Enteral resorbable diet versus standard diet in primary sphincter reconstructionA prospective, randomized trial

Not Applicable

• Conditions: N82.3; Anal fistula; Fistula of vagina to large intestine; K60.3

• Registration Number: DRKS00020524
• Lead Sponsor: niversitätsklinikum Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2012-10-22
• Study Start: 2020-01-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Known anorectal or rectovaginal fistula
• Planned elective primary sphincter reconstruction
• The patient's signed consent
• Age =18 years

Exclusion Criteria

• Non-consentable patients
• Patients with allergies and / or intolerance to components of the resorbable enteral diet

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing rate after 2 months

Secondary Outcome Measures

Name	Time	Method
- Quality of life <br>- Time to resume work<br>- stool behaviour <br>- number of bowel movements<br>- time to the first postoperative<br>defecation