Clinical trial 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Keywords: rectal cancer
ileostomy
quality of life
anterior resection syndrome
Lead sponsor: Althaia Xarxa Assistencial Universitària de Manresa
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized clinical trial on the efficacy of efferent loop stimulation prior to ileostomy closure together with pelvic floor rehabilitation after closure of the ileostomy, in the quality of life of patients undergoing anterior rectal resection
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Quality of life related to health (European Organization for the Research and treatment of Cancer Quality of Life Questionnaire (QLQ-CR29).
timeFrame: 1 month post closure of the ileostomy
measure: Quality of life related to health (European Organization for the Research and treatment of Cancer Quality of Life Questionnaire (QLQ-CR29).
timeFrame: 3 month post closure of the ileostomy
measure: Quality of life related to health (European Organization for the Research and treatment of Cancer Quality of Life Questionnaire (QLQ-CR29).
timeFrame: 6 month post closure of the ileostomy
measure: Quality of life related to health (European Organization for the Research and treatment of Cancer Quality of Life Questionnaire (QLQ-CR29).
timeFrame: 12 month post closure of the ileostomy
Secondary outcomes:
measure: Low anterior resection syndrome (LARS)
timeFrame: 1 month post closure of the ileostomy
measure: Low anterior resection syndrome (LARS)
timeFrame: 3 month post closure of the ileostomy
measure: Low anterior resection syndrome (LARS)
timeFrame: 6 month post closure of the ileostomy
measure: Low anterior resection syndrome (LARS)
timeFrame: 12 month post closure of the ileostomy
Other outcomes:
measure: Percentatge of patients with postoperative paralytic ileus
timeFrame: In the first 48 hours postoperatively after the closure of the ileostomy
Locations:
city: Manresa
country: Spain
facility: Althaia Xarxa Assistencial de Manresa
state: Barcelona
Study officials:
affiliation: Althaia Xarxa Assitencial Universitària de Manresa
name: Cristina Vidal Morral
role: PRINCIPAL_INVESTIGATOR
References: