Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mansoura University
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- the number of lymph nodes (LNs) harvested among both groups
Study Overview
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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking 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 The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
laparoscopic right hemicolectomy with CME and central v
laparoscopic right hemicolectomy with CME and central v
Intervention: 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
Intervention: Open right hemicolectomy with CME and central v (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- blood loss,(intraoperative)
- operative time(INTRAOPERATIVE)
- post-operative complications(30 days)
Investigators
Ayman El Nakeeb
gastrointestinal surgical center, Mansoura University
Mansoura University