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

Sponsor

Tang-Du Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05034692

Collaborator

(none)

Enrollment

Location

Arms

33.4

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Colon Neoplasm	Procedure: Total laparoscopic with intracorporeal anastomosis by overlap method Procedure: Laparoscopic-assisted colectomy with extracorporeal anastomosis	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Mar 21, 2022

Anticipated Primary Completion Date :

Apr 20, 2022

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

The incidence of early complications [one month after surgery]
According to Clavein Dindo grading standards, the incidence of complications within one month after surgery, such as incision infection, bleeding, anastomotic leakage, ileus, etc., was counted

Secondary Outcome Measures

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 defecation [one month after surgery]
Observation of patients bowl movement 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Surgery Gastrointestinal Department，Tang-Du of Fourth Military Medical University	Xian	Shan XI Province	China	710000

Sponsors and Collaborators

Tang-Du Hospital

Investigators

Study Chair: Wang Nan, Doctor, General surgery ,Tang Du of Fourth Military Medical University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tang-Du Hospital

ClinicalTrials.gov Identifier:

NCT05034692

Other Study ID Numbers:

K202012-10

First Posted:

Sep 5, 2021

Last Update Posted:

Apr 11, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colonic Neoplasms

Study Results

No Results Posted as of Apr 11, 2022