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

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: Colorectal Cancer; Postoperative Ileus
• Intervention / Treatment: Procedure: Tibial nerve stimulation; Procedure: Sham tibial nerve stimulation

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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 to first bowel movement or flatus	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

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: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: jm-001