Staple-line bleeding reduction using a bioabsorbable reinforcement in day surgery stapled hemorrhoidopexy

Staple-line bleeding reduction using a bioabsorbable reinforcement in day surgery stapled hemorrhoidopexy: a randomied controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33808948

Enrollment

Registered

2010-03-03

Start date

2009-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic II-III grade haemorrhoids and rectal mucosal prolapse Urological and Genital Diseases

Interventions

Patients treated in the Operative Unit of Day Surgery (Saint Andrew?s Hospital), were randomly assigned to stapled hemorrhoidopexy performed using 1. Group A: the stapler PPH33-01® (Ethicon Endo-Surg

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse 2. Adults aged = 65, male or female

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1. Intraoperative staple-line bleeding (yes or no) 2. Postoperative staple-line bleeding	—

Secondary

Measure	Time frame
1. Operative time (from the start to the end of anaesthesia) 2. Use of additional stitches for haemostasis 3. Postoperative pain and/or tenesmus, assessed by VAS (visual analogue scale) at 6 and 24 hours post-operatively 4. Patient satisfaction, assessed by questionnaire at day 45	—

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026