Condition category
Digestive System
Date applied
05/11/2010
Date assigned
08/12/2010
Last edited
08/12/2010
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

Dr George Piendo

ORCID ID

Contact details

Marcoleta 367
Santiago
-
Chile
gpinedom@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Zinc-aluminium ointment for patients with faecal incontinence: a double blind randomised trial

Acronym

ZAOT

Study hypothesis

The use of Zinc-aluminium (Zn-Al) ointment improve the continence in patients with faecal incontinence.

Ethics approval

Medical Ethics Committee of the Pontificia Universidad Catolica de Chile approved on the 1st April 2008 (ref: 109/08)

Study design

Double blind randomised placebo controlled phase II 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

Faecal incontinence

Intervention

Treatment group:
Topical application of ointment in the perianal region for 4 weeks. Ointment consists of
Aluminum Sulphate (0.5%), Zinc Sulphate (0.1%), Benzocaine (0.05%), Clorhexidine (0.09%) and Titanium Dioxide (0.1%)

Placebo group:
Topical application of Novobase II in the perianal region for 4 weeks.

Intervention type

Drug

Phase

Not Applicable

Drug names

Zinc-aluminium ointment

Primary outcome measures

Wexner Score, measured at baseline and 4 weeks

Secondary outcome measures

Faecal Incontinence Quality of Life (FIQL) score, measured at baseline and 4 weeks

Overall trial start date

10/03/2010

Overall trial end date

24/04/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female
2. Aged 18 years or older
3. Consulted the outpatient clinic in the Colorectal unit of Pontificia Universidad Catolica de Chile
4. Faecal incontinence
5. Wexner Score greater than or equal to 7
6. Minima sphincter disruption in anal endosonography
7. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

50 patients

Participant exclusion criteria

1. Male
2. Sphincter disruption greater than 50%

Recruitment start date

10/03/2010

Recruitment end date

24/04/2010

Locations

Countries of recruitment

Chile

Trial participating centre

Marcoleta 367
Santiago
-
Chile

Sponsor information

Organisation

Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile)

Sponsor details

c/o Dr George Pinedo
Marcoleta 367
Santiago
-
Chile
gpinedom@hotmail.com

Sponsor type

University/education

Website

http://www.uc.cl/

Funders

Funder type

University/education

Funder name

Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile) - Surgical Department

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

Publication citations

Additional files

Editorial Notes