Clinical trial NCT05368168: Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
Official title: Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Disorders
Low Anterior Resection Syndrome
Low Anterior Resection
Keywords: Posterior tibial nerve stimulation (PTNS)
Urgent PC
Transcutaneous neurostimulator
Lead sponsor: Innovacion en Cirugía Vigo
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Efficacy of PTNS (Posterior Tibial Nerve Stimulation) treatment on the incidence and duration of RAS symptoms in patients undergoing anterior rectal resection with sphincter-sparing surgery.
timeFrame: 12 months
measure: Impact of PTNS on the quality of life (EORTC-QLQ C30)
timeFrame: 12 months
Secondary outcomes:
measure: LARS Scale
timeFrame: 12 months
measure: Impact of PTNS on the quality of life (EORTC-QLQ C29)
timeFrame: 12 months
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
state: Pontevedra
Study officials:
affiliation: Complejo Hospitalario Universitario de Vigo
name: Raquel Sánchez Santos, PhD
role: STUDY_DIRECTOR
References: