Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

NCT ID: NCT04434508

Last Updated: 2020-06-17

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

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2020-01-25

Brief Summary

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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

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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

Conditions

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Colonic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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

TREATMENT

Blinding Strategy

SINGLE

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.

Study Groups

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laparoscopic right hemicolectomy with CME and central v

laparoscopic right hemicolectomy with CME and central v

Group Type ACTIVE_COMPARATOR

laparoscopic right hemicolectomy with CME and central v

Intervention Type PROCEDURE

laparoscopic right hemicolectomy with CME and central v

open right hemicolectomy with CME and central v

open right hemicolectomy with CME and central v

Group Type ACTIVE_COMPARATOR

Open right hemicolectomy with CME and central v

Intervention Type PROCEDURE

Open right hemicolectomy with CME and central v

Interventions

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laparoscopic right hemicolectomy with CME and central v

laparoscopic right hemicolectomy with CME and central v

Intervention Type PROCEDURE

Open right hemicolectomy with CME and central v

Open right hemicolectomy with CME and central v

Intervention Type PROCEDURE

Other Intervention Names

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LHC with CME ORH with CME

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Ayman El Nakeeb

gastrointestinal surgical center, Mansoura University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayman E Nakeeb

Role: PRINCIPAL_INVESTIGATOR

Mansoura University, Gastrointestinal Surgery Center

Mohamed E el sorogy, MD

Role: STUDY_DIRECTOR

Mansoura University, Gastrointestinal Surgery Center

Locations

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Ayman El Nakeeb

Al Mansurah, Outside U.S and Canada, Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 25072438 (View on PubMed)

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.

Reference Type RESULT
PMID: 32172577 (View on PubMed)

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.

Reference Type RESULT
PMID: 31243573 (View on PubMed)

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.

Reference Type RESULT
PMID: 26833471 (View on PubMed)

Study Documents

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Document Type: Study Protocol

[email protected]

View Document

Related Links

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http://www.mans.edu.eg/en/

Mansoura university

Other Identifiers

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laparoscopic hemicolectomy

Identifier Type: -

Identifier Source: org_study_id

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