Clinical trial NCT04434508: Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer
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
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Cancer
Keywords: Colonic Cancer
laparoscopic right hemicolectomy
complete mesocolic excision
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
Primary purpose: TREATMENT

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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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

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)

Primary outcomes:
measure: the number of lymph nodes (LNs) harvested among both groups
timeFrame: 30 DAYS
Secondary outcomes:
measure: operative time
timeFrame: INTRAOPERATIVE
measure: blood loss,
timeFrame: intraoperative
measure: post-operative complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ayman El Nakeeb
state: Outside U.S And Canada
Study officials:
affiliation: Mansoura University, Gastrointestinal Surgery Center
name: Ayman E Nakeeb
role: PRINCIPAL_INVESTIGATOR
affiliation: Mansoura University, Gastrointestinal Surgery Center
name: Mohamed E el sorogy, MD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.