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

Not Applicable

Completed

• Conditions: Postoperative Ileus; Colorectal Cancer
• Interventions: Procedure: Tibial nerve stimulation; Procedure: Sham tibial nerve stimulation

• Registration Number: NCT02433938
• Lead Sponsor: University of Florence

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.

Study Timeline

• Study First Submitted: 2015-04-09
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Study Start: 2015-07
• Primary Completion: 2016-11
• Study Completion: 2017-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-01
• Last Update Posted: 2018-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients that underwent colorectal surgery

Exclusion Criteria

• Severe comorbidities
• Postoperative or intraoperative complications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Underwent tibial nerve stimulation	Tibial nerve stimulation	Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days
Did not undergo tibial nerve stimulation	Sham tibial nerve stimulation	Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns)

Primary Outcome Measures

Name	Time	Method
bowel function recovery (Time to first bowel movement or flatus)	7 days	Time to first bowel movement or flatus

Secondary Outcome Measures

Name	Time	Method
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