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711 result(s) for "Anastomotic Leak - epidemiology"
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Efficacy and safety of anastomotic leak testing in gastric cancer: a randomized controlled trial
BackgroundAnastomosis-related complications such as bleeding, leakage, and strictures, continue to be serious complications of gastric cancer surgery. Presently, these complications have yet to be reliably prevented. Here we design a comprehensive leak testing procedure which combines gastroscopy, air, and methylene blue (GAM) leak testing. We aimed to evaluated the efficacy and safety of the GAM procedure in patients with gastric cancer.MethodsPatients aged 18–85 years without an unresectable factor as confirmed via CT were enrolled in a prospective randomized clinical trial at a tertiary referral teaching hospital and were randomly assigned to two groups: intraoperative leak testing group (IOLT) and no intraoperative leak testing group (NIOLT). The primary endpoint was the incidence of postoperative anastomosis-related complications in the two groups.Results148 patients were initially randomly assigned to the IOLT group (n = 74) and to the NIOLT group (n = 74) between September 2018 and September 2022. After exclusions, 70 remained in the IOLT group and 68 in the NIOLT group. In the IOLT group, 5 patients (7.1%) were found to have anastomotic defects intraoperatively, which included anastomotic discontinuity, bleeding, and strictures. The NIOLT group had a higher incidence of postoperative anastomotic leakage compared to the IOLT group: 4 patients (5.8%) vs 0 patients (0%), respectively. No GAM-related complications were observed.ConclusionThe GAM procedure is an intraoperative leak test that can be performed safely and efficiently after a laparoscopic total gastrectomy. GAM anastomotic leak testing may effectively prevent technical defect-related anastomotic complications in patients with gastric cancer who undergo a gastrectomy.Trial registration: Clinical Trials.gov Identifier: NCT04292496.
Short-term and long-term results of a randomized study comparing high tie and low tie inferior mesenteric artery ligation in laparoscopic rectal anterior resection: subanalysis of the HTLT (High tie vs. low tie) study
BackgroundIn rectal anterior resection, a clear consensus regarding the optimal level of inferior mesenteric artery (IMA) ligation does not exist because of a lack of randomized trials. We conducted a randomized trial to determine if the IMA should be tied at the origin (high tie, HT) or distal to the left colic artery (low tie, LT) (HTLT study). This study is a subanalysis of HTLT study for laparoscopic surgery.MethodsAll candidates were randomly divided into the HT or LT groups. The lymph node dissection around the origin of the IMA was performed in the LT group. The stratified factor was the approach (open or laparoscopy). Evaluation parameters were operative factors, short-term and long-term results. In the present study, laparoscopic surgeries were examined as subgroup analysis.ResultsFrom June 2006 to September 2012, 331 patients were registered. Two hundred and fifteen patients (107 for HT: 108 for LT) underwent laparoscopic surgeries. There was no difference between the groups in background. The incidence of anastomotic leakage (HT: LT %) showed no significant differences for grade 2 or higher (11.2:9.3), and grade 3 or higher (2.8:4.6). There were no differences in operative time (200:205 min), blood loss (15:15 ml), number of dissected lymph nodes (22:20), and postoperative hospital stay (10:10 days). The incidence of bowel obstruction in HT was significant (3.7 vs. 0%, p = 0.043). There were no significant differences in overall survival (5-year: 91.3 vs. 90.2%, p = 0.850) and disease-free survival (5-year: 83.2 vs. 78.0%, p = 0.525). There were no differences in the first recurrent site and death reason between both groups. The risk factors for leakage were being male and an anastomotic level in a multivariate analysis by logistic regression.ConclusionThe IMA ligation level was unrelated to anastomotic leakage. No significant difference was detected in long-term results between HT and LT.
COLOR IV: a multicenter randomized clinical trial comparing intracorporeal and extracorporeal ileocolic anastomosis after laparoscopic right colectomy for colon cancer
Introduction Right-sided colon cancer is a prevalent malignancy. The standard surgical treatment for this condition is laparoscopic right hemicolectomy, with ileocolic anastomosis being a crucial step in the procedure. Recently, intracorporeal ileocolic anastomosis has garnered attention for its minimally invasive benefits. However, there remains a paucity of rigorously designed, large-scale, international multicenter randomized controlled trials to definitively assess the safety and efficacy of intracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for right-sided colon cancer. Methods This study is an international, multicenter, randomized, controlled, open-label, non-inferiority trial designed to compare the safety and efficacy of intracorporeal versus extracorporeal ileocolic anastomosis in patients with right-sided colon cancer undergoing right hemicolectomy. The primary endpoint is the anastomotic leakage rate within 30 days post-surgery. The main secondary endpoint is the 3-year disease-free survival rate post-surgery. A comprehensive quality assurance protocol will be established before the trial begins, including CT review, pathological evaluation, and the standardization and assessment of surgical techniques. Discussion This study aims to evaluate the safety and efficacy of intracorporeal ileocolic anastomosis following right hemicolectomy in patients with right-sided colon cancer. The anticipated outcome is that intracorporeal ileocolic anastomosis will show an anastomotic leakage rate and a 3-year disease-free survival rate comparable to those of extracorporeal anastomosis, while offering the added benefit of faster postoperative recovery. Graphical abstract
Modified pull-through procedure versus coloanal anastomosis with temporary stoma for low/ultra-low rectal cancer following preoperative chemoradiotherapy: protocol for a multicentre randomised controlled trial
IntroductionColorectal cancer (CRC) incidence is increasing, and treating low rectal cancer poses challenges in balancing oncological control with functional preservation. While preoperative chemoradiotherapy (CRT) improves sphincter preservation, anastomotic leakage (AL) remains a major complication. This trial aims to compare the efficacy of modified pull-through procedure versus coloanal anastomosis (CAA) with temporary stoma in low rectal cancer patients following preoperative CRT.Methods and analysisThis is a multicentre, assessor-blinded, randomised controlled trial. A total of 216 patients with low rectal cancer (≤7 cm from the anal verge) after preoperative CRT will be enrolled and randomly assigned (1:1) to undergo either the modified pull-through procedure or CAA with temporary stoma. The primary outcome is the incidence of AL within 1 month. Secondary outcomes include complications (Clavien-Dindo classification), length of hospital stay, anorectal function (LARS score (Low Anterior Resection Syndrome Score)), and quality of life (EQ-5D questionnaire (EuroQol five dimensions questionnaire)). Patients will be followed for 36 months.Ethics and disseminationThe study has obtained ethics approval from the Biomedical Ethics Committee of West China Hospital, Sichuan University (ethics approval ID: 2025-Review-(144)). All centres have obtained local institutional review board approval. Results will be disseminated via academic conferences and peer-reviewed journals to optimise clinical practice for low rectal cancer surgery.Trial registration numberChiCTR2500100246.
Multicenter analysis of risk factors for anastomotic leakage after middle and low rectal cancer resection without diverting stoma: a retrospective study of 319 consecutive patients
Purpose The purpose of this study was to evaluate the risk factors for anastomotic leakage (AL) after anterior resection for middle and low rectal cancer in order to help surgeons to decide which patients could benefit from a diverting stoma. Methods Data on 319 patients having a middle and low rectal cancer resection with anastomosis between May 2011 and October 2015 from two hospitals were included in the study. The analysis included the following variables: patient-related variables (gender, age, diabetes mellitus, ASA score, preoperative radiochemotherapy, body mass index, blood hemoglobin, and serum albumin level), tumor-related variables (K-ras status, distance of tumor from the anal verge, histopathologic grade, pathological T stage, pathological N stage, pathological M stage, TNM stage, and tumor size), and surgery-related variables (laparoscopic or open surgery, blood loss, and operative time). Univariate and multivariate regression analysis were carried out to identify risk factors for AL. Results The AL rate was 11.91% (38/319). Male (OR 2.898, 95% CI 1.265–6.637, p  = 0.012), diabetes mellitus (OR 2.482, 95% CI 1.004–6.134, p  = 0.049), K-ras mutation (OR 2.544, 95% CI 1.210–5.348, p  = 0.014), distance of tumor from the anal verge (OR 3.445, 95% CI 1.631–7.279, p  = 0.001), and preoperative radiochemotherapy (OR 2.790, 95% CI 1.056–7.372, p  = 0.039) were independent risk factors of AL. One (2.63%) in 38 patients with AL presented with no risk factor of AL, 6 (15.8%) in 38 patients with 1 risk factor, 16 (42.1%) in 38 patients with 2 risk factors, 9 (23.7%) in 38 patients with 3 risk factors, and 6 (15.7%) in 38 patients with 4 risk factors. No patient with 5 risk factors in our study. AL rate increased with the elevated number of risk factors clustering in individuals. Conclusions K-ras mutation is first reported to be an independent risk factor for AL after sphincter-preserving surgery without diverting stoma. A diverting stoma should be performed in sphincter-preserving surgery for middle and low rectal cancer patients with 2 or more risk factors identified in this analysis.
Risk factors for anastomotic leakage after laparoscopic surgery with the double stapling technique for stage 0/I rectal carcinoma: a subgroup analysis of a multicenter, single-arm phase II trial
PurposeThe aim of this study was to determine the risk factors for anastomotic leakage after laparoscopic rectal surgery.MethodsWe conducted a prospective trial involving 395 patients with stage 0/I rectal carcinoma who underwent laparoscopic low anterior resection using a double stapling technique. Data concerning variables related to patient background, tumors and surgical factors were evaluated. The outcomes with respect to anastomotic leakage were recorded, and univariate and multivariate analyses were performed to identify relevant risk factors.ResultsThe overall anastomotic leakage rate was 8.4%. A univariate analysis showed male gender (P = 0.006) and preoperative blood sugar level (P = 0.0034) to be significantly associated with anastomotic leakage. The variables of gender, preoperative blood sugar level, American Society of Anesthesiologists (ASA) classification (P = 0.15), transanal decompression tube (P = 0.06) and number of stapler cartridges used for rectal transection (P = 0.18) were selected for the multivariate analysis because of their P values being <0.2. The multivariate analysis identified male gender (odds ratio 4.12, P = 0.006) and the absence of a transanal decompression tube (odds ratio 3.11, P = 0.0484) as independent risk factors predicting anastomotic leakage.ConclusionsMale gender and the absence of a transanal decompression tube appeared to be independent risk factors for anastomotic leakage. Insertion of a transanal decompression tube may help prevent anastomotic leakage after low anterior resection, particularly in male patients.
Randomized Trial Comparing Side-to-Side Stapled and Hand-Sewn Esophagogastric Anastomosis in Neck
Background Leak from cervical esophagogastric anastomosis (CEGA) following esophagectomy is associated with morbidity and poor functional outcome. To address this issue, we conducted a randomized trial comparing “hand-sewn” with “stapled side-to-side” CEGA. Methods Of 174 patients who underwent esophageal resection and CEGA between 2004 and 2010, 87 each were randomized to “hand-sewn” and “stapled side-to-side” CEGA [ www.Clinical Trials.gov: NCT00497549]. The primary outcome measure was anastomotic leak rate. The secondary outcome measures included CEGA construction time and occurrence of anastomotic stricture during follow up. Results The overall anastomotic leak rate was 17.2 % (major leaks: 8 %). The leak rate was similar among the two groups (hand-sewn: 14/87, stapled: 16/87; p  = 0.33). The stapled anastomotic technique was faster (25 ± 6.5 min vs. 27 ± 5.5 min; p  = 0.02). The overall operative mortality and morbidity rates were 6.3 % and 40.8 %, respectively. At a median follow up of 12 (6–42) months, anastomotic stricture occurred in 24 (14.7 %) patients and was significantly more common in the “hand-sewn” group (17/82 vs. 7/81; p  = 0.045). Conclusion There were no differences in the leak rates and postoperative outcome between the two CEGA techniques. At follow up, anastomotic strictures occurred less frequently following stapled CEGA. The ideal CEGA technique remains elusive.
Can Transanal Tube Placement after Anterior Resection for Rectal Carcinoma Reduce Anastomotic Leakage Rate? A Single-institution Prospective Randomized Study
Background Anastomotic leakage is the most significant complication after low anterior resection (LAR) for rectal carcinoma, and it is the major cause of postoperative mortality and morbidity. The objective of the present study was to investigate whether the use of a transanal tube as an alternative endoluminal diversion technique for rectal carcinoma can reduce the 30-day leakage rate after LAR. Methods From June 2003 to December 2009, a total of 398 patients were randomized to a transanal tube or not after LAR. Inclusion criteria for randomization were biopsy-proven carcinoma of the rectum located ≤15 cm above the anal verge, measured with a rigid rectoscope; age ≥ 18 years; informed consent; ability to understand the study information; estimated survival of >6 months; anterior resection for the lesion; final negative air leakage test; intact anastomotic stapler rings; and the absence of major intraoperative adverse events. Results Patient demographics, tumor size and location, Duke’s stage, preoperative co-morbidity, and operative details were comparable between the two groups in general analysis and subgroup analysis (double-staple technique and handsewn technique). The overall rate of symptomatic leakage was 6.78% (27 of 398 patients). Patients randomized to a transanal tube ( n  = 200) had leakage in 4.0% (8 of 200 patients) and those without a tube ( n  = 198) in 9.6% (19 of 198 patients) ( p  = 0.026). With regard to the double-staple technique subgroup, 3.7% (7 of 188) patients with a tube presented with a symptomatic anastomotic leakage, compared with 9.3% (17 of 182) of those without a tube ( p  = 0.028). Of the patients with anastomotic leakage in the double-staple technique subgroup, the need for urgent abdominal reoperation was 28.6% (two of seven patients) in those randomized to a transanal tube and 82.4% (14 of 17) in those without ( p  = 0.021). The 30-day mortality after LAR was nil. In the double-staple technique subgroup, a quicker resumption of gastrointestinal motility manifested by a smaller ratio of patients with flatus > postoperative day (POD) 3 ( p  = 0.019) and a smaller ratio of poor gastrointestinal electromyogram on POD 3 ( p  < 0.001) was associated with use of a transanal tube. Additionally, patients with a tube appeared to have a lower rectal resting pressure by POD 3 (4.0 ± 2.2 vs. 5.0 ± 2.2 kPa; p  < 0.001) or POD 5 (4.3 ± 2.3 vs. 5.6 ± 2.3 kPa; p  < 0.001), compared to the resting pressures patients without the device, respectively. A shorter length of hospital stay was associated with use of a transanal tube both in the double-staple technique subgroup ( p  < 0.001) and the handsewn technique subgroup ( p  = 0.011). Multivariate logistic regression analysis revealed that body mass index > 25 kg/m 2 and a poor gastrointestinal electromyogram on POD 3 were found to be independent risk factors for anastomotic leakage in the low anastomosis subgroup. Conclusions The presence of a transanal tube is effective and safe in decreasing the rate of clinically significant anastomotic leaks and in mitigating the clinical consequences of leakage after anterior resection for rectal cancer with the technique of total mesorectal excision and double-staple anastomosis. The potential benefits of transanal tube placement are multifactorial, including drainage, reduction of endoluminal pressure, and promotion of gastrointestinal motility. Obesity and poor gastrointestinal electromyogram on POD 3 are independent risk factors for anastomotic leakage in patients with low anastomosis.
Reinforcing the Staple Line During Laparoscopic Sleeve Gastrectomy: Prospective Randomized Clinical Study Comparing Two Different Techniques. Preliminary results
Background Sleeve gastrectomy involves the creation of small gastric reservoir based on lesser curvature of the stomach, which is fashioned by a longitudinal gastrectomy that preserves the antrum and pylorus together with its vagal innervation. The main complications in the early postoperative course are bleeding and gastric leak. In order to reduce these complications the staple line can be reinforced in many different ways. The purpose of this study was to randomly compare two different techniques in laparoscopic sleeve gastrectomy (LSG): buttressing the staple line at the gastroesophageal junction (angle of Hiss) with Gore Seamguard and staple-line suturing with PDS 2.0. Methods Between July 2009 and July 2010, 90 patients were prospectively and randomly enrolled in the two different techniques of handling the staple line during LSG. Forty-eight of these patients belonged in group A (application of Gore Seamguard) and 42 in group B (application of a continuous suture). Operative and postoperative complications were recorded. Results Postoperative leak affected two patients in group A (4.2%) and bleeding occurred in one patient of group A (2%). Total complication rate was 6.2% for group A. No major surgical complication occurred in group B. The differences between the two groups did not reach statistical significance. Conclusions No significant difference is evidenced in terms of bleeding and postoperative leak between the two techniques of enhancing the staple line in LSG. Suturing of the staple line may be more time consuming but costs are considerably less.
Laparoscopy-assisted versus open distal gastrectomy for gastric cancer in elderly patients: a retrospective comparative study
Background With the current increased longevity in elderly population, surgeons can expect to operate more frequently on elderly patients with both malignancies and comorbid medical conditions. This study aimed to compare the surgical and early postoperative outcomes of laparoscopy-assisted distal gastrectomy (LADG) with those of open distal gastrectomy (ODG) for gastric cancer in patients 70 years of age or older. Methods Retrospective analysis based on a prospectively collected database of elderly patients who underwent laparoscopy-assisted distal gastrectomy or ODG from February 2013 to January 2014. Preoperative patient baseline parameters, surgical and oncological outcomes, postoperative complications and pathologic results were analyzed in this report. Results Distal gastrectomy was performed for 50 patients with the age of 70 years or older, using laparoscopic surgery for 23 patients (LADG group) and open surgery for 27 patients (ODG group). The mean age of LADG group was 76.6 years and ODG group 80.0 years. The comparison between the two groups revealed statistically similar results regarding age, gender, BMI, ASA class, history of previous surgeries, CCI and pathologic characteristics. The LADG group was characterized by less intraoperative blood loss (LADG group 100 mL vs. ODG group 250 mL, P  < 0.001), less narcotic use (LADG group 1 day vs. ODG group 3 days, P  < 0.001), faster bowel function recovery (time to first flatus: LADG group 51.6 h vs. ODG group 67.2 h, P  < 0.001; days to oral intake: LADG group 6.1 days vs. ODG group 7.9 days, P  = 0.002) and shorter postoperative hospital stay (LADG group 12 days vs. ODG group 16 days, P  < 0.001). There was no significant difference in postoperative complication rate (overall complication rate: LADG group 21.7 % vs. ODG group 25.9 %, P  = 0.730), survival rate ( P  = 0.719), postoperative recurrence and metastasis rate between the patients who underwent LADG and ODG. Conclusions LADG for gastric cancer is feasible, efficacious and safe in elderly patients and may be superior to conventional open resection as regards some surgical outcomes.