications like anastomotic leak, surgical site infection, intra-abdominal collection were recorded.Results: Of 107 cases, 3 were planned permanent ileostomy and 2 lost follow up. About 77 underwent reversal with mean reversal time of 74.47days, 25 (24.50%) were nonreversed. 51 underwent ileostomy during their second surgical procedure (secondary stoma). End ileostomy, adjuvant chemotherapy, intra-abdominal collection and a secondary stoma caused a delay in the reversal of ileostomy.Conclusions: Although it is said that temporary ileostomies are reversed within 6 to 12weeks time, but reversal time is considerably delayed as what would be anticipated. Ileostomy carries considerable morbidity and psychological impact on lifestyle of patient. Non-reversal of ileostomy should be an important part of pre-procedural counselling because considerable number of ostomies may not be reversed which were deemed to be temporary initially.

Patient-Reported Outcomes and Readmission after Ileostomy Creation in Older Adults

Because of the concern about risk of poor outcome, ileostomy creation is sometimes avoided in older adults. We sought to evaluate the effect of a rigorous postoperative pathway and checklist on readmission and self-efficiacy in older surgical patients. After implementing a self-care checklist and standardized care pathway at our institution, we performed a retrospective review of patients between June 2013 and June 2016 and compared characteristics and outcomes for patients aged <65 and ≥65 years. Using logistic regression, we identified independent predictors of readmission. We also conducted a survey of patient self-efficacy after discharge to assess independence. There were 288 younger patients and 72 older patients. The older group had more patients with an American Society of Anesthesiologists >2 (53.0% vs 81.4%, P < 0.01) and were more likely to have had surgery for cancer (22.9% vs 48.5%, P < 0.01). In the multivariable analyses, age was not a predictor of readmission but American Society of Anesthesiologist and length of stay were. In the 57 patients surveyed after discharge, we found that older and younger patients reported similar self-efficacy scores. In our study, older and younger patients have similar rates of readmission and similar ability to independently care for their themselves after ileostomy creation.

Readmissions With Dehydration After Ileostomy Creation: Rethinking Risk Factors.

Twenty-nine percent of postileostomy discharges are readmitted, most commonly because of dehydration. However, there is a lack of detailed data specifically evaluating factors associated with readmission with dehydration. In addition, patients with a history of an ileostomy have often been excluded from previous studies and therefore represent a group of understudied ileostomates. This study aimed to evaluate factors available at discharge associated with 30-day readmission for dehydration, rather than all-cause readmissions. This was a retrospective cohort study. Study patients received ileostomies at a tertiary academic medical center from 2014 to 2016. Patients with a preexisting ileostomy that was not recreated per the operative note were excluded, whereas those who received a new ileostomy were included. The primary outcome measured was 30-day readmission for dehydration as defined by objective clinical criteria. A total of 262 patients underwent ileostomy creation and were discharged alive. Twenty-five percent were ≥65 years of age, 53% were men, 14% had a history of ileostomy, 18% had a creatinine >1.0 on discharge, and 26% had high ileostomy output at any time during the index admission. Among all ileostomates, the all-cause readmission rate was 30%. Mean days to readmission for any cause was 8.5, whereas for dehydration it was 11.6 days. Of the readmissions, 37% were readmitted with a diagnosis of dehydration, and dehydration was the sole reason in 26%. Among those with dehydration, the most common length of stay was 2 days. In multivariable logistic regression, 30-day readmission with dehydration was associated with older age, male sex, history of an ileostomy, high ileostomy output during index admission, and a discharge creatinine >1.0. This study was limited by its retrospective design. Ileostomy dehydration efforts have focused on new ileostomy patients; however, our data suggest that patients with a history of an ileostomy are actually at risk for readmission with dehydration. Further studies aimed at the reduction of readmission with dehydration after ileostomy are warranted and should include patients with a history of an ileostomy. See Video Abstract at http://links.lww.com/DCR/A643.

Readmissions after Ileostomy Creation Using a Nationwide Database

Readmissions occur frequently in patients undergoing ostomy creation, ranging from 12 per cent to more than 30 per cent. The objective of this study was to compare the reasons for early versus intermediate readmissions after surgical procedures involving formation of ileostomies at a national level. Patients receiving a new ileostomy were identified in the 2010 to 2014 Nationwide Readmission Database. Patients were categorized into Early, Intermediate, and Late cohorts (0-7, 8-30, 31-90 days, respectively), based on discharge-to-readmission interval. Of the 76,590 patients undergoing ileostomy creation, 28 per cent were nonelectively rehospitalized within 90 days after discharge: 10 per cent Early, 12 per cent Intermediate, and 7 per cent Late. Compared with the Intermediate cohort, the Early readmissions were more frequently because of anastomotic complications (20% vs 12%, P < 0.001) and gastrointestinal obstruction (10% vs 5%, P < 0.001), whereas Intermediate readmissions were because of renal failure (17% vs 9%, P < 0.001). In the Late group, the most common reason for readmission was renal failure (14%), followed by anastomotic complications (11%), and stoma reversal (8%). In this nationwide study, all-cause 90-day nonelective readmissions after ileostomy procedures occurred in nearly 30 per cent of patients. Although early rehospitalizations were mainly because of surgical complications and gastrointestinal complications, late readmissions were because of ileostomy reversal.

Preoperative stoma site marking: a simple practice to reduce stoma-related complications.

To evaluate the incidence and identify the risk factors of stoma-related complications in a consecutive series of patients treated at a single institution. For this retrospective analysis, the medical records of patients followed up at the stoma care centre of our institution over the last 16years were reviewed. The primary end point was the incidence of stoma-related complications. Risk factors were tested using univariate and multivariate Cox proportional hazards models. Of a total of 1076 patients, 604 received a colostomy and 472 an ileostomy. In all, 1055 stoma-related complications were recorded in 797 patients. Univariate analysis identified the following risk factors for stoma-related complications: male sex (p = 0.032), emergency surgery (p = 0.010), open surgery (p < 0.001), and ileostomy creation (p = 0.004). Preoperative stoma site marking was noted to play a protective role (hazard ratio 0.739; 95% confidence interval 0.576-0.947; p = 0.017). Multivariate analysis confirmed male sex and ileostomy creation as risk factors (p = 0.030 and p = 0.013, respectively) and preoperative stoma site marking as an independent protective factor (p = 0.001). Stoma-related complications are quite common, especially when an ileostomy is present. Preoperative stoma site marking was noted to play a highly protective role not only in reducing the complication rate but also in improving the patients' quality of life.

Defunctioning ileostomy reduces leakage rate in rectal cancer surgery - systematic review and meta-analysis.

ObjectivesThe role of a defunctioning ileostomy in every anterior rectal resection with total mesorectal excision (TME) is still controversial. In this study, we aimed to review the current literature to determine the impact of ileostomy creation on postoperative outcomes in patients undergoing anterior rectal resection with TME.MethodsMEDLINE, Embase and Cochrane Library were searched for eligible studies. We analyzed data up to October 2017. Eligible studies had to compare patients with vs. without a defunctioning ileostomy in rectal cancer surgery and comprise data on anastomotic leakage in both groups. The primary outcome was anastomotic leakage. Secondary outcomes included the complication rate, mortality, reoperation rate, length of hospital stay and 30-day readmission.ResultsInitial search yielded 1,966 articles. Thorough evaluation resulted in 13 eligible articles which were analyzed. Leakage rate (RR = 0.43, 95% CI 0.28-0.67) and the number of reoperations (RR = 0.62, 95% CI 0.40-0.94) were significantly lower in the defunctioning stoma group. Morbidity was significantly higher in the stoma group (RR = 1.32, 95% CI 1.05–1.65). Analysis of mortality, length of hospital stay and readmission rate did not show any significant differences.ConclusionA defunctioning ileostomy may decrease the anastomotic leakage rate, additionally significantly reducing the risk of reoperations but it may also increase the overall complication rate. The presence of the protective stoma has no effect on mortality, length of hospital stay and readmission rate.

Incidence and Factors Correlating With Incisional Hernia Following Open Bowel Resection in Patients With Inflammatory Bowel Disease: A Review of 1000 Patients.

The aim of this study was to identify the incidence and factors associated with the development of incisional hernia (IH) in patients with inflammatory bowel disease (IBD) undergoing open bowel resections. Predisposing factors for IH have not been well studied in patients with IBD undergoing open bowel resection. The role of duration of the disease, nutritional factors, anti-inflammatory treatment, previous operative procedures, wound infection, and other complicating factors remains unclear. One thousand patients with ulcerative colitis and Crohn's disease were followed for a mean of 8 years after open bowel resection. The incidence of IH was recorded as well as correlating factors with the development of IH. The overall incidence of IH in this series was 20% (21% for ulcerative colitis and 20% for Crohn's disease). Statistically significant risk factors for development of IH were wound infection (HR 3.66, P <0.001), hypoalbuminemia (HR 2.02, P = 0.002), history of previous bowel resection (HR 1.60, P = 0.003), creation of ileostomy at the time of procedure (HR 1.53, P = 0.01), history of smoking (HR 1.52, P = 0.013), body mass index at surgery (1.036, P = 0.009), age at surgery (HR 1.021, P <0.001), and age at the onset of disease (HR 1.018, P <0.001). Patients with IBD have a high incidence of incisional hernia after open bowel resection. Wound infection had the strongest correlation with the development of IH. The other factors were age at onset of IBD, age at surgery, body mass index, serum albumin, presence of ileostomy, previous surgical procedures, and history of smoking. Duration of disease, preoperative steroids, immunosuppressive therapy, and blood transfusion were not found to correlate with IH.

Discussion of: Individual surgeon practice is the most important factor influencing diverting ileostomy creation for patients undergoing sigmoid colectomy for diverticulitis

Discussion of: Individual surgeon practice is the most important factor influencing diverting ileostomy creation for patients undergoing sigmoid colectomy for diverticulitis

Use of an ACE inhibitor or angiotensin receptor blocker is a major risk factor for dehydration requiring readmission in the setting of a new ileostomy.

Diverting ileostomies help prevent major complications related to anastomoses after colorectal resection but can cause metabolic derangement and hypovolemia, leading to readmission. This paper aims to determine whether angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB) use increased the risk of readmission, or readmission specifically for dehydration after new ileostomy creation. Retrospective analysis of patients undergoing diverting ileostomy at a tertiary-care hospital, 2009-2015. Primary outcome was 60-day readmission for dehydration; secondary outcomes included 60-day readmission for any cause, or for infection obstruction. Ninety-nine patients underwent diverting ileostomy creation, 59% with a primary diagnosis of colorectal cancer. The 60-day readmission rate was 36% (n = 36). Of readmitted patients, 39% (n = 14) were admitted for dehydration. Other readmission reasons were infection (33%) and obstruction (3%). The majority (64%, n = 9) of patients readmitted for dehydration were taking either an ACEi or an ARB. Compared to patients not readmitted for dehydration, those who were readmitted for dehydration were more likely to be on an ACEi or an ARB (11/85, 13% vs. 9/14, 64%). After controlling for covariates, ACEi or ARB use was significantly associated with risk of readmission (p < 0.0001, odds ratio = 13.56, 95% confidence interval 3.54-51.92,). No other diuretic agent was statistically associated with readmission for dehydration. ACEi and ARB use is a significant risk factor for readmission for dehydration following diverting ileostomy creation. Consideration should be given to withholding these medications after ileostomy creation to reduce this risk.

Readmission After Elective Ileostomy in Colorectal Surgery Is Predictable.

Background and Objectives:Patients who undergo colorectal surgery have high postoperative morbidity, with ileostomates being the most disadvantaged. Recent studies assessing readmission risk factors do not provide a specific prediction model and, if so, do not focus on patients who have had colorectal surgery; thus, the results of these studies have limited applicability to our specialized practice. We wanted to develop a prediction model for readmission within 30 days of discharge after ileostomy creation.Methods:Patients who underwent elective ileostomy creation from 2013 to 2016 at the University of Florida were included in this retrospective study. Factors significantly associated with readmission within 30 days after discharge were identified by comparing a cohort that was readmitted within 30 days with one that was not. A practical, predictive model that stratified a patient's risk of readmission after the index procedure was developed.Results:A total of 86 iliostomates were included; of those, 22 (26%) were readmitted within 30 days. Factors significantly associated with readmission included preoperative steroid use, history of diabetes, history of depression, lack of a hospital social worker or postoperative ostomy education, and the presence of complications after the index procedure. A model predicting readmission within 30 days of discharge that comprised the first 4 factors was developed, with a sensitivity of 73% and a specificity of 77%.Conclusion:Prediction of readmission in patients who undergo ileostomy creation is possible, suggesting interventions addressing predictive factors that may help decrease the readmission rate. Prospective validation of the model in a larger cohort is needed.

Incidence and risk factor of outlet obstruction after construction of ileostomy.

There are several reports on the usefulness of diverting ileostomy for decreasing the incidence of anastomotic leakage and the severity of pelvic peritonitis. However, a number of complications induced by ileostomy itself have also been reported, including a special condition induced by obstruction at the outlet of the stoma known as “outlet obstruction.” In this study, we examined the frequency and risk factors of this complication based on the data of ileostomy cases in our institution. Methods: One hundred and seven patients who received ileostomy creation at our department from January 2010 to December 2015 were included. The incidence of outlet obstruction and risk factors were analyzed. Results: Outlet obstruction occurred in 18 cases (16.8%). The incidence was significantly higher in total colectomy or proctocolectomy cases as well as in those with left side construction and laparoscopic surgery than in other patients in a univariate analysis. However, in a multivariate analysis, no risk factors were extracted. Conclusions: To determine the true cause of this disease, a prospective study with a large number of cases is needed. Since multiple terms are used for this condition, resulting in confusion, a consensus on the appropriate terms is also important.

Individual surgeon practice is the most important factor influencing diverting loop ileostomy creation for patients undergoing sigmoid colectomy for diverticulitis

BackgroundTo identify factors associated with diverting ileostomy creation (DLI) in patients undergoing sigmoid colectomy for diverticular disease in a high volume colorectal unit and to obtain information for better preoperative patient counseling. MethodsPatients who underwent sigmoid colectomy with colorectal anastomosis with or without DLI for diverticulitis between 01/1994-12/2014 were identified. Preoperative characteristics, surgeon practice year, individual surgeon and postoperative outcomes were compared between patients with DLI or not. Results1320 patients were identified and DLI was created in 204 (15.4%) patients. DLI creation was associated with older age (p < 0.001), female gender (p = 0.01), higher ASA-class (p < 0.001), hypertension (p = 0.01), DM(p < 0.001), renal comorbidities (p < 0.001), preoperative steroid use (p = 0.03), preoperative anemia (p = 0.004), and open surgery (p < 0.001). While ileostomy creation rates did not vary over the years during the study period or with increased surgeons' experience, surgeon identity had significant impact on ileostomy creation (Rate range 6.8–60.7%, p < 0.001). Multivariate logistic regression analysis revealed that individual surgeon, open approach, preoperative steroid use, and disease-related factors remained independently associated with DLI creation. ConclusionIndividual surgeon's practice affects the rate of diverting ileostomy creation in patients undergoing sigmoid colectomy for diverticular disease.

Institutional Experience with Ostomies Created During Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemoperfusion.

Cytoreductive surgery and hyperthermic intraperitoneal chemoperfusion (CRS-HIPEC) is a complex procedure that often requires ostomy creation to protect high-risk anastomoses. This study aimed to evaluate the authors' institutional experience with CRS-HIPEC-associated ostomies, determine predictors of ostomy creation and reversal, and assess their impact on survival. The study analyzed clinicopathologic, perioperative, and oncologic data from a prospective database of 1435 CRS-HIPEC procedures for peritoneal metastases. The Kaplan-Meier method was used to estimate survival. Multivariate analyses identified associations with ostomy creation/reversal and survival. Ostomies were created in 34% of the patients, most commonly loop ileostomies (82%). Loop ileostomies were reversed in the majority of patients (83%), whereas non-loop ileostomies were infrequently reversed (<10% reversal rate). In a multivariate logistic regression model, intermediate or high tumor grade, colectomy/proctectomy, longer operative time, and lower Charlson comorbidity index were associated with loop ileostomy creation, whereas incomplete macroscopic resection, colorectal histology, and major postoperative complications were associated with non-reversal of loop ileostomy. In a multivariate Cox proportional hazards model, intermediate or high tumor grade and non-reversal of loop ileostomy were associated with worse overall survival. Loop ileostomies were almost always reversed, whereas non-loop ileostomies were almost always permanent. Hospital readmissions for loop ileostomy-related complications were common. Therefore, formal outpatient protocols for prevention and management should be implemented. Non-reversal of loop ileostomy was associated with very poor survival.

Factors associated with hospital readmission following diverting ileostomy creation.

The creation of a diverting loop ileostomy is associated with the risk of readmission due to stoma-related complications. We hypothesized that the assessment of our institution-specific readmissions following ileostomy creation would help identifying at-risk groups which should be the focus of future preventative strategies. Patients who underwent loop ileostomy formation from 2009 to 2013 were reviewed. We evaluated readmissions within 30days after discharge following loop ileostomy construction. Possible associations between readmission and demographic, disease-related and treatment-related factors were assessed using univariate and multivariate analyses. Out of 1267 patients undergoing loop ileostomy construction, 163 patients (12.9%) were readmitted. The main causes of readmissions were organ/space infections (43, 3.4%), small bowel obstruction/ileus (42, 3.3%) and dehydration (38, 3%). Independent factors associated with overall readmission were cardiovascular (OR=2.0) and renal comorbidity (OR=2.9), preoperative chemo/radiotherapy (OR=4.0), laparoscopic approach (OR=1.7) and longer operative time (OR=1.2). Cancer diagnosis was associated with reduced readmission rates (OR=0.2). Independent factors associated with readmission due to dehydration were chemo/radiotherapy (OR=4.7) and laparoscopic approach (OR=2.6). Dehydration associated with diverting ileostomy creation was relevant as an individual cause of readmission, but its overall incidence was relatively rare. Dedicated strategies to prevent dehydration should be directed to patients who received chemoradiotherapy and/or laparoscopic surgery.

Long-term Outcomes Following Continent Ileostomy Creation in Patients With Crohn's Disease.

Los Angeles, California Financial Disclosures: None reported. Correspondence: Robert W. Beart, Jr., M.D., University of Southern California, Los Angeles, CA. Email: [email protected]

Long-term Outcomes After Continent Ileostomy Creation in Patients With Crohn's Disease.

Patients with Crohn's disease have a higher failure rate after ileal pouch surgery compared with their counterparts with ulcerative colitis. We hypothesized that risk of continent ileostomy failure can be stratified based on the timing of Crohn's disease diagnosis and aimed to assess long-term outcomes. This was a retrospective cohort study. The investigation took place in a high-volume, specialized colorectal surgery department. Patients with Crohn's disease who underwent continent ileostomy surgery between 1978 and 2013 were evaluated. Functional outcomes, postoperative complications, requirement of revision surgery, and continent ileostomy failure were analyzed. There were 48 patients (14 male patients) with a median age of 33 years at the time of continent ileostomy creation. Crohn's disease diagnosis was before continent ileostomy (intentional) in 15 or made in a delayed fashion at a median 4 years after continent ileostomy in 33 patients. Median follow-up was 19 years (range, 1-33 y) after index continent ileostomy creation. Major and minor revisions were performed in 40 (83%) and 13 patients (27%). Complications were fistula (n = 20), pouchitis (n = 16), valve slippage (n = 15), hernia (n = 9), afferent limb stricture (n = 9), difficult intubation (n = 8), incontinence (n = 7), bowel obstruction (n = 7), valve stricture (n = 5), leakage (n = 4), bleeding (n = 3), and valve prolapse (n = 3). Median Cleveland global quality-of-life score was 0.8. Continent ileostomy failure occurred in 22 patients (46%). Based on Kaplan-Meier estimates, continent ileostomy survival was 48 % (95% CI, 33%-63%) at 20 years. Continent ileostomy failure was similar regardless of timing of diagnosis of Crohn's disease (p = 0.533). This study was limited by its retrospective and nonrandomized nature. Outcomes of continent ileostomy in patients with Crohn's disease are poor, regardless of the timing of diagnosis. Very careful consideration should be given by both the surgeon and the patient before undertaking this procedure in patients with Crohn's disease. See Video Abstract at http://links.lww.com/DCR/A327.

Is An Ostomy Rod Useful for Bridging the Retraction During the Creation of a Loop Ileostomy? A Randomized Control Trial.

A loop ileostomy is generally created during restorative proctocolectomy (RPC) for treating ulcerative colitis (UC), and an ostomy rod is often used to prevent stoma retraction. However, its usefulness or harmfulness has not been proven. We performed a prospective randomized control study to investigate the non-inferiority of ostomy creation without a rod to prevent stoma retraction. Patients with UC who underwent RPC were enrolled and randomly divided into groups either with or without ostomy rod use. Incidences of stoma retraction and dermatitis were compared. Of the 320 patients in the study groups, 308 qualified for the intention-to-treat (ITT) analysis, and 257 were included in the per-protocol (PP) analysis. Ostomy retraction was recognized in 6 patients, 3 with a rod and 3 without. The difference with rod use (95% confidence interval) was 0.1 (-2.9 to 3.1)% in the PP analysis and 0.0 (-2.2 to 2.2)% in the ITT analysis. There were no significant differences in stoma retraction regardless of whether an ostomy rod was used in either analysis. Dermatitis was more common in patients with rod use (84/154) than in those without (40/154) (p<0.01). Although median body mass indices were extremely low (20kg/m2), an ostomy rod is not routinely needed as it may increase the risk of dermatitis. However, results in obese patients may differ from those shown here, which should be clarified via further studies.