search
Back to results

J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer

Primary Purpose

Quality of Life, Fecal Incontinence, Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Linear cutter-Circular stapler
Circular stapler
Sponsored by
Dr. Lutfi Kirdar Kartal Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Quality of Life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope

Exclusion Criteria:

  • refusal of the patient to participate
  • pregnancy,
  • previous radiation therapy,
  • those have cancers other than adenocarcinoma,
  • those planned to have local excision or abdominoperineal resection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Linear cutter-Circular stapler J pouch

    Circular stapler Side-to-end anastomosis

    Arm Description

    J pouch anal anastomosis after laparoscopic low anterior resection

    side to end coloanal anastomosis after laparoscopic low anterior resection

    Outcomes

    Primary Outcome Measures

    Short Form 36 Quality of life Questionnaire

    Secondary Outcome Measures

    Postoperative complications
    Functional outcome measured with Fecal Incontinence Severity Index
    Functional outcome measured with Sexual Health Inventory
    Functional outcome measured with Overactive Bladder validated 8 scale

    Full Information

    First Posted
    December 7, 2015
    Last Updated
    December 9, 2015
    Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02627729
    Brief Title
    J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer
    Official Title
    J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer: Short and Long-Term Outcomes of a Prospective Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2009 (undefined)
    Primary Completion Date
    April 2012 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Dr. Lutfi Kirdar Kartal Training and Research Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Current study aims to analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Quality of Life, Fecal Incontinence, Postoperative Complications

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    74 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Linear cutter-Circular stapler J pouch
    Arm Type
    Active Comparator
    Arm Description
    J pouch anal anastomosis after laparoscopic low anterior resection
    Arm Title
    Circular stapler Side-to-end anastomosis
    Arm Type
    Active Comparator
    Arm Description
    side to end coloanal anastomosis after laparoscopic low anterior resection
    Intervention Type
    Device
    Intervention Name(s)
    Linear cutter-Circular stapler
    Intervention Description
    a 5 to 6 cm-long colonic pouch will be created with a 80 mm linear cutting-closing stapler. The anastomosis of j-pouch will be routinely strengthened with 3:0 vicryl sutures. Then, a pouch to anal anastomosis will be performed
    Intervention Type
    Device
    Intervention Name(s)
    Circular stapler
    Intervention Description
    a 5 to 6 cm-long colonic segment will be left at the distal part and a side-to-end anastomosis will be performed.
    Primary Outcome Measure Information:
    Title
    Short Form 36 Quality of life Questionnaire
    Time Frame
    Change from baseline scores at 4th, 8th and 12th months after stoma reversal
    Secondary Outcome Measure Information:
    Title
    Postoperative complications
    Time Frame
    30 days postoperatively
    Title
    Functional outcome measured with Fecal Incontinence Severity Index
    Time Frame
    Change from baseline scores at 4th, 8th and 12th months after stoma reversal
    Title
    Functional outcome measured with Sexual Health Inventory
    Time Frame
    Change from baseline scores at 4th, 8th and 12th months after stoma reversal
    Title
    Functional outcome measured with Overactive Bladder validated 8 scale
    Time Frame
    Change from baseline scores at 4th, 8th and 12th months after stoma reversal

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: patients with rectal cancer which is located up to 12 cm from the dentate line observed with a rigid rectosigmoidoscope Exclusion Criteria: refusal of the patient to participate pregnancy, previous radiation therapy, those have cancers other than adenocarcinoma, those planned to have local excision or abdominoperineal resection

    12. IPD Sharing Statement

    Learn more about this trial

    J-Pouch vs Side-to-End Anastomosis After Hand-Assisted Laparoscopic Low Anterior Resection for Rectal Cancer

    We'll reach out to this number within 24 hrs