Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
Acronym
Study hypothesis
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
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)
Study design
Multicentre prospective randomised parallel group 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 the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
20/04/2006
Overall trial end date
23/08/2007
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
84
Participant 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
Recruitment start date
20/04/2006
Recruitment end date
23/08/2007
Locations
Countries of recruitment
France
Trial participating centre
Service de Chirurgie colorectale - Hôpital Beaujon
Clichy
92118
France
Funders
Funder type
Industry
Funder name
Brothier Laboratories S.A. (France)
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
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20155788
Publication citations
-
Results
Maggiori L, Rullier E, Meyer C, Portier G, Faucheron JL, Panis Y, Randomized controlled trial of pelvic calcium alginate following rectal cancer surgery., Br J Surg, 2010, 97, 4, 479-484, doi: 10.1002/bjs.6917.