Staple-line bleeding reduction using a bioabsorbable reinforcement in day surgery stapled hemorrhoidopexy
| ISRCTN | ISRCTN33808948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33808948 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Via di Grottarossa 1035
Rome
00189
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient 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 | 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 study start date | 01/09/2009 |
| Completion date | 20/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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
00189
Italy
Sponsor information
La Sapienza University of Rome (Italy)
University/education
University/education
Faculty of Medicine and Surgery
Via di Grottarossa 1035
Rome
00189
Italy
"ROR" |
https://ror.org/02be6w209 |
|---|
Funders
Funder type
Hospital/treatment centre
University Sapienza of Rome (Italy) - 2nd Faculty of Medicine and Surgery, Saint Andrews Hospital, Operative Unit of Day Surgery
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
