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CRP-guided Transanal Drainage Removal After Rectal Surgery

Primary Purpose

Rectal Cancer, Anastomotic Leak

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
removal of transanal drainage tube
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Rectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • age from 18 to 75 years old
  • male and female
  • primary rectal adenocarcinoma
  • ASA I, II, or III
  • laparoscopic LAR + DST
  • with or without preoperative radio- or chemotherapy
  • no distal metastasis
  • no preoperative bowel obstruction
  • no preventive ileostomy or colostomy
  • patients and their families can understand and are willing to participate in this study and provide written informed consent

Exclusion Criteria:

  • emergency operation
  • preoperative abnormal liver function
  • tatme or ISR procedure (healing process might differ from anterior resection)
  • severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak
  • severe perioperative infection unrelated to anastomotic leak
  • patients with serious mental illness
  • pregnant or breastfeeding women
  • patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    patients with TDT removal guided by postoperative CRP trajectory

    Arm Description

    Outcomes

    Primary Outcome Measures

    anastomotic rate
    anastomotic rate

    Secondary Outcome Measures

    the grades of anastomotic leak
    The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer
    rates of diarrhea after transanal drainage tube removal
    rates of diarrhea after transanal drainage tube removal
    visual analogue scale to assess anal postoperative pain
    visual analogue scale of the included patients to assess the transanal drainage tube tolerability. Visual analogue scale ranges from 0-10. 0 indicates perfectly tolerated while 10 indicates complete intolerant and the tube has to be removed.
    transanal drainage tube-related adverse events
    transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations

    Full Information

    First Posted
    August 11, 2022
    Last Updated
    March 28, 2023
    Sponsor
    Qilu Hospital of Shandong University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05502354
    Brief Title
    CRP-guided Transanal Drainage Removal After Rectal Surgery
    Official Title
    A Single Arm Study to Investigate the Safety and Efficacy of C Reactive Protein (CRP) Guided Transanal Drainage Tube (TDT) Removal for Anastomotic Leak (AL) Prevention Following Laparoscopic Anterior Resection for Rectal Carcinoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    February 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Qilu Hospital of Shandong University

    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
    Transanal drainage tube (TDT) has the benefit of reducing intraluminal pressure after rectal surgery and may provide ideal regional environment for anastomotic healing. Postoperative C-reactive protein (CRP) trajectory has a high negative predictive value of 0.99 for ruling out anastomotic leak (AL). Previously, TDT was removed at the surgeon's own discretion. In the present study, we design a single arm study to investigate the safety and efficacy of CRP-guided TDT removal for AL prevention following laparoscopic anterior resection for rectal carcinoma

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Cancer, Anastomotic Leak

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    250 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with TDT removal guided by postoperative CRP trajectory
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    removal of transanal drainage tube
    Intervention Description
    removal of transanal drainage tube after laparoscopic anterior resection for rectal carcinoma according to postoperative CRP trajectory
    Primary Outcome Measure Information:
    Title
    anastomotic rate
    Description
    anastomotic rate
    Time Frame
    30 days after surgery
    Secondary Outcome Measure Information:
    Title
    the grades of anastomotic leak
    Description
    The severity grading of anastomotic leak according to the International Study Group of Rectal Cancer
    Time Frame
    30 days after surgery
    Title
    rates of diarrhea after transanal drainage tube removal
    Description
    rates of diarrhea after transanal drainage tube removal
    Time Frame
    from transanal drainage tube removal to 30 days after surgery
    Title
    visual analogue scale to assess anal postoperative pain
    Description
    visual analogue scale of the included patients to assess the transanal drainage tube tolerability. Visual analogue scale ranges from 0-10. 0 indicates perfectly tolerated while 10 indicates complete intolerant and the tube has to be removed.
    Time Frame
    from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks
    Title
    transanal drainage tube-related adverse events
    Description
    transanal drainage tube-related adverse events such as bleeding and iatrogenic colonic perforations
    Time Frame
    from the date of transanal drainage tube positioning until the tube is removed, assessed up to 2 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: age from 18 to 75 years old male and female primary rectal adenocarcinoma ASA I, II, or III laparoscopic LAR + DST with or without preoperative radio- or chemotherapy no distal metastasis no preoperative bowel obstruction no preventive ileostomy or colostomy patients and their families can understand and are willing to participate in this study and provide written informed consent Exclusion Criteria: emergency operation preoperative abnormal liver function tatme or ISR procedure (healing process might differ from anterior resection) severe postoperative (Clavien-Dindo grade III IV V) complications other than anastomotic leak severe perioperative infection unrelated to anastomotic leak patients with serious mental illness pregnant or breastfeeding women patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiang Zhang, M.D. Ph.D.
    Phone
    +8618560089182
    Email
    xiang.zhang02@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Zhiqiang Cheng, M.D. Ph.D.
    Phone
    +8618560085238
    Email
    hill988276@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kexin Wang, M.D. Ph.D.
    Organizational Affiliation
    Qilu Hospital of Shandong University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    CRP-guided Transanal Drainage Removal After Rectal Surgery

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