A Prospective Phase II Clinical Study on Continuous Circumferential Reinforcement of the Anastomotic Site With Laparoscopic Rectal Anastomosis to Prevent Complications.
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- ZHI-ZHONG PAN
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Incidence of Clinically and Radiologically Confirmed Anastomotic Leakage within 30 Days Postoperatively
Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histological Confirmation:
- •Diagnosed with rectal adenocarcinoma confirmed by histology.
- •Tumor Location:
- •MRI confirms a mid to upper rectal tumor, with the lower margin of the tumor located 6-12 cm from the anal verge.
- •Preoperative Staging:
- •Preoperative MRI staging indicates the presence or absence of MRF positivity and/or EMVI positivity; the surgical team assesses the tumor as resectable with an estimated R0 resection.
- •Bowel Obstruction:
- •No signs of bowel obstruction.
- •Neoadjuvant Chemoradiotherapy:
- •For patients who have received neoadjuvant chemoradiotherapy, complete radiotherapy and baseline imaging records must be available at this center.
Exclusion Criteria
- •Patients meeting any of the following conditions will be excluded from the study:
- •Need for Multiorgan Resection:
- •Patients requiring combined organ resection.
- •Preventive or Permanent Stoma:
- •Patients requiring preventive or permanent stoma.
- •Hartmann or Miles Procedures:
- •Patients requiring Hartmann's procedure or Miles' surgery.
- •Cardiac Conditions:
- •Arrhythmias requiring antiarrhythmic treatment (excluding β-blockers or digoxin), symptomatic coronary artery disease, localized myocardial ischemia (myocardial infarction within the last 6 months), or congestive heart failure beyond NYHA Class II.
- •Uncontrolled Hypertension:
Outcomes
Primary Outcomes
Incidence of Clinically and Radiologically Confirmed Anastomotic Leakage within 30 Days Postoperatively
Time Frame: 30-days after surgery
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.
Secondary Outcomes
- Time to First Postoperative Flatus(3-days after surgery)
- Time to First Postoperative Oral Intake(3-days after surgery)
- Incidence of Postoperative Intra-abdominal Hemorrhage(14-days after surgery)
- Incidence of Postoperative Anastomotic Stricture(60-days after surgery)
- Incidence of Postoperative Anastomotic Hemorrhage(14-days after surgery)
Investigators
ZHI-ZHONG PAN
Prof.
Sun Yet-Sen University Cancer Center