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

Not Applicable

Completed

• Conditions: Rectal Cancer
• Interventions: Procedure: Stimulation of efferent loop; Procedure: Rehabilitation pelvic floor

• Registration Number: NCT04569331
• Lead Sponsor: Althaia Xarxa Assistencial Universitària de Manresa

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.

Study Timeline

• Study Start: 2020-05-15
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-28
• Study First Posted: 2020-09-29
• Primary Completion: 2023-12-13
• Study Completion: 2023-12-13
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimulation of efferent loop and rehabilitation pelvic floor	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.
Stimulation of efferent loop and rehabilitation pelvic floor	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 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.

Primary Outcome Measures

Name	Time	Method
Quality of life related to health (European Organization for the Research and treatment of Cancer Quality of Life Questionnaire (QLQ-CR29).	12 month post closure of the ileostomy	The EORTC QLQ CR-29 questionnaire consists of 29 items (Likert scale), with a response scale for each of them from 1 to 4, with the following structure: 1 = Not at All 2 = A little; 3 = Quite a Bit; 4 = Very much. The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia). Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.

Secondary Outcome Measures

Name	Time	Method
Low anterior resection syndrome (LARS)	12 month post closure of the ileostomy	Low anterior resection syndrome (LARS) score The LARS questionnaire consists of 5 questions which include: gas incontinence, fluid incontinence, stool frequency, fractionation of defecation and defecation urgency. Each question is scored based on the answer; the total can range from 0 to 42 points. According to the score, the patients are classified into two groups: without LARS, which correspond to scores between 0 and 20 points, and with LARS, which range from 21 to 42 points; Furthermore, this second group is subdivided into mild LARS (21 to 29 points) and severe LARS (30 to 42 points).

Trial Locations

Locations (1)

Althaia Xarxa Assistencial de Manresa; 🇪🇸 Manresa, Barcelona, Spain