Condition category
Cancer
Date applied
09/03/2009
Date assigned
27/03/2009
Last edited
11/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Yves Panis

ORCID ID

Contact details

Service de Chirurgie colorectale - Hôpital Beaujon
100 Boulevard du Général Leclerc
Clichy
92118
France

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 measures

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

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

Sponsor information

Organisation

Brothier Laboratories S.A. (France)

Sponsor details

41 Rue de Neuilly
Nanterre
92735
France

Sponsor type

Industry

Website

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

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20155788

Publication citations

  1. 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.

Additional files

Editorial Notes