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Clinical Trials/NCT05421702
NCT05421702
Completed
Not Applicable

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

Sohag University1 site in 1 country150 target enrollmentJuly 1, 2022

Overview

Phase
Not Applicable
Intervention
laparoscopic conventional colectomy
Conditions
Colon Cancer Stage I
Sponsor
Sohag University
Enrollment
150
Locations
1
Primary Endpoint
Intraoperative vascular injury
Status
Completed
Last Updated
2 months ago

Overview

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?

Registry
clinicaltrials.gov
Start Date
July 1, 2022
End Date
July 21, 2024
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mostafa Farrag Mohammed

assistant lecturer of general surgery

Sohag University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Arms & Interventions

Group A Operable colon cancer cases

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

Intervention: laparoscopic conventional colectomy

Group B Operable colon cancer cases

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

Intervention: laparoscopic complete mesocolic excision

Outcomes

Primary Outcomes

Intraoperative vascular injury

Time Frame: Intraoperative

Yes/No with measurement in Cubic Cm and how managed

Intraoperative blood loss

Time Frame: Intraoperative

Yes/No with measurement in Cubic Cm

Amount of anastomotic leak

Time Frame: within 4 weeks postoperative

Amount in cubic cm and nature of it with its management

Operative time

Time Frame: Reporting immediately postoperative (at end of operation)

Reporting operative time with measurements in minutes

Postoperative lymph node status

Time Frame: 2 weeks postoperative

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

Postoperative peritonitis

Time Frame: 4 weeks postoperative

Cause and how to manage?

Colon cancer stage

Time Frame: 2 weeks Preoperative

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

length of resected mesocolon

Time Frame: 2 weeks postoperative

In cm

Postoperative histopathological result

Time Frame: 2 weeks postoperative

Type of the colon cancer

Occurence of anastomotic leak

Time Frame: within 4 weeks postoperative

Yes/No

Carcinoembryonic antigen (CEA) level

Time Frame: 2 weeks preoperative

Carcinoembryonic antigen (CEA) level by ng/mL

Intraoperative visceral injury type

Time Frame: Intraoperative reporting

Yes/No and its type

Intraoperative visceral injury management

Time Frame: Intraoperative reporting

How managed

Postoperative complications

Time Frame: 4 weeks postoperative

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

Resection margins in postoperative histopathological status

Time Frame: 2 weeks postoperative

Free or invaded

Postoperative faecal fistula

Time Frame: 12 weeks postoperative

Reporting Yes/No with amount in cm3 and management

Urological complications

Time Frame: Intraoperative and 4 weeks postoperative

Type and management

Type of anastomosis

Time Frame: Intraoperative

Type of anastomosis (intra- or extracorporeal)

Secondary Outcomes

  • Wound dehiscence(4 weeks postoperative)
  • Preoperative haemoglobin level(preoperative)
  • Preoperative histopathological result(2 weeks preoperative)
  • Neurological complications(4 weeks postoperative)
  • Conversion to open surgery(intraoperative)
  • Neoadjuvant therapy(2 weeks Preoperative)
  • Average daily amount in intraperitoneal drain(2 weeks Postoperative)
  • Postoperative ileus(2 weeks postoperative)
  • Type of colonic anastomosis(Intraoperative)
  • Cardiopulmonary complications(4 weeks postoperative)
  • application of subcutaneous suction(1 week Postoperative)
  • Age(preoperative)
  • Site of cancer colon(2 weeks preoperative)
  • Preoperative preparation(3 days Preoperative)
  • Wound infection(2 weeks postoperative)
  • Average daily amount in subcutaneous suction(2 weeks Postoperative)
  • Preoperative colonoscopic examination result(2 weeks preoperative)
  • Hospital stay(4 weeks postoperative)

Study Sites (1)

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