Condition category
Urological and Genital Diseases
Date applied
19/02/2010
Date assigned
03/03/2010
Last edited
03/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Antonio Brescia

ORCID ID

Contact details

Via di Grottarossa 1035
Rome
00189
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet.

Condition

Symptomatic II-III grade haemorrhoids and rectal mucosal prolapse

Intervention

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-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

Phase

Not Specified

Drug names

Primary outcome measures

1. Intraoperative staple-line bleeding (yes or no)
2. Postoperative staple-line bleeding

Secondary outcome measures

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

Overall trial start date

01/09/2009

Overall trial end date

20/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

70

Participant 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

Recruitment start date

01/09/2009

Recruitment end date

20/12/2009

Locations

Countries of recruitment

Italy

Trial participating centre

Via di Grottarossa 1035
Rome
00189
Italy

Sponsor information

Organisation

La Sapienza University of Rome (Italy)

Sponsor details

Faculty of Medicine and Surgery
Via di Grottarossa 1035
Rome
00189
Italy

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Sapienza of Rome (Italy) - 2nd Faculty of Medicine and Surgery, Saint Andrew’s Hospital, Operative Unit of Day Surgery

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes