An interventional study of Posterior tibial nerve stimulation (PTNS) in Rectal Disorders, Low Anterior Resection Syndrome and Low Anterior Resection, sponsored by Innovacion en Cirugía Vigo. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-06.
Sponsored by Innovacion en Cirugía Vigo · Not applicable, Interventional, and Treatment
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.
82 studies on the registry are indexed under Low Anterior Resection Syndrome; 38 are open to participants now.
This study's planned enrollment of 114 is above the median of 72 across 56 interventional studies indexed under Low Anterior Resection Syndrome.
Browse Low Anterior Resection Syndrome studies →This is the only study on the registry with Innovacion en Cirugía Vigo as lead sponsor.
Compared within Low Anterior Resection Syndrome, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Rectal Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: 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 NOT BE treated with posterior tibial nerve stimulation.
Posterior tibial nerve neurostimulation in postoperative patients treated for rectal neoplasms for 6 weeks at a rate of 2 sessions per week (12 sessions). The sessions will be carried out by the nursing staff of the anorectal functional testing cabinet. The sessions will begin 3 weeks after hospital discharge for patients without lateral ileostomy and after ileostomy closure for patients with lateral ileostomy.
Also known as: Transcutaneous neurostimulator (Urgent PC)
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.
Variables: Age (years), Sex (F/M), Gestation (Y/N), Births (Y/N), Tumor location (cm from anus), Radiotherapy (Y/N), Radiotherapy regimen (short/long), Neoadjuvant chemotherapy (Y/N), Surgical approach (open, laparoscopic,transanal/converted), Distance between anus and anastomosis (cm), Type of anastomosis (colorectal, coloanal, mechanical, manual, term-terminal, term-lateral), Performance of derivative stoma (Y/N), Extent of mesorectal excision (total/partial), Postoperative dehiscence (Y/N), Postoperative abdominal collection(Y/N). Postoperative bleeding (Y/N), Clavien-dindo classification. Time from surgery to stoma closure (months), sphincter disruption (Y/N), Manometry (mmHg), neurostimulation parameters: stimulation intensity (mA), foot (right/left), stimulus (sensitive/motor/both). LARS score (0-42)
Time frame: 12 months
Impact of PTNS on the quality of life (EORTC-QLQ C30)
To evaluate the impact of PTNS on the quality of life of patients undergoing anterior rectal resection with sphincter-sparing surgery (as assessed by the EORTC-QLQ C30 quality of life questionnaire). The "European organization for reseach and treatment of cáncer quality life questionnaire core 30" (EORTC-QLQ C30) is a cancer-specific, multidimensional questionnaire comprising 30 items on five scales (physical, functional, emotional, cognitive, social), three items on symptoms (fatigue, nausea/vomiting, pain), six single-item items (constipation, diarrhea, hyporexia, insomnia, dyspnea,economic difficulties) and others on a global state of health. The score is between 1 and 100, where the higher the score, the greater the decrease in quality of life.
Time frame: 12 months
LARS Scale
To evaluate continence and number of stools (assessed by the LARS scale) in patients undergoing anterior rectal resection. "Low Anterior Resection Score" LARS scale is a quantitative variable of anterior resection syndrome related to quality of life. The scale ranges from 0 to 42 points with the highest score being a worsening result and it is categorized into 3 groups: no LARS (0-20 points), minor LARS (21-29 points) and major LARS (30-42 points).
Time frame: 12 months
Impact of PTNS on the quality of life (EORTC-QLQ C29)
To evaluate sexual dysfunction in patients undergoing anterior rectal resection (assessed by the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaires: EORTC-QLQ C29). The "European organization for reseach and treatment of cáncer quality life questionnaire core 29" (EORTC-QLQ C29) is a questionnaire specific to patients with rectal neoplasms. It comprises 19 questions common to all patients, four questions on female or male sexual dysfunction and seven questions for patients with or without stoma. The score is between 1 and 136, where the higher the score, the greater the decrease in quality of life.
Time frame: 12 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Low Anterior Resection Syndrome →