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Laparoscopic Colectomies In Management of Colonic Cancers

Primary Purpose

Laparoscopic Colectomy, Cancer Colon, Intracorporeal Anastomosis

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies

About this trial

This is an interventional treatment trial for Laparoscopic Colectomy focused on measuring laparoscopic, intracorporeal, extracorporeal, anastomosis, hemicolectomies, , colonic cance

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sohag University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

laparoscopic intracorporeal anastomosis for right and left hemicolectomies

laparoscopic extracorporeal anastomosis for right and left hemicolectomies

Arm Description

Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers

Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

Outcomes

Primary Outcome Measures

intraoperative time of surgery

intraoperative time of surgery by minutes

post operative hospital stay

post operative hospital stay by days

Post operative leakage

Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect & wound infection

early recurrence of the cancer

early recurrence of the cancer by CT scan

Secondary Outcome Measures

Full Information

NCT ID

NCT04972994

First Posted

July 6, 2021

Last Updated

July 21, 2021

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT04972994

Brief Title

Laparoscopic Colectomies In Management of Colonic Cancers

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

December 1, 2022 (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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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 .

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Colectomy, Cancer Colon, Intracorporeal Anastomosis

Keywords

laparoscopic, intracorporeal, extracorporeal, anastomosis, hemicolectomies, , colonic cance

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

right and left hemicolectomies in colonic cancers

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

laparoscopic intracorporeal anastomosis for right and left hemicolectomies

Arm Type

Active Comparator

Arm Description

Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers

Arm Title

laparoscopic extracorporeal anastomosis for right and left hemicolectomies

Arm Type

Active Comparator

Arm Description

Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

Intervention Type

Procedure

Intervention Name(s)

laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies

Intervention Description

laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

Primary Outcome Measure Information:

Title

intraoperative time of surgery

Description

intraoperative time of surgery by minutes

Time Frame

intraoperative time of surgery

Title

post operative hospital stay

Description

post operative hospital stay by days

Time Frame

up to 1 year

Title

Post operative leakage

Description

Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect & wound infection

Time Frame

1 year

Title

early recurrence of the cancer

Description

early recurrence of the cancer by CT scan

Time Frame

6 months after surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Abdullah AA Abdullah, M.B.B.Ch,M.Sc

Phone

01060105272

Ext

0114386363

abdallah.attia@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Omar AS AlTabary, professor

Phone

01001164704

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Omar AS Al tabary, Professor

Organizational Affiliation

Sohag University Hospital

Official's Role

Study Director

Facility Information:

Facility Name

Sohag University Hospital

City

Sohag

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omar AS Al tabary, professor

First Name & Middle Initial & Last Name & Degree

Abd El-Aal AS Mahran, Assistant professor

First Name & Middle Initial & Last Name & Degree

Ahmed A Aldardeer, Lecturer

First Name & Middle Initial & Last Name & Degree

Ahmed Farag, professor

12. IPD Sharing Statement

Learn more about this trial

Laparoscopic Colectomies In Management of Colonic Cancers

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