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

Primary Purpose

Colonic Cancer

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic right hemicolectomy with CME and central v
Open right hemicolectomy with CME and central v
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colonic Cancer focused on measuring Colonic Cancer, laparoscopic right hemicolectomy, complete mesocolic excision

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Ayman El Nakeeb

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

laparoscopic right hemicolectomy with CME and central v

open right hemicolectomy with CME and central v

Arm Description

laparoscopic right hemicolectomy with CME and central v

open right hemicolectomy with CME and central v

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

operative time
operative time
blood loss,
blood loss,
post-operative complications
post-operative complications

Full Information

First Posted
June 12, 2020
Last Updated
June 12, 2020
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT04434508
Brief Title
Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer
Acronym
CME
Official Title
Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 25, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Cancer
Keywords
Colonic Cancer, laparoscopic right hemicolectomy, complete mesocolic excision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
laparoscopic right hemicolectomy with CME and central v
Arm Type
Active Comparator
Arm Description
laparoscopic right hemicolectomy with CME and central v
Arm Title
open right hemicolectomy with CME and central v
Arm Type
Active Comparator
Arm Description
open right hemicolectomy with CME and central v
Intervention Type
Procedure
Intervention Name(s)
laparoscopic right hemicolectomy with CME and central v
Other Intervention Name(s)
LHC with CME
Intervention Description
laparoscopic right hemicolectomy with CME and central v
Intervention Type
Procedure
Intervention Name(s)
Open right hemicolectomy with CME and central v
Other Intervention Name(s)
ORH with CME
Intervention Description
Open right hemicolectomy with CME and central v
Primary Outcome Measure Information:
Title
the number of lymph nodes (LNs) harvested among both groups
Description
the number of lymph nodes (LNs) harvested among both groups
Time Frame
30 DAYS
Secondary Outcome Measure Information:
Title
operative time
Description
operative time
Time Frame
INTRAOPERATIVE
Title
blood loss,
Description
blood loss,
Time Frame
intraoperative
Title
post-operative complications
Description
post-operative complications
Time Frame
30 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayman E Nakeeb
Organizational Affiliation
Mansoura University, Gastrointestinal Surgery Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed E el sorogy, MD
Organizational Affiliation
Mansoura University, Gastrointestinal Surgery Center
Official's Role
Study Director
Facility Information:
Facility Name
Ayman El Nakeeb
City
Mansoura
State/Province
Outside U.S And Canada
ZIP/Postal Code
35111
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study Protocol
IPD Sharing Time Frame
6 months
IPD Sharing Access Criteria
elnakeebayman@yahoo.com
IPD Sharing URL
http://www.mans.edu.eg/en/
Citations:
PubMed Identifier
25072438
Citation
Cho MS, Baek SJ, Hur H, Soh Min B, Baik SH, Kyu Kim N. Modified complete mesocolic excision with central vascular ligation for the treatment of right-sided colon cancer: long-term outcomes and prognostic factors. Ann Surg. 2015 Apr;261(4):708-15. doi: 10.1097/SLA.0000000000000831.
Results Reference
background
PubMed Identifier
32172577
Citation
Vajda K, Horti I, Cserni G, Bori R, Sikorszki L. [Laparoscopic and open complete mesocolic excision in right-sided colon cancer compared with open and laparoscopic surgery]. Magy Seb. 2020 Mar;73(1):23-28. doi: 10.1556/1046.73.2020.1.3. Hungarian.
Results Reference
result
PubMed Identifier
31243573
Citation
Dewulf M, Kalmar A, Vandenberk B, Muysoms F, Defoort B, Claeys D, Pletinckx P. Complete mesocolic excision does not increase short-term complications in laparoscopic left-sided colectomies: a comparative retrospective single-center study. Langenbecks Arch Surg. 2019 Aug;404(5):557-564. doi: 10.1007/s00423-019-01797-8. Epub 2019 Jun 26.
Results Reference
result
PubMed Identifier
26833471
Citation
Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30.
Results Reference
result
Links:
URL
http://www.mans.edu.eg/en/
Description
Mansoura university
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://www.mans.edu.eg/en/
Available IPD/Information Identifier
Ayman El Nakeeb
Available IPD/Information Comments
elnakeebayman@yahoo.com

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Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

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