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

NCT ID: NCT05034692

Last Updated: 2022-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Colon Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Overlap group

Total laparoscopic with intracorporeal anastomosis by overlap method

Group Type EXPERIMENTAL

Total laparoscopic with intracorporeal anastomosis by overlap method

Intervention Type 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

Traditional group

Laparoscopic-assisted colectomy with extracorporeal anastomosis

Group Type ACTIVE_COMPARATOR

Laparoscopic-assisted colectomy with extracorporeal anastomosis

Intervention Type 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.

Interventions

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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

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tang-Du Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wang Nan, Doctor

Role: STUDY_CHAIR

General surgery ,Tang Du of Fourth Military Medical University

Locations

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

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Nan Wang, Doctor

Role: CONTACT

0086-029-84778829

Nan Wang, Master

Role: CONTACT

0086-029-84717400

Facility Contacts

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Wang Nan, Doctor

Role: primary

0086-029-84778829

Nan Wang, Master

Role: backup

0086-029-84717400

Other Identifiers

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K202012-10

Identifier Type: -

Identifier Source: org_study_id

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