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

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

Study Overview

• Status: Recruiting
• Conditions: Colon Neoplasm
• Intervention / Treatment: Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method; Procedure: Laparoscopic-assisted colectomy with extracorporeal 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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nan Wang, Doctor; Phone Number: 0086-029-84778829; Email: wangnandoc@163.com
• Study Contact Backup: Name: Nan Wang, Master; Phone Number: 0086-029-84717400; Email: 1620544187@qq.com

Study Locations

• China
  • Shan XI Province
    • Xian, Shan XI Province, China, 710000
      • Recruiting
      • General Surgery Gastrointestinal Department,Tang-Du of Fourth Military Medical University
      • Contact: Nan Wang, Master; Phone Number: 0086-029-84717400; Email: 1620544187@qq.com
      • Contact: Wang Nan, Doctor; Phone Number: 0086-029-84778829; Email: wangnandoc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Overlap group; Total laparoscopic with intracorporeal anastomosis by overlap method	Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method; After the intestinal canal was dissociated and vascularized, the intestinal canal was nuded and cut off, and the distal and proximal intestinal canals were overlapped by 6 cm
Active Comparator: Traditional group; Laparoscopic-assisted colectomy with extracorporeal anastomosis	Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis; After the corresponding colon and blood vessels were dissociated and treated, the carbon dioxide pneumoperitoneum was removed. The appropriate length of the incision was cut at the corresponding position of the abdomen, and the incision protector was placed. The tumor was lifted together with the free intestinal canal to the outside of the abdomen. The intestinal canals at the quasi-dismembered sites on both sides of the tumor were nuded, and the colon-colon functional end-to-end anastomosis was performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of early complications	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	one month after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
anastomotic orifice stricture and torsion	According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment	one month after surgery
the time of first flatus	Observation of patients exhaust on days after operation	one month after surgery
the time of first defecation	Observation of patients bowl movement on days after operation	one month after surgery
the time of first oral feeding	Observation of patients oral intake on days after operation	one month after surgery
postoperative hospitalization days	Observation of patients hospitalization duration on days post-surgery	one month after surgery
the incision length and cosmetic	Comparing length and cosmetic of two groups measuring with metric	one month after surgery
pain score	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.)	postoperative 6 hours, the first day and the third day

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Study Chair: Wang Nan, Doctor, General surgery ,Tang Du of Fourth Military Medical University

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2022
• Primary Completion (Anticipated): December 20, 2024
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: February 6, 2021
• First Submitted That Met QC Criteria: August 29, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: K202012-10

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No