Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

Colonic Cancer Clinical Trial

— CME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04434508
• Other study ID #: laparoscopic hemicolectomy
• Status: Completed
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: January 25, 2020

Study information

• Verified date: June 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: January 25, 2020
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Colonic Cancer
• Colonic Neoplasms

Intervention

Procedure:
• laparoscopic right hemicolectomy with CME and central v
laparoscopic right hemicolectomy with CME and central v
• Open right hemicolectomy with CME and central v
Open right hemicolectomy with CME and central v

Locations

Country	Name	City	State
Egypt	Ayman El Nakeeb	Mansoura	Outside U.S And Canada

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View 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 — View 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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the number of lymph nodes (LNs) harvested among both groups	the number of lymph nodes (LNs) harvested among both groups	30 DAYS
Secondary	operative time	operative time	INTRAOPERATIVE
Secondary	blood loss,	blood loss,	intraoperative
Secondary	post-operative complications	post-operative complications	30 days

External Links

•   Mansoura university