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Completed

NCT Number: NCT05421702

Comparison Between Results of 2 Laparoscopic Surgical Procedures in 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

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Key information

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laparoscopic conventional colectomy

Procedure

Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.

Other names: D2 colectomy

laparoscopic complete mesocolic excision

Procedure

Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.

Primary outcomes

  1. Postoperative lymph node status

    Time frame: 2 weeks postoperative

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

  2. Postoperative histopathological result

    Time frame: 2 weeks postoperative

    Type of the colon cancer

  3. Occurence of anastomotic leak

    Time frame: within 4 weeks postoperative

    Yes/No

  4. Amount of anastomotic leak

    Time frame: within 4 weeks postoperative

    Amount in cubic cm and nature of it with its management

  5. Intraoperative visceral injury type

    Time frame: Intraoperative reporting

    Yes/No and its type

  6. Intraoperative visceral injury management

    Time frame: Intraoperative reporting

    How managed

  7. Postoperative complications

    Time frame: 4 weeks postoperative

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

  8. Operative time

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

    Reporting operative time with measurements in minutes

  9. Intraoperative vascular injury

    Time frame: Intraoperative

    Yes/No with measurement in Cubic Cm and how managed

  10. Intraoperative blood loss

    Time frame: Intraoperative

    Yes/No with measurement in Cubic Cm

  11. Resection margins in postoperative histopathological status

    Time frame: 2 weeks postoperative

    Free or invaded

  12. Postoperative peritonitis

    Time frame: 4 weeks postoperative

    Cause and how to manage?

  13. Colon cancer stage

    Time frame: 2 weeks Preoperative

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

  14. Postoperative faecal fistula

    Time frame: 12 weeks postoperative

    Reporting Yes/No with amount in cm3 and management

  15. length of resected mesocolon

    Time frame: 2 weeks postoperative

    In cm

  16. Urological complications

    Time frame: Intraoperative and 4 weeks postoperative

    Type and management

  17. Carcinoembryonic antigen (CEA) level

    Time frame: 2 weeks preoperative

    Carcinoembryonic antigen (CEA) level by ng/mL

  18. Type of anastomosis

    Time frame: Intraoperative

    Type of anastomosis (intra- or extracorporeal)

Secondary outcomes

  1. Age

    Time frame: preoperative

    In years

  2. Preoperative haemoglobin level

    Time frame: preoperative

    measured by g/dl

  3. Type of colonic anastomosis

    Time frame: Intraoperative

    Stapler or hand sewing

  4. Preoperative histopathological result

    Time frame: 2 weeks preoperative

    Histopathological examination

  5. Neoadjuvant therapy

    Time frame: 2 weeks Preoperative

    Type of the neoadjuvant and duration

  6. Site of cancer colon

    Time frame: 2 weeks preoperative

    cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon

  7. Neurological complications

    Time frame: 4 weeks postoperative

    Type and management

  8. Preoperative preparation

    Time frame: 3 days Preoperative

    Mechanical and/or chemical

  9. Cardiopulmonary complications

    Time frame: 4 weeks postoperative

    Yes/No Cardiopulmonary complications type and how managed

  10. Conversion to open surgery

    Time frame: intraoperative

    Yes/No with the cause

  11. application of subcutaneous suction

    Time frame: 1 week Postoperative

    Yes/No

  12. Average daily amount in subcutaneous suction

    Time frame: 2 weeks Postoperative

    in Milliliters

  13. Average daily amount in intraperitoneal drain

    Time frame: 2 weeks Postoperative

    in Milliliters

  14. Wound infection

    Time frame: 2 weeks postoperative

    Yes/No and how managed

  15. Postoperative ileus

    Time frame: 2 weeks postoperative

    Postoperative ileus Yes/No

  16. Hospital stay

    Time frame: 4 weeks postoperative

    In days

  17. Wound dehiscence

    Time frame: 4 weeks postoperative

    Yes/No

  18. Preoperative colonoscopic examination result

    Time frame: 2 weeks preoperative

    mass/ulcer

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jun 16, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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