Mean Closure Time Research Articles

Comparative study between continuous and interrupted suturing for rectus sheath closure in exploratory laparotomy

Background: Exploratory laparotomy is a major surgical procedure. Midline laparotomy is the most common technique of opening the abdomen as it is simple, provides adequate exposure to all four quadrants, and affords quick exposure with minimal blood loss. Laparotomy wounds have been closed in various ways in terms of continuous versus interrupted closure, single layer versus mass closure, and absorbable versus non-absorbable sutures. Aims and Objectives: The aim of the study was to find out the technique of rectus sheath closure in patients undergoing exploratory laparotomy that can reduce the burden of complications in post-operative period. Materials and Methods: It is a hospital-based prospective randomized observational study which was conducted in a rural-based tertiary care hospital and medical college with a time frame of about 1½ years. A total number of 74 patients of adult age group (21–70 yrs) admitted in general surgery ward of Bankura Sammilani Medical College and Hospital, undergoing exploratory laparotomy. Results: Thirty-seven (50%) patients of midline laparotomy were closed in continuous technique. Rest 37 (50%) patients were closed in interrupted technique. The hospital stay was similar in both groups. There was no significant difference in incidence of wound infection (P=0.4687). Wound dehiscence and requirement of burst abdomen repair was significantly higher in continuous suture group as compared to interrupted suture group, but mean closure time (P<0.0001) and mean suture length (P=0.0436) were significantly higher in interrupted suture group. Conclusion: The major complication of emergency laparotomy is wound dehiscence which leads to increased morbidity and subsequent requirement of re-operation of burst abdomen and hospital cost. In our study, we found that interrupted suturing method of abdominal closure is better in respect to major post-operative complications though it requires more suture length and time.

A comparison of barbed continuous suture versus conventional interrupted suture for fascial closure in total hip arthroplasty

A barbed suture is a self-anchoring knotless suture hypothesized to shorten suture time and reduce the tension point of the wound. The purpose of this study was to compare the barbed suture and the interrupted suture for fascial closure in total hip arthroplasty. We retrospectively reviewed patients who underwent total hip arthroplasty from March 2014 to June 2020. We evaluated 324 cases among 274 patients consisting of 188 males and 86 females. We collected the following data: demographics, time for wound closure, the number of threads used, hemoglobin level, surgical site pain, and wound complications. Variables were analyzed for their association with closure time using multiple regression analyses between the barbed suture (the SFX group) and the interrupted suture (the Vicryl group). Mean closure time was 5.8 min lower and the mean number of sutures used was 2.2 lower in the SFX group versus the Vicryl group (P < 0.01 and < 0.01, respectively). There were no statistical intergroup differences in the mean largest hemoglobin drop, the incidence of transfusion, surgical site pain, and the incidence of wound complications. The use of barbed sutures for fascial closure in total hip arthroplasty effectively reduces the surgical time without increasing wound complications.

Early Experience With a Novel Suture Device for Sternal Closure in Pediatric Cardiac Surgery

BackgroundSternal closure by absorbable suture material is an established method for chest closure in pediatric cardiac surgical procedures. However, the formation of granuloma around knotted suture material is frequently observed and has potential for prolonged wound healing and infection, particularly in newborns and infants. This retrospective study analyzed the suitability and reliability of a novel absorbable, self-locking, multianchor knotless suture with antibacterial technology for sternal closure in pediatric cardiac surgical procedures. MethodsThe applied material (STRATAFIX Symmetric PDS Plus, Ethicon) presents a polydioxanon (PD) suture with a self-locking, multianchor design that enables a sternal closure in a continuous knotless suture technique. All children undergoing knotless closure after standard median sternotomy were examined for the occurrence of sternal wound infection or sternal instability by applying the screening criteria of the Centers for Disease Control and Prevention at hospital discharge and at 30 and 60 days. ResultsThe new knotless sternal closure was used in 130 patients. Patients were a mean age of 19.0 ± 31.9 months (range, 0-142 months), and mean bodyweight was 7.8 ± 6.6 kg (range, 2.4-35 kg). Delayed sternal closure occurred in 23 patients, with a mean closure time after 2.9 ± 2.6 days. One superficial incisional sternal site infection occurred, but no cases of deep sternal site infection or sternal instability were observed. ConclusionsThe application of the absorbable, knotless suture technique provides excellent results regarding the rate of sternal wound infection and improved healing after median sternotomy in pediatric patients.

Topical Application of bFGF Alone for the Regeneration of Chronic Tympanic Membrane Perforations: A Preliminary Case Series.

Results A total of 29 patients consisting 13 in the bFGF alone group and 16 in the myringoplasty group were finally included in the analysis. Of the 13 patients in the bFGF alone group, the perforations were small in 6 and medium in 7; the etiology was secondary to COM in 11 and to trauma in 2. One patient with an unhealed perforation continued bFGF treatment until 6 months, while the others stopped at 3 months. Of the seven medium-sized perforations, none of the five COM perforations closed, while the two traumatic perforations achieved complete closure within 2 and 4 weeks, respectively. The successful closure rate was 28.6% (2/7). Successful closure was achieved in 66.7% (4/6) of the six small perforations with COM, with a mean closure time of 4.75 weeks. Of the 16 patients in the myringoplasty group, all perforations were medium-sized and were secondary to COM in 15 cases and traumatic in 1 case; all achieved complete closure. Conclusions bFGF alone facilitated the repair of chronic traumatic perforations and small perforations with COM, but not medium-sized perforations with COM. These observations indicated that the regenerative conditions of traumatic perforations are better than those of COM perforations when using bFGF alone, and that graft materials could play a critical role in the regeneration of larger-sized chronic perforations with COM.

Clinical characteristics of full thickness macular holes that closed without surgery

PurposeTo ascertain the anatomic factors that help achieve non-surgical sealing in full thickness macular hole (FTMH).MethodsRetrospective collaborative study of FTMH that closed without surgical intervention.ResultsA total of 78 patients (mean...

Effective Activation of BKCa Channels by QO-40 (5-(Chloromethyl)-3-(Naphthalen-1-yl)-2-(Trifluoromethyl)Pyrazolo [1,5-a]pyrimidin-7(4H)-one), Known to Be an Opener of KCNQ2/Q3 Channels.

QO-40 (5-(chloromethyl)-3-(naphthalene-1-yl)-2-(trifluoromethyl) pyrazolo[1,5-a]pyrimidin-7(4H)-one) is a novel and selective activator of KCNQ2/KCNQ3 K+ channels. However, it remains largely unknown whether this compound can modify any other type of plasmalemmal ionic channel. The effects of QO-40 on ion channels in pituitary GH3 lactotrophs were investigated in this study. QO-40 stimulated Ca2+-activated K+ current (IK(Ca)) with an EC50 value of 2.3 μM in these cells. QO-40-stimulated IK(Ca) was attenuated by the further addition of GAL-021 or paxilline but not by linopirdine or TRAM-34. In inside-out mode, this compound added to the intracellular leaflet of the detached patches stimulated large-conductance Ca2+-activated K+ (BKCa) channels with no change in single-channel conductance; however, there was a decrease in the slow component of the mean closed time of BKCa channels. The KD value required for the QO-40-mediated decrease in the slow component at the mean closure time was 1.96 μM. This compound shifted the steady-state activation curve of BKCa channels to a less positive voltage and decreased the gating charge of the channel. The application of QO-40 also increased the hysteretic strength of BKCa channels elicited by a long-lasting isosceles-triangular ramp voltage. In HEK293T cells expressing α-hSlo, QO-40 stimulated BKCa channel activity. Overall, these findings demonstrate that QO-40 can interact directly with the BKCa channel to increase the amplitude of IK(Ca) in GH3 cells.

Antiplatelet Direncinin Miyokard İnfarktüsü Sonrası Sol Ventrikül Trombüsü Gelişimine Etkisi: Prospektif, Gözlemsel, Vaka-kontrol Çalışması

Objective: Left ventricular (LV) thrombus is a serious complication of acute myocardial infarction (MI). In this study, the effect of biochemical resistance to antiplatelet agents used after ST elevation MI on LV thrombus development was investigated. Material and Methods: Patients who were diagnosed with anterior MI and undergone primary percutaneous coronary intervention were included in this study. The patients were divided into two groups: Patients with thrombus (Group 1) and the patients without thrombus (Group 2). PFA-100 platelet analyzer was used to measure platelet reactivity. Clopidogrel resistance was defined as collagen adenosine 5-diphosphate closure time (COLL/ADP CT) <120 seconds and acetylsalicylic acid (ASA) resistance was defined as collagen epinephrine closure time (COLL/EPI CT) <180 seconds. Group 1 and Group 2 were compared with ASA and clopidogrel resistance. Results: The mean CT for COLL/EPI was similar in two groups (Group 1: 221.4±64.8 sec, Group 2: 217.7±70.2 sec; p=0.81). ASA resistance was detected in 24 (26.7%) patients in the whole patient group. There was no difference between the two groups in terms of ASA resistance [8 patients (26.7%) in Group 1, 16 patients (26.7%) in Group 2; p=1.0]. The mean closure times for COLL/ADP were similar in two groups (Group 1: 145.9±63.9 sec, Group 2: 155.9±63.9 sec; p=0.48). Clopidogrel resistance was detected in 27 (30%) patients in the whole patient group. There was no difference between two groups in terms of clopidogrel resistance [9 (30%) patients in Group 1, 18 (30%) patients in Group 2; p=1.0]. There was no difference between two groups in patients with both clopidogrel and aspirin resistance. Conclusion: In vivo resistance to dual antiplatelet therapy does not appear to be an effective mechanism in the development of LV thrombus after MI.

Preliminary Clinical Evaluation Using a Novel Bioengineered Wound Product to Treat Lower Extremity Ulcers.

Diabetes mellitus affects hundreds of millions of people worldwide, each of which have up to a 25% risk of developing a diabetic foot ulcer (DFU) during their lifetime. With poor DFU healing rates using standard of care, advanced treatments are introduced to attempt to close the wound. The objective of this preliminary clinical evaluation was to evaluate lower extremity ulcers treated with a novel bioengineered wound product (BWP). The BWP, a solid absorbable and conformable sheet composed of gelatin, Manuka honey, and hydroxyapatite, was applied on 12 patients with lower extremity ulcers. The patients in this evaluation spanned across 4 sites and had complicated medical histories, including little to no progression of healing with standard of care or treatment with other biomaterials. The ulcers were treated with debridement, BWP placement, dressing, appropriate compression, and offloading as necessary. Weekly follow-up visits were recommended for evaluation, debridement, and BWP reapplication. Nine patients had the BWP applied to aid in full closure. These patients achieved 100% closure within 8 weeks, with a mean closure time of 4.1 weeks. At 4 weeks, the mean percent wound closure was 94%. Three patients had the BWP applied to aid in achieving a healthy wound bed for continued treatment (eg, splitthickness skin graft) and to cover (epithelialization over) an exposed tendon. In all 12 cases, no treatment site infections were observed. The results and observations from this preliminary clinical evaluation suggest that the BWP supports rapid wound closure, a predictor of complete healing for DFUs.

Open-label Venous Leg Ulcer Pilot Study Using a Novel Autolologous Homologous Skin Construct.

Background:Venous leg ulcers (VLUs) are often refractory to compression therapy, and their prevalence is increasing. An autologous homologous skin construct (AHSC) that uses the endogenous regenerative capacity of healthy skin has been developed to treat cutaneous defects, with a single application. The ability of AHSC to close VLUs with a single treatment was evaluated in an open-label, single-arm feasibility study to test the hypothesis that AHSC treatment will result in wound closure by providing healthy autologous tissue to the wound bed.Methods:Ten VLUs were treated with a single application of AHSC. A 1.5 cm2 full-thickness skin harvest from the proximal calf was collected and sent to a Food and Drug Administration–registered facility, where it was processed into AHSC and returned to the provider within 48 hours. AHSC was spread evenly across the wound and dressed with silicone. The primary endpoint was wound closure rate at 12 weeks. Wound closure was followed with 3-dimensional planimetry, and closure was confirmed by a panel of plastic surgeons. Additional endpoints followed for 12 weeks included graft take, harvest site closure, adverse event rate, complications, and patient-reported pain.Results:All 10 VLUs demonstrated successful graft take as evidenced by graft persisting in wound and harvest site closure. Eight VLUs exhibited complete closure within 12 weeks. One VLU that failed to heal with a prior split thickness skin graft closed within 13.5 weeks with AHSC. The mean time of closure was 34 days (95% confidence interval, 14–53). Pain improved by closure confirmation visit. There was 1 serious adverse event unrelated to the product or procedure.Conclusion:This pilot study demonstrated that AHSC may be a viable single-application topical intervention for VLUs and warrants further investigation in larger, controlled studies.

Tu1547 ENDOSCOPIC CLIPS VERSUS ENDOSCOPIC SUTURE FOR MUCOSAL CLOSURE AFTER PER ORAL ENDOSCOPIC PYLOROMYOTOMY - A PROSPECTIVE STUDY

Gastric per-oral endoscopic pyloromyotomy (GPOEM) is an emerging method for treatment of gastroparesis. Safe mucosal closure is necessary to avoid adverse events. The aim of this study was to compare the effectivity of two closure methods: clips and endoscopic suturing (ES) in patients undergoing GPOEM. A single center, prospective study (NCT:03679104). All patients, who underwent GPOEM and agreed to participate were enrolled.The closure method was assigned at the discretion of an endoscopist (one endoscopist performed all procedures) prior to the procedure. The main outcome was the proportion of subjects with successful closure. Unsuccessful closure was defined as a need for a rescue method, or a need for an additional intervention. Secondary outcomes were easiness of closure measured by a Visual Analogue Scale (scored by endoscopist and nurse) and closure time. A total of 25 patients [M:F/11:14; mean age, range: 49.2 (26–74)] have been included; 15 received ES and 10 clips (mean 6; range 5–19). All patients with ES had successful closure. One patient with clips needed a rescue method (KING closure with endoloop) and another patient needed additional clipping because of a leak on POD1. The remaining 8 patients (80%) had a successful closure with clips. Closure with clips was quicker (mean closure time 10.3 min (range 4–15) vs 14 (5–20); p=0.048). Endoscopist tended to assess closure with ES easier compared to clips (mean visual analogue scale for ES 7.4 (3–10) vs. 6.4 (3–10) for clips; p=0.25). A nurse assessed easines of both closure methods as comparable (p=0.68). Endoscopic suturing system may be more reliable than clipping for mucosal closure in patients undergoing G-POEM. Besides clips, centers performing G-POEM should have an alternative (rescue) closure method. (Supported by a grant from the Czech Ministry of Health 17-28797A).

Interaction of CYP2C19 G681A polymorphism and omeprazole on clopidogrel responsiveness and impact in patients with acute coronary syndrome.

The aim of this study was to explore the individual effects of the CYP2C19 G681A polymorphism and omeprazole use and their interaction on clopidogrel responsiveness in acute coronary syndrome (ACS). The CYP2C19 G681A polymorphism and omeprazole use were both known for retarding the effects of clopidogrel under broad cardiovascular conditions; however, data from ACS patients were limited. We conducted a cross-sectional study of 102 ACS patients who received clopidogrel before percutaneous coronary intervention. The platelet function was assessed by a Platelet Function Analyzer-200, in which clopidogrel hyporesponsiveness was defined as a closure time (CT) of ≤ 106 s. The CYP2C19 G681A polymorphism was investigated using the PCR-RFLP technique. Statistical analysis was performed by using χ test, Student's t-test, binary logistic regression, and receiver-operating characteristic (ROC) curve. Carriages of the CYP2C19 681A allele and omeprazole use were present in 47.1 and 37.3% patients, respectively. The mean CT ± SD was 103.1 ± 1.7 s and the prevalence of clopidogrel hyporesponsiveness was 66.7%. The CT was significantly shorter in carriages of the 681A allele compared with the 681G allele (P = 0.002), but had no significant difference in patients with vs. without omeprazole use (P = 0.467). The ROC analysis of an effect on clopidogrel hyporesponsiveness of CYP2C19 G681A alone and combination with omeprazole use had area under the curve values of 0.654 and 0.672, respectively. In ACS patients, the effect of the CYP2C19 G681A polymorphism on clopidogrel responsiveness, but not omeprazole use, is strong. However, a combination of both factors enhances clopidogrel hyporesponsiveness.

The Use of Autologous Serum Eye Drops after Epithelium-off Corneal Collagen Crosslinking.

After epithelium-off crosslinking (CXL), epithelial closure time and post-operative pain are an important issue in terms of possible complications and patient comfort. We report a prospective randomized study about the use of autologous serum eye drops after CXL. This study aims to evaluate the effect of autologous serum eye drops on epithelial healing and post-operative pain after CXL. Sixty patients diagnosed as having progressive keratoconus and treated with accelerated CXL (9 mW/cm for 10 minutes) randomly received 20% autologous serum eye drops (autologous serum group, n = 30) or artificial tears (control group, n = 30). Patients were evaluated every day after the surgery, and the day of epithelial closure was recorded. All patients were asked to report the maximum pain level using the Wong-Baker FACES Pain Rating Scale at the end of each day until the epithelial closure was completed. The change in topographic parameters and haze were recorded at 6 months. The mean epithelial closure time was significantly lower in the autologous serum group than in the control group (2.37 ± 0.49 and 2.67 ± 0.47 days, respectively; P = .02). There was a statistically significant difference between the pain scores in the first and second days of surgery between the two groups (first-day autologous serum autologous serum group: 2.80 ± 0.66 and control group: 3.50 ± 0.82, P = .01; second-day autologous serum group: 1.73 ± 0.69 and control group: 2.20 ± 0.76, P = .02). Pre-operative and post-operative topographic parameters and haze at 6 months were similar between the two groups (P > .05 for all). Use of autologous serum eye drops after CXL accelerates epithelial healing and reduces post-operative pain. Shortening the duration of epithelial closure would be beneficial in reducing possible complications and increasing patient comfort.

Upper blepharoplasty: A comparative study between wound closure strips and subcuticular closure

The objective is to compare the results of patients having their upper blepharoplasty incision closed by subcuticular suturing versus the usage of wound closure strips (Omnistrips®). Also evaluating the time required for incision closure, any complication, and the aesthetic outcome of each technique. In this study a total of 54 upper blepharoplasty had been performed on 27 patients. Retrospective study done on 16 patients, whom incision closure done by continuous subcuticular non-absorbable suture using 6-0 polypropylene (prolene), and another 11 patients prospectively studied for using omnistrips for their blepharoplasty incision closure. The intraoperative time which was required to finish the closure was one of the most important parameter of the study. The other parameters were the incidence of milia occurrence, presence of pain postoperatively at time of stitch and omnistrips removal, infection rate and suture acceptance. The result of this study indicated that mean time of closure was 12.36 minutes with usage of steristrips and (16.88) minutes with subcuticular suturing (P&lt;0.01). The incidence of milia was significantly reduced by using the omnistrips (P 0.004), and there was no pain encountered at time of omnistrips removal in all patients, while all other patients whom subcuticular suturing done for them complained of pain at the time of stitch removal. The study showed no infection associated with closure of the incision in either groups. In conclusion the closure of the incision in upper lid blepharoplasty using omnistrips is a safe, effective, faster, painless and with less complication rate than that using subcuticular suturing technique.

Traumatic macular hole study: a multicenter comparative study between immediate vitrectomy and six-month observation for spontaneous closure.

Closure of traumatic macular hole (TMH) can be achieved spontaneously or by surgical intervention. Thus far, there exist no prospective comparative studies that have analyzed the difference between the two modalities. This study aimed to compare the anatomical and visual recovery of eyes with TMH following either an immediate vitrectomy or six-month observation. This was a multicenter prospective comparative study. Eight centers participated in the study. Patient data from 40 eyes with a recent history of blunt ocular trauma and newly formed full-thickness TMH were recruited in this study. The participating patients selected between an early vitrectomy or a six-month observation after a doctor explained the potential benefits and risks of both strategies in an unbiased manner. Twenty-five patients underwent an immediate vitrectomy, and 15 patients received six-month observation. Patients were assessed by spectral-domain optical coherence tomography (SD-OCT) and best-corrected visual acuity (BCVA). Closure rates were 66.7% for the observational group, and 100% for the surgical group (P=0.002). There were no vision-threatening ocular complications in both groups. For the observational group, the mean closure time was 2.5±1.6 months, and 80% of the hole closure occurred within 3 months; cystic edema on the edge of the hole at baseline was significantly more frequent in the non-closed subgroup than in the closed subgroup (P=0.03). There were no significant differences in the foveal microstructure and in the final visual outcome between the spontaneously closed cases and the surgically closed cases. TMH had a moderately high incidence of spontaneous closure, but an immediate vitrectomy achieved an even higher closure rate. Vitrectomy was effective and safe to treat TMH, while a 3-month observation for spontaneous closure may be an alternative modality for TMH management. Cystic edema on the edge of the hole may be an unfavorable factor for the spontaneous closure of TMH.

Efficacy and feasibility of OverStitch suturing of leaks in the upper gastrointestinal tract.

Management of upper gastrointestinal leaks is challenging. A new potential treatment option for this complication is endoscopic suturing with the OverStitch system (Apollo Endosurgery, Texas, USA), which is today mainly used for endoscopic sleeve gastroplasty. The aim of this study was to analyze the efficacy and feasibility of this new treatment option in patients with leaks in the upper gastrointestinal tract. We performed a retrospective, single-center study of all patients who underwent endoscopic suturing with OverStitch of leaks in the upper gastrointestinal tract. Endoscopic suturing was performed on 13 patients (mean age, 59.62 ± 16.29years; mean leak size, 22.31 ± 22.6mm) over a period of 8months. Postoperative leaks were detected in 10 patients (76.9%) after foregut surgery. Interventional success was achieved in all endoscopic attempts (n = 16, 100%) with a mean closure time of 28.0 ± 12.36min per patient. Follow-up technical success rate for each suture was (n = 8, 50.0%). Clinical success, including repeated suture attempts was achieved in 8 of the 13 patients (61.5%). These 8 patients had not received prior treatment for the leak. No immediate or delayed serious complications occurred as a result of OverStitch. The mean follow-up was 95 ± 91.07days. Endoscopic suturing with OverStitch for leaks in the upper gastrointestinal tract is feasible and effective in patients who have not received prior treatment. This minimally invasive technique seems to be a promising option especially for patients with large leaks and significant comorbidities.

Dose- and starting time-dependent effect of the application of EGF to the regeneration of traumatic eardrum

Background: Some studies have shown that topical application of epidermal growth factor (EGF) accelerates healing in traumatic tympanic membrane perforations (TMPs), however, the optimal dose and starting time of application have not been established.Objectives: To determine the optimal dose and starting time of application of EGF for the regeneration of TMPs.Methods and materials: Patients with traumatic TMPs were first randomly assigned to low-dose EGF, high-dose EGF, and spontaneous healing groups. Then, the same patients were retrospectively analyzed at 6 months based on the starting time of treatment. The closure times, closure rates, and hearing gain were compared among the groups at 6 months.Results: The mean closure time was 10.20 ± 5.13 days in the low-dosage EGF group, 14.39 ± 6.20 days in the high-dosage EGF group, and 33.17 ± 16.37 days in the spontaneous healing group; the difference was significant (p < .001).Conclusions: Daily application of EGF shortened the closure time of traumatic TMPs compared with those that healed spontaneously. However, high-dose EGF instead prolonged the closure time compared to low-dose EGF.

Comparison of continuous versus interrupted abdominal fascia closure using polydioxanone suture in laparotomy

Background: Laparotomy is a major surgical procedure in emergency settings. There is paucity of data regarding abdominal fascia closure in emergency laparotomies in Indian population. This study was planned to compare two techniques of fascial closure namely continuous and interrupted using polydioxanone in patients undergoing midline emergency laparotomies in our institute.Methods: This prospective study was conducted in Surgery Department, MMC&amp;H, Muzaffarnagar, from January 2017 to June 2018. 60 patients undergoing emergency laparotomies were divided into two groups of 30 each. Group I (study group) patients underwent interrupted suture abdominal closure; Group II (control group) patients underwent continuous suture closure.Results: Commonest diagnoses were duodenal and enteric perforations. Mean closure time in Group 1 was 31.6 minutes and in Group 2 -17.3 minutes. Mean hospital stay in Group I and II were 12.88 and13.76 days respectively. 4 Group I patients developed wound discharge versus 6 patients in Group II. Burst abdomen occurred in 3 out of 60 patients. One Group I patient had localised fascial burst. One Group II patient had localized while one had complete fascial burst. One incisional hernia was observed in each group at 3rd month of follow up. Three patients in Group 1 and one in Group 2 developed suture sinus.Conclusions: Major complication is wound dehiscence leading to increased morbidity, hospital stay and cost. In our study, we used continuous and interrupted PDS sutures and found that interrupted suturing method of abdominal wall closure is better, though it takes more time.

Anastomotic Sinus That Developed From Leakage After a Rectal Cancer Resection: Should We Wait for Closure of the Stoma Until the Complete Resolution of the Sinus?

PurposeThe aims of this study were to identify the clinical characteristics of an anastomotic sinus and to assess the validity of delaying stoma closure in patients until the complete resolution of an anastomotic sinus.MethodsThe subject patients are those who had undergone a resection of rectal cancer from 2011 to 2017, who had a diversion ileostomy protectively or therapeutically and who developed a sinus as a sequelae of anastomotic leakage. The primary outcomes that were measured were the incidence, management and outcomes of an anastomotic sinus.ResultsOf the 876 patients who had undergone a low anterior resection, 14 (1.6%) were found to have had an anastomotic sinus on sigmoidoscopy or a gastrografin enema before their ileostomy closure. In the 14 patients with a sinus, 7 underwent ileostomy closure as scheduled, with a mean closure time of 4.1 months. The remaining 7 patients underwent ileostomy repair, but it was delayed until after the follow-up for the widening of the sinus opening by using digital dilation, with a mean closure time of 6.9 months. Four of those remaining seven patients underwent stoma closure even though their sinus condition had not yet been completely resolved. No pelvic septic complications occurred after closure in any of the 14 patients with an anastomotic sinus, but 2 of the 14 needed a rediversion due to a severe anastomotic stricture.ConclusionPatients with an anastomotic sinus who had been carefully selected underwent successful ileostomy closure without delay.

A randomized, double-blind, phase I clinical trial of fetal cell-based skin substitutes on healing of donor sites in burn patients

BackgroundDue to limited graft donor sites in extensive burns, re-harvesting of a single donor area is very common. Given the importance of fetal fibroblasts in accelerating fetal wound healing, fetal cell-based skin substitutes have emerged as a novel therapeutic modality for regenerating damaged skin. In this trial, we aimed to evaluate the safety, feasibility and potential efficacy of application of amniotic membranes seeded with fetal fibroblasts for accelerating donor sites healing in burn patients. MethodsIn this randomized, double-blind, phase I clinical trial, 10 patients with total burn surface area of 10–55% were enrolled. Three equal parts (10×10cm) were selected in donor site of each patient and covered by Vaseline gauze (control group), amniotic membrane (AM group), or amniotic membrane seeded with fetal fibroblasts (AM-F group). Adverse events, pain intensity scores, and wound sizes were recorded on days 4, 8, 11, 14, and 20 post-treatment. Also, histological assessments were done on days 0 and 14 after the surgery. ResultsAll patients underwent surgery, and no adverse events occurred during the procedure and follow-up period. Significantly lower pain intensity and higher healing rates were observed in AM-F and AM groups compared to the control group. Moreover, mean complete re-epithelializatin in AM-F and AM groups were 10.1±2.4 and 11.3±2.9 days, showing that the healing process was significantly accelerated compared to the control group with mean closure time of 14.8±1.6 days. Histological assessment showed lower inflammatory cells infiltration in AM-F and AM groups compared to control group. ConclusionsThis study indicated the safety of transplantation of amniotic membrane seeded with fetal fibroblasts for treatment of donor sites in burn patients; however, preliminary assessments showed no benefits for this therapeutic modality over amniotic membrane alone. Thus, to draw accurate conclusions, further trials in larger populations should be conducted.Level of Evidence: This study is assigned as level I.

Clinical Experience With a Double Balloon Interventional Endoscopic Platform to Facilitate Colonic Endoscopic Submucosal Dissection, Endoscopic Mucosal Resection and Endoscopic Suturing: First 137 Procedures: Presidential Poster Award

Introduction: Endoscopic submucosal dissection (ESD) is gaining popularity worldwide. Despite clinical advantages of ESD over piecemeal endoscopic mucosal resection (EMR), colonic ESD remains technically challenging, labor-intensive and time-consuming. New endolumenal interventional platform (Lumendi LLC, USA) consists of overtube with 2 manually inflatable balloons and compatible with most standard endoscopes. Methods: Colonoscope with preloaded device was advanced into colon. The “fore-balloon” was advanced beyond colonic lesion and then both balloons were inflated stabilizing the lesion inside “therapeutic zone” between balloons. ESD or EMR was performed. After lesion resection, colonoscope was removed and a double channel endoscope loaded with endoscopic suturing device (Apollo Endosurgery, USA) was inserted through the platform to perform endoscopic suturing closure of large mucosal defect post ESD/EMR. Results: From November 2017 till April 2018 the device was used in consecutive patients with large (mean size 35.0±19.7 mm) lesions located in cecum (38), ascending colon (58), hepatic flexure (13), transverse colon (10), descending colon (4), sigmoid (9) and rectum (2). Majority (126 lesions, 92%) were removed by ESD, and only 11 lesions (8%) were removed by EMR. En bloc resection rate in EMR group was only 18.2%. En bloc resection rate in ESD group was 87.1%. Advancement of colonoscope preloaded with the device to reach colonic lesion was successful in all cases, requiring 10.0±8.3 minutes. Stabilization of the lesions by the balloons facilitated endoscopic intervention (mean intervention time 45.0 ±40.6 minutes), enabled quick advancement and closure of the defect utilizing the suturing device (mean advancement time 2.5±2.9 minutes, mean closure time 13.3±8.7 minutes). Total procedure time was 70.6±24.9 minutes. There were no device or procedure related serious adverse events during the study. Conclusion: This new interventional platform appears safe, effective and easy to use. Stabilization of colonic lesions with deployed balloons markedly facilitated colonic ESD and EMR, simplified suturing closure of large mucosal defects post lesion removal and significantly shortened the total procedure time. Retrospective and prospective case matched studies will be performed to better quantify the time benefit. The device has the potential to expand the number of complex benign polyps that can be handled endoscopically vs. surgically.