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

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ClinicalTrials.gov Identifier: NCT02770911
Recruitment Status : Unknown
Verified May 2016 by Guoxian Guan, Fujian Medical University.
Recruitment status was:  Not yet recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
Sponsor:
Information provided by (Responsible Party):
Guoxian Guan, 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.

Condition or disease Intervention/treatment Phase
Rectal Carcinoma Laparoscopy Anastomotic Leak Procedure: without "Dog Ear" group Procedure: with "Dog Ear" group Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anastomotic Leakage in Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer : A Prospective, Randomized, Controlled Study
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

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 Name: 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 Name: traditional laparoscopic double-stapled anastomosis




Primary Outcome Measures :
  1. anastomotic leakage rate [ Time Frame: 30 days since the date of surgery ]

Secondary Outcome Measures :
  1. Intra-operative and post-operative complications [ Time Frame: 30 days since the date of surgery ]
  2. post-operative Mortality [ Time Frame: 30 days since the date of surgery ]
  3. re-operation rate [ Time Frame: 30 days since the date of surgery ]
  4. QLQ 30 [ Time Frame: at postoperative 3,6 and 12 months ]
  5. Wexner's scoring [ Time Frame: at postoperative 3,6 and 12 months ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770911


Contacts
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Contact: Guo-xian Guan, MD,PhD 86-13609592321 gxguan1108@126.com

Sponsors and Collaborators
Fujian Medical University
Investigators
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Principal Investigator: Guo-xian Guan, MD,PhD Fujian Medical University Union Hospital

Publications of Results:
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Responsible Party: Guoxian Guan, Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT02770911     History of Changes
Other Study ID Numbers: FJMU-20160424
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: May 12, 2016
Last Verified: May 2016

Keywords provided by Guoxian Guan, Fujian Medical University:
Rectal Carcinoma
Laparoscopy
Anastomotic Leak
Double-stapling technique

Additional relevant MeSH terms:
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Rectal Neoplasms
Anastomotic Leak
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes