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.

The impact of anastomotic leakage characteristics on the occurrence of anastomotic stenosis after colorectal resection, a retrospective cohort study.

INTRODUCTION: Anastomotic stenosis (AS) is a common complication after colorectal resection. However, the predisposing factors for stricture formation are not fully understood. Previous studies have shown anastomotic leakage (AL) to be a risk factor for the occurrence of AS. Therefore, we aim to investigate the impact of anastomotic leakage characteristics on the occurrence of anastomotic stenosis after colorectal resection. METHODS: Consecutive patients with AL following elective, sphincter preserving, colorectal resection, with or without diversion ostomy, between January 2009 and March 2023 were identified from a prospectively collected database. The characteristics of the anastomotic leakage, patient baseline and operative characteristics as well as the postoperative outcomes were analyzed using univariate and multivariate logistic regression to identify factors associated with the occurrence of post-leakage AS. RESULTS: A total of 129 patients developed AL and met the inclusion criteria. Among these, 28 (21.7%) patients were diagnosed with post-leakage AS. There was a significantly higher frequency of patients with neoadjuvant radiotherapy (18% vs 3%; p = .026) and hand-sewn anastomoses (39% vs 17%; p = .011) within the AS group. Furthermore, the extent of the anastomotic defect was significantly higher in the AS group compared with the non-AS group (50%, IQR 27-71 vs. 20%, IQR 9-40, p = 0.011). Similar findings were observed between the study groups regarding age, sex, BMI, ASA score, medical comorbidities, diagnosis, surgical procedure, surgical approach (open vs. minimally invasive), and anastomotic fashioning (side-to-end vs. end-to-end). On multivariate analysis, the extent of the anastomotic defect (OR 1.01; 95% CI 1.00-1.03; p = 0.034) and hand-sewn anastomoses (OR 2.68; 95% CI 1.01-6.98; p = 0.043) were confirmed as independent risk factors for post-leakage AS. No correlation could be observed between the occurrence of post-leakage AS and the ISREC grading of AL, the anastomotic height or the management of AL. Time to ostomy reversal was significantly longer in the AS group (202d, IQR 169-275 vs. 318d IQR 192-416, p = 0.014). CONCLUSION: The extent of the anastomotic defect and hand-sewn anastomoses were confirmed as independent risk factors for the occurrence of post-leakage AS. No correlation could be observed between the ISREC grading of AL, the anastomotic height or AL management, and the occurrence of post-leakage AS.

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.

Short-term outcomes of the "minimal skin incision and no stoma" procedure in needlescopic intersphincteric resection and delayed coloanal anastomosis for low rectal cancer.

BACKGROUND: Needlescopic surgery is a minimally invasive procedure that uses thin trocars with 3-mm diameter. We used Turnbull-Cutait pull-through and delayed coloanal anastomosis in needlescopic surgery to avoid diverting ileostomy during intersphincteric resection for low rectal cancer. In this study, we aim to assess the diverting ileostomy avoidance rate and technical safety of this "minimal skin incision and no stoma" procedure. METHODS: This single-center retrospective study was conducted at the Cancer Institute Hospital, a tertiary referral center in Japan. Between January 2017 and December 2020, 11 patients underwent needlescopic intersphincteric resection with diverting ileostomy (NSI group), and 19 patients underwent needlescopic intersphincteric resection with delayed coloanal anastomosis (NSD group) for low rectal cancer. Data regarding patient backgrounds and short-term outcomes, including diverting ileostomy avoidance rate, pathological results, and postoperative defecatory function, were compared between the groups. RESULTS: There were no statistically significant differences between the NSI and NSD groups with respect to patient background, operation time (239 min versus 220 min, p = 0.68), estimated blood loss (45 g versus 25 g, p = 0.29), R0 resection rate (100% versus 100%, p = 1.00), and length of postoperative hospital stay (16 days versus 17 days, p = 0.42). The diverting ileostomy avoidance rate was 94.4% in the NSD group. The LARS and Wexner scores 12 months after surgery were not significantly different between the two groups. CONCLUSIONS: Needlescopic intersphincteric resection and delayed coloanal anastomosis can be safely performed in selected patients with a high rate of diverting ileostomy avoidance and comparable short-term outcomes.

Late anastomotic perforation of the ileum 3 years after intestinal resection.

Late perforation of the ileum is a rare and potentially life-threatening complication following intestinal resection. We present a unique case of a woman in her 60s with a history of appendiceal carcinoid tumour, who underwent a right hemicolectomy. Positron emission tomography and surveillance CTs showed normal surgical changes and no recurrent malignancy. Three years postoperatively, she presented with severe abdominal pain. CT revealed a perforation along the ileal wall of the ileocolonic anastomosis. She underwent emergent resection and repeat ileocolonic anastomosis. We conclude that the patient had subclinical ischaemia of the anastomosis, which eventually progressed to perforation 3 years later. We discuss a literature review on late small intestinal anastomotic perforations and their associated risk factors. Our case and literature review emphasise the importance of considering delayed anastomotic leak in postoperative patients with a history of intestinal cancer, inflammatory bowel disease, Roux-en-Y enteroenterostomy or side-to-side anastomosis.

Risk factors for esophageal anastomotic stricture after esophagectomy: a meta-analysis.

BACKGROUND: The aim of this study was to assess the risk factors for anastomotic stricture in esophageal cancer patients undergoing esophagectomy. Esophageal anastomotic stricture is the most common long-term complication for esophagectomy. The risk factors for esophageal anastomotic stricture still remain controversial. METHODS: MEDLINE, Cochrane Library, and EMBASE were searched to identify observational studies reporting the risk factors for esophageal anastomotic stricture after esophagectomy. A meta-analysis was conducted to investigate the impact of various risk factors on esophageal anastomotic stricture. The GRADE [Grading of Recommendations Assessment, Development and Evaluation] approach was used for quality assessment of evidence on outcome levels. RESULTS: This review included 14 studies evaluating 5987 patients.The meta-analysis found that anastomotic leakage (odds ratio [OR]: 2.75; 95% confidence interval[CI]:2.16-3.49), cardiovascular disease [OR:1.62; 95% CI: 1.22-2.16],diabete [OR: 1.62; 95% CI: 1.20-2.19] may be risk factors for esophageal anastomotic stricture.There were no association between neoadjuvant therapy [OR: 0.78; 95% CI:0.62-0.97], wide gastric conduit [OR:0.98; 95% CI: 0.37-2.56],mechanical anastomosis [OR: 0.84; 95% CI:0.47-1.48],colonic interposition[OR:0.20; 95% CI: 0.12-0.35],and transhiatal approach[OR:1.16; 95% CI:0.81-1.64],with the risk of esophageal anastomotic stricture. CONCLUSIONS: This meta-analysis provides some evidence that anastomotic leakage,cardiovascular disease and diabete may be associated with higher rates of esophageal anastomotic stricture.Knowledge about those risk factors may influence treatment and procedure-related decisions,and possibly reduce the anastomotic stricture rate.

Safety and effectivity of Kono-S anastomosis in Crohn's patients: a systematic review and Meta-analysis.

PURPOSE: Kono-S anastomosis, an antimesenteric, functional, end-to-end handsewn anastomosis, was introduced in 2011. The aim of this meta-analysis is to evaluate the safety and effectivity of the Kono-S technique. METHODS: A comprehensive search of MEDLINE (PubMed), Embase (Elsevier), Scopus (Elsevier), and Cochrane Central (Ovid) from inception to August 24th, 2023, was conducted. Studies reporting outcomes of adults with Crohn's disease undergoing ileocolic resection with subsequent Kono-S anastomosis were included. PRISMA and Cochrane guidelines were used to screen, extract and synthesize data. Primary outcomes assessed were endoscopic, surgical and clinical recurrence rates, as well as complication rates. Data were pooled using random-effects models, and heterogeneity was assessed with I² statistics. ROBINS-I and ROB2 tools were used for quality assessment. RESULTS: 12 studies involving 820 patients met the eligibility criteria. A pooled mean follow-up time of 22.8 months (95% CI: 15.8, 29.9; I2 = 99.8%) was completed in 98.3% of patients. Pooled endoscopic recurrence was reported in 24.1% of patients (95% CI: 9.4, 49.3; I2 = 93.43%), pooled surgical recurrence in 3.9% of patients (95% CI: 2.2, 6.9; I2 = 25.97%), and pooled clinical recurrence in 26.8% of patients (95% CI: 14, 45.1; I2 = 84.87%). The pooled complication rate was 33.7%. The most common complications were infection (11.5%) and ileus (10.9%). Pooled anastomosis leakage rate was 2.9%. CONCLUSIONS: Despite limited and heterogenous data, patients undergoing Kono-S anastomosis had low rates of surgical recurrence and anastomotic leakage with moderate rates of endoscopic recurrence, clinical recurrence and complications rate.

Anastomotic bleeding from invaginated pancreaticogastrostomy following pancreatoduodenectomy: incidence, risk factors, treatment and prevention.

BACKGROUND: Meta-analysis of 10 randomized prospective trials demonstrated a higher risk of postoperative bleeding from pancreaticogastrostomy (PG) compared with pancreatojejunostomy following pancreatoduodenectomy (PD). This study evaluated the incidence, risk factors, and treatment of anastomotic bleeding from invaginated PG. METHODS: We retrospectively evaluated all consecutive PDs performed between April 1, 2011 and December 31, 2022 using invaginated PG by the double purse-string technique. Multivariate analysis identified risk factors for anastomotic PG bleeding. RESULTS: During the study, 695 consecutive patients with a median age of 66 years underwent PD; the majority was performed for ductal pancreatic adenocarcinomas. Simultaneous vascular resections were performed in 328 patients. Postoperative mortality was 4.1%. Bleeding from PG occurred in 33(4.6%) patients at a median interval of 5 days (range, 1-14) from surgery, leading to reoperation in 21(63%). PG bleeding-related mortality was 9.0%. Multivariate analyses identified a soft pancreatic texture and Wirsung duct > 3 or ≤ 3 mm (Class C and D, respectively, of the ISGPS) (odds ratio [OR]: 2.17, 95% confidence interval [95% CI]: 1.38-3.44; P = 0.0009) and wrapping of the invaginated pancreas (OR: 0.37, 95% CI: 0.17-0.84; P = 0.01) as independent risk factors for PG bleeding. CONCLUSIONS: In a large volume setting, anastomotic bleeding from invaginated PG occurred in ~ 5% of patients and was associated with soft pancreatic parenchyma and small wirsung duct. The reduced rate of PG bleeding observed with wrapping of the invaginated pancreatic stump warrants further evaluation in a prospective randomized study.

Comparison of clinical efficacy between modified Kamikawa anastomosis in laparoscopic proximal gastrectomy and Roux-en-Y anastomosis in laparoscopic total gastrectomy.

To investigate the short-term clinical efficacy of laparoscopic proximal gastrectomy with modified Kamikawa anastomosis and laparoscopic total gastrectomy with Roux-en-Y anastomosis. Retrospective cohort study was conducted. The clinicopathological data of 268 patients who underwent laparoscopic proximal gastrectomy for adenocarcinoma of esophagogastric junction and upper gastric adenocarcinoma from January 2016 to October 2022 were collected. Among 268 patients, 26 underwent laparoscopic proximal gastrectomy with modified Kamikawa anastomosis were assigned to Kamikawa group and 242 underwent laparoscopic total gastrectomy with Roux-en-Y anastomosis were assigned to Roux-en-Y group. The sex, age, BMI, preoperative albumin, maximum tumor diameter, histological grade, and pathological stage of patients in the Kamikawa group and the Roux-en-Y group were subjected to 1:1 propensity score matching. After matching, 16 patients in Kamikawa group and Roux-en-Y group were respectively included in this study. Outcome measures: (1) Intraoperative condition. (2) Postoperative recovery. (3) Follow-up information. The patients' nutritional status, reflux esophagitis and anastomotic stoma were investigated by outpatient and telephone follow-up. Nutritional status assessment comprising body mass index and Nutritional Risk Screening 2002 score. (1) Intraoperative condition. All patients successfully underwent laparoscopic proximal gastrectomy and total gastrectomy. Compared with Roux-en-Y group, the digestive tract reconstruction time in Kamikawa group was longer 93.0(74.0-111.0)min vs. 39.7(35.1-46.2)min, t = -2.001, P = 0.055., and the difference was statistically significant (P < 0.05). There was no statistically significant difference in total operation time and intraoperative blood loss (P > 0.05). (2) Postoperative recovery. There was no statistically significant difference between Kamikawa group and Roux-en-Y group in first anal exhaust time, first postoperative liquid intake time, postoperative hospitalization time, and postoperative complications (P > 0.05). (3) Follow-up information. All patients were followed up. BMI and NRS 2002 scores in Kamikawa group were better than those in Roux-en-Y group at 6 and 12 months after surgery 22.9 ± 3.0 kg/m2 vs. 20.8 ± 2.2 kg/m2, t = 2.165, P = 0.038; 23.1 ± 3.0 kg/m2 vs. 20.3 ± 2.2 kg/m2, t = 3.022, P = 0.005 and 2 (1-2) vs. 2 (1-3), Z = -2.585, P = 0.010; 2 (1-2) vs. 2 (1-3), Z = -2.273, P = 0.023., the difference was statistically significant (P < 0.05). There was no significant difference in GERD scale score and occurrence of ≥ Grade B reflux esophagitis at 6 and 12 months after surgery between Kamikawa group and Roux-en-Y group (P > 0.05). Anastomotic stenosis was not found in all patients by postoperative upper gastrointestinal angiography. Laparoscopic proximal gastrectomy with modified Kamikawa anastomosis is safe and feasible for the treatment of esophagogastric junction and upper gastric adenocarcinoma, and can achieve good anti-reflux effect. Besides, compared with traditional laparoscopic total gastrectomy, its postoperative nutritional status is better.

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.

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.

Custom silicone Y-stents for the management of anastomotic stenosis in lung transplant recipients.

BACKGROUND: Airway stenting may be needed to manage anastomotic complications in lung transplant recipients. Conventional stenting strategies may be inadequate due to anatomic variations between the recipient and donor or involvement of both the anastomosis and lobar bronchi. METHODS: We investigated the efficacy of 3D-designed patient-specific silicone Y-stents in managing this scenario. 9 patients with complex airway stenosis underwent custom stent insertion after either failing traditional management strategies or having anatomy not suitable for conventional stents. CT images were uploaded to stent design software to make a virtual stent model. 3D printing technology was then used to make a mold for the final silicone stent which was implanted via rigid bronchoscopy. Forced expiratory volume in 1 s (FEV1) was measured pre- and post-stent placement. RESULTS: 78 % of patients experienced an increase in their FEV1 after stent insertion, (p = 0.001, 0.02 at 30 and 90 days respectively). Unplanned bronchoscopies primarily occurred due to mucous plugging. 2 patients had sufficient airway remodeling allowing for stent removal. CONCLUSIONS: Personalized 3D-designed Y-stents demonstrate promising results for managing complicated airway stenosis, offering improved lung function and potential long-term benefits for lung transplant recipients.

Association of resection margin distance with anastomotic recurrence in stage I-III colon cancer: data from the National Colorectal Cancer Cohort (NCRCC) study in China.

PURPOSE: Few studies have focused on anastomotic recurrence (AR) in colon cancer. This study aimed to clarify the association of resection margin distance with AR and compare the prognosis with nonanastomotic local recurrence (NAR). METHODS: This retrospective cohort study included the clinical data of patients who underwent radical colon cancer surgery between January 1, 2009, and December 31, 2019. RESULTS: A total of 1958 colon cancer patients were included in the study. 34 of whom (1.7%) had AR and 105 of whom (5.4%) had NAR. Multivariate analysis revealed that the lower distal resection margin distance, advanced N stage, and number of lymph nodes dissected were risk factors for AR. In the proximal resection margin, the risk of AR was lowest at a distance of 6 cm or greater, with a 3-year rate of 1.3%. In the distal resection margin, the 3-year AR risk increased rapidly if the distance was less than 3 cm. The prognosis of patients in the AR group was similar to that of patients in the NAR group, regardless of synchronous distant metastases. Furthermore, the radical surgery rate for AR was significantly higher than that for NAR, but the prognosis of AR was comparable to that of NAR. CONCLUSIONS: The distal resection margin distance, advanced N stage, and less number of lymph nodes dissected are associated with AR of colon cancer. The prognosis of patients with AR was similar to that of patients with NAR. TRIAL REGISTRATION: Clinical Trial Numbers NCT04074538 ( clinicaltrials.gov ), August 26, 2019, registered, retrospectively registered.