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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02433938
Other study ID # jm-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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