Intracorporeal Versus Extracorporeal Anastomotic After Laparoscopic Right Colectomy
- Conditions
- Colon Cancer
- Interventions
- Procedure: Intracorporeal anastomotic after LRCProcedure: Extracorporeal anastomotic after LRC
- Registration Number
- NCT05493033
- Lead Sponsor
- Beijing Friendship Hospital
- Brief Summary
Background: Laparoscopic assisted right hemicolectomy is recommended for right colon cancer. As a more minimally invasive procedure, intracorporeal ileocolic anastomosis has potential advantages: reducing torsion and traction on the mesentery, reducing skin incision length and enhancing postoperative recovery. However, the longer operative time, greater risk of intra-abdominal infection and steep learning curve for intestinal anastomosis performed under laparoscopic conditions, does this increase the incidence of postoperative complications, especially the incidence of anastomotic leakage, and whether it affects There is no high-level research evidence on the survival of patients.
Study design: COlOR IV study is an international prospective, multicenter, randomized controlled clinical study of intraperitoneal anastomosis versus extraperitoneal anastomosis after laparoscopic right hemicolectomy for colon cancer . The study will include a quality assessment phase before randomisation to ensure required competency level and uniformity of the intracorporeal and extracoporeal techniques.
Endpoint: Primary outcome is anastomotic leakage within 30 days after surgery. Main secondary endpoint is 3-year disease-free survival rate. Secondary endpoints are mortality and morbidity, postoperative recovery, overall survival, surgical specimen quality, quality of life.
Statistics: The primary endpoint is anastomotic leakage within 30 days after surgery. The anastomotic leakage rate was set to 2% in the both groups, and an increase in the incidence of anastomotic leakage of 2.5% was considered inferior. The one-sided significance level was 0.025, the power was 0.9. The dropout rate was 20%, and taking into account the post-randomization analysis (dropout 5%), the total sample size was 1158. There were 579 cases in the intracorporeal anastomosis group and 579 cases in the extracorporeal anastomosis group.
Main selection: Patients with histologically proven right colon cancer (cecum, ascending colon and proximal 1/3 of the transverse colon malignant tumor), clinically stage I-III, and intention for right hemicolectomy with primary anastomosis.
Hypothesis: The hypothesis is that intracoporeal anastomosis will have comparable anastomotic leak rate and 3-year DFS, but faster postoperative recovery with extracoporeal anastomosis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 1158
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intracorporeal anastomotic after LRC Intracorporeal anastomotic after LRC - Extracorporeal anastomotic after LRC Extracorporeal anastomotic after LRC -
- Primary Outcome Measures
Name Time Method Anastomotic leak 30 days Anastomotic leakage is defined as a defect of the intestinal wall at the anastomotic site leading to a communication between intra- and extraluminal compartments.
Diagnosis of anastomotic leakage: The radiological examination (CT abdomen) will be completed if clinically suspected AL. AL is confirmed clinically, radiologically, endoscopically or intraoperatively. The severity of anastomotic leakage was judged with reference to the Clavien-Dindo classification.
- Secondary Outcome Measures
Name Time Method Length of hospital stay after surgery 1 month days from surgery to discharge
Pain score (VAS score) 1-3 days The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Health-related quality of life 1 year EORTC QLQ-CR29 and C30: questionnaires to evaluate the overall quality of life of patients with colorectal cancer, including 30 and 29 items, respectively, to score patients' overall quality of life, function, and symptoms. These are coded with four-point scales, namely "Not at all", "A little", "Quite a bit" and "Very much."
Conversion rate 1 month conversion to open surgery or conversion to extracorporeal anastomosis
Surgical incision length Intraoperative morbidity 5 years Disease-free survival rate 3/5 years Main secondary outcome
Overall survival 3/5 years Mortality 5 years Duration of surgery Intraoperative from incision to suture completion
Duration of anastomosis Intraoperative from the start of dissection of the bowel to the compeletion of the anastomosis
Time to first oral intake up to 1 week The day of surgery is day 0. The time interval between the day of the first oral intake after surgery and the day of surgery.
Time to first flatus passage after surgery 1 month The day of surgery is day 0. The time interval between the day of the first flatus passage after surgery and the day of surgery.
Time to first stool passage after surgery up to 1 week The day of surgery is day 0. The time interval between the day of the first stool passage after surgery and the day of surgery.
Specimen quality 1 month West pathological assessment criteria. Grading of the plane of mesocolic dissection.
1. Muscularis propria planeļ¼little bulk to mesocolon with disruptions extending down onto the muscularis propriapropria
2. Intramesocolic plane: moderate bulk to mesocolon with irregularity but the incisions do not reach down to the muscularis propria
3. Mesocolic plane: intact mesocolon with a smooth peritoneal-lined surfacehealth-related quality of life 1 year EQ 5D-5L (Euroqol): This questionnaire is a simple, generic tool for describing and assessing health-related quality of life. It consists of 5 items (mobility, personal care, activities of daily living, pain and anxiety and depression) that answer questions on a 5-point scale ranging from "no problem" (level 1) to "very severe" (level 5).
Incision herniation 1 year The incision herniation is classified by the criteria of the European Hernia Society. The location (Midline/Lateral) and size (length and width) of the herniation will be recorded.