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

Not Applicable

Active, not recruiting

• Conditions: Colon Cancer Stage I; Colon Cancer Stage II
• Interventions: Procedure: laparoscopic complete mesocolic excision; Procedure: laparoscopic conventional colectomy

• Registration Number: NCT05421702
• Lead Sponsor: Sohag University

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

Detailed Description

Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment .

When Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC).

The principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes.

CME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen.

Some surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival.

Although CME has a theoretical advantages and promising early results, it is not widely adopted as the standard in some areas. CME is technically more demanding than CC and suggested to be associated with more intraoperative visceral injuries and non-surgical complications and many doubts persist about safety and efficacy of the procedure.

The questions of interest and research, should CME be regarded as the optimal procedure for colon cancer cases? And also another question; is conventional colectomy suboptimal?

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-06-13
• Study First Submitted QC: 2022-06-13
• Study First Posted: 2022-06-16
• Study Start: 2022-07-01
• Status Verified: 2022-12
• Primary Completion: 2022-12
• Last Update Submitted: 2022-12-13
• Last Update Posted: 2022-12-14
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

1. Irresectable colon cancer.
2. Inoperable colon cancer.
3. Rectal cancer.
4. Unfit patients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B Operable colon cancer cases	laparoscopic complete mesocolic excision	All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision
Group A Operable colon cancer cases	laparoscopic conventional colectomy	All patients with operable colon cancer who will undergo laparoscopic conventional colectomy

Primary Outcome Measures

Name	Time	Method
Postoperative histopathological result	2 weeks postoperative	Type of the colon cancer
Intraoperative vascular injury	Intraoperative	Yes/No with measurement in Cubic Cm and how managed
Intraoperative blood loss	Intraoperative	Yes/No with measurement in Cubic Cm
Amount of anastomotic leak	within 4 weeks postoperative	Amount in cubic cm and nature of it with its management
Operative time	Reporting immediately postoperative (at end of operation)	Reporting operative time with measurements in minutes
Postoperative lymph node status	2 weeks postoperative	Histopathological examination of the resected colon with lymph node status and number
Postoperative peritonitis	4 weeks postoperative	Cause and how to manage?
Colon cancer stage	2 weeks Preoperative	According to primary tumor, regional nodes, metastasis (TNM) staging system
length of resected mesocolon	2 weeks postoperative	In cm
Occurence of anastomotic leak	within 4 weeks postoperative	Yes/No
Carcinoembryonic antigen (CEA) level	2 weeks preoperative	Carcinoembryonic antigen (CEA) level by ng/mL
Intraoperative visceral injury type	Intraoperative reporting	Yes/No and its type
Intraoperative visceral injury management	Intraoperative reporting	How managed
Postoperative complications	4 weeks postoperative	Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
Resection margins in postoperative histopathological status	2 weeks postoperative	Free or invaded
Postoperative faecal fistula	12 weeks postoperative	Reporting Yes/No with amount in cm3 and management
Urological complications	Intraoperative and 4 weeks postoperative	Type and management
Type of anastomosis	Intraoperative	Type of anastomosis (intra- or extracorporeal)

Secondary Outcome Measures

Name	Time	Method
Preoperative haemoglobin level	preoperative	measured by g/dl
Preoperative histopathological result	2 weeks preoperative	Histopathological examination
Neurological complications	4 weeks postoperative	Type and management
Conversion to open surgery	intraoperative	Yes/No with the cause
Neoadjuvant therapy	2 weeks Preoperative	Type of the neoadjuvant and duration
Average daily amount in intraperitoneal drain	2 weeks Postoperative	in Milliliters
Postoperative ileus	2 weeks postoperative	Postoperative ileus Yes/No
Wound dehiscence	4 weeks postoperative	Yes/No
Type of colonic anastomosis	Intraoperative	Stapler or hand sewing
Cardiopulmonary complications	4 weeks postoperative	Yes/No Cardiopulmonary complications type and how managed
application of subcutaneous suction	1 week Postoperative	Yes/No
Age	preoperative	In years
Site of cancer colon	2 weeks preoperative	cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon
Preoperative preparation	3 days Preoperative	Mechanical and/or chemical
Wound infection	2 weeks postoperative	Yes/No and how managed
Average daily amount in subcutaneous suction	2 weeks Postoperative	in Milliliters
Preoperative colonoscopic examination result	2 weeks preoperative	mass/ulcer
Hospital stay	4 weeks postoperative	In days

Trial Locations

Locations (1)

Sohag faculty of medicine; 🇪🇬 Sohag, Egypt