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

NCT05034692 | Unknown

• 1 other identifier: K202012-10
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Colon Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• anastomotic orifice stricture and torsion

  one month after surgery

• the time of first flatus

  one month after surgery

• the time of first defecation

  one month after surgery

• the time of first oral feeding

  one month after surgery

• postoperative hospitalization days

  one month after surgery

Study Arms (2)

Overlap group

EXPERIMENTAL

Total laparoscopic with intracorporeal anastomosis by overlap method

Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method

Traditional group

ACTIVE COMPARATOR

Laparoscopic-assisted colectomy with extracorporeal anastomosis

Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis

Interventions

Total laparoscopic with intracorporeal anastomosis by overlap method PROCEDURE

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

Overlap group

Laparoscopic-assisted colectomy with extracorporeal anastomosis PROCEDURE

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.

Traditional group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA\<3 classification
• kg/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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

General Surgery Gastrointestinal Department，Tang-Du of Fourth Military Medical University

Xi'an, Shaanxi, 710000, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Wang Nan, Doctor

  General surgery ,Tang Du of Fourth Military Medical University

  STUDY CHAIR

Central Study Contacts

Nan Wang, Doctor

CONTACT

0086-029-84778829; wangnandoc@163.com

Nan Wang, Master

CONTACT

0086-029-84717400; 1620544187@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2021
• First Posted: September 5, 2021
• Study Start: March 21, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 31, 2025
• Last Updated: October 24, 2022

Record last verified: 2022-10

Locations

CN (1)