Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt

NCT05421702 | Completed DMC

• 1 other identifier: Soh-Med-22-06-17
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt

Conditions

Colon Cancer Stage I; Colon Cancer Stage II

Keywords

Colon cancer; Colectomy; Mesocolic; Conventional; Laparoscopic; Surgical; Pathological

Outcome Measures

Primary Outcomes (18)

• Postoperative lymph node status

  Histopathological examination of the resected colon with lymph node status and number

  2 weeks postoperative

• Postoperative histopathological result

  Type of the colon cancer

  2 weeks postoperative

• Occurence of anastomotic leak

  Yes/No

  within 4 weeks postoperative

• Amount of anastomotic leak

  Amount in cubic cm and nature of it with its management

  within 4 weeks postoperative

• Intraoperative visceral injury type

  Yes/No and its type

  Intraoperative reporting

• Intraoperative visceral injury management

  How managed

  Intraoperative reporting

• Postoperative complications

  Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System

  4 weeks postoperative

• Operative time

  Reporting operative time with measurements in minutes

  Reporting immediately postoperative (at end of operation)

• Intraoperative vascular injury

  Yes/No with measurement in Cubic Cm and how managed

  Intraoperative

• Intraoperative blood loss

  Yes/No with measurement in Cubic Cm

  Intraoperative

• Resection margins in postoperative histopathological status

  Free or invaded

  2 weeks postoperative

• Postoperative peritonitis

  Cause and how to manage?

  4 weeks postoperative

• Colon cancer stage

  According to primary tumor, regional nodes, metastasis (TNM) staging system

  2 weeks Preoperative

• Postoperative faecal fistula

  Reporting Yes/No with amount in cm3 and management

  12 weeks postoperative

• length of resected mesocolon

  In cm

  2 weeks postoperative

• Urological complications

  Type and management

  Intraoperative and 4 weeks postoperative

• Carcinoembryonic antigen (CEA) level

  Carcinoembryonic antigen (CEA) level by ng/mL

  2 weeks preoperative

• Type of anastomosis

  Type of anastomosis (intra- or extracorporeal)

  Intraoperative

Secondary Outcomes (18)

• Age

  preoperative

• Preoperative haemoglobin level

  preoperative

• Type of colonic anastomosis

  Intraoperative

• Preoperative histopathological result

  2 weeks preoperative

• Neoadjuvant therapy

  2 weeks Preoperative

Study Arms (2)

Group A Operable colon cancer cases

ACTIVE COMPARATOR

All patients with operable colon cancer who will undergo laparoscopic conventional colectomy

Procedure: laparoscopic conventional colectomy

Group B Operable colon cancer cases

ACTIVE COMPARATOR

All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision

Procedure: laparoscopic complete mesocolic excision

Interventions

laparoscopic conventional colectomy PROCEDURE

Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.

Also known as: D2 colectomy

Group A Operable colon cancer cases

laparoscopic complete mesocolic excision PROCEDURE

Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.

Group B Operable colon cancer cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Both sexes will be included.
• Age: all adult patients.
• All diagnosed patients with operable cancer colon.
• Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.
• Fit patients.

You may not qualify if:

• Irresectable colon cancer.
• Inoperable colon cancer.
• Rectal cancer.
• Unfit patients.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag faculty of medicine

Sohag, 82524, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Ahmed E Ahmed, Professor

  Sohag University

  STUDY CHAIR

• Mena Z Helmy, Ass prof.

  Sohag University

  STUDY DIRECTOR

• Mostafa F Mohammed, Ass lecturer

  Sohag University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of general surgery

Model Details: Operable colon cancer cases

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: July 1, 2022
• Primary Completion: April 24, 2024
• Study Completion: July 21, 2024
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)