Laparoscopic Colectomies In Management of Colonic Cancers

July 21, 2021 updated by: Abdullah Atyah Ali, Sohag University

Surgical Outcomes After Laparoscopic Intracorporeal Versus Extracorporeal Anastomosis for Right and Left Hemicolectomies In Management of Colonic Cancers

The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is clinical trial ,Interventional quasi experiment study to evaluate the surgical outcomes between intracorporeal versus extracorporeal anastomosis in laparoscopic right and left hemicolectomies including post operative pain, hospital stay, leakage from anastomosis, early recurrence, hernias patient satisfaction operative time and more surgical outcomes.

In Egyptian hospitals. Source of data the investigators follow up and medical reports and more . surgical procedures This trial including two groups of patients with right and left cancer colon undergoing Laparoscopic colectomy. First group (A) will be operated as intracorporeal anastomosis while the second group (B) will be operated as extracorporeal anastomosis.

Sample size more than 50 person Statistical analysis plan Statistical Package for the Social Sciences (SPSS) program

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • 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 Contact

Study Contact Backup

  • Name: Omar AS AlTabary, professor
  • Phone Number: 01001164704

Study Locations

  • Egypt
      • Sohag, Egypt
        • Recruiting
        • Sohag university Hospital
        • Sub-Investigator:
          • Omar AS Al tabary, professor
        • Sub-Investigator:
          • Abd El-Aal AS Mahran, Assistant professor
        • Sub-Investigator:
          • Ahmed A Aldardeer, Lecturer
        • Sub-Investigator:
          • Ahmed Farag, professor

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

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients had to present histologically confirmed cancer( right and left) colon.
  • All grades of cancer will be included.
  • Cancer at cecum ,appendix, ascending colon, hepatic flexure or at splenic flexure , descending colon and sigmoid colon.

Exclusion Criteria:

  • Locally advanced disease with invasion of adjacent important organs.
  • Acute bowel obstruction or perforation from cancer.
  • Pregnant ladies.
  • Rectal cancer and transverse colon cancer.

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
Intervention / Treatment
Active Comparator: laparoscopic intracorporeal anastomosis for right and left hemicolectomies
Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers
Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies
laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers
Active Comparator: laparoscopic extracorporeal anastomosis for right and left hemicolectomies
Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers
Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies
laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative time of surgery
Time Frame: intraoperative time of surgery
intraoperative time of surgery by minutes
intraoperative time of surgery
post operative hospital stay
Time Frame: up to 1 year
post operative hospital stay by days
up to 1 year
Post operative leakage
Time Frame: 1 year
Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect & wound infection
1 year
early recurrence of the cancer
Time Frame: 6 months after surgery
early recurrence of the cancer by CT scan
6 months after surgery

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Study Director: Omar AS Al tabary, Professor, Sohag university Hospital

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)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

July 6, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 21, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med206018

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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