Prospective Phase II Study on Continuous Circumferential Reinforcement of Laparoscopic Rectal Anastomosis to Prevent Complications
NCT Number: NCT06495853
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Colorectal Cancer|Anastomotic Leakage|Operation
Interventions: PROCEDURE: Continuous Circumferential Reinforcement of the Anastomotic
Sponsor: ZHI-ZHONG PAN
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 208
Study Design: Allocation: NON_RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-07-20
Completion Date: 2025-11-01
Locations: Colorectal Department,SunYat-sen University Cancer Center, Guangzhou, Guangdong, 510062, China

Summary:
Anastomotic leakage (AL) is one of the most severe complications following laparoscopic rectal cancer surgery. According to the International Study Group of Rectal Cancer (ISREC), AL is defined as a defect of intestinal wall integrity at the colorectal or coloanal anastomosis leading to a communication between the intra- and extraluminal compartments, including defects of the suture or staple lines of the neorectal reservoir. AL is classified into three grades based on clinical severity: Grade A, identified only radiologically without clinical symptoms; Grade B, presenting with localized or atypical peritonitis requiring antibiotics and local drainage but not surgery; and Grade C, causing severe peritonitis, systemic toxicity symptoms requiring urgent surgical intervention, and potentially leading to life-threatening situations.

AL can prolong hospitalization, necessitate reoperation, delay chemotherapy, increase local recurrence rates, and adversely affect survival and quality of life. Emergency surgical management of AL often requires meticulous peritoneal lavage and ileostomy, aiming for subsequent anastomotic healing or future digestive tract reconstruction. However, some patients face significant challenges due to postoperative adhesions and persistent anastomotic defects despite prolonged lavage.

Identified risk factors for AL after rectal cancer surgery include male gender, advanced age, hypertension, diabetes, smoking, and advanced TNM staging (III-IV). Additionally, preoperative chemoradiotherapy-induced bowel edema and fibrosis, bowel obstruction, and long-term malnutrition resulting in hypoproteinemia are significant contributors. Mechanical reinforcement of anastomoses using sutures or absorbable barbed sutures has been shown to significantly reduce AL rates in previous studies.

This single-center prospective phase II clinical trial aims to evaluate the efficacy and safety of continuous circumferential reinforcement using absorbable barbed sutures in laparoscopic rectal anastomosis to prevent AL. We will compare the incidence of AL and other postoperative complications between patients undergoing reinforced anastomosis and a control group receiving standard laparoscopic rectal anastomosis.

Primary Outcome Measures: Incidence of Clinically and Radiologically Confirmed Anastomotic Leakage within 30 Days Postoperatively, Clinical and radiological assessment of anastomotic leakage within 30 days postoperatively, including Grade A and B leaks detected through imaging without clinical symptoms, as well as Grade C leaks with clear clinical manifestations., 30-days after surgery
Secondary Outcome Measures: Time to First Postoperative Flatus, Time to First Postoperative Flatus, 3-days after surgery|Time to First Postoperative Oral Intake, This refers to the duration from the end of surgery until the patient is able to tolerate oral intake of food or liquids., 3-days after surgery|Incidence of Postoperative Intra-abdominal Hemorrhage, This refers to the frequency at which patients experience bleeding within the abdominal cavity following surgery. It is typically assessed through clinical signs, imaging studies, and the need for interventions such as transfusions or reoperations., 14-days after surgery|Incidence of Postoperative Anastomotic Hemorrhage, This refers to the frequency at which patients experience bleeding at the site of the anastomosis following surgery. It is typically evaluated based on clinical symptoms, endoscopic findings, or imaging studies, and may require interventions such as endoscopic hemostasis, transfusions, or reoperation., 14-days after surgery|Incidence of Postoperative Anastomotic Stricture, This refers to the frequency at which patients develop a narrowing at the anastomotic site following surgery. This condition can be identified through symptoms such as difficulty in passing stool, abdominal pain, or diagnosed via endoscopy or imaging studies. It may require interventions such as balloon dilation, stenting, or surgical revision., 60-days after surgery