Rectal DisordersLARSNCT05368168
Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
A study testing Posterior tibial nerve stimulation (PTNS) in people with Rectal Disorders and Low Anterior Resection Syndrome, run by Innovacion en Cirugía Vigo at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Disorders, Low Anterior Resection Syndrome, Low Anterior Resection
- What is being tested?
- Posterior tibial nerve stimulation (PTNS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jun 2022to Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marta Paniagua García-Señoráns, MD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36213
Raquel Sánchez Santos, PhD, 629357242, raquelsanchezsantos@gmail.com
Marta Paniagua García-Señoráns, MD, paniolas@gmail.com
About this study
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.
Read more
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.
- Being tested
- Posterior tibial nerve stimulation (PTNS)
- Keywords
- Posterior tibial nerve stimulation (PTNS), Urgent PC, Transcutaneous neurostimulator
- Medical subject headings
- Rectal Diseases, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posterior tibial nerve stimulation (PTNS)Device
Also called Transcutaneous neurostimulator (Urgent PC)
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Posterior tibial nerve stimulation (PTNS) | Experimental | 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. Receives: Device: Posterior tibial nerve stimulation (PTNS) |
| Group 2: Standard of care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start3 Jun 2022
- Primary completionOct 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovacion en Cirugía Vigo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raquel Sánchez Santos, PhD, Study director, Complejo Hospitalario Universitario de Vigo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368168
- Sponsor's protocol ID
- LARS
- Acronym
- LARS
- Status last verified
- Jul 2023
- First submitted
- 4 May 2022
- Last updated
- 6 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Early Postoperative Treatment With Posterior Tibial Nerve Stimulation on the Incidence and Duration of Low Anterior Rectal Resection Syndrome
- ClinicalTrials.gov ID
- NCT05368168
- Acronym / sponsor ID
- LARS / LARS
- Keywords
- Posterior tibial nerve stimulation (PTNS), Urgent PC, Transcutaneous neurostimulator
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Innovacion en Cirugía VigoUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Posterior tibial nerve stimulation (PTNS) | Experimental | 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 BE treated with posterior tibial nerve stimulation. |
| Group 2: Standard of care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Inability to understand the study instructions and recommendations.
- Dementia or any type of mental disability.
- Palliative surgery.
- Patients with pacemakers.
- Anti-coagulated patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Posterior tibial nerve stimulation (PTNS)Also: Transcutaneous neurostimulator (Urgent PC)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. | Device | Group 1: Posterior tibial nerve stimulation (PTNS) |
Primary outcome
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.
Time frame: 12 months
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)
Impact of PTNS on the quality of life (EORTC-QLQ C30)
Time frame: 12 months
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.
2 secondary outcomes
LARS Scale
Time frame: 12 months
Impact of PTNS on the quality of life (EORTC-QLQ C29)
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marta Paniagua García-Señoráns, MD contact
Raquel Sánchez Santos, PhD study director
Complejo Hospitalario Universitario de Vigo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posterior tibial nerve stimulation (PTNS) in people with Rectal Disorders and Low Anterior Resection Syndrome, run by Innovacion en Cirugía Vigo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raquel Sánchez Santos, PhD (629357242, raquelsanchezsantos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2023.