Role of the serosa in intestinal anastomotic healing: insights from in-depth histological analysis of human and murine anastomoses.

BACKGROUND: Anastomotic leakage following colorectal surgery remains a significant complication despite advances in surgical techniques. Recent findings on serosal injury repair in coelomic cavities, such as the peritoneum, challenge the current understanding of the cellular origins and mechanisms underlying intestinal anastomotic healing. Understanding the contribution of each layer of the intestinal wall during anastomotic healing is needed to find new therapeutic strategies to prevent anastomotic leakage. The aim of this experimental study was to investigate the role of the serosal layer of the intestinal wall in anastomotic healing. MATERIALS AND METHODS: Comprehensive histologic analysis of human and murine anastomoses was performed to elucidate histologic changes in the different intestinal layers during anastomotic healing. In vivo staining of the extracellular matrix (ECM) in the serosal layer was performed using a fluorophore-conjugated N-hydroxysuccinimide-ester before anastomosis surgery in a murine model. RESULTS: Histological examination of both human and murine anastomoses revealed that closure of the serosal layer occurred first during the healing process. In vivo serosal ECM staining demonstrated that a significant portion of the newly formed ECM within the anastomosis was indeed deposited onto the serosal layer. Furthermore, mesenchymal cells within the anastomotic scar were positive for mesothelial cell markers, podoplanin and Wilms tumour protein. CONCLUSIONS: In this experimental study, the results suggest that serosal scar formation is an important mechanism for anastomotic integrity in intestinal anastomoses. Mesothelial cells may significantly contribute to scar formation during anastomotic healing through epithelial-to-mesenchymal transition, potentially suggesting a novel therapeutic target to prevent anastomotic leakage by enhancing physiological healing processes.

Transanal Intubation for Preventing Colorectal Anastomotic Failure.

Introduction: Failure of low colorectal anastomosis remains challenging in surgical oncology, necessitating the exploration of new methods and improvements in existing preventive measures. Materials and Methods: This prospective study was conducted in two stages: intraluminal pressure in the colon was monitored in 32 patients by manometry and sonography over a 5-day postoperative period; 213 patients who underwent anterior resection of the rectum were analyzed, of whom 126 and 87 underwent diverting stoma (DS) and transanal intubation (TAI), respectively. Results: The effectiveness of the recommended technique for applying and removing transanal intubation (TAI) to prevent pneumo hydro strike (≥15 kPa) on the anastomosis line was analyzed in 87 patients and compared with imposed DS. TAI showed better borderline statistical significance (p = 0.051). The incidence of repeat surgery for anastomotic failure (AL) was seven (5.55%) and four (4.59%) in the DS and TAI groups, respectively. The distance of the anastomosis from the dentate line <60 mm was associated with a higher risk of AL occurrence (odds ratio (OR), 1.012; 95% confidence interval (CI), 1.007-1.017; p < 0.001; area under the curve (AUC) = 0.82). DS is recommended for men, as the risk of AL is significantly lower among women (OR, 0.41; 95% CI, 0.16-1.04; p = 0.062; AUC, 0.61; 95% CI, 0.54-0.67). Conclusions: Although TAI is advantageous over DS for preventing AL, surgeons select the method for the preventive approach based on the preoperative and intraoperative results.

Suture reinforcement using a modified cyanoacrylate glue to prevent anastomotic leak in colorectal surgery: a prospective multicentre randomized trial : The Rectal Anastomotic seaL (ReAL) trial.

BACKGROUND: Anastomotic leakage (AL) is the most frequent life-threating complication following colorectal surgery. Several attempts have been made to prevent AL. This prospective, randomized, multicentre trial aimed to evaluate the safety and efficacy of nebulised modified cyanoacrylate in preventing AL after rectal surgery. METHODS: Patients submitted to colorectal surgery for carcinoma of the high-medium rectum across five high-volume centres between June 2021 and January 2023 entered the study and were randomized into group A (anastomotic reinforcement with cyanoacrylate) and group B (no reinforcement) and followed up for 30 days. Anastomotic reinforcement was performed via nebulisation of 1 mL of a modified cyanoacrylate glue. Preoperative features and intraoperative and postoperative results were recorded and compared. The study was registered at ClinicalTrials.gov (ID number NCT03941938). RESULTS: Out of 152 patients, 133 (control group, n = 72; cyanoacrylate group, n = 61) completed the follow-up. ALs were detected in nine patients (12.5%) in the control group (four grade B and five grade C) and in four patients (6.6%), in the cyanoacrylate group (three grade B and one grade C); however, despite this trend, the differences were not statistically significant (p = 0.36). However, Clavien-Dindo complications grade > 2 were significantly higher in the control group (12.5% vs. 3.3%, p = 0.04). No adverse effects related to the glue application were reported. CONCLUSION: The role of modified cyanoacrylate application in AL prevention remains unclear. However its use to seal colorectal anastomoses is safe and could help to reduce severe postoperative complications.

Leaks after laparoscopic sleeve gastrectomy: 2024 update on risk factors.

PURPOSE: Leaks after sleeve gastrectomy remain a deadly complication significantly affecting outcomes and medical costs. The aim of the present review is to provide an updated decalogue on leak prevention. METHODS: Risk factors of leakage after LSG were examined based on an extensive review of literature (in period time 2016-2024) and summary of evidence was provided using Oxford levels of evidence scale. RESULTS: Pathogenesis of leakage after LSG still remain related to ischemic and mechanical factors and, therefore, no new evidence has been reported. Conversely, some technical aspect of the procedure has changed: bougie size, antrum resection, staple line reinforcement, and intraoperative leak testing. CONCLUSIONS: Bougie size 36 F is effective and safe achieving similar leakage rate compared to larger bougie sizes (EL:2) 2024 UPDATE; There is no significant difference in the leak rate between restrictive (< 6 cm) and conservative (6 cm) antrum resection (EL: 1) 2024 UPDATE; Surgical experience and case volume affect the leak rate more consistently than every kind of SLR (EL: 2) 2024 UPDATE; Intraoperative leak test after LSG represents a decision based on surgeon preference in absence of standardization (endoscopy, bubble test, methylene blue, indocyanine green.) and strong detection/prevention rate (EL: 3) 2024 UPDATE.

Low ligation of the inferior mesenteric artery in robotic mid-low rectal cancer surgery: a comparative study from a single-center.

Laparoscopic total mesorectal excision is the main surgical approach for treating rectal cancer, but there is still no clear consensus on the issue of low ligation of the inferior mesenteric artery during the procedure. Robotic surgery has been shown to have certain advantages over laparoscopic surgery in multiple studies, but further research is needed to better understand the outcomes of robotic surgery in the context of low ligation procedures. In this study, we included 1590 patients with mid-low rectal cancer. Among them, 942 patients underwent low ligation surgery (LL), divided into 138 in the robotic group and 804 in the laparoscopic group. The high ligation surgery (HL) group consisted of 648 patients. The results of LL vs HL showed that the LL group had faster bowel movement recovery (P = 0.003), lower anastomotic leak rate (P = 0.032), and lower International Prostate Symptom Score (IPSS) at 6 months postoperatively (P < 0.001). The results of Rob-LL vs Lap-LL showed that the Rob-LL group had longer operative time (P < 0.001), less blood loss (P = 0.001), more lymph nodes retrieved (P = 0.045), and lower Wexner score at 2 weeks postoperatively (P = 0.029). The concept of low ligation of the inferior mesenteric artery is a promising surgical approach that can accelerate the patient's functional recovery. When combined with robotic technology, it may offer more benefits than laparoscopic techniques.

Blood perfusion assessment by near-infrared fluorescence angiography of epiploic appendages in prevention of anastomotic leakage after laparoscopic intersphincteric resection for ultra-low rectal cancer: a case-matched study.

BACKGROUND: The role of intraoperative near-infrared fluorescence angiography with indocyanine green in reducing anastomotic leakage (AL) has been demonstrated in colorectal surgery, however, its perfusion assessment mode, and efficacy in reducing anastomotic leakage after laparoscopic intersphincteric resection (LsISR) need to be further elucidated. AIM: Aim was to study near-infrared fluorescent angiography to help identify bowel ischemia to reduce AL after LsISR. MATERIAL AND METHODS: A retrospective case-matched study was conducted in one referral center. A total of 556 consecutive patients with ultra-low rectal cancer including 140 patients with fluorescence angiography of epiploic appendages (FAEA)were enrolled. Perfusion assessment by FAEA in the monochrome fluorescence mode. Patients were divided into two groups based on perfusion assessment by FAEA. The primary endpoint was the AL rate within 6 months, and the secondary endpoint was the structural sequelae of anastomotic leakage (SSAL). RESULTS: After matching, the study group (n = 109) and control group (n = 190) were well-balanced. The AL rate in the FAEA group was lower before (3.6% vs. 10.1%, P = 0.026) and after matching (3.7% vs. 10.5%, P = 0.036). Propensity scores matching analysis (OR 0.275, 95% CI 0.035-0.937, P 0.039), inverse probability of treatment weighting (OR 0.814, 95% CI 0.765-0.921, P 0.002), and regression analysis (OR 0.298, 95% CI 0.112-0.790, P = 0.015), showed that FAEA was an independent protector factor for AL. This technique can significantly shorten postoperative hospital stay [9 (6-13) vs. 10 (8-13), P = 0.024] and reduce the risk of SSAL (1.4% vs. 6.0%, P = 0.029). CONCLUSIONS: Perfusion assessment by FAEA can achieve better visualization in LsISR and reduce the incidence of AL, subsequently avoiding SSAL after LsISR.

Epiploic steal: is this concept the key to reducing colorectal anastomotic leak rates?

PURPOSE: Ensuring optimal colonic perfusion is a critical step in every colorectal anastomosis. The aim of this study is to describe the concept of epiploic steal. METHODS: A literature review was performed to identify studies evaluating anastomotic blood supply. The fundamental principle of epiploic steal is outlined. RESULTS: Epiploic steal has not been previously evaluated in the literature, and likely has a negative effect on colonic blood supply. Resection of colonic epiploicae may improve perfusion at the distal most lengths of a mobilised colonic conduit where the anastomosis requires it. CONCLUSION: This novel concept has the potential to change practice and reduce colorectal anastomotic leak rates. Further clinical studies are required.

Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study.

PURPOSE: Anastomotic leak (AL) represents the most relevant and devastating complication in colorectal surgery. Endoscopic vacuum therapy (EVT) using the VACStent is regarded as a significant improvement in the treatment of upper gastrointestinal wall defects. The innovative concept of the VACStent was transferred to the lower GI tract, gaining initial experience by investigating safety and efficacy in 12 patients undergoing colorectal resections. METHODS: The pilot study, as part of a German registry, began with 2 patients suffering from AL, who were treated with the VACStent after stoma placement. Subsequently, 6 patients with AL were treated with the VACStent omitting a stoma placement, with a focus on fecal passage and wound healing. Finally, the preemptive anastomotic coverage was investigated in 4 patients with high-risk anastomoses to avoid prophylactic stoma placement. RESULTS: In total 26 VACStents were placed without problems. The conditioning and drainage function were maintained, and no clogging problems of the sponge cylinder were observed. No relevant clinical VACStent-associated complications were observed; however, in 2 patients, a dislodgement of a VACStent occurred. The 6 patients with AL but without stoma had a median treatment with 3 VACStents per case with a laytime of 17 days, leading to complete wound healing in all cases. The 4 prophylactic VACStent applications were without complications. CONCLUSION: The clinical application of the VACStent in the lower GI tract shows that successful treatment of anastomotic colonic leaks and avoidance of creation of an anus praeter is possible. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov NCT04884334, date of registration 2021-05-04, retrospectively registered.

Incidence of anastomotic leakage using powered circular staplers versus manual circular staplers for left colorectal anastomosis: a cost-effectiveness analysis.

BACKGROUND: Colorectal anastomotic leakage causes severe consequences for patients and healthcare system as it will lead to increased consumption of hospital resources and costs. Technological improvements in anastomotic devices could reduce the incidence of leakage and its economic impact. The aim of the present study was to assess if the use of a new powered circular stapler is cost-effective. METHOD: This observational study included patients undergoing left-sided circular stapled colorectal anastomosis between January 2018 and December 2021. Propensity score matching was carried out to create two comparable groups depending on whether the anastomosis was performed using a manual or powered circular device. The rate of anastomotic leakage, its severity, the consumption of hospital resources, and its cost were the main outcome measures. A cost-effectiveness analysis comparing the powered circular stapler versus manual circular staplers was performed. RESULTS: A total of 330 patients were included in the study, 165 in each group. Anastomotic leakage rates were significantly different (p = 0.012): 22 patients (13.3%) in the manual group versus 8 patients (4.8%) in the powered group. The effectiveness of the powered stapler and manual stapler was 98.27% and 93.69%, respectively. The average cost per patient in the powered group was €6238.38, compared with €9700.12 in the manual group. The incremental cost-effectiveness ratio was - €74,915.28 per patient without anastomotic complications. CONCLUSION: The incremental cost of powered circular stapler compared with manual devices was offset by the savings from lowered incidence and cost of management of anastomotic leaks.

Analysis of the effect of staple line reinforcement on leaking and bleeding after sleeve gastrectomy from the UK National Bariatric Surgery Registry.

INTRODUCTION: Sleeve gastrectomy (SG) is currently the most frequently performed procedure for obesity worldwide. Staple line reinforcement (SLR) has been suggested as a strategy to reduce the risk of staple line leak or bleeding; however, its use for SG in the United Kingdom (UK) is unknown. This study examined the effect of SLR on the development of postoperative complications from SG using a large national dataset from the UK. METHODS: Patients undergoing either primary or revision SG over 10 years from Jan 2012 to Dec 2021 were identified by the National Bariatric Surgery Registry. Comparative and logistic regression analyses were undertaken to determine the effect of SLR on staple line leak and bleeding. RESULTS: During this time, 14,231 patients underwent SG for whom there were complete data. Of these, 76.5% were female and the median age was 46 years (IQR: 36-53). The rate of surgical complications was 2.3% (n = 219/14,231). The incidence of bleeding was 1.3% (n = 179/14,231) and leak was 1.0% (n = 140/14,231). Over time, the use of SLR of any variety declined significantly from 99.7% in 2012 to 57.3% in 2021 (p < 0.001). Multivariable (adjusted) regression analysis demonstrated that neither the use of nor the type of reinforcement had any effect on the rate of bleeding or leaking. CONCLUSION: SLR for SG has declined in the UK since 2012. There were no differences in staple line leak or bleed with or without reinforcement.

Endoscopic vacuum therapy (eVAC) combined with continuous perianastomotic irrigation for prevention of anastomotic leak after surgical ampullectomy.

PURPOSE: Transduodenal surgical ampullectomy (tAMP) with papillary reimplantation is a valid alternative to pancreaticoduodenectomy for lesions of the periampullary region not amenable to endoscopic resection. As tAMP is burdened by high rates of biliopancreatic-enteric anastomotic leak, we tested preventive endoluminal vacuum therapy (eVAC) combined with post-operative continuous perianastomotic irrigation (CPI) to reduce such anastomotic leak. METHODS: Between 10/2013 and 09/2023, 37 patients undergoing laparotomic tAMP (with or without jejunal transposition) and papillary reimplantation at Hirslanden Klinik Zurich were retrospectively analysed; of these, 16 received prophylactic eVAC combined with CPI, while the remaining represented the historical cohort. RESULTS: The eVAC-CPI-group and the historical-cohort were homogeneous in demographic characteristics. Surgery in the prophylactic eVAC-CPI-group lasted about 30 min longer due to eVAC application (p = 0.008). The biliopancreatico-enteric anastomotic leak rates were 6.2% in the eVAC-CIP-group vs. 19.0% in the historical-cohort (p = 0.266). Along, a strong trend of less severe post-operative complications in general (p = 0.073), and borderline-significantly less cases of acute pancreatitis (p = 0.057) and tAMP-related re-operations or re-interventions (p = 0.057) in particular, were observed in the eVAC-CPI-group. The only anastomotic leak in the eVAC-CPI-group was successfully managed through repeated cycles of eVAC. The device was well tolerated by all patients; no vacuum/irrigation-related complications or malfunctioning occurred. CONCLUSION: Our study is the first to provide some technical insights demonstrating the safety and feasibility of a prophylactic approach with eVAC and perianastomotic irrigation to reduce anastomotic leak after tAMP. Increasing the number of subjects will confirm the benefit of our promising results.

Fully robotic side-to-side stapled anastomosis provides less anastomotic leakage than conventional minimally invasive approach in Ivor Lewis esophagectomy.

INTRODUCTION: This study evaluates surgical outcomes of minimally invasive Ivor Lewis esophagectomy (ILE) for esophageal and esophagogastric cancer, with the comparison of the robotic approach (RA) and the conventional minimally invasive approach (CA). METHODS: Selected patients who underwent minimally invasive ILE for esophageal cancer were included between January 2017 and December 2023. We retrospectively investigated the patients' background characteristics and the short-term surgical outcomes. RESULTS: In this period, among a total of 840 esophagectomies, 81 patients (9.6%) underwent minimally invasive ILE, consisting of 24 cases with RA and 57 with CA. The major indications for ILE were adenocarcinoma of the distal esophagus or esophagogastric junction and patients with prior head and neck cancer treatment. Among these thoracic approaches, there were no significant differences in the patients' indications and characteristics, including age, histology, tumor location, clinical TNM stage, and preoperative therapy. Compared with the CA group, no anastomotic leakage was observed in the RA group (17.5% vs. 0, p = .035). Rates of total postoperative complications and length of hospital stay also tended to be reduced in the RA group but did not reach significance. CONCLUSION: In the Ivor Lewis esophagectomy with a side-to-side linear-stapled anastomosis, the fully robotic approach has the potential to powerfully reduce anastomotic leakage compared to the conventional minimally invasive approach.

Updated evidence of the effectiveness and safety of transanal drainage tube for the prevention of anastomotic leakage after rectal low anterior resection: a systematic review and meta-analysis.

BACKGROUNDS: Anastomotic leakage (AL) represents a major complication after rectal low anterior resection (LAR). Transanal drainage tube (TDT) placement offers a potential strategy for AL prevention; however, its efficacy and safety remain contentious. METHODS: A systematic review and meta-analysis were used to evaluate the influence of TDT subsequent to LAR as part of the revision of the surgical site infection prevention guidelines of the Japanese Society of Surgical Infectious Diseases (PROSPERO registration; CRD42023476655). We searched each database, and included randomized controlled trials (RCTs) and observational studies (OBSs) comparing TDT and non-TDT outcomes. The main outcome was AL. Data were independently extracted by three authors and random-effects models were implemented. RESULTS: A total of three RCTs and 18 OBSs were included. RCTs reported no significant difference in AL rate between the TDT and non-TDT groups [relative risk (RR): 0.69, 95% confidence interval (CI) 0.42-1.15]. OBSs reported that TDT reduced AL risk [odds ratio (OR): 0.45, 95% CI 0.31-0.64]. In the subgroup excluding diverting stoma (DS), TDT significantly lowered the AL rate in RCTs (RR: 0.57, 95% CI 0.33-0.99) and OBSs (OR: 0.41, 95% CI 0.27-0.62). Reoperation rates were significantly lower in the TDT without DS groups in both RCTs (RR: 0.26, 95% CI 0.07-0.94) and OBSs (OR: 0.40, 95% CI 0.24-0.66). TDT groups exhibited a higher anastomotic bleeding rate only in RCTs (RR: 4.28, 95% CI 2.14-8.54), while shorter hospital stays were observed in RCTs [standard mean difference (SMD): -0.44, 95% CI -0.65 to -0.23] and OBSs (SMD: -0.54, 95% CI -0.97 to -0.11) compared with the non-TDT group. CONCLUSIONS: A universal TDT placement cannot be recommended for all rectal LAR patients. Some patients may benefit from TDT, such as patients without DS creation. Further investigation is necessary to identify the specific beneficiaries.

[Application of multi-technology integrated total mesorectal excision in mid to low rectal cancer].

Total mesorectal excision is the standard procedure for the treatment of low and medium rectal cancer. Anastomotic leakage has always been one of the serious complications in these patients. Blood supply, tension and intestinal condition are important factors affecting anastomotic quality. How to optimize the surgical technique and reduce the occurrence of anastomotic leakage is the goal of surgeons. Based on traditional total mesorectal excision, we integrated several surgical techniques, including (1) Preserving the left colic artery; (2) High ligation of the inferior mesenteric vein; (3) Patterned mobilization of the spleen flexure and left transverse colon; (4) Multi-plane mesocolic tailoring; (5) Selective anastomosis suturing, and proposed the concept of multi-technique integrated total mesorectal resection (MTI-TME). The application of MTI-TME in clinical practice and significance was discussed.

Optimizing ischemic preconditioning for esophagogastric anastomosis: A standardized rat model to evaluate histological changes.

INTRODUCTION: A reproducible and simple model is essential for verifying gastric conduit vitality before esophagectomy. Ischemia is a major cause of esophagogastric anastomotic dehiscence and leakage. Ischemic conditioning of the stomach prior to esophageal surgery has been shown to lower the incidence of postoperative complications, including anastomotic leakage. However, the optimal timing and technique of ischemization remain uncertain. METHODS: Male Sprague-Dawley rats (n=24) were randomly divided into four groups: ischemic group - samples collected 1 hour after ischemia (I1H), ischemic group - samples collected 1 day after ischemia (I1D), ischemic group - samples collected 7 days after ischemia (I7D), and control group (C). Ischemia was induced by ligation of the left gastric (LGA) and short gastric arteries (SGA). The samples were verified using histological and macroscopic analysis, and the number and percentage of immunocompetent cells were determined. RESULTS: One hour after ischemization (I1H), ischemic denudation with mucosal erosion was observed, and the total number of eosinophils was significantly higher (p.

Low anterior resection with transanal transection and single-stapled anastomosis: technical aspects and initial results.

BACKGROUND: Rectal cancer (RC) is a surgical challenge due to its technical complexity. The double-stapled (DS) technique, a standard for colorectal anastomosis, has been associated with notable drawbacks, including a high incidence of anastomotic leak (AL). Low anterior resection with transanal transection and single-stapled (TTSS) anastomosis has emerged to mitigate those drawbacks. METHODS: Observational study in which it described the technical aspects and results of the initial group of patients with medium-low RC undergoing elective laparoscopic total mesorectal excision (TME) and TTSS. RESULTS: Twenty-two patients were included in the series. Favourable postoperative outcomes with a median length of stay of 5 days and an AL incidence of 9.1%. Importantly, all patients achieved complete mesorectal excision with tumour-free margins, and no mortalities were reported. CONCLUSION: TTSS emerges as a promising alternative for patients with middle and lower rectal tumours, offering potential benefits in terms of morbidity reduction and oncological integrity compared with other techniques.

Double-row staple technology versus triple-row staple technology for colorectal surgery: A systematic review and meta-analysis.

BACKGROUND: Some observational data have suggested that anastomotic leak may be reduced with triple-row staple technology compared to double-row staple technology. We aimed to investigate this further by performing a systematic review comparing double- and triple-row staple technology for colorectal anastomoses. METHODS: This systematic review was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. MEDLINE, Embase, and Cochrane Central Register of Controlled Trials databases were searched up to November 2023. Articles were eligible for inclusion if they were comparing double-row staple and triple-row staple technology for left-sided colo-colic, colorectal, or coloanal anastomosis. The main outcomes included anastomotic leak, anastomotic hemorrhage, 30-day mortality, and reoperation. Meta-analyses with inverse variance random effects were performed. Certainty of evidence was assessed with Grading of Recommendations, Assessment, Development, and Evaluations. RESULTS: After reviewing 340 relevant citations, 6 retrospective cohort studies met inclusion. Overall, 19,372 patients (mean age: 60.2 years, 52.7% female sex) had anastomoses with double-row staple technology, and 2,298 patients (mean age: 61.3 years, 50.3% female sex) with triple-row staple technology. Most operations were anterior resections (double-row: 55.3%; triple-row: 43.6%). Across all included studies, the risk of anastomotic leak was reduced with triple-row staple technology (6.3% vs 7.5%, risk ratio 0.54, 95% confidence interval 0.31-0.94, P = .03, I2=75%). There were no significant differences in anastomotic hemorrhage (risk ratio 0.47, 95% confidence interval 0.15-1.49, P = .20, I2 = 57%), 30-day mortality (risk ratio 0.66, 95% confidence interval 0.17-2.55, P = .55, I2 = 0%), or reoperation (risk ratio 1.05, 95% confidence interval 0.42-2.64, P = .91, I2 = 56%). CONCLUSION: Triple-row staple technology may reduce the risk of anastomotic leak in left-sided colorectal anastomoses.

Efficacy of Omentopexy on Complications of Laparoscopic Sleeve Gastrectomy.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is a commonly performed type of bariatric surgery. Early complications of LSG include bleeding, leakage, pulmonary embolism, and surgical site infections. Most surgeons try to implement preventive methods, such as omentopexy. Staple line-imbrication, which has a difficult learning curve, often prevents complications. This study aimed to evaluate the effect of omentopexy on patients with imbricated LSG. MATERIAL AND METHODS: The study applied a retrospective data analysis design to patients who underwent LSG between 2020 and 2023. All patients' staple lines were imbricated, and patients were then divided into two groups: omentopexy group and control group. Patients' demographic features, such as age, gender, height, weight, body mass index(BMI), bleeding, leakage, and reoperations, were recorded and examined retrospectively. RESULTS: A total of 1356 patients were included in the study (540 in omentopexy, 816 in control), of which the mean age was 37.9 ± 10.5 years, 82.3% were women, and mean BMI was 40.9 ± 5.8 kg/m2. The mean bleeding rate was 1.0% (1.3-0.7%), the mean leakage rate was 0.2% (0.2-0.2%, respectively), and the mean reoperation rate was 0.6% (0.7% and 0.5%, respectively). No statistically significant differences were observed. CONCLUSION: Omentopexy is a technique that is widely used to prevent staple line complications. According to our study, omentopexy applied to an imbricated stapler line increased the operation time but did not affect bleeding or leakage ratios. This is the first study to evaluate the effect of omentopexy on imbricated staple lines. The findings of the study indicate that omentopexy has no additional benefit on early complications when using staple-line imbrication.

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.