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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rectal Carcinoma, Laparoscopy, Anastomotic Leak

Intervention / Treatment
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* Procedure: without Dog Ear group
* Procedure: with Dog Ear group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: without Dog Ear group<br>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. | Procedure: without Dog Ear group<br>* a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection<br>* Other names: modified laparoscopic double-stapled anastomosis;|
| Active Comparator: with Dog Ear group<br>traditional double-stapled anastomosis was used for laparoscopic anterior resection | Procedure: with Dog Ear group<br>* a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection<br>* Other names: traditional laparoscopic double-stapled anastomosis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic leakage rate |  | 30 days since the date of surgery | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique