- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07361016
Comparison of Laparoscopic and Open Total Mesocolic Excision With Central Vascular Ligation for Right Colon Carcinoma
The goal of this observational comparative study is to assess whether laparoscopic complete mesocolic excision with central vascular ligation (L-CME with CVL) provides improved short-term surgical outcomes compared with open complete mesocolic excision with central vascular ligation (O-CME with CVL) in patients with right-sided colon cancer.
The primary questions this study aims to answer are:
Does laparoscopic CME with CVL reduce blood loss, postoperative complications, and length of hospital stay compared with open CME?
Does laparoscopic CME with CVL achieve equivalent surgical specimen quality and short-term oncological outcomes compared to the open approach?
Researchers compared laparoscopic versus open right hemicolectomy with CME and CVL in adult patients diagnosed with right colon cancer who were eligible for elective surgical resection.
Participants underwent standard preoperative assessment, including clinical evaluation, laboratory testing, imaging studies, colonoscopy, and biopsy confirmation. Surgical treatment consisted of either laparoscopic or open complete mesocolic excision with central vascular ligation, performed according to standardized oncologic surgical principles. Postoperative care followed an enhanced recovery protocol.
Primary outcome measures included operative time, intraoperative blood loss, time to first flatus, postoperative complications, and duration of hospital stay. Secondary outcomes included quality of the surgical specimen (lymph node yield, mesocolic integrity, and margin status) and short-term oncologic outcomes, including early recurrence during follow-up.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mohamed Gohar, assistant lecturer
- Phone Number: 01007664482
- Email: dr.mmmg.1990@gmail.com
Study Locations
-
-
Kafrelsheikh
-
Kafr ash Shaykh, Kafrelsheikh, Egypt
- Kafrelsheikh University
-
Contact:
- mohamed toulba el khoby, phd
- Phone Number: +2 01006786978
- Email: m.elkhoby2018@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- rt cancer colon
Exclusion Criteria:
- metastatisis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Open CME with CVL
|
Open right hemicolectomy or extended right hemicolectomy using complete mesocolic excision with central vascular ligation, via midline laparotomy, lateral-to-medial mobilization, ligation of ileocolic (and right colic/middle colic branch when indicated) at origin, extracorporeal ileotransverse anastomosis with hand-sewn sutures, standard perioperative care.
|
|
Active Comparator: Laparoscopic CME with CVL
|
Laparoscopic right hemicolectomy or extended right hemicolectomy using complete mesocolic excision with central vascular ligation, pneumoperitoneum 12-14 mmHg via umbilical port, diamond-shaped port placement, medial-to-lateral dissection along embryological planes, ligation of ileocolic (and right colic/middle colic branch when indicated) at origin, intra- or extracorporeal stapled ileotransverse anastomosis, specimen extraction through Pfannenstiel or right subcostal incision, standard perioperative care.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Length of Postoperative Hospital Stay
Time Frame: From surgery until discharge (up to 30 days)
|
Number of days from the date of surgery to the date of hospital discharge.
|
From surgery until discharge (up to 30 days)
|
|
Overall Postoperative Morbidity ( Incidence of postoperative complications)
Time Frame: Up to 30 days after surgery
|
Occurrence of any postoperative complication, including wound infection, anastomotic leak, abdominal collection, pulmonary infection, urinary tract infection, or deep vein thrombosis, occurring within the early postoperative period.
|
Up to 30 days after surgery
|
|
Intraoperative Blood Loss ( Estimated blood loss (milliliters))
Time Frame: During surgery
|
Volume of blood lost during surgical resection, measured intraoperatively.
|
During surgery
|
|
Operative Time ( Duration of surgery (minutes))
Time Frame: During surgery
|
Time from skin incision to skin closure.
|
During surgery
|
|
Postoperative Recovery of Bowel Function (Time to first passage of flatus (hours))
Time Frame: Up to 72 hours postoperatively
|
Time elapsed from completion of surgery to first postoperative flatus, indicating recovery of gastrointestinal motility.
|
Up to 72 hours postoperatively
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohamed MM Gohar, Kafr Elsheikh university hospitals
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- laparoscpic colon cancer
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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