NCT02770911

Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer

Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique which to eliminate the 'dog ears' in laparoscopic rectal anterior resection.

Detailed description

Laparoscopic surgeons commonly make rectal transection intracorporeally by laparoscopic linear stapler during rectal anterior resection and perform an end-to-end anastomosis by circular stapler. But the so-called 'dog ears', two stapled corners of the rectal stump after laparoscopic linear transection of rectum, are very common. The lateral intersections of double-stapled anastomoses are structural weak spot area, and they are considered to be the potential ischemic areas leading to anastomosis leakage and the possible sites occurring local recurrence. Previous study reported a modified technique for rectal reconstruction during open surgery, and they could use circular stapler to eliminate the staple line on the rectal stump and cut off the 'dog ears'. But because of the narrow pelvic cavity, it is very difficult to perform this technique in laparoscopic rectal surgery and there is no related report on laparoscopic application. In this study, we evaluates the feasibility and advantage of modified laparoscopic double-staple anastomosis technique, to eliminate the "dog ears" in laparoscopic rectal anterior resection by laparoscopic suturing on the staple line.

Conditions

• Rectal Carcinoma
• Laparoscopy
• Anastomotic Leak

Interventions

Type	Name	Description
PROCEDURE	without "Dog Ear" group	a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
PROCEDURE	with "Dog Ear" group	a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2016-05-12
• Last updated: 2016-05-12