Laparoscopic Colectomies In Management of Colonic Cancers

Cancer Colon Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972994
• Other study ID #: Soh-Med206018
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cancer Colon
• Colonic Neoplasms
• Laparoscopic Colectomy

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