A Prospective Randomized Study Between the Use of Bulking Agent and the Endoanal Electrostimulation Therapy in Patients With Mild or Moderate Anal Incontinence
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Fecal Incontinence
- Sponsor
- University of Sao Paulo
- Enrollment
- 60
- Primary Endpoint
- Fecal incontinence
- Last Updated
- 8 years ago
Overview
Brief Summary
Randomized trial with a estimated number of 60 patients with mild or moderate anal incontinence at the clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP).
- Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded.
- The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
Detailed Description
* Prospective randomized trial * Estimated number of 60 patients with mild or moderate anal incontinence with isolated anal sphincter muscle damage or evidence of anal incontinence without verification of anatomical damage to the anorectal sphincter complex with dysfunction or inadequate action of the internal anal sphincter accompanied at the outpatient clinic Physiology of the Hospital das Clínicas of the Medical School of the University of São Paulo (HC-FMUSP). * Exclusion criteria: symptoms of anal incontinence for less than six months, with severe anal incontinence, associated external anal sphincter damage, past pelvic radiotherapy, evidence of perineal sepsis, rectal prolapse, anorectal cancer, inflammatory bowel disease, malignant disease Congenital formation, scleroderma, Parkinson's disease, immunosuppression and ongoing gestation. In addition, those patients who do not agree to participate in the survey will be excluded. * The study will have 4 phases: preoperative, surgical, recent postoperative and later postoperative
Investigators
Leonardo Alfonso Bustamante
Surgeon research at the colon and rectum service. Gastroenterology Department
University of Sao Paulo
Eligibility Criteria
Inclusion Criteria
- •Moderate fecal incontinence
Exclusion Criteria
- •Severe fecal incontinence
- •Pelvic radiotherapy
Outcomes
Primary Outcomes
Fecal incontinence
Time Frame: 6 months
Score of Fecal Incontinence