Staple-line bleeding reduction using a bioabsorbable reinforcement in day surgery stapled hemorrhoidopexy
Completed
- Conditions
- Symptomatic II-III grade haemorrhoids and rectal mucosal prolapseUrological and Genital Diseases
- Registration Number
- ISRCTN33808948
- Lead Sponsor
- a Sapienza University of Rome (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
Inclusion Criteria
1. Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
2. Adults aged = 65, male or female
Exclusion Criteria
1. Patients without day surgery eligibility criteria
2. Concomitant ano-rectal disease (fissure, fistula, abscess, inflammatory bowel disease, rectal cancer)
3. Altered coagulation
4. Receiving anticoagulant-antiaggregant therapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Intraoperative staple-line bleeding (yes or no)<br>2. Postoperative staple-line bleeding
- Secondary Outcome Measures
Name Time Method 1. Operative time (from the start to the end of anaesthesia)<br>2. Use of additional stitches for haemostasis<br>3. Postoperative pain and/or tenesmus, assessed by VAS (visual analogue scale) at 6 and 24 hours post-operatively<br>4. Patient satisfaction, assessed by questionnaire at day 45