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Completed

NCT Number: NCT04434508

Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

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.

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Key information

Conditions

Colonic Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ayman El Nakeeb

Al Mansurah, Outside U.S and Canada, 35111, Egypt

About this 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.

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

laparoscopic right hemicolectomy with CME and central v

Procedure

laparoscopic right hemicolectomy with CME and central v

Other names: LHC with CME

Open right hemicolectomy with CME and central v

Procedure

Open right hemicolectomy with CME and central v

Other names: ORH with CME

Primary outcomes

  1. the number of lymph nodes (LNs) harvested among both groups

    Time frame: 30 DAYS

    the number of lymph nodes (LNs) harvested among both groups

Secondary outcomes

  1. operative time

    Time frame: INTRAOPERATIVE

    operative time

  2. blood loss,

    Time frame: intraoperative

    blood loss,

  3. post-operative complications

    Time frame: 30 days

    post-operative complications

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Acronym: CME

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jun 17, 2020
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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