Laparoscopic Colectomies In Management of Colonic Cancers

Not Applicable

• Conditions: Cancer Colon; Laparoscopic Colectomy; Intracorporeal Anastomosis
• Interventions: Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies

• Registration Number: NCT04972994
• Lead Sponsor: Sohag University

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

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-06
• Study First Submitted QC: 2021-07-21
• Last Update Submitted: 2021-07-21
• Study First Posted: 2021-07-22
• Last Update Posted: 2021-07-22
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
laparoscopic intracorporeal anastomosis for right and left hemicolectomies	laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies	Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers
laparoscopic extracorporeal anastomosis for right and left hemicolectomies	laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies	Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt