End to End Versus Side to End Anastomosis After Anterior Resection of Cancer Rectum

Comparison between end to end and side to end anastomosis after anterior resection of cancer rectum and compare the outcomes of both surgical techniques. The main outcomes were bowel functional outcomes and QoL. Bowel functional outcomes mainly included three indexes: stool frequency, urgency, incomplete defecation, and incontinence. The secondary outcomes were surgical outcomes including operative time, postoperative hospital stay, postoperative complications, reoperation, and mortality.

Study Overview

• Status: Recruiting
• Conditions: Rectum Cancer
• Intervention / Treatment: Procedure: Anterior resection of Rectal cancer

Detailed Description

During the past two decades, remarkable progress has been made in the treatment of rectal cancer. The main goal of rectal surgery for malignancy is oncologic radicality in an effort to achieve the preservation of sphincters and sexual-urinary function.The introduction of circular stapling devices is largely responsible for their increasing popularity and utilization. Sphincter-saving procedures associated to partial or total mesorectal excision (TME) for the treatment of mid and distal rectal cancer have become increasingly prevalent as their safety and efficacy have been proved. Total mesorectal excision (TME) is the best available treatment for rectal cancer. With the advancement of surgical techniques, the majority of patients with mid and upper rectal cancer can undergo a sphincter-saving TME procedure. After TME, the most widely used reconstructive technique is straight coloanal anastomosis. With the advancement of surgical technique, the local recurrence rate after rectal cancer surgery has been decreased from 25-50% to 3-8%. Naturally, it is time to focus on how to improve bowel functional outcomes and quality of life (QoL) for rectal cancer patients. However, because the sigmoid colon is usually excised during surgery which decreases the storage volume of stool, there is a common problem seriously influencing the life quality of patients, including increased tool frequency, urgency and incontinence, which is termed as anterior resection syndrome (ARS). About 19-56% of patients would suffer from ARS. Thus, the demand for a technique with better functional outcomes made surgeons modify the straight anastomotic technique. Thus, another modified anastomotic technique, side-to-end anastomosis, which has been used since 1966, has gained attention. Side-to-end anastomosis usually needs a 3-5 cm-long colonic segment. Multiple studies on the literature have shown that compared with straight anastomosis, side-to-end anastomosis has advantages in bowel functional and operative outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nabil A Al-Ameer, MD; Phone Number: 0020 1118416290; Email: Nabil.abdelnaser@med.sohag.edu.eg
• Study Contact Backup: Name: Nabil A Al-Ameer, MD; Phone Number: 0020 1067833019; Email: Nabil.abdelnaser@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 82511
    • Recruiting
    • Sohag University
    • Contact: Nabil A Al-Ameer, MD; Phone Number: 1118416290; Email: Nabil.abdelnaser@med.sohag.edu.eg
    • Contact: Ahmed G Hassanein, MD; Phone Number: 0020 1552538300; Email: ethics@med.sohag.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18 years of age to 80 years.
• Laparoscopic or open anterior resection of cancer rectum.

Exclusion Criteria:

• synchronous colorectal carcinoma
• emergency surgery
• history of colon or rectal segmental resections
• fixed rectal carcinoma who received preoperative radiotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; the first group included patients who will have anterior resection with end-to-end anastomosis	Procedure: Anterior resection of Rectal cancer; Anterior resection of cancer rectum and type of anastomosis (End to end or side to end)
Active Comparator: Group B; the second group included patients will have anterior resection with side to end anastomosis.	Procedure: Anterior resection of Rectal cancer; Anterior resection of cancer rectum and type of anastomosis (End to end or side to end)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	in minutes	Immediate postoperative
Anastomotic leakage	yes or No	2 weeks postoperative
hospital stay	in days	2 weeks postoperative
Mortality	yes or no	4 weeks postoperative
Anastomotic leak amount	in cubic centimeters	2 weeks postoperative

Collaborators and Investigators

• Sponsor: Sohag University
• Investigators: Study Chair: AbdElhafez H Mohamed, MD, Sohag University; Study Director: Ahmed A Ahmed, MD, Ain Shams University; Principal Investigator: Nabil A Al-Ameer, MD, Sohag University; Study Director: Emad G Mohamed, MD, Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): March 20, 2025

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Anastomosis; cancer rectum; End to end; side to end
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms
• Other Study ID Numbers: Soh-Med-24-03-01MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No