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

Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt

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

Study Overview

• Status: Active, not recruiting
• Conditions: Colon Cancer Stage II; Colon Cancer Stage I
• Intervention / Treatment: Procedure: laparoscopic conventional colectomy; Procedure: laparoscopic complete mesocolic excision

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?

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Sohag Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A Operable colon cancer cases; All patients with operable colon cancer who will undergo laparoscopic conventional colectomy	Procedure: laparoscopic conventional colectomy; Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.; Other Names: D2 colectomy
Active Comparator: Group B Operable colon cancer cases; All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision	Procedure: laparoscopic complete mesocolic excision; Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: Ahmed E Ahmed, Professor, Sohag University; Study Director: Mena Z Helmy, Ass prof., Sohag University; Principal Investigator: Mostafa F Mohammed, Ass lecturer, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 13, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Laparoscopic; Colectomy; Colon cancer; Surgical; Conventional; Mesocolic; Pathological
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: Soh-Med-22-06-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No