Actively Recruiting
Impact of Early Postoperative Posterior Tibial Nerve Stimulation on Low Anterior Rectal Resection Syndrome Incidence and Duration
Led by Innovacion en Cirugía Vigo · Updated on 2023-07-06
114
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of early postoperative posterior tibial nerve stimulation (PTNS) on patients who have undergone low anterior resection of the rectum for cancer. This surgery, often combined with neoadjuvant radiochemotherapy, commonly leads to issues with bowel and defecation function known as Anterior Resection Syndrome (ARS). The study aims to determine if PTNS treatment can reduce the incidence and duration of ARS and improve patients' quality of life after surgery. Participants are randomly assigned to one of two groups: one receives PTNS treatment, and the other receives standard care without PTNS. The PTNS treatment involves 12 sessions over 6 weeks, starting three weeks after hospital discharge or after ileostomy closure if applicable. The stimulation sessions are performed by nursing staff specialized in anorectal functional testing. During the 12 months following surgery, patients will be monitored to assess the impact of PTNS on ARS symptoms and quality of life using validated measures such as the LARS Scale and EORTC-QLQ questionnaires. The study includes regular evaluations to track symptom incidence, duration, and quality of life changes. Safety and adherence to the treatment protocol will also be observed throughout the study period.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Patients undergoing elective surgery who had anterior rectal resection or transit reconstruction with low anastomosis (below 10 cm from the anal margin) at the designated hospital after the study start date
- Anastomotic tightness confirmed (no leakage)
- Patients aged 18 years or older
- Acceptance to participate in the study
You will not qualify if you...
- Inability to understand study instructions and recommendations
- Dementia or any mental disability
- Palliative surgery
- Presence of pacemaker
- Use of anticoagulant medications
- Presence of trophic skin lesions on the ankles
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo anterior rectal resection surgery with sphincter-sparing technique.
1 visit (in-person)
Duration - 6 weeks
Participants in the treatment group receive posterior tibial nerve stimulation for 6 weeks starting 3 weeks after hospital discharge or ileostomy closure, with 2 sessions per week.
Twice weekly visits for up to 6 weeks
Duration - 12 months
Participants are monitored for the incidence and duration of Low Anterior Rectal Resection Syndrome symptoms and quality of life for up to 12 months after treatment.
Periodic follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, Spain, 36213
Actively Recruiting
Research Team
R
Raquel Sánchez Santos, PhD
M
Marta Paniagua García-Señoráns, MD
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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