Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
NCT ID: NCT05368168
Last Updated: 2023-07-06
Study Results
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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RECRUITING
NA
114 participants
INTERVENTIONAL
2022-06-03
2027-01-31
Brief Summary
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Surgical resections with sphincter preservation are frequently (60% of cases) associated with problems related to intestinal and defecatory function, which together are called Anterior Resection Syndrome (ARS) with varying degrees of severity.
Among the different treatments the investigators find posterior tibial nerve stimulation, a simple and non-invasive technique, which is currently used.
The study aims to analyze whether postoperative posterior tibial nerve stimulation in patients undergoing low anterior resection of the rectum has an impact on the incidence and duration of low anterior resection syndrome (LARS) and therefore on the quality of life of patients undergoing this type of intervention.
Therefore, treatment with PNTS is currently established for the management of LARS symptoms. Given that a large percentage of patients operated on for rectal neoplasms will develop this syndrome, the investigators intend to apply this treatment before the onset of symptoms in patients at risk for LARS. It is also an intervention with a low rate of side effects, the benefit that the investigators can obtain from its preventive application is clearly superior to the risk of undergoing such treatment.
The investigators´ hypothesis is: Posterior tibial stimulation for 6 weeks post-operative of low anterior resection with anastomosis has a favorable impact by reducing the incidence and duration of ARS and improving the quality of life of patients undergoing anterior rectal resections for cancer.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Double-blind masking will be performed (patients will not know to which group they belong and the investigator will not know to which group each patient is assigned). The only person aware of the outcome of the randomization will be the functional tests nurse, who will apply the PTNS treatment.
Patients in both groups will be appointed in the same way in the functional testing office, although patients in group 2 will not receive PTNS, the tibial nerve puncture will be applied, they will be stimulated until they perceive the corresponding current and then the neurostimulator will be turned off so that they do not receive the treatment.
Study Groups
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Group 1: Posterior tibial nerve stimulation (PTNS)
Patients operated on at the Hospital Álvaro Cunqueiro for rectal neoplasia with anastomosis below 10 cm and who, after randomization, WILL BE treated with posterior tibial nerve stimulation.
Posterior tibial nerve stimulation (PTNS)
Posterior tibial nerve neurostimulation in postoperative patients treated for rectal neoplasms for 6 weeks at a rate of 2 sessions per week (12 sessions).
The sessions will be carried out by the nursing staff of the anorectal functional testing cabinet. The sessions will begin 3 weeks after hospital discharge for patients without lateral ileostomy and after ileostomy closure for patients with lateral ileostomy.
Group 2: Standard of care
Patients operated on at the Hospital Álvaro Cunqueiro for rectal neoplasia with anastomosis below 10 cm and who, after randomization,WILL NOT BE treated with posterior tibial nerve stimulation.
No interventions assigned to this group
Interventions
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Posterior tibial nerve stimulation (PTNS)
Posterior tibial nerve neurostimulation in postoperative patients treated for rectal neoplasms for 6 weeks at a rate of 2 sessions per week (12 sessions).
The sessions will be carried out by the nursing staff of the anorectal functional testing cabinet. The sessions will begin 3 weeks after hospital discharge for patients without lateral ileostomy and after ileostomy closure for patients with lateral ileostomy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Anastomotic tightness (absence of dehiscence).
* Patients older than 18 years old.
* Acceptance to participate in the study.
Exclusion Criteria
* Dementia or any type of mental disability.
* Palliative surgery.
* Patients with pacemakers.
* Anti-coagulated patients.
* Patients with trophic lesions on the skin of the ankles.
18 Years
ALL
No
Sponsors
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Innovacion en Cirugía Vigo
OTHER
Responsible Party
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Principal Investigators
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Raquel Sánchez Santos, PhD
Role: STUDY_DIRECTOR
Complejo Hospitalario Universitario de Vigo
Locations
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Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LARS
Identifier Type: -
Identifier Source: org_study_id
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