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

NCT06311279 | Recruiting DMC

• 1 other identifier: Soh-Med-24-03-01MD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rectum Cancer

Keywords

cancer rectum; Anastomosis; End to end; side to end

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Group A

ACTIVE COMPARATOR

the first group included patients who will have anterior resection with end-to-end anastomosis

Procedure: Anterior resection of Rectal cancer

Group B

ACTIVE COMPARATOR

the second group included patients will have anterior resection with side to end anastomosis.

Procedure: Anterior resection of Rectal cancer

Interventions

Anterior resection of Rectal cancer PROCEDURE

Anterior resection of cancer rectum and type of anastomosis (End to end or side to end)

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, 82511, Egypt

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• AbdElhafez H Mohamed, MD

  Sohag University

  STUDY CHAIR

• Ahmed A Ahmed, MD

  Ain Shams University

  STUDY DIRECTOR

• Nabil A Al-Ameer, MD

  Sohag University

  PRINCIPAL INVESTIGATOR

• Emad G Mohamed, MD

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Nabil A Al-Ameer, MD

CONTACT

1118416290; Nabil.abdelnaser@med.sohag.edu.eg

Nabil A Al-Ameer, MD

CONTACT

1067833019; Nabil.abdelnaser@med.sohag.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: randomized comparative clinical trial
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer, physician and MD candidate

Model Details: 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 Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: March 5, 2024
• Primary Completion: January 1, 2025
• Study Completion: March 20, 2025
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)