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

NCT ID: NCT02433938

Last Updated: 2018-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Postoperative Ileus Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Underwent tibial nerve stimulation

Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days

Group Type EXPERIMENTAL

Tibial nerve stimulation

Intervention Type PROCEDURE

patients underwent a three days postoperative transcutaneous tibial nerve stimulation

Did not undergo tibial nerve stimulation

Patients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns)

Group Type SHAM_COMPARATOR

Sham tibial nerve stimulation

Intervention Type PROCEDURE

patients did not undergo a postoperative transcutaneous tibial nerve stimulation

Interventions

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Tibial nerve stimulation

patients underwent a three days postoperative transcutaneous tibial nerve stimulation

Intervention Type PROCEDURE

Sham tibial nerve stimulation

patients did not undergo a postoperative transcutaneous tibial nerve stimulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients that underwent colorectal surgery

Exclusion Criteria

* Severe comorbidities
* Postoperative or intraoperative complications
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florence

OTHER

Sponsor Role lead

Responsible Party

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Jacopo Martellucci

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jacopo Martellucci, MD, PhD

Role: STUDY_CHAIR

University of Florence

Other Identifiers

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jm-001

Identifier Type: -

Identifier Source: org_study_id

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