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

Colorectal Cancer Clinical Trial

— TiRex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433938
• Other study ID #: jm-001
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2018
• Source: University of Florence
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: December 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients that underwent colorectal surgery

Exclusion Criteria:

• Severe comorbidities

• Postoperative or intraoperative complications

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Postoperative Ileus

Intervention

Procedure:
• Tibial nerve stimulation
patients underwent a three days postoperative transcutaneous tibial nerve stimulation
• Sham tibial nerve stimulation
patients did not undergo a postoperative transcutaneous tibial nerve stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	bowel function recovery (Time to first bowel movement or flatus)	Time to first bowel movement or flatus	7 days
Secondary	Length of postoperative hospital stay	Length of postoperative hospital stay	30 days
Secondary	Post-operative vomiting (episodes of vomiting)	Episodes of vomiting	30 days
Secondary	Use of NG Tubes (Nasogastric tube (re)insertions)	Nasogastric tube (re)insertions	30 days