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

NCT ID: NCT04569331

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-15
• Study Completion Date: 2023-12-13

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

Patients undergoing anterior rectal resection with protective ileostomy will follow routine clinical practice.

During hospital admission for ileostomy closure surgery, the stoma therapist reinforces the information on the possibility of anterior resection syndrome (ARS) and hygienic-dietary measures. At the level of the ARS, the patient is informed of the possibility of increased frequency of bowel movements, evacuation dysfunction, such as urgency to defecate or feeling of incomplete emptying. At the level of diet, an astringent diet is recommended during the first week after ileostomy closure to avoid liquid stools. It is also recommended at the level of perineal hygiene to use a cleanser with a pH similar to that of the skin, applying the least possible force on the skin, dry gently after each bowel movement and apply a skin protection product to avoid dermatitis associated with incontinence.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Stimulation of efferent loop and rehabilitation pelvic floor

Stimulation of efferent loop: 3 weeks before the ileostomy closure surgery, efferent loop will be stimulated with 250 ml of water and thickened every 48-hours the first two weeks and once daily the thrid week.

Rehabilitation of pelvic floor: 3 months after the ileostomy closure surgery, patient will be referred to the pelvic floor unit for pelvic floor rehabilitation.

Group Type: EXPERIMENTAL

Stimulation of efferent loop

Intervention Type: PROCEDURE

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.

Rehabilitation pelvic floor

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• End ileostomy patients
• Patients with active treatment of Qt or Rt
• Patients with some stoma complication such as mucosal prolapse or peristomal hernia
• Patients with fecal incontinence prior to anterior rectal resection surgery (Wexner scale: greater than 3 points)
• Patients who do not agree to participate in the study
• Patients with cognitive deficit

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Althaia Xarxa Assistencial Universitària de Manresa

OTHER

Sponsor Role: lead

Responsible Party

Cristina Vidal

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cristina Vidal Morral

Role: PRINCIPAL_INVESTIGATOR

Althaia Xarxa Assitencial Universitària de Manresa

Locations

Althaia Xarxa Assistencial de Manresa

Manresa, Barcelona, Spain

Countries

Spain

Other Identifiers

CEI 19/26

Identifier Type: -

Identifier Source: org_study_id