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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-06-30

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.

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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.

Conditions

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Rectal Carcinoma Laparoscopy Anastomotic Leak

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

without "Dog Ear" group

Intervention Type PROCEDURE

a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection

with "Dog Ear" group

traditional double-stapled anastomosis was used for laparoscopic anterior resection

Group Type ACTIVE_COMPARATOR

with "Dog Ear" group

Intervention Type PROCEDURE

a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection

Interventions

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without "Dog Ear" group

a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection

Intervention Type PROCEDURE

with "Dog Ear" group

a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection

Intervention Type PROCEDURE

Other Intervention Names

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modified laparoscopic double-stapled anastomosis traditional laparoscopic double-stapled anastomosis

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No