Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer

Overview

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.

Full Title of Study: “Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 1, 2020

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: laparoscopic right hemicolectomy with CME and central v
    • laparoscopic right hemicolectomy with CME and central v
  • Active Comparator: open right hemicolectomy with CME and central v
    • open right hemicolectomy with CME and central v

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • operative time
    • Time Frame: INTRAOPERATIVE
    • operative time
  • blood loss,
    • Time Frame: intraoperative
    • blood loss,
  • post-operative complications
    • Time Frame: 30 days
    • post-operative complications

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Mansoura University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ayman El Nakeeb, gastrointestinal surgical center, Mansoura University – Mansoura University
  • Overall Official(s)
    • Ayman E Nakeeb, Principal Investigator, Mansoura University, Gastrointestinal Surgery Center
    • Mohamed E el sorogy, MD, Study Director, Mansoura University, Gastrointestinal Surgery Center

References

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.

Citations Reporting on Results

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.

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.

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. Review.

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