Comparison of Laparoscopic and Open Total Mesocolic Excision With Central Vascular Ligation for Right Colon Carcinoma

NCT07361016 | Not Yet Recruiting DMC

• 1 other identifier: laparoscpic colon cancer
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Right-sided Colon Cancer; Colon Adenocarcinoma; Colorectal Neoplasms

Outcome Measures

Primary Outcomes (5)

• Length of Postoperative Hospital Stay

  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)

  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))

  Volume of blood lost during surgical resection, measured intraoperatively.

  During surgery

• Operative Time ( Duration of surgery (minutes))

  Time from skin incision to skin closure.

  During surgery

• Postoperative Recovery of Bowel Function (Time to first passage of flatus (hours))

  Time elapsed from completion of surgery to first postoperative flatus, indicating recovery of gastrointestinal motility.

  Up to 72 hours postoperatively

Study Arms (2)

Open CME with CVL

ACTIVE COMPARATOR

Procedure: open rt hemicolectmy

Laparoscopic CME with CVL

ACTIVE COMPARATOR

Procedure: right hemicolectomy laparoscopic surgery

Interventions

right hemicolectomy laparoscopic surgery PROCEDURE

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.

Laparoscopic CME with CVL

open rt hemicolectmy PROCEDURE

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.

Open CME with CVL

Eligibility Criteria

• Age: 25 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• rt cancer colon

You may not qualify if:

• metastatisis

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Location

Related Publications (1)

• Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.

  PMID: 19016817 BACKGROUND

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Mohamed MM Gohar

  Kafr Elsheikh university hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Gohar, assistant lecturer

CONTACT

01007664482; dr.mmmg.1990@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Model Details: Comparison study

Study Record Dates

• First Submitted: December 20, 2025
• First Posted: January 22, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 12/12/2022 to 12/12/2024
• Access Criteria: anyone

Locations

EG (1)