NCT05368168 Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
| NCT ID | NCT05368168 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Innovacion en Cirugía Vigo |
| Condition | Rectal Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 114 participants |
| Start Date | 2022-06-03 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 114 participants in total. It began in 2022-06-03 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The treatment of rectal cancer is currently based on surgical resection of the rectum with total excision of the mesorectum, associated with neoadjuvant radiochemotherapy. 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.
Eligibility Criteria
Inclusion Criteria: * Patients undergoing elective surgery (scheduled, non-urgent) who underwent anterior rectal resection or transit reconstruction with low anastomosis (below 10 cm from the anal margin) at the Hospital Álvaro Cunqueiro in Vigo after the start date of the study. * Anastomotic tightness (absence of dehiscence). * Patients older than 18 years old. * Acceptance to participate in the study. Exclusion Criteria: * Inability to understand the study instructions and recommendations. * 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.
Contact & Investigator
Raquel Sánchez Santos, PhD
STUDY DIRECTOR
Complejo Hospitalario Universitario de Vigo
Frequently Asked Questions
Who can join the NCT05368168 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rectal Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05368168 currently recruiting?
Yes, NCT05368168 is actively recruiting participants. Contact the research team at raquelsanchezsantos@gmail.com for enrollment information.
Where is the NCT05368168 trial being conducted?
This trial is being conducted at Vigo, Spain.
Who is sponsoring the NCT05368168 clinical trial?
NCT05368168 is sponsored by Innovacion en Cirugía Vigo. The principal investigator is Raquel Sánchez Santos, PhD at Complejo Hospitalario Universitario de Vigo. The trial plans to enroll 114 participants.