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

Primary Purpose

Rectal Carcinoma, Laparoscopy, Anastomotic Leak

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
without "Dog Ear" group
with "Dog Ear" group
Sponsored by
Fujian Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Carcinoma focused on measuring Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    without "Dog Ear" group

    with "Dog Ear" group

    Arm Description

    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.

    traditional double-stapled anastomosis was used for laparoscopic anterior resection

    Outcomes

    Primary Outcome Measures

    anastomotic leakage rate

    Secondary Outcome Measures

    Intra-operative and post-operative complications
    post-operative Mortality
    re-operation rate
    QLQ 30
    Wexner's scoring

    Full Information

    First Posted
    May 8, 2016
    Last Updated
    May 11, 2016
    Sponsor
    Fujian Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02770911
    Brief Title
    Laparoscopic Anterior Resection With or Without "Dog Ear" Double-stapled Anastomosis for Rectal Cancer
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    June 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Fujian Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Carcinoma, Laparoscopy, Anastomotic Leak
    Keywords
    Rectal Carcinoma, Laparoscopy, Anastomotic Leak, Double-stapling technique

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    without "Dog Ear" group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    with "Dog Ear" group
    Arm Type
    Active Comparator
    Arm Description
    traditional double-stapled anastomosis was used for laparoscopic anterior resection
    Intervention Type
    Procedure
    Intervention Name(s)
    without "Dog Ear" group
    Other Intervention Name(s)
    modified laparoscopic double-stapled anastomosis
    Intervention Description
    a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
    Intervention Type
    Procedure
    Intervention Name(s)
    with "Dog Ear" group
    Other Intervention Name(s)
    traditional laparoscopic double-stapled anastomosis
    Intervention Description
    a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection
    Primary Outcome Measure Information:
    Title
    anastomotic leakage rate
    Time Frame
    30 days since the date of surgery
    Secondary Outcome Measure Information:
    Title
    Intra-operative and post-operative complications
    Time Frame
    30 days since the date of surgery
    Title
    post-operative Mortality
    Time Frame
    30 days since the date of surgery
    Title
    re-operation rate
    Time Frame
    30 days since the date of surgery
    Title
    QLQ 30
    Time Frame
    at postoperative 3,6 and 12 months
    Title
    Wexner's scoring
    Time Frame
    at postoperative 3,6 and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Guo-xian Guan, MD,PhD
    Phone
    86-13609592321
    Email
    gxguan1108@126.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guo-xian Guan, MD,PhD
    Organizational Affiliation
    Fujian Medical University Union Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    10789750
    Citation
    Roumen RM, Rahusen FT, Wijnen MH, Croiset van Uchelen FA. "Dog ear" formation after double-stapled low anterior resection as a risk factor for anastomotic disruption. Dis Colon Rectum. 2000 Apr;43(4):522-5. doi: 10.1007/BF02237198.
    Results Reference
    result
    PubMed Identifier
    23288715
    Citation
    Kang J, Lee HB, Cha JH, Hur H, Min BS, Baik SH, Kim NK, Sohn SK, Lee KY. Feasibility and impact on surgical outcomes of modified double-stapling technique for patients undergoing laparoscopic anterior resection. J Gastrointest Surg. 2013 Apr;17(4):771-5. doi: 10.1007/s11605-012-2122-0. Epub 2013 Jan 4.
    Results Reference
    result
    PubMed Identifier
    23014975
    Citation
    Kim HJ, Choi GS, Park JS, Park SY. Comparison of intracorporeal single-stapled and double-stapled anastomosis in laparoscopic low anterior resection for rectal cancer: a case-control study. Int J Colorectal Dis. 2013 Jan;28(1):149-56. doi: 10.1007/s00384-012-1582-8. Epub 2012 Sep 27.
    Results Reference
    result
    PubMed Identifier
    26902367
    Citation
    Chen ZF, Liu X, Jiang WZ, Guan GX. Laparoscopic double-stapled colorectal anastomosis without "dog-ears". Tech Coloproctol. 2016 Apr;20(4):243-7. doi: 10.1007/s10151-016-1437-3. Epub 2016 Feb 22. No abstract available.
    Results Reference
    result
    PubMed Identifier
    20004450
    Citation
    Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.
    Results Reference
    result

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

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