NCT04569331Completed
Efficacy of Stimulation of the Efferent Loop and Rehabilitation of the Pelvic Floor in the Quality of Life of Patients Who Underwent Anterior Resection of the Rectum (ENESP): Randomized Clinical Trial
Efficacy of Stimulation of the Efferent Loop Prior to the Closure of the Ileostomy Along With Rehabilitation of the Pelvic Floor After the Closure of the Ileostomy, in the Quality of Life of Patients Who Underwent Anterior Resection of the Rectum(ENESP): Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 1 Feb 2024
Brief summary (registry, in English)
Many of the patients operated with sphincter preservation will present an alteration of bowel function and defecation. This dysfunction is variable in its symptoms and severity, and manifests itself in the form of urgency, incontinence and fragmentation of faeces, with repeated, incomplete or difficult evacuations. The set of these symptoms constitutes what is known as anterior resection syndrome (ARS), which can negatively influence the quality of life of the operated patients and constitutes the main objective of the study to be investigated. From this study, the investigators want to evaluate the efficacy of stimulation of the efferent loop prior to the closure of the ileostomy along with rehabilitation of the pelvic floor after the closure of the ileostomy, in the quality of life of patients who underwent anterior resection of the rectum. A non-pharmacological randomized clinical trial will be conducted, comparing a control group (usual clinical practice), with respect to the experimental group where stimulation of the efferent loop will be performed prior to the closure of the ostomy along with pelvic floor rehabilitation after the closure of the latter. The main dependent variable will be the quality of life evaluated according to the QLQ CR-29 questionnaire, and secondary dependent variables will be evaluated postoperative paralytic ileus and the previous resection syndrome using the LARS scale.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 16 Sept 2020
- Start date
- 15 May 2020
- Primary completion date
- 13 Dec 2023
- Lead sponsor
- Althaia Xarxa Assistencial Universitària de Manresa
- Diseases
- Colorectal cancer
- NCT number
- NCT04569331
What you commit to
- Study type: Interventional
- Participants enrolled: 25
- From 15 May 2020 to the primary completion date, 13 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with fecal incontinence prior to anterior rectal resection surgery (Wexner scale: greater than 3 points)
Lab values
- Patients with active treatment of Qt or Rt
Other
- End ileostomy patients
- Patients with some stoma complication such as mucosal prolapse or peristomal hernia
- Patients who do not agree to participate in the study
- Patients with cognitive deficit
Who the study is looking for
- Patients undergoing scheduled rectal cancer surgery, carriers of a protective ileostomy with a scheduled surgery date for ileostomy closure
- Patients over 18 years of age
- Patients with absence of cognitive deficit (Pfeiffer: 0-2 errors)
- Patients who agree to participate in the study and sign the informed consent
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Althaia-Xarxa Assistencial de Manresa Coordinator of this site? Confirm its status | Manresa | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.