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

Rectum Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311279
• Other study ID #: Soh-Med-24-03-01MD
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: March 20, 2025

Study information

• Verified date: March 2024
• Source: Sohag University
• Contact: Nabil A Al-Ameer, MD
• Phone: 1118416290
• Email: Nabil.abdelnaser[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 20, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Neoplasms
• Rectum Cancer

Intervention

Procedure:
• Anterior resection of Rectal cancer
Anterior resection of cancer rectum and type of anastomosis (End to end or side to end)

Locations

Country	Name	City	State
Egypt	Sohag university	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operative time	in minutes	Immediate postoperative
Primary	Anastomotic leakage	yes or No	2 weeks postoperative
Primary	hospital stay	in days	2 weeks postoperative
Primary	Mortality	yes or no	4 weeks postoperative
Primary	Anastomotic leak amount	in cubic centimeters	2 weeks postoperative