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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04972994
Other study ID # Soh-Med206018
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2022

Study information

Verified date July 2021
Source Sohag University
Contact Abdullah AA Abdullah, M.B.B.Ch,M.Sc
Phone 01060105272
Email abdallah.attia@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 .


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


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 90 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Sohag University Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

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