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

Sohag University

Status: Active, not recruiting

Conditions: Colon Cancer Stage I; Colon Cancer Stage II

Treatments: Procedure: laparoscopic complete mesocolic excision; Procedure: laparoscopic conventional colectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05421702

Soh-Med-22-06-17

Details and patient eligibility

About

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

Full 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?

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Group A Operable colon cancer cases

Active Comparator group

Description:

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

Treatment:

Procedure: laparoscopic conventional colectomy

Group B Operable colon cancer cases

Active Comparator group

Description:

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

Treatment:

Procedure: laparoscopic complete mesocolic excision