Zinc-aluminium ointment for patients with faecal incontinence
| ISRCTN | ISRCTN05200282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05200282 |
| Secondary identifying numbers | N/A |
- Submission date
- 05/11/2010
- Registration date
- 08/12/2010
- Last edited
- 08/12/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
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
Dr George Piendo
Scientific
Scientific
Marcoleta 367
Santiago
-
Chile
| gpinedom@hotmail.com |
Study information
| Study design | Double blind randomised placebo controlled phase II 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 | Zinc-aluminium ointment for patients with faecal incontinence: a double blind randomised trial |
| Study acronym | ZAOT |
| Study objectives | The use of Zinc-aluminium (Zn-Al) ointment improve the continence in patients with faecal incontinence. |
| Ethics approval(s) | Medical Ethics Committee of the Pontificia Universidad Catolica de Chile approved on the 1st April 2008 (ref: 109/08) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Zinc-aluminium ointment |
| Primary outcome measure | 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 study start date | 10/03/2010 |
| Completion date | 24/04/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 50 patients |
| Key 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 |
| Key exclusion criteria | 1. Male 2. Sphincter disruption greater than 50% |
| Date of first enrolment | 10/03/2010 |
| Date of final enrolment | 24/04/2010 |
Locations
Countries of recruitment
- Chile
Study participating centre
Marcoleta 367
Santiago
-
Chile
-
Chile
Sponsor information
Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile)
University/education
University/education
c/o Dr George Pinedo
Marcoleta 367
Santiago
-
Chile
| gpinedom@hotmail.com | |
| Website | http://www.uc.cl/ |
"ROR" |
https://ror.org/04teye511 |
Funders
Funder type
University/education
Pontifical Catholic University of Chile (Pontificia Universidad Católica de Chile) (Chile) - Surgical Department
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 |
