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

October 1, 2018 updated by: Jacopo Martellucci, University of Florence
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients that underwent colorectal surgery

Exclusion Criteria:

  • Severe comorbidities
  • Postoperative or intraoperative complications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Underwent tibial nerve stimulation
Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days
Procedure: Tibial nerve stimulation
patients underwent a three days postoperative transcutaneous tibial nerve stimulation
SHAM_COMPARATOR: Did not undergo tibial nerve stimulation
Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns)
Procedure: Sham tibial nerve stimulation
patients did not undergo a postoperative transcutaneous tibial nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bowel function recovery (Time to first bowel movement or flatus)
Time Frame: 7 days
Time to first bowel movement or flatus
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of postoperative hospital stay
Time Frame: 30 days
Length of postoperative hospital stay
30 days
Post-operative vomiting (episodes of vomiting)
Time Frame: 30 days
Episodes of vomiting
30 days
Use of NG Tubes (Nasogastric tube (re)insertions)
Time Frame: 30 days
Nasogastric tube (re)insertions
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Investigators

  • Study Chair: Jacopo Martellucci, MD, PhD, University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (ACTUAL)

November 1, 2016

Study Completion (ACTUAL)

December 1, 2017

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (ESTIMATE)

May 5, 2015

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2018

Last Update Submitted That Met QC Criteria

October 1, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jm-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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