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

NCT ID: NCT06311279

Last Updated: 2024-03-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-05
• Study Completion Date: 2025-03-20

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.

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.

Conditions

Rectum Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group A

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

Group Type: ACTIVE_COMPARATOR

Anterior resection of Rectal cancer

Intervention Type: PROCEDURE

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

Group B

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

Group Type: ACTIVE_COMPARATOR

Anterior resection of Rectal cancer

Intervention Type: PROCEDURE

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

Interventions

Anterior resection of Rectal cancer

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Nabil Abdelnaser Al-ameer

assistant lecturer, physician and MD candidate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AbdElhafez H Mohamed, MD

Role: STUDY_CHAIR

Sohag University

Ahmed A Ahmed, MD

Role: STUDY_DIRECTOR

Ain Shams University

Nabil A Al-Ameer, MD

Role: PRINCIPAL_INVESTIGATOR

Sohag University

Emad G Mohamed, MD

Role: STUDY_DIRECTOR

Sohag University

Locations

Sohag university

Sohag, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Nabil A Al-Ameer, MD

Role: CONTACT

Nabil.abdelnaser@med.sohag.edu.eg

1118416290 ext. 0020

Nabil A Al-Ameer, MD

Role: CONTACT

Nabil.abdelnaser@med.sohag.edu.eg

1067833019 ext. 0020

Facility Contacts

Nabil A Al-Ameer, MD

Role: primary

Nabil.abdelnaser@med.sohag.edu.eg

1118416290

Ahmed G Hassanein, MD

Role: backup

ethics@med.sohag.edu.eg

1552538300 ext. 0020

Other Identifiers

Soh-Med-24-03-01MD

Identifier Type: -

Identifier Source: org_study_id