Postoperative IleusTiRexNCT02433938
Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery
A study testing Tibial nerve stimulation in people with Postoperative Ileus and Colorectal Cancer, run by University of Florence.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Postoperative Ileus, Colorectal Cancer
- What is being tested?
- Tibial nerve stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Jul 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients that underwent colorectal surgery
Who cannot join
- Severe comorbidities
- Postoperative or intraoperative complications
About this study
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.
Read the 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.
- Conditions
- Postoperative Ileus, Colorectal Cancer
- Being tested
- Tibial nerve stimulation, Sham tibial nerve stimulation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibial nerve stimulationProcedure or surgery
patients underwent a three days postoperative transcutaneous tibial nerve stimulation
Sham tibial nerve stimulationProcedure or surgery
patients did not undergo a postoperative transcutaneous tibial nerve stimulation
| Study group | Role | What they receive |
|---|---|---|
| Underwent tibial nerve stimulation | Experimental | Patients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days Receives: 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) Receives: Procedure: Sham tibial nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
bowel function recovery (Time to first bowel movement or flatus)
Time to first bowel movement or flatus
Measured: 7 days
Secondary outcomes (3)
Length of postoperative hospital stay
Length of postoperative hospital stay
Measured: 30 days
Post-operative vomiting (episodes of vomiting)
Episodes of vomiting
Measured: 30 days
Use of NG Tubes (Nasogastric tube (re)insertions)
Nasogastric tube (re)insertions
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startJul 2015
- Primary completionNov 2016
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florence
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacopo Martellucci, University of Florence
- Investigators
- Jacopo Martellucci, MD, PhD, Study chair, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02433938
- Sponsor's protocol ID
- jm-001
- Acronym
- TiRex
- Status last verified
- Oct 2018
- First submitted
- 9 Apr 2015
- Last updated
- 2 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Tibial Nerve Stimulation for Enhanced Postoperative Recovery After Colorectal Surgery
- ClinicalTrials.gov ID
- NCT02433938
- Acronym / sponsor ID
- TiRex / jm-001
- Conditions
- Postoperative Ileus, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University of FlorenceUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Underwent tibial nerve stimulation | Experimental | Procedure: Tibial nerve stimulationPatients that underwent standard postoperative protocol + tibial nerve stimulation for 3 days |
| Did not undergo tibial nerve stimulation | Sham comparator | Procedure: Sham tibial nerve stimulationPatients that underwent standard postoperative protocol + sham tibial nerve stimulation (standard postoperative protocol+sham tns) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that underwent colorectal surgery
Key exclusion criteria (2 listed)
- Severe comorbidities
- Postoperative or intraoperative complications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibial nerve stimulationpatients underwent a three days postoperative transcutaneous tibial nerve stimulation | Procedure or surgery | Underwent tibial nerve stimulation |
| Sham tibial nerve stimulationpatients did not undergo a postoperative transcutaneous tibial nerve stimulation | Procedure or surgery | Did not undergo tibial nerve stimulation |
Primary outcome
bowel function recovery (Time to first bowel movement or flatus)
Time frame: 7 days
Time to first bowel movement or flatus
3 secondary outcomes
Length of postoperative hospital stay
Time frame: 30 days
Post-operative vomiting (episodes of vomiting)
Time frame: 30 days
Use of NG Tubes (Nasogastric tube (re)insertions)
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
Related trials for Postoperative Ileus
Recruiting
Rectus Sheath Catheters Following Midline Laparotomy
Acute Abdomen, Ileus
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
At-Home Bowel Stimulation
Post-Operative Ileus (POI)
Recruiting
The Food Network Effect
Post Operative Patients
RecruitingPhase 4
Effect of Tegileridine on Postoperative Bowel Function Recovery in Abdominal Surgery
Pain, Postoperative, Postoperative Ileus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacopo Martellucci, MD, PhD study chair
University of Florence
Questions about this trial
What is this clinical trial studying?
A study testing Tibial nerve stimulation in people with Postoperative Ileus and Colorectal Cancer, run by University of Florence.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bowel function recovery (Time to first bowel movement or flatus) (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.