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

ISRCTN	ISRCTN33808948
DOI	https://doi.org/10.1186/ISRCTN33808948
Protocol serial number	N/A
Sponsor	La Sapienza University of Rome (Italy)
Funder	University Sapienza of Rome (Italy) - 2nd Faculty of Medicine and Surgery, Saint Andrews Hospital, Operative Unit of Day Surgery

Submission date: 19/02/2010
Registration date: 03/03/2010
Last edited: 03/03/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Antonio Brescia
Scientific

Via di Grottarossa 1035
Rome
00189
Italy

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Staple-line bleeding reduction using a bioabsorbable reinforcement in day surgery stapled hemorrhoidopexy: a randomied controlled trial
Study objectives	To demonstrate that the use of circular bioabsorbable staple-line reinforcement can reduce the intraoperative and the postoperative bleeding while performing a stapled hemorrhoidopexy.
Ethics approval(s)	Local medical ethics committee of the University Sapienza of Rome did not consider approval necessary as this trial is comparing two techniques and devices already in general use.
Health condition(s) or problem(s) studied	Symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
Intervention	Patients treated in the Operative Unit of Day Surgery (Saint Andrews Hospital), were randomly assigned to stapled hemorrhoidopexy performed using 1. Group A: the stapler PPH33-01® (Ethicon Endo-Surgery, Inc. Cincinnati, OH) with a circular bioabsorbable staple-line reinforcement, seamguard BSG® (WL Gore & Associates, Flagstaff, AZ) 2. Group B: the more haemostatic stapler, PPH33-03® (Ethicon Endo-Surgery, Inc. Cincinnati, OH) only. The total duration of follow up is 90 days. All patients receive proctological examinations on 15, 45 and 90 days post-operatively. Patients in group A also receive retroscopy on these days.
Intervention type	Other
Primary outcome measure(s)	1. Intraoperative staple-line bleeding (yes or no) 2. Postoperative staple-line bleeding
Key secondary outcome measure(s)	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
Completion date	20/12/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	70
Key inclusion criteria	1. Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse 2. Adults aged ≤ 65, male or female
Key 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
Date of first enrolment	01/09/2009
Date of final enrolment	20/12/2009

Locations

Countries of recruitment

Italy

Study participating centre

Via di Grottarossa 1035

Rome
00189
Italy

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes