Intracorporeal Anastomosis Versus Extracorporeal Anastomosis for Left Colon Cancer

Not Applicable

Active, not recruiting

• Conditions: Colon Cancer

• Registration Number: NCT04201717
• Lead Sponsor: Jilin University

Brief Summary

This study aims to investigate the effects of intracorporeal anastomosis and extracorporeal anastomosis in laparoscopic-assisted radical left hemicolectomy on surgical site infection. Also consider perioperative recovery, safety, and oncology outcomes.

Detailed Description

This is a prospective, randomized controlled trial. In this trial, cases in the intracorporeal anastomosis group and the extracorporeal anastomosis group are allocated at a 1:1 ratio among patients undergoing laparoscopic radical left hemicolectomy. The peri-operative recovery data, complications, oncology outcomes, and survival are compared.

Study Timeline

• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-14
• Study First Posted: 2019-12-17
• Study Start: 2021-01-27
• Primary Completion: 2024-07-03
• Results First Submitted: 2024-11-08
• Results First Submitted QC: 2025-02-04
• Results First Posted: 2025-02-26
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-20
• Last Update Posted: 2025-05-07
• Study Completion: 2029-07-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Count of Participants With Surgical Site Infection (SSI)	one month after surgery	The primary outcome was the incidence of SSI based on the Definitions of CDC guidelines: superficial incisional, deep incisional, and organ/space infections . Infections involving both organ/space and the incisional site (superficial or deep) were categorized as organ/space infections. Surgeons and nurses assessed the presence of infection daily during hospitalization. After hospital discharge, all patients were followed up until 30 days after surgery at outpatient clinics to check the wound.

Secondary Outcome Measures

Name	Time	Method
the Incidence of Complications	one month after surgery	It includes fever of unknown origin, bowel obstruction, anastomotic leakage, SSI, other incisional complications, respiratory complications, urinary complications, cardiovascular and cerebrovascular complications, diarrhea, chylous fistula, intraperitoneal hemorrhage, digestive hemorrhage, gastroparesis, and others (including bacteremia, cholecystitis, ion discharge, pancreatitis, and mental and behavioral abnormalities). Complications are graded according to the Clavien-Dindo classification.
Completeness of Specimens	one hour after surgery	It is evaluated according to the West classification. The resected specimens will be classified into three groups according to the plane of dissection: mesocolic plane, intramesocolic plane, and muscularis propria plane.
Number of Lymph Nodes Dissected	one week after surgery	The number of lymph nodes in the mesentery will be calculated. Additionally, the metastatic lymph nodes will be counted.
the Incision Length	one hour after surgery	The incision length is measured with an aseptic ruler at the end of the surgery, after the incision is sutured. It is measured in millimeters.
Visual Analogue Scale/Score (VAS)	2 days after surgery	Pain severity was assessed 48 hours after the operation using a ruler about 10 cm long. The ruler is numbered from 0 to 10. 0-3 points indicate no to mild pain. 4-6 points represent moderate pain. 7-10 points stand for severe pain.
3-year DFS (Disease-free Survival)	three years after the operation	DFS was defined as the time from randomization until the discovery of local recurrence, distant metastasis, or death from the tumor.
5-year OS (Overall Survival)	five years after the operation	OS was defined as the time from randomization to death due to any cause.
The Rate of Conversion to Open Surgery	one hour after surgery	It is defined as an abdominal incision larger than that necessary for specimen extraction.
First Defecation Time	one week after surgery	time to first defecate, measured in days.
Postoperative Hospital Stay	one month after surgery	The length of hospital stay after surgery.
the Blood Loss	one hour after surgery	It is defined as the blood loss during operation and is measured in milliliters.
the Operating Time	one hour after surgery	It is defined as the period from cutting the skin to suturing the skin or doing enterostomy. It is measured in minutes
First Time for Fluid Diet	one week after surgery	time to start food intake, measured in days

Trial Locations

Locations (3)

the First Hospital of Jilin University; 🇨🇳 Changchun, Ji Lin, China

Beijing Friendship Hospital, Capital Medical University; 🇨🇳 Beijing, China

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China