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

May 11, 2016 updated by: Guoxian Guan, Fujian Medical University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: without "Dog Ear" group
a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
Other Names:
  • modified laparoscopic double-stapled anastomosis
Active Comparator: with "Dog Ear" group
traditional double-stapled anastomosis was used for laparoscopic anterior resection
Procedure: with "Dog Ear" group
a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection
Other Names:
  • traditional laparoscopic double-stapled anastomosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
anastomotic leakage rate
Time Frame: 30 days since the date of surgery
30 days since the date of surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Investigators

  • Principal Investigator: Guo-xian Guan, MD,PhD, Fujian Medical University Union Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2018

Study Registration Dates

First Submitted

May 8, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimate)

May 12, 2016

Study Record Updates

Last Update Posted (Estimate)

May 12, 2016

Last Update Submitted That Met QC Criteria

May 11, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FJMU-20160424

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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