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

Phase 3

• Conditions: Anastomotic Leak; Rectal Carcinoma; Laparoscopy
• Interventions: Procedure: without "Dog Ear" group; Procedure: with "Dog Ear" group

• Registration Number: NCT02770911
• Lead Sponsor: Fujian Medical University

Brief 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.

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-11
• Last Update Submitted: 2016-05-11
• Study First Posted: 2016-05-12
• Last Update Posted: 2016-05-12
• Study Start: 2016-06
• Primary Completion: 2017-06
• Study Completion: 2018-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Eligibility rule of enrollment
• Rectal adenocarcinoma above the peritoneal reflection
• at least 18 years old & at most 80 years old
• Clinically diagnosed cT1-T4aN0-2 disease
• no contraindication to laparoscopic surgery
• without other malignancies in medical history

Exclusion Criteria

• concurrent or previous diagnosis of invasive cancer within 5 years
• locally advanced cancers requiring en bloc multivisceral resection
• intestinal obstruction
• intestinal perforation
• American Society of Anesthesiologists(ASA) class 4 or 5
• pregnant or breast-feeding women
• history of mental disorder
• participation in another rectal cancer clinical trial relating to surgical technique

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
without "Dog Ear" group	without "Dog Ear" group	Before anastomosis, the surgeon made a laparoscopic suturing on the two dog ears by using 3-0 monofilament sutures, and pull two dogears of staple line around the trocar by a tied suture through two dog ears. By this way, the staple line was kept within the circular knife when the circular stapler was closed. Then a true end-to-end anastomosis was performed after stapler firing.
with "Dog Ear" group	with "Dog Ear" group	traditional double-stapled anastomosis was used for laparoscopic anterior resection

Primary Outcome Measures

Name	Time	Method
anastomotic leakage rate	30 days since the date of surgery

Secondary Outcome Measures

Name	Time	Method
QLQ 30	at postoperative 3,6 and 12 months
Intra-operative and post-operative complications	30 days since the date of surgery
re-operation rate	30 days since the date of surgery
post-operative Mortality	30 days since the date of surgery
Wexner's scoring	at postoperative 3,6 and 12 months