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

Sponsor

University of Florence (Other)

Overall Status

Completed

CT.gov ID

NCT02433938

Collaborator

(none)

160

Enrollment

Arms

Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Ileus Colorectal Cancer	Procedure: Tibial nerve stimulation Procedure: Sham tibial nerve stimulation	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Jul 1, 2015

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

bowel function recovery (Time to first bowel movement or flatus) [7 days]
Time to first bowel movement or flatus

Secondary Outcome Measures

Length of postoperative hospital stay [30 days]
Length of postoperative hospital stay
Post-operative vomiting (episodes of vomiting) [30 days]
Episodes of vomiting
Use of NG Tubes (Nasogastric tube (re)insertions) [30 days]
Nasogastric tube (re)insertions

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients that underwent colorectal surgery

Exclusion Criteria:

Severe comorbidities
Postoperative or intraoperative complications

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Florence

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jacopo Martellucci, MD, PhD, University of Florence

ClinicalTrials.gov Identifier:

NCT02433938

Other Study ID Numbers:

jm-001

First Posted:

May 5, 2015

Last Update Posted:

Oct 2, 2018

Last Verified:

Oct 1, 2018

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Oct 2, 2018