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

Colon Cancer Stage II Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05421702
• Other study ID #: Soh-Med-22-06-17
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: April 2023

Study information

• Verified date: December 2022
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Colon Cancer Stage I
• Colon Cancer Stage II
• Colonic Neoplasms

Intervention

Procedure:
• laparoscopic conventional colectomy
Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.
• laparoscopic complete mesocolic excision
Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.

Locations

Country	Name	City	State
Egypt	Sohag faculty of medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative lymph node status	Histopathological examination of the resected colon with lymph node status and number	2 weeks postoperative
Primary	Postoperative histopathological result	Type of the colon cancer	2 weeks postoperative
Primary	Occurence of anastomotic leak	Yes/No	within 4 weeks postoperative
Primary	Amount of anastomotic leak	Amount in cubic cm and nature of it with its management	within 4 weeks postoperative
Primary	Intraoperative visceral injury type	Yes/No and its type	Intraoperative reporting
Primary	Intraoperative visceral injury management	How managed	Intraoperative reporting
Primary	Postoperative complications	Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System	4 weeks postoperative
Primary	Operative time	Reporting operative time with measurements in minutes	Reporting immediately postoperative (at end of operation)
Primary	Intraoperative vascular injury	Yes/No with measurement in Cubic Cm and how managed	Intraoperative
Primary	Intraoperative blood loss	Yes/No with measurement in Cubic Cm	Intraoperative
Primary	Resection margins in postoperative histopathological status	Free or invaded	2 weeks postoperative
Primary	Postoperative peritonitis	Cause and how to manage?	4 weeks postoperative
Primary	Colon cancer stage	According to primary tumor, regional nodes, metastasis (TNM) staging system	2 weeks Preoperative
Primary	Postoperative faecal fistula	Reporting Yes/No with amount in cm3 and management	12 weeks postoperative
Primary	length of resected mesocolon	In cm	2 weeks postoperative
Primary	Urological complications	Type and management	Intraoperative and 4 weeks postoperative
Primary	Carcinoembryonic antigen (CEA) level	Carcinoembryonic antigen (CEA) level by ng/mL	2 weeks preoperative
Primary	Type of anastomosis	Type of anastomosis (intra- or extracorporeal)	Intraoperative
Secondary	Age	In years	preoperative
Secondary	Preoperative haemoglobin level	measured by g/dl	preoperative
Secondary	Type of colonic anastomosis	Stapler or hand sewing	Intraoperative
Secondary	Preoperative histopathological result	Histopathological examination	2 weeks preoperative
Secondary	Neoadjuvant therapy	Type of the neoadjuvant and duration	2 weeks Preoperative
Secondary	Site of cancer colon	cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon	2 weeks preoperative
Secondary	Neurological complications	Type and management	4 weeks postoperative
Secondary	Preoperative preparation	Mechanical and/or chemical	3 days Preoperative
Secondary	Cardiopulmonary complications	Yes/No Cardiopulmonary complications type and how managed	4 weeks postoperative
Secondary	Conversion to open surgery	Yes/No with the cause	intraoperative
Secondary	application of subcutaneous suction	Yes/No	1 week Postoperative
Secondary	Average daily amount in subcutaneous suction	in Milliliters	2 weeks Postoperative
Secondary	Average daily amount in intraperitoneal drain	in Milliliters	2 weeks Postoperative
Secondary	Wound infection	Yes/No and how managed	2 weeks postoperative
Secondary	Postoperative ileus	Postoperative ileus Yes/No	2 weeks postoperative
Secondary	Hospital stay	In days	4 weeks postoperative
Secondary	Wound dehiscence	Yes/No	4 weeks postoperative
Secondary	Preoperative colonoscopic examination result	mass/ulcer	2 weeks preoperative