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Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery (TiRex)

Primary Purpose

Postoperative Ileus, Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tibial nerve stimulation
Sham tibial nerve stimulation
Sponsored by
University of Florence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Ileus

Eligibility Criteria

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

Inclusion Criteria:

  • Patients that underwent colorectal surgery

Exclusion Criteria:

  • Severe comorbidities
  • Postoperative or intraoperative complications

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Underwent tibial nerve stimulation

    Did not undergo tibial nerve stimulation

    Arm Description

    Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days

    Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns)

    Outcomes

    Primary Outcome Measures

    bowel function recovery (Time to first bowel movement or flatus)
    Time to first bowel movement or flatus

    Secondary Outcome Measures

    Length of postoperative hospital stay
    Length of postoperative hospital stay
    Post-operative vomiting (episodes of vomiting)
    Episodes of vomiting
    Use of NG Tubes (Nasogastric tube (re)insertions)
    Nasogastric tube (re)insertions

    Full Information

    First Posted
    April 9, 2015
    Last Updated
    October 1, 2018
    Sponsor
    University of Florence
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02433938
    Brief Title
    Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery
    Acronym
    TiRex
    Official Title
    Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    November 2016 (Actual)
    Study Completion Date
    December 2017 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Aim of the study is to evaluate the role of postoperative tibial nerve stimulation in the enhancement of the recovery of bowel function and in shortening the hospital stay.
    Detailed Description
    Patients were randomized in two groups. The first group underwent a three days postoperative transcutaneous tibial nerve stimulation. The second group underwent a sham stimulation. Aim of the study is to evaluate the role of tibial nerve stimulation in the postoperative recovery after colorectal surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postoperative Ileus, Colorectal Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Underwent tibial nerve stimulation
    Arm Type
    Experimental
    Arm Description
    Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days
    Arm Title
    Did not undergo tibial nerve stimulation
    Arm Type
    Sham Comparator
    Arm Description
    Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns)
    Intervention Type
    Procedure
    Intervention Name(s)
    Tibial nerve stimulation
    Intervention Description
    patients underwent a three days postoperative transcutaneous tibial nerve stimulation
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham tibial nerve stimulation
    Intervention Description
    patients did not undergo a postoperative transcutaneous tibial nerve stimulation
    Primary Outcome Measure Information:
    Title
    bowel function recovery (Time to first bowel movement or flatus)
    Description
    Time to first bowel movement or flatus
    Time Frame
    7 days
    Secondary Outcome Measure Information:
    Title
    Length of postoperative hospital stay
    Description
    Length of postoperative hospital stay
    Time Frame
    30 days
    Title
    Post-operative vomiting (episodes of vomiting)
    Description
    Episodes of vomiting
    Time Frame
    30 days
    Title
    Use of NG Tubes (Nasogastric tube (re)insertions)
    Description
    Nasogastric tube (re)insertions
    Time Frame
    30 days

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients that underwent colorectal surgery Exclusion Criteria: Severe comorbidities Postoperative or intraoperative complications
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jacopo Martellucci, MD, PhD
    Organizational Affiliation
    University of Florence
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery

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