Overview

This trial has been completed.

Conditions postoperative ileus, colorectal cancer
Treatments tibial nerve stimulation, sham tibial nerve stimulation
Sponsor University of Florence
Start date July 2015
End date November 2016
Trial size 160 participants
Trial identifier NCT02433938, jm-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver)
Primary purpose supportive care
Arm
(Experimental)
Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days
tibial nerve stimulation
patients underwent a three days postoperative transcutaneous tibial nerve stimulation
(Sham Comparator)
Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns)
sham tibial nerve stimulation
patients did not undergo a postoperative transcutaneous tibial nerve stimulation

Primary Outcomes

Measure
bowel function recovery (Time to first bowel movement or flatus)
time frame: 7 days

Secondary Outcomes

Measure
Length of postoperative hospital stay
time frame: 30 days
Post-operative vomiting (episodes of vomiting)
time frame: 30 days
Use of NG Tubes (Nasogastric tube (re)insertions)
time frame: 30 days

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patients that underwent colorectal surgery Exclusion Criteria: - Severe comorbidities - Postoperative or intraoperative complications

Additional Information

Official title Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Florence.