Prevention of post-operative pelvic bleeding and collection after sphincter-saving surgery for rectal cancer using a calcium-alginate haemostatic
| ISRCTN | ISRCTN79721331 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79721331 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/03/2009
- Registration date
- 27/03/2009
- Last edited
- 11/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Yves Panis
Scientific
Scientific
Service de Chirurgie colorectale - Hôpital Beaujon
100 Boulevard du Général Leclerc
Clichy
92118
France
Study information
| Study design | Multicentre prospective randomised parallel group 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 the contact details below to request a patient information sheet |
| Scientific title | Prevention of post-operative pelvic bleeding and collection after sphincter-saving surgery for rectal cancer using a calcium-alginate haemostatic: a multicentric randomised study |
| Study objectives | Assess the possible benefit of Hemoionic®, a new haemostatic, in sphincter-saving surgery for rectal cancer with special reference to pelvic fluid collection reduction. |
| Ethics approval(s) | 1. French ethics committee (Comité Consultatif de Protection des Personnes dans la Recherche Biomédicale [CCPPRB]) approved on 4th January 2006 (ref: 0511240) 2. French drug administration (Agence Française de Sécurité Sanitaire des Produits de Santé [AFSSAPS]) approved on 6th January (ref: 2005/12/007) |
| Health condition(s) or problem(s) studied | Rectal cancer/colorectal surgery |
| Intervention | Resections were performed according to the standard technique of optimal mesorectal excision (either partial or total according to the level of the rectal tumour) either by laparotomy or laparoscopy. Complete pelvic haemostasis was obtained prior to randomisation, according to the surgeons' routine practice, with electrical coagulation and/or vessel ligation. Randomisation was performed during the surgical procedure in a 1:1 ratio to an Hemoionic® group or a control group. After complete pelvic hemostasis, patients randomised in the Hemoionic® group had two applications of Hemoionic® in the sacral cavity for at least 5 and 10 minutes respectively. For the Hemoionic® group a proctectomy with partial mesorectal excision and stapled colorectal anastomosis was performed for tumours of the upper rectum. A proctectomy with total mesorectal excision was performed for tumours of the middle and lower rectum. Anastomosis was performed mechanically or manually, according to the level of the anastomosis. Pelvic drainage was standardised for all procedures as an aspirative cross-perforated redon drain (from 10 to 14 ch.) placed in the pelvic cavity, behind the anastomosis. A temporary stoma was systematically fashioned at the end of the operation. For the control group the same surgery was perfomed without using any other haemostatic. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hemoionic® |
| Primary outcome measure | Volume of fluid collected by the pelvic suction drain. |
| Secondary outcome measures | 1. Duration of drainage 2. Post-operative mortality and morbidity rates 3 months after surgery |
| Overall study start date | 20/04/2006 |
| Completion date | 23/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 84 |
| Key inclusion criteria | 1. Written informed consent from all patients at least the day before surgery 2. Patients aged 18 years or older, either sex 3. Scheduled for elective restorative proctectomy for rectal cancer |
| Key exclusion criteria | 1. Advanced local disease (tumour staged T4 on pre-operative rectal ultrasound, magnetic resonance imaging, or intra-operative findings) 2. No temporary protective ileostomy or colostomy after rectal resection 3. Anticoagulation or antiplatelet treatment which cannot be postponed for surgery 4. Known associated haemostasis disorder 5. Synchronous other surgical resection (excepted appendectomy and liver biopsy) 6. Emergency presentation 7. Systemic infection 8. Pelvic infection 9. Pregnancy |
| Date of first enrolment | 20/04/2006 |
| Date of final enrolment | 23/08/2007 |
Locations
Countries of recruitment
- France
Study participating centre
Service de Chirurgie colorectale - Hôpital Beaujon
Clichy
92118
France
92118
France
Sponsor information
Brothier Laboratories S.A. (France)
Industry
Industry
41 Rue de Neuilly
Nanterre
92735
France
"ROR" |
https://ror.org/007jkh405 |
|---|
Funders
Funder type
Industry
Brothier Laboratories S.A. (France)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2010 | Yes | No |
