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Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

Primary Purpose

Slow Transit, Constipation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic total colectomy + low resection of rectum
Laparoscopic total colectomy + High resection of rectum
Sponsored by
Shanghai Minimally Invasive Surgery Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Slow Transit

Eligibility Criteria

15 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed as constipation according to Rome IV criteria
  • Diagnosed as slow transit constipation
  • With more than 2 years' drug treatment or with outlet obstruction or with surgical history

Exclusion Criteria:

  • Colon cancer
  • History of colon, rectum, anus surgery
  • With severe cardio, renal, neural disease
  • Pregnant patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    High resection

    Low resection

    Arm Description

    Laparoscopic total colectomy + High resection of rectum

    Laparoscopic total colectomy + Low resection of rectum

    Outcomes

    Primary Outcome Measures

    1-year recurrence rate of constipation
    1-year recurrence rate of constipation

    Secondary Outcome Measures

    1-year rate of diarrhea
    1-year rate of diarrhea
    perioperative complications
    perioperative complications

    Full Information

    First Posted
    August 18, 2020
    Last Updated
    August 23, 2020
    Sponsor
    Shanghai Minimally Invasive Surgery Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04525248
    Brief Title
    Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation
    Official Title
    High Resection vs. Low Resection of Rectum in Laparoscopic Total Colectomy for Slow Transit Constipation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2020
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2020 (Anticipated)
    Primary Completion Date
    August 1, 2023 (Anticipated)
    Study Completion Date
    August 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai Minimally Invasive Surgery Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum
    Detailed Description
    The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12~15cm from anus and low resection as 6~8cm.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Slow Transit, Constipation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    78 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    High resection
    Arm Type
    Active Comparator
    Arm Description
    Laparoscopic total colectomy + High resection of rectum
    Arm Title
    Low resection
    Arm Type
    Experimental
    Arm Description
    Laparoscopic total colectomy + Low resection of rectum
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic total colectomy + low resection of rectum
    Intervention Description
    Laparoscopic total colectomy + low resection of rectum
    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic total colectomy + High resection of rectum
    Intervention Description
    Laparoscopic total colectomy + High resection of rectum
    Primary Outcome Measure Information:
    Title
    1-year recurrence rate of constipation
    Description
    1-year recurrence rate of constipation
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    1-year rate of diarrhea
    Description
    1-year rate of diarrhea
    Time Frame
    1 year
    Title
    perioperative complications
    Description
    perioperative complications
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed as constipation according to Rome IV criteria Diagnosed as slow transit constipation With more than 2 years' drug treatment or with outlet obstruction or with surgical history Exclusion Criteria: Colon cancer History of colon, rectum, anus surgery With severe cardio, renal, neural disease Pregnant patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Junjun Ma, Dr
    Phone
    +86 13917283686
    Email
    marsnew1997@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xuan Zhao, Dr
    Phone
    +86 15900826056
    Email
    patrickzhao_sjtu@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Minhua Zheng
    Organizational Affiliation
    Shanghai MISC
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation

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