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

February 5, 2026 updated by: Mostafa Farrag Mohammed, Sohag University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt, 82524
        • Sohag faculty of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative lymph node status
Time Frame: 2 weeks postoperative
Histopathological examination of the resected colon with lymph node status and number
2 weeks postoperative
Postoperative histopathological result
Time Frame: 2 weeks postoperative
Type of the colon cancer
2 weeks postoperative
Occurence of anastomotic leak
Time Frame: within 4 weeks postoperative
Yes/No
within 4 weeks postoperative
Amount of anastomotic leak
Time Frame: within 4 weeks postoperative
Amount in cubic cm and nature of it with its management
within 4 weeks postoperative
Intraoperative visceral injury type
Time Frame: Intraoperative reporting
Yes/No and its type
Intraoperative reporting
Intraoperative visceral injury management
Time Frame: Intraoperative reporting
How managed
Intraoperative reporting
Postoperative complications
Time Frame: 4 weeks postoperative
Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
4 weeks postoperative
Operative time
Time Frame: Reporting immediately postoperative (at end of operation)
Reporting operative time with measurements in minutes
Reporting immediately postoperative (at end of operation)
Intraoperative vascular injury
Time Frame: Intraoperative
Yes/No with measurement in Cubic Cm and how managed
Intraoperative
Intraoperative blood loss
Time Frame: Intraoperative
Yes/No with measurement in Cubic Cm
Intraoperative
Resection margins in postoperative histopathological status
Time Frame: 2 weeks postoperative
Free or invaded
2 weeks postoperative
Postoperative peritonitis
Time Frame: 4 weeks postoperative
Cause and how to manage?
4 weeks postoperative
Colon cancer stage
Time Frame: 2 weeks Preoperative
According to primary tumor, regional nodes, metastasis (TNM) staging system
2 weeks Preoperative
Postoperative faecal fistula
Time Frame: 12 weeks postoperative
Reporting Yes/No with amount in cm3 and management
12 weeks postoperative
length of resected mesocolon
Time Frame: 2 weeks postoperative
In cm
2 weeks postoperative
Urological complications
Time Frame: Intraoperative and 4 weeks postoperative
Type and management
Intraoperative and 4 weeks postoperative
Carcinoembryonic antigen (CEA) level
Time Frame: 2 weeks preoperative
Carcinoembryonic antigen (CEA) level by ng/mL
2 weeks preoperative
Type of anastomosis
Time Frame: Intraoperative
Type of anastomosis (intra- or extracorporeal)
Intraoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age
Time Frame: preoperative
In years
preoperative
Preoperative haemoglobin level
Time Frame: preoperative
measured by g/dl
preoperative
Type of colonic anastomosis
Time Frame: Intraoperative
Stapler or hand sewing
Intraoperative
Preoperative histopathological result
Time Frame: 2 weeks preoperative
Histopathological examination
2 weeks preoperative
Neoadjuvant therapy
Time Frame: 2 weeks Preoperative
Type of the neoadjuvant and duration
2 weeks Preoperative
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
2 weeks preoperative
Neurological complications
Time Frame: 4 weeks postoperative
Type and management
4 weeks postoperative
Preoperative preparation
Time Frame: 3 days Preoperative
Mechanical and/or chemical
3 days Preoperative
Cardiopulmonary complications
Time Frame: 4 weeks postoperative
Yes/No Cardiopulmonary complications type and how managed
4 weeks postoperative
Conversion to open surgery
Time Frame: intraoperative
Yes/No with the cause
intraoperative
application of subcutaneous suction
Time Frame: 1 week Postoperative
Yes/No
1 week Postoperative
Average daily amount in subcutaneous suction
Time Frame: 2 weeks Postoperative
in Milliliters
2 weeks Postoperative
Average daily amount in intraperitoneal drain
Time Frame: 2 weeks Postoperative
in Milliliters
2 weeks Postoperative
Wound infection
Time Frame: 2 weeks postoperative
Yes/No and how managed
2 weeks postoperative
Postoperative ileus
Time Frame: 2 weeks postoperative
Postoperative ileus Yes/No
2 weeks postoperative
Hospital stay
Time Frame: 4 weeks postoperative
In days
4 weeks postoperative
Wound dehiscence
Time Frame: 4 weeks postoperative
Yes/No
4 weeks postoperative
Preoperative colonoscopic examination result
Time Frame: 2 weeks preoperative
mass/ulcer
2 weeks preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohag University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 24, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 13, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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