Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
Hospital Álvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Raquel Sánchez Santos, PhD
raquelsanchezsantos@gmail.com
629357242
Backup
Marta Paniagua García-Señoráns, MD
paniolas@gmail.com
Time Frame
Start Date: 2022-06-03
Estimated Completion Date: 2027-01
Participants
Target number of participants: 114
Treatments
Experimental: 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.
No_intervention: 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.
Related Therapeutic Areas
Sponsors
Leads: Innovacion en Cirugía Vigo

This content was sourced from clinicaltrials.gov