Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation
NCT ID: NCT01313026
Last Updated: 2018-12-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
14 participants
INTERVENTIONAL
2011-01-31
2018-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Transanal Irrigation - Best Treatment Possibility for Low Anterior Resection Syndrome? Multicenter, Randomized Clinical Trial
NCT05920681
Pathway of Low Anterior Resection Syndrome Relief After Surgery: a Feasibility Study
NCT05319054
Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome
NCT04758195
The Efficacy of Antegrade and Retrograde Enemas Management in Low Anterior Resection Syndrome and Improving the Rate of Ileostomy Reversal
NCT07082699
Feasibility Bowel Dysfunction Program After Low Anterior Resection
NCT04733794
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Detailed records of bowel, micturition and sexual function and QoL will be obtained at regular intervals during the entire trial fase.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PNE first
patients randomised to start with PNE stimulation over 4 weeks. Then the stimulator will be removed and after a wash out period of 4 weeks they will be trained in transanal irrigation
Percutaneous nerve evaluation
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
TAI first
Patients randomised to start with transanal irrigation treatment in 8 weeks, thereafter a wash out period of 4 weeks before being implanted with a neuro stimulator
Percutaneous nerve evaluation
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Percutaneous nerve evaluation
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* metastatic disease
* Chemotherapy
* Radiotherapy
* Previously treated for another cancer
* Dementia or other mental retardation/severe mental disease
* Inability to read and understand the Danish language
* Recurrent disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Aarhus
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katrine J. Emmertsen, MD
Role: PRINCIPAL_INVESTIGATOR
University of Aarhus
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Colorectal Surgical Department P, Aarhus University Hospital
Aarhus, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LARS 001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.