|
ISRCTN
|
ISRCTN33808948
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Staple-line bleeding reduction using a bioabsorbable reinforcement in day surgery stapled hemorrhoidopexy
|
|
Scientific title
|
Staple-line bleeding reduction using a bioabsorbable reinforcement in day surgery stapled hemorrhoidopexy: a randomied controlled trial
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N/A
|
|
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.
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
Italy
|
|
Disease/condition/study domain
|
Symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
|
|
Participants - inclusion criteria
|
1. Patients with symptomatic II-III grade haemorrhoids and rectal mucosal prolapse
2. Adults aged ≤ 65, male or female
|
|
Participants - 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
|
|
Anticipated start date
|
01/09/2009
|
|
Anticipated end date
|
20/12/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
Not available in web format, please use contact details below to request a patient information sheet.
|
|
Target number of participants
|
70
|
|
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-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.
|
|
Primary outcome measure(s)
|
1. Intraoperative staple-line bleeding (yes or no)
2. Postoperative staple-line bleeding
|
|
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
|
|
Sources of funding
|
University Sapienza of Rome (Italy) - 2nd Faculty of Medicine and Surgery, Saint Andrew’s Hospital, Operative Unit of Day Surgery
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Prof
Antonio
Brescia
|
|
Address
|
Via di Grottarossa 1035
|
|
City/town
|
Rome
|
|
Zip/Postcode
|
00189
|
|
Country
|
Italy
|
|
Sponsor
|
La Sapienza University of Rome (Italy)
|
|
Address
|
Faculty of Medicine and Surgery
Via di Grottarossa 1035
|
|
City/town
|
Rome
|
|
Zip/Postcode
|
00189
|
|
Country
|
Italy
|
|
Date applied
|
19/02/2010
|
|
Last edited
|
03/03/2010
|
|
Date ISRCTN assigned
|
03/03/2010
|
