Outcomes of Side-to-end Versus End-to-end Colorectal Anastomosis in Non-emergent Sigmoid and Rectal Cancers: Randomized Controlled Clinical Trial

NCT04694521 | Completed

• 1 other identifier: zagazig university 2
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Cancer rectum and sigmoid is increasing nowadays. Resection and anastomosis is done laparoscopic approach with various techniques of anastomosis. Aim of this study: to compare between open side to end colorectal anastomosis versus laparoscopic end to end colorectal anastomosis in Non-emergent colo- rectal Cancers in adults as regard anastomotic leak, intestinal function and quality of life. Patients and Methods: Randomized controlled trial was performed on patients with Non-emergent colo rectal cancers between September 2016 and September 2018.

Conditions

Gastrointestinal Neoplasms

Outcome Measures

Primary Outcomes (2)

• : the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.

  : the incidence of the anastomotic leak during hospital admission and during 30 days postoperative.

  30 days

• intestinal function

  intestinal function and LAR score

  24 months after surgery.

Secondary Outcomes (1)

• the overall postoperative morbidities

  within 90 days

Study Arms (2)

antegrade colorectal single stapler anastomosis

EXPERIMENTAL

open Side to end antegrade colorectal anastomosis colo rectal cancers.

Procedure: openSide to end colorectal anastomosis .

open end to end colorectal stapler anastomosis

EXPERIMENTAL

open end to end colorectal single anastomosis in non-emergent colo rectal cancers.

Procedure: open end end to end stapler anastomosis

Interventions

openSide to end colorectal anastomosis . PROCEDURE

open Side to end colorectal anastomosis

antegrade colorectal single stapler anastomosis

open end end to end stapler anastomosis PROCEDURE

open end to end stapler anastomosis

open end to end colorectal stapler anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. colo rectum adenocarcinoma proved by biopsy and histo-pathological examination.
• \. Only resections performed with immediate anastomosis, not under cover of stoma.
• \. Expected R0 resection. 4. patients \>18 years ,both sex 6. No previous history of stool or flatus incontinence, and clinically normal function of anal sphincter.

You may not qualify if:

• Patients younger than 18 years , Pregnant female.
• Inability to understand the informed consent or refuse to participate or psychiatric patients.
• Patients with recurrent cancer, Irresectable tumour, widespread loco-regional, distant metastasis ,Combination operation and Complicated cancer e.g. obstructed or perforated.
• Cases covered by proximal stoma.
• Patients with lesion \<3 cm from anal verge or cancer involving anal sphincter
• preoperative chemo radiotherapy
• Previous left sided colorectal surgery or anorectal surgeries.

Sponsors & Collaborators

• Zagazig University: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professour of general and laparoscopic surgery

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 5, 2021
• Study Start: September 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2020
• Last Updated: September 7, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share