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

Low Anterior Resection Syndrome Clinical Trial

— LARS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05368168
• Other study ID #: LARS
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2022
• Est. completion date: January 2027

Study information

• Verified date: July 2023
• Source: Innovacion en Cirugía Vigo
• Contact: Raquel Sánchez Santos, PhD
• Phone: 629357242
• Email: raquelsanchezsantos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 114
• Est. completion date: January 2027
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Low Anterior Resection
• Low Anterior Resection Syndrome
• Rectal Diseases
• Syndrome

Intervention

Device:
• Posterior tibial nerve stimulation (PTNS)
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.

Locations

Country	Name	City	State
Spain	Hospital Álvaro Cunqueiro	Vigo	Pontevedra

Sponsors (1)

Lead Sponsor	Collaborator
Innovacion en Cirugía Vigo

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	12 months
Primary	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.	12 months
Secondary	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).	12 months
Secondary	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.	12 months