Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy

Not Applicable

Recruiting

• Conditions: Colon Neoplasm
• Interventions: Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method; Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis

• Registration Number: NCT05034692
• Lead Sponsor: Tang-Du Hospital

Brief Summary

Objective:The comparison between total laparoscopic colectomy with intracorporeal anastomosis by overlap method and laparoscopic-assisted colectomy with extracorporeal anastomosis for colon cancer surgery.

Condition or disease：Left colon cancer Intervention/treatment： Procedure:Intracorporeal left colectomy Overlap anastomosis Procedure: Extracorporeal left colectomy convention anastomosis

Detailed Description

This a simple randomized, single-center, single-blind, randomized controlled trial study.The patients were randomly divided into experimental groups and control groups by computer.The perioperative recovery data, complications and oncology index of total laparoscopic colectomy with intracorporeal anastomosis and laparoscopic-assisted colectomy with extracorporeal anastomosis would be compared.

Study Timeline

• Study First Submitted: 2021-02-06
• Study First Submitted QC: 2021-08-29
• Study First Posted: 2021-09-05
• Study Start: 2022-03-21
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-20
• Last Update Posted: 2022-10-24
• Primary Completion: 2024-12-20
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• ASA<3 classification
• 18kg/m2≤BMI≤30kg/m2
• Neoplasm staging is T1-4a, N0-2, M0
• No previous history of abdominal surgery
• No previous history of neoplasm chemoradiotherapy
• No status of ileus, bowel obstruction and active hemorrhage of the digestive tract

Exclusion Criteria

• Age<18 years or >75 years
• ASA≥3 classification
• BMI<18kg/m2 or BMI>30kg/m2
• Neoplasm staging is T4b or M1 Underwent chemoradiotherapy Appeared status of ileus,bowel perforation or active hemorrhage of digestive tract Patients with pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Overlap group	Total laparoscopic with intracorporeal anastomosis by overlap method	Total laparoscopic with intracorporeal anastomosis by overlap method
Traditional group	Laparoscopic-assisted colectomy with extracorporeal anastomosis	Laparoscopic-assisted colectomy with extracorporeal anastomosis

Primary Outcome Measures

Name	Time	Method
The incidence of early complications	one month after surgery	According to Clavein Dindo grading standards（The scale is divided into four levels, with the minimum（Ⅰ） and the maximum（Ⅳ） level. The higher the level that more severe symptoms.）, the incidence of complications within one month after surgery, such as incision infection, bleeding, anastomotic leakage, ileus, etc., was counted

Secondary Outcome Measures

Name	Time	Method
the time of first defecation	one month after surgery	Observation of patients bowl movement on days after operation
anastomotic orifice stricture and torsion	one month after surgery	According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment
the time of first flatus	one month after surgery	Observation of patients exhaust on days after operation
the time of first oral feeding	one month after surgery	Observation of patients oral intake on days after operation
postoperative hospitalization days	one month after surgery	Observation of patients hospitalization duration on days post-surgery
the incision length and cosmetic	one month after surgery	Comparing length and cosmetic of two groups measuring with metric
pain score	postoperative 6 hours, the first day and the third day	Estimate for pain of subject By Visual Analog Scale for Pain (VAS Pain，The scale is divided into four levels, with the minimum（1 score） and the maximum（10 score） level. The higher the level that more severe pain.)

Trial Locations

Locations (1)

General Surgery Gastrointestinal Department，Tang-Du of Fourth Military Medical University; 🇨🇳 Xian, Shan XI Province, China