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 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
Phase
Not Specified
Drug names
Primary outcome measure
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 (if study stopped)
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
Funders
Funder type
Hospital/treatment centre
Funder name
University Sapienza of Rome (Italy) - 2nd Faculty of Medicine and Surgery, Saint Andrews 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
Basic results (scientific)
Publication list