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

Althaia Xarxa Assistencial Universitària de Manresa

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Rehabilitation pelvic floor; Procedure: Stimulation of efferent loop

Study type: Interventional

Funder types: Other

Identifiers

NCT04569331

CEI 19/26

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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25 participants in 2 patient groups

Control group

No Intervention group

Description:

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.

Stimulation of efferent loop and rehabilitation pelvic floor

Experimental group

Description:

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.

Treatment:

Procedure: Stimulation of efferent loop

Procedure: Rehabilitation pelvic floor