Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer
CME
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2020
CompletedFirst Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedJune 17, 2020
June 1, 2020
2.5 years
June 12, 2020
June 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the number of lymph nodes (LNs) harvested among both groups
the number of lymph nodes (LNs) harvested among both groups
30 DAYS
Secondary Outcomes (3)
operative time
INTRAOPERATIVE
blood loss,
intraoperative
post-operative complications
30 days
Study Arms (2)
laparoscopic right hemicolectomy with CME and central v
ACTIVE COMPARATORlaparoscopic right hemicolectomy with CME and central v
open right hemicolectomy with CME and central v
ACTIVE COMPARATORopen right hemicolectomy with CME and central v
Interventions
laparoscopic right hemicolectomy with CME and central v
Open right hemicolectomy with CME and central v
Eligibility Criteria
You may qualify if:
- Patients with right colonic cancer
You may not qualify if:
- Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ayman El Nakeeb
Al Mansurah, Outside U.S and Canada, 35111, Egypt
Related 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.
PMID: 25072438BACKGROUNDVajda 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.
PMID: 32172577RESULTDewulf 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.
PMID: 31243573RESULTEmmanuel 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.
PMID: 26833471RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayman E Nakeeb
Mansoura University, Gastrointestinal Surgery Center
- STUDY DIRECTOR
Mohamed E el sorogy, MD
Mansoura University, Gastrointestinal Surgery Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- gastrointestinal surgical center, Mansoura University
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 17, 2020
Study Start
July 1, 2017
Primary Completion
January 1, 2020
Study Completion
January 25, 2020
Last Updated
June 17, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 6 months
- Access Criteria
- elnakeebayman@yahoo.com
Study Protocol