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Background The efficacy and safety outcomes of laparoscopy-assisted distal gastrectomy (LADG) with D2 lymph node dissection for locally advanced gastric cancer remain unclear. Therefore, we conducted a randomized, controlled phase II trial to confirm the feasibility of LADG in terms of technical safety, and short-term surgical outcomes were investigated. Methods Eligibility criteria included pre-operatively diagnosed advanced gastric cancer that could be treated by distal gastrectomy with D2 lymph node dissection; MP, SS, and SE without involvement of other organs; and N0–2 and M0. Patients aged 20–80 years were pre-operatively randomized. Results In total, 180 patients were registered and randomized to the open (89 patients) and laparoscopic arms (91 patients). Among 91 patients in the laparoscopic arm, 86 underwent laparoscopic gastrectomy according to the study protocol. Regarding the primary endpoint of the phase II trial, the proportion of patients with either anastomotic leakage or pancreatic fistula was 4.7 % (4/86). The grade 3 or higher morbidity rate, including systemic and local complications, was 5.8 %. Conversion to open surgery was required for 1 patient (1.2 %), without any intra-operative complication. The post-operative mortality rate was 0, and no patient required readmission for surgical complications within 6 months after initial discharge. Conclusions The technical safety of LADG with D2 lymph node dissection for locally advanced gastric cancer was demonstrated. A phase III trial to confirm the non-inferiority of this procedure to open gastrectomy in terms of long-term outcomes is ongoing. Registered Number: UMIN 000003420 ( www.umin.ac.jp/ctr/ ).

BackgroundRight hemicolectomy is a very common surgery. Many studies compare different options for laparoscopic ileocolic anastomoses: intra- or extracorporeal; handsewn or stapled; side-to-side or end-to-side. However, there are no studies about the influence that peristalsis could have on this anastomosis. The aim of this study is to compare safety and feasibility of isoperistaltic and antiperistaltic anastomosis in terms of postoperative morbidity and mortality between both groups. The secondary endpoint is to compare long-term functional outcomes (chronic diarrhoea) and quality of life (GIQLI questionnaire) after a 1-year follow-up period.MethodsA double-blind, randomised, prospective trial in patients undergoing scheduled surgery for right colon cancer with laparoscopic right hemicolectomy and isoperistaltic (ISO) or antiperistaltic (ANTI) ileocolic anastomoses.ResultsHundred and eight patients were included in the study. Patients were randomised either to isoperistaltic or antiperistaltic configuration (54 ISO/ANTI). No significant differences in baseline variables were found. No differences in surgical time (130 [120–150] min ISO vs. 140 [127–160] ANTI, p = 0.481), nor in anastomotic time (19 [17–22] vs. 20 [16–25], p = 0.207) and nor in postoperative complications: 37.0% ISO versus 40.7% ANTI, (p = 0.693) were found. There were no differences in postoperative ileus (p = 0.112) nor in anastomotic leakage (3.7% vs. 5.56%, p = 1.00). Differences in “time to first flatus” and “time to first deposition” were found in favour of the antiperistaltic group (p = 0.004 and p = 0.017). Anastomotic configuration did not influence hospital stay (3 days [2–6] isoperistaltic vs. 3 [2–4] antiperistaltic, p = 0.236). During follow-up, there were no differences between the two groups at 1, 6 and 12 months (p = 0.154, p = 0.498 and p = 0.683), nor in chronic diarrhoea rates in GIQLI scores (24% ISO vs. 31.4% ANTI, p = 0.541).ConclusionsThe isoperistaltic and antiperistaltic ileocolic anastomosis present similar results in terms of performance, safety and functionality. However, further studies must be carried out in order to assess relationship between postoperative ileus and anastomosis configuration.Trial registrationRandomised Clinical trial (Identifier: NCT02309931).

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.

AimIn addition to ischemia there is also anastomotic ends tension proven to be a risk factor for anastomotic leak. HT vascular ligation is accepted as a rule, in attempt to achieve tension-free anastomosis. LT is a preferred option, based on the more accurate preservation of proximal intestinal segment microperfusion and lower risk of damage to the hypogastric plexus. The aim of this study is evaluation of comparative indicators in high tie (HT) and low tie (LT) laparoscopic rectal resections.MethodsA prospective nonrandomized comparative cohort study of patients in our department with cancer of the rectum in clinical stage I–III, operated on in laparoscopic approach over a 6-years period.ResultsFor the period 2015–2020, a number of 208 laparoscopic surgeries have been done for rectal cancer. Patients were divided into three groups—group A with HT vascular ligation 116 pts. (69%), group B—53 pts. (25%), underwent low ligation—LT and group C—39pts. (19%) low tie plus lymph node dissection of the apical LN group (LT-appic LND). The distribution was made without randomization, based on the operators’ expertise. Anastomotic leaks were 3.8% in group A, 3.0% in group B and 2.9% in group C (p > 0.05) with no significance difference. There is no significant difference in the number of lymph nodes obtained in group A and group B, while in group C the number of the harvested lymph nodes was higher (p < 0.05). The indicators for intestinal / defecation dysfunction, as well as for urinary/sexual dysfunction, according to our data, are significantly more favorable in patients with LT, in contrast to the other two groups.ConclusionHT vascular ligation attempts to achieve tension-free anastomosis and more harvested lymph nodes. However, LT could be a preferred option, based on the lack of significant evidence for a difference in specific oncological survival and due to more accurate preservation of proximal intestinal segment microperfusion to prevent anastomosis dehiscence, also for its lower risk of damage to the hypogastric plexus. Splenic flexure mobilization provides elongation of the proximal intestinal segment, but has no proven effect on anastomotic leakage incidence. It increases surgical duration and is in fact necessary in up to 30% of the cases. At the present moment there is no precise data whether LT has an advantage in terms of prevention of autonomic nervous and urogenital dysfunction. New prospective randomized and highly probative studies are needed to standardize the procedures in specific clinical situations.

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

BackgroundGastro-cutaneous fistula is a rare complication after laparoscopic sleeve gastrectomy (LSG) with incidence of occurrence 1–2%. Most of gastro-cutaneous fistulae do not respond to conservative management and need intervention either surgically or endoscopically. MethodsThis prospective randomized clinical study included referred patients who had LSG performed at our department or other centers, and complicated with post-LSG leak or gastro-cutaneous fistula between December/2019 and March/2021. Included patients were ASA Physical status I–II. Primary and secondary outcomes were recurrence of the fistula and mortality in each group after the intervention during the 18 months follow-up period, respectively.ResultsThirty patients were randomized into two groups: Surgery Group (SG, n = 15) and Endoscopy Group (EG, n = 15). Mean age of patients was 42.3 ± 8.7 and 42.6 ± 8.3 years-old in SG and EG, respectively. Females constituted 73.3% and 80% in SG and EG, respectively. Median time-to-gastric leak post LSG was six (range: 4–7) days in both groups. SG patients were surgically managed with primary repair of the gastric fistula and gastrojejunostomy in 13 patients or converting SG into Roux-en-Y gastric bypass in two patients, while EG patients were endoscopically managed with stitching, stenting, stenting and dilation, and clipping and dilation in 5, 4, 4 and 2 patients, respectively. Incidence of recurrent leak during 1st week was significantly higher in SG than EG (p < 0.001). No mortality reported in EG, while 2 patients died in SG (p = 0.48).ConclusionEndoscopic intervention may offer a successful modality in managing post-LSG gastric leak and gastro-cutaneous fistula that do not respond to conservative measures in stable patients.

BackgroundColonic anastomotic leak and fistula following anterior resection surgery for rectal cancer are associated with high mortality rates. The incidence of occurrence varies from 2 to 25% and it is difficult to accurately calculate the incidence of fistula and leak post anterior resection, as most of them are asymptomatic. Endoscopic management of fistula and leak has become the first line of management after conservative management in many gastrointestinal surgical centers with the advantages of being less invasive, shorter length of post-operative hospital stay, effective and rapid recovery in comparison to revision surgery. Effective endoscopic management for colonic fistula or leak depends on the clinical status of the patient and fistula characters (time-to-occur and size and site of defect), and device availability.MethodsThis prospective randomized controlled clinical trial included all patients who developed the manifestations of low output recurrent colonic fistula or leak after colonic anterior resection for rectal cancer at Zagazig University Hospital between (December 2020 and August 2022). Sample size was 78 patients divided into two equal groups. Endoscopic group (EG): included 39 patients who underwent endoscopic management. Surgical group (SG): included 39 patients who underwent surgical management.ResultsThe investigators randomized eligible 78 patients into two groups: 39 patients in SG and 39 patients in EG. The median size of the fistula or leak was nine (range: 7–14) mm in EG, versus ten (range: 7–12) mm in SG. Clipping and Endo-stitch device were used in 24 patients versus 15 patients, respectively, in EG while primary repair with ileostomy, and resection & anastomosis were used in 15 patients versus 24 patients, respectively, in SG. Recurrence, abdominal collection, and mortality were the post procedure’s complications with incidence of occurrence of 10.3, 7.7 and 0%, respectively, in EG versus 20.5, 20.5 and 2.6%, respectively, in SG. Excellent, good, and poor were the parameters for quality of life with incidence of occurrence of 43.6, 54.6 and 0%, respectively, in EG versus 28.2, 33.3 and 38.5%, respectively, in SG. Median hospital stay was one (range: 1–2) day in endoscopic group, and seven (range: 6–8) days in SG.ConclusionEndoscopic intervention may offer a successful modality in managing low output recurrent colonic fistula or leak after anterior resection for rectal cancer that did not respond to conservative measures in stable patients.ClinicalTrials.gov ID: NCT05659446.

Esophageal cancer has an overall five-year survival rate of < 20%. The McKeown esophagectomy is invasive and carries a high risk of anastomotic leakage. Robust prospective outcome data comparing non-placement versus placement of a cervical drainage tube during McKeown esophagectomy are lacking. This study aimed to evaluate whether the placement of a cervical drainage tube is useful. In this randomized controlled, noninferiority trial, 106 patients with histologically proven, surgically resectable esophageal carcinoma were randomized to either placement or non-placement of a cervical drainage tube. The primary outcome was the percentage of Clavien-Dindo grade 2 or higher anastomotic leakage. Secondary outcomes included the duration from surgery to oral intake, hospital stay, and type and dose of analgesics used during hospitalization. Fifty-two and 54 patients were randomized to McKeown esophagectomy with non-placement and placement of a cervical drainage tube, respectively. There was no significant difference in anastomotic leakage rates between the non-placement (12/52 [23%]) and placement (13/54 [24%]) of drainage tube. However, non-inferiority was not demonstrated (risk difference, -0.100 [-0.17, 0.15]; p = 0.0591). There were no significant differences in the secondary outcome measures. Non-inferiority of nonplacement of a drainage tube around the cervical anastomosis after McKeown esophagectomy to placement of that was not demonstrated. Further large multicenter studies are needed.Trial registration: Japan Registry of Clinical Trials (identification number jRCT1052180016).

BackgroundAnastomotic leak is a serious complication following esophagectomy. The aim of the study was to report our experience with indocyanine green fluorescence angiography (ICG-FA)—PINPOINT® assisted minimally invasive Ivor Lewis esophagectomy (MILE) and assess factors associated with anastomotic leak.MethodsWe reviewed consecutive patients undergoing MILE from 2013 to 2018. Intraoperative real-time assessment of gastric conduit was performed using ICG-FA with PINPOINT®. Perfusion was categorized as good perfusion (brisk ICG visualization to conduit tip) or non-perfusion (any demarcation along the conduit).Results100 patients (81 males, median age 68 [60–72]) underwent MILE for malignancy in 96 patients and benign disease in 4 patients. There were six anastomotic leaks all managed with endoscopic stent placement. There was no intraoperative mortality and no 30-day mortality in leak patients. Patients with a leak were more likely to be overweight with BMI > 25 (100% versus 53%, p = 0.03), have pre-existing diabetes (50% versus 13%, p = 0.04), and have higher intraoperative estimated blood loss (260 mL [95–463] versus 75 mL [48–150], p = 0.03). Anastomotic leaks occurred more frequently in the non-perfusion (67%) versus the good perfusion category (33%, p = 0.03). By multivariable analysis, diabetes (odds ratio [OR] 6.42; p = 0.04) and non-perfusion (OR 6.60; p = 0.04) were independently associated with leak.ConclusionIntraoperative use of ICG-FA may be a useful adjunct to assess perfusion of the gastric conduit with non-perfusion being independently associated with a leak. While perfusion plays an important role in anastomotic integrity, development of a leak is multifactorial, and ICG-FA should be used in conjunction with the optimization of patient and procedural components to minimize leak rates. Prospective, randomized studies are required to validate the interpretation, efficacy, and application of this novel technology in minimally invasive esophagectomies.

Purpose Remote ischemic preconditioning (RIPC) reportedly reduces ischemia‒reperfusion injury (IRI) in various organ systems. In addition to tension and technical factors, ischemia is a common cause of anastomotic leakage (AL) after rectal resection. The aim of this pilot study was to investigate the potentially protective effect of RIPC on anastomotic healing and to determine the effect size to facilitate the development of a subsequent confirmatory trial. Materials and methods Fifty-four patients with rectal cancer (RC) who underwent anterior resection were enrolled in this prospectively registered (DRKS0001894) pilot randomized controlled triple-blinded monocenter trial at the Department of Surgery, University Medicine Mannheim, Mannheim, Germany, between 10/12/2019 and 19/06/2022. The primary endpoint was AL within 30 days after surgery. The secondary endpoints were perioperative morbidity and mortality, reintervention, hospital stay, readmission and biomarkers of ischemia‒reperfusion injury (vascular endothelial growth factor, VEGF) and cell death (high mobility group box 1 protein, HMGB1). RIPC was induced through three 10-min cycles of alternating ischemia and reperfusion to the upper extremity. Results Of the 207 patients assessed, 153 were excluded, leaving 54 patients to be randomized to the RIPC or the sham-RIPC arm (27 each per arm). The mean age was 61 years, and the majority of patients were male (37:17 (68.5:31.5%)). Most of the patients underwent surgery after neoadjuvant therapy (29/54 (53.7%)) for adenocarcinoma (52/54 (96.3%)). The primary endpoint, AL, occurred almost equally frequently in both arms (RIPC arm: 4/25 (16%), sham arm: 4/26 (15.4%), p = 1.000). The secondary outcomes were comparable except for a greater rate of reintervention in the sham arm (9 (6–12) vs. 3 (1–5), p = 0.034). The median duration of endoscopic vacuum therapy was shorter in the RIPC arm (10.5 (10–11) vs. 38 (24–39) days, p = 0.083), although the difference was not statistically significant. Conclusion A clinically relevant protective effect of RIPC on anastomotic healing after rectal resection cannot be assumed on the basis of these data.