Impact of Early Postoperative Treatment With Posterior Tibial Nerve

Status Recruiting

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05368168
Study type	Interventional
Source	Innovacion en Cirugía Vigo
Contact	Raquel Sánchez Santos, PhD
Phone	629357242
Email	raquelsanchezsantos@gmail.com
Status	Recruiting
Phase	N/A
Start date	June 3, 2022
Completion date	January 2027

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See also
Status	Clinical Trial	Phase
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Recruiting	`NCT04040842` - International Low Anterior Resection Score Evaluation
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Not yet recruiting	`NCT06424522` - A Bowel Management Program (Retrograde Rectal Enema) for the Treatment of Low Anterior Resection Syndrome in Rectal Cancer Patients	Early Phase 1
Completed	`NCT05605600` - Translation of the International Consensus Definition of LARS Into a Bowl Dysfunction Severity Scoring Tool (New LARS Score)
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Active, not recruiting	`NCT05042700` - The Effect of Melatonin in Patients With Low Anterior Resection Syndrome	Phase 2
Recruiting	`NCT04612569` - Feasibility and Impact of a Prehabilitation and Rehabilitation Program for the Continuity of Care in Severe Low Anterior Resection Syndrome.
Completed	`NCT04896879` - Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
Recruiting	`NCT06162143` - Effect of Gelsectan® in the Treatment of Low Anterior Resection Syndrome
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Completed	`NCT03916549` - Acupuncture in Low Anterior Resection Syndrome Treatment	Phase 1
Completed	`NCT05020132` - Bowel Dysfunction After Rectal Cancer Treatment
Completed	`NCT03598231` - Effectiveness of Sacral Neuromodulation in Low Anterior Resection Syndrome	N/A
Recruiting	`NCT05420870` - Effect of Exercise on Bowel Function in Colorectal Cancer Survivors	N/A
Active, not recruiting	`NCT05319054` - Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study	N/A
Completed	`NCT01589471` - The Value of Botox-A for Management of Low Anterior Resection Syndrome	Phase 2
Completed	`NCT03215017` - Effect of Treatment of Low Anterior Resection Syndrome After Rectal Cancer Surgery	N/A
Completed	`NCT05129215` - Development and Validation of The Post-RT LARS Prediction Model (PORTLARS)

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms