Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

Not Applicable

Completed

• Conditions: Colonic Cancer
• Interventions: Procedure: Open right hemicolectomy with CME and central v; Procedure: laparoscopic right hemicolectomy with CME and central v

• Registration Number: NCT04434508
• Lead Sponsor: Mansoura University

Brief Summary

The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.

Detailed Description

The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.

Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.

The primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2020-01-01
• Study Completion: 2020-01-25
• Status Verified: 2020-06
• Study First Submitted: 2020-06-12
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study First Posted: 2020-06-17
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with right colonic cancer

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Exclusion Criteria

• Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
open right hemicolectomy with CME and central v	Open right hemicolectomy with CME and central v	open right hemicolectomy with CME and central v
laparoscopic right hemicolectomy with CME and central v	laparoscopic right hemicolectomy with CME and central v	laparoscopic right hemicolectomy with CME and central v

Primary Outcome Measures

Name	Time	Method
the number of lymph nodes (LNs) harvested among both groups	30 DAYS	the number of lymph nodes (LNs) harvested among both groups

Secondary Outcome Measures

Name	Time	Method
blood loss,	intraoperative	blood loss,
operative time	INTRAOPERATIVE	operative time
post-operative complications	30 days	post-operative complications

Trial Locations

Locations (1)

Ayman El Nakeeb; 🇪🇬 Mansoura, Outside U.S And Canada, Egypt