NCT02433938

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2015

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 5, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

1.3 years

First QC Date

April 9, 2015

Last Update Submit

October 1, 2018

Conditions

Postoperative IleusColorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • bowel function recovery (Time to first bowel movement or flatus)

    Time to first bowel movement or flatus

    7 days

Secondary Outcomes (3)

  • Length of postoperative hospital stay

    30 days

  • Post-operative vomiting (episodes of vomiting)

    30 days

  • Use of NG Tubes (Nasogastric tube (re)insertions)

    30 days

Study Arms (2)

Underwent tibial nerve stimulation

EXPERIMENTAL

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

Procedure: Tibial nerve stimulation

Did not undergo tibial nerve stimulation

SHAM COMPARATOR

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

Procedure: Sham tibial nerve stimulation

Interventions

Tibial nerve stimulationPROCEDURE

patients underwent a three days postoperative transcutaneous tibial nerve stimulation

Underwent tibial nerve stimulation
Sham tibial nerve stimulationPROCEDURE

patients did not undergo a postoperative transcutaneous tibial nerve stimulation

Did not undergo tibial nerve stimulation

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients that underwent colorectal surgery

You may not qualify if:

  • Severe comorbidities
  • Postoperative or intraoperative complications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Jacopo Martellucci, MD, PhD

    University of Florence

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

April 9, 2015

First Posted

May 5, 2015

Study Start

July 1, 2015

Primary Completion

November 1, 2016

Study Completion

December 1, 2017

Last Updated

October 2, 2018

Record last verified: 2018-10