Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05368168

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

Led by Innovacion en Cirugía Vigo · Updated on 2023-07-06

114

Participants Needed

1

Research Sites

239 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing elective surgery for anterior rectal resection or transit reconstruction with low anastomosis (below 10 cm from the anal margin) at Hospital Álvaro Cunqueiro in Vigo after study start
  • Anastomosis must be intact without any leaks (anastomotic tightness)
  • Patients must be older than 18 years
  • Acceptance to participate in the study
Not Eligible

You will not qualify if you...

  • Inability to understand study instructions and recommendations
  • Presence of dementia or any mental disability
  • Undergoing palliative surgery
  • Having a pacemaker
  • Patients on anticoagulant therapy
  • Having trophic skin lesions on the ankles

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain, 36213

Actively Recruiting

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Research Team

R

Raquel Sánchez Santos, PhD

CONTACT

M

Marta Paniagua García-Señoráns, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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