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

Primary Purpose

Colon Cancer Stage I, Colon Cancer Stage II

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
laparoscopic conventional colectomy
laparoscopic complete mesocolic excision
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer Stage I focused on measuring Colon cancer, Colectomy, Mesocolic, Conventional, Laparoscopic, Surgical, Pathological

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Sohag faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group A Operable colon cancer cases

Group B Operable colon cancer cases

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative lymph node status
Histopathological examination of the resected colon with lymph node status and number
Postoperative histopathological result
Type of the colon cancer
Occurence of anastomotic leak
Yes/No
Amount of anastomotic leak
Amount in cubic cm and nature of it with its management
Intraoperative visceral injury type
Yes/No and its type
Intraoperative visceral injury management
How managed
Postoperative complications
Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
Operative time
Reporting operative time with measurements in minutes
Intraoperative vascular injury
Yes/No with measurement in Cubic Cm and how managed
Intraoperative blood loss
Yes/No with measurement in Cubic Cm
Resection margins in postoperative histopathological status
Free or invaded
Postoperative peritonitis
Cause and how to manage?
Colon cancer stage
According to primary tumor, regional nodes, metastasis (TNM) staging system
Postoperative faecal fistula
Reporting Yes/No with amount in cm3 and management
length of resected mesocolon
In cm
Urological complications
Type and management
Carcinoembryonic antigen (CEA) level
Carcinoembryonic antigen (CEA) level by ng/mL
Type of anastomosis
Type of anastomosis (intra- or extracorporeal)

Secondary Outcome Measures

Age
In years
Preoperative haemoglobin level
measured by g/dl
Type of colonic anastomosis
Stapler or hand sewing
Preoperative histopathological result
Histopathological examination
Neoadjuvant therapy
Type of the neoadjuvant and duration
Site of cancer colon
cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon
Neurological complications
Type and management
Preoperative preparation
Mechanical and/or chemical
Cardiopulmonary complications
Yes/No Cardiopulmonary complications type and how managed
Conversion to open surgery
Yes/No with the cause
application of subcutaneous suction
Yes/No
Average daily amount in subcutaneous suction
in Milliliters
Average daily amount in intraperitoneal drain
in Milliliters
Wound infection
Yes/No and how managed
Postoperative ileus
Postoperative ileus Yes/No
Hospital stay
In days
Wound dehiscence
Yes/No
Preoperative colonoscopic examination result
mass/ulcer

Full Information

First Posted
June 13, 2022
Last Updated
December 13, 2022
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05421702
Brief Title
Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt
Official Title
Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer Stage I, Colon Cancer Stage II
Keywords
Colon cancer, Colectomy, Mesocolic, Conventional, Laparoscopic, Surgical, Pathological

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Operable colon cancer cases
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A Operable colon cancer cases
Arm Type
Active Comparator
Arm Description
All patients with operable colon cancer who will undergo laparoscopic conventional colectomy
Arm Title
Group B Operable colon cancer cases
Arm Type
Active Comparator
Arm Description
All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision
Intervention Type
Procedure
Intervention Name(s)
laparoscopic conventional colectomy
Other Intervention Name(s)
D2 colectomy
Intervention Description
Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.
Intervention Type
Procedure
Intervention Name(s)
laparoscopic complete mesocolic excision
Intervention Description
Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.
Primary Outcome Measure Information:
Title
Postoperative lymph node status
Description
Histopathological examination of the resected colon with lymph node status and number
Time Frame
2 weeks postoperative
Title
Postoperative histopathological result
Description
Type of the colon cancer
Time Frame
2 weeks postoperative
Title
Occurence of anastomotic leak
Description
Yes/No
Time Frame
within 4 weeks postoperative
Title
Amount of anastomotic leak
Description
Amount in cubic cm and nature of it with its management
Time Frame
within 4 weeks postoperative
Title
Intraoperative visceral injury type
Description
Yes/No and its type
Time Frame
Intraoperative reporting
Title
Intraoperative visceral injury management
Description
How managed
Time Frame
Intraoperative reporting
Title
Postoperative complications
Description
Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System
Time Frame
4 weeks postoperative
Title
Operative time
Description
Reporting operative time with measurements in minutes
Time Frame
Reporting immediately postoperative (at end of operation)
Title
Intraoperative vascular injury
Description
Yes/No with measurement in Cubic Cm and how managed
Time Frame
Intraoperative
Title
Intraoperative blood loss
Description
Yes/No with measurement in Cubic Cm
Time Frame
Intraoperative
Title
Resection margins in postoperative histopathological status
Description
Free or invaded
Time Frame
2 weeks postoperative
Title
Postoperative peritonitis
Description
Cause and how to manage?
Time Frame
4 weeks postoperative
Title
Colon cancer stage
Description
According to primary tumor, regional nodes, metastasis (TNM) staging system
Time Frame
2 weeks Preoperative
Title
Postoperative faecal fistula
Description
Reporting Yes/No with amount in cm3 and management
Time Frame
12 weeks postoperative
Title
length of resected mesocolon
Description
In cm
Time Frame
2 weeks postoperative
Title
Urological complications
Description
Type and management
Time Frame
Intraoperative and 4 weeks postoperative
Title
Carcinoembryonic antigen (CEA) level
Description
Carcinoembryonic antigen (CEA) level by ng/mL
Time Frame
2 weeks preoperative
Title
Type of anastomosis
Description
Type of anastomosis (intra- or extracorporeal)
Time Frame
Intraoperative
Secondary Outcome Measure Information:
Title
Age
Description
In years
Time Frame
preoperative
Title
Preoperative haemoglobin level
Description
measured by g/dl
Time Frame
preoperative
Title
Type of colonic anastomosis
Description
Stapler or hand sewing
Time Frame
Intraoperative
Title
Preoperative histopathological result
Description
Histopathological examination
Time Frame
2 weeks preoperative
Title
Neoadjuvant therapy
Description
Type of the neoadjuvant and duration
Time Frame
2 weeks Preoperative
Title
Site of cancer colon
Description
cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon
Time Frame
2 weeks preoperative
Title
Neurological complications
Description
Type and management
Time Frame
4 weeks postoperative
Title
Preoperative preparation
Description
Mechanical and/or chemical
Time Frame
3 days Preoperative
Title
Cardiopulmonary complications
Description
Yes/No Cardiopulmonary complications type and how managed
Time Frame
4 weeks postoperative
Title
Conversion to open surgery
Description
Yes/No with the cause
Time Frame
intraoperative
Title
application of subcutaneous suction
Description
Yes/No
Time Frame
1 week Postoperative
Title
Average daily amount in subcutaneous suction
Description
in Milliliters
Time Frame
2 weeks Postoperative
Title
Average daily amount in intraperitoneal drain
Description
in Milliliters
Time Frame
2 weeks Postoperative
Title
Wound infection
Description
Yes/No and how managed
Time Frame
2 weeks postoperative
Title
Postoperative ileus
Description
Postoperative ileus Yes/No
Time Frame
2 weeks postoperative
Title
Hospital stay
Description
In days
Time Frame
4 weeks postoperative
Title
Wound dehiscence
Description
Yes/No
Time Frame
4 weeks postoperative
Title
Preoperative colonoscopic examination result
Description
mass/ulcer
Time Frame
2 weeks preoperative

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed E Ahmed, Professor
Organizational Affiliation
Sohag University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mena Z Helmy, Ass prof.
Organizational Affiliation
Sohag University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Mostafa F Mohammed, Ass lecturer
Organizational Affiliation
Sohag University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sohag faculty of medicine
City
Sohag
ZIP/Postal Code
82524
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It is not yet known if there will be a plan to make IPD available.

Learn more about this trial

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

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