Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer (CME)

June 12, 2020 updated by: Ayman El Nakeeb, Mansoura University

Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Outside U.S And Canada
      • Mansoura, Outside U.S And Canada, Egypt, 35111
        • Ayman El Nakeeb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with right colonic cancer

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: laparoscopic right hemicolectomy with CME and central v
Procedure: laparoscopic right hemicolectomy with CME and central v
laparoscopic right hemicolectomy with CME and central v
Other Names:
  • LHC with CME
Active Comparator: open right hemicolectomy with CME and central v
Procedure: Open right hemicolectomy with CME and central v
Open right hemicolectomy with CME and central v
Other Names:
  • ORH with CME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the number of lymph nodes (LNs) harvested among both groups
Time Frame: 30 DAYS
the number of lymph nodes (LNs) harvested among both groups
30 DAYS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
operative time
Time Frame: INTRAOPERATIVE
operative time
INTRAOPERATIVE
blood loss,
Time Frame: intraoperative
blood loss,
intraoperative
post-operative complications
Time Frame: 30 days
post-operative complications
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Ayman E Nakeeb, Mansoura University, Gastrointestinal Surgery Center
  • Study Director: Mohamed E el sorogy, MD, Mansoura University, Gastrointestinal Surgery Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2017

Primary Completion (Actual)

January 1, 2020

Study Completion (Actual)

January 25, 2020

Study Registration Dates

First Submitted

June 12, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 12, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • laparoscopic hemicolectomy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Study Protocol

IPD Sharing Time Frame

6 months

IPD Sharing Access Criteria

elnakeebayman@yahoo.com

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Study Data/Documents

  1. Study Protocol
    Information identifier: Ayman El Nakeeb
    Information comments: elnakeebayman@yahoo.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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