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

Primary Purpose

Colon Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Total laparoscopic with intracorporeal anastomosis by overlap method
Laparoscopic-assisted colectomy with extracorporeal anastomosis
Sponsored by
Tang-Du Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Neoplasm

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Overlap group

Traditional group

Arm Description

Total laparoscopic with intracorporeal anastomosis by overlap method

Laparoscopic-assisted colectomy with extracorporeal anastomosis

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

anastomotic orifice stricture and torsion
According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment
the time of first flatus
Observation of patients exhaust on days after operation
the time of first defecation
Observation of patients bowl movement on days after operation
the time of first oral feeding
Observation of patients oral intake on days after operation
postoperative hospitalization days
Observation of patients hospitalization duration on days post-surgery
the incision length and cosmetic
Comparing length and cosmetic of two groups measuring with metric
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.)

Full Information

First Posted
February 6, 2021
Last Updated
October 20, 2022
Sponsor
Tang-Du Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05034692
Brief Title
Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
Official Title
Application of Overlap Method to Digestive Tract Reconstruction of Totally Laparoscopic Left Colectomy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
December 20, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tang-Du Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Overlap group
Arm Type
Experimental
Arm Description
Total laparoscopic with intracorporeal anastomosis by overlap method
Arm Title
Traditional group
Arm Type
Active Comparator
Arm Description
Laparoscopic-assisted colectomy with extracorporeal anastomosis
Intervention Type
Procedure
Intervention Name(s)
Total laparoscopic with intracorporeal anastomosis by overlap method
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic-assisted colectomy with extracorporeal anastomosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
The incidence of early complications
Description
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
Time Frame
one month after surgery
Secondary Outcome Measure Information:
Title
anastomotic orifice stricture and torsion
Description
According to results of intestinal barium contrast, colonoscopy and clinical symptoms to judgment
Time Frame
one month after surgery
Title
the time of first flatus
Description
Observation of patients exhaust on days after operation
Time Frame
one month after surgery
Title
the time of first defecation
Description
Observation of patients bowl movement on days after operation
Time Frame
one month after surgery
Title
the time of first oral feeding
Description
Observation of patients oral intake on days after operation
Time Frame
one month after surgery
Title
postoperative hospitalization days
Description
Observation of patients hospitalization duration on days post-surgery
Time Frame
one month after surgery
Title
the incision length and cosmetic
Description
Comparing length and cosmetic of two groups measuring with metric
Time Frame
one month after surgery
Title
pain score
Description
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.)
Time Frame
postoperative 6 hours, the first day and the third day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Wang, Doctor
Phone
0086-029-84778829
Email
wangnandoc@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Wang, Master
Phone
0086-029-84717400
Email
1620544187@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wang Nan, Doctor
Organizational Affiliation
General surgery ,Tang Du of Fourth Military Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
General Surgery Gastrointestinal Department，Tang-Du of Fourth Military Medical University
City
Xian
State/Province
Shan XI Province
ZIP/Postal Code
710000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wang Nan, Doctor
Phone
0086-029-84778829
Email
wangnandoc@163.com
First Name & Middle Initial & Last Name & Degree
Nan Wang, Master
Phone
0086-029-84717400
Email
1620544187@qq.com

12. IPD Sharing Statement

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

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