NCT04569331

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Althaia Xarxa Assistencial Universitària de Manresa · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	Stimulation of efferent loop	Stimulation of efferent loop: 3 weeks before the ileostomy closure surgery, efferent loop will be stimulated with 250 ml of water and thickened. This procedure consists of introducing through the light efferent loop ileostomy 250 ml of water with thickener every 48-hours during the first two weeks and once daily the thrid week with a Foley catheter. Patient will be provided with all the material and the procedure sheet for all the stimulation of the efferent loop sessions. This technique will be performed at patient's home until the day before the ostomy patient closure surgery.
PROCEDURE	Rehabilitation pelvic floor	3 months after the closure of the ileostomy, you will be referred to the pelvic floor rehabilitation unit,where will start 15 individual sessions, 2 days a week (8 weeks of sessions), with reeducation of defecatory habits and hygienic-dietary measures, defecation record where assess stool consistency using the Bristol Scale and number of bowel movements that take place in 24 hours, muscle toning exercises (Exercises Kegel), Biofeedback (BF), rectal balloon work to improve sensitivity and accommodation, reeducation of the expulsive maneuver, and perineal block in situations hyperpressive.

Timeline

• Start date: 2020-05-15
• Primary completion: 2023-12-13
• Completion: 2023-12-13
• First posted: 2020-09-29
• Last updated: 2024-02-01

Locations

1 site across 1 country: Spain