ISRCTN ISRCTN50105150
DOI https://doi.org/10.1186/ISRCTN50105150
Secondary identifying numbers 001
Submission date
27/11/2008
Registration date
02/01/2009
Last edited
29/06/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Parés
Scientific

Hospital del Mar
Colorectal Surgery Unit
Passeig maritim 25 - 29
Barcelona
08003
Spain

Study information

Study designRandomised controlled, two-arm trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleSitz bath for acute anal pain: cold or warm? A randomised controlled trial
Study acronymFRI.CA study
Study objectivesA warm sitz bath is better than a cold one to relieve acute anal pain.
Ethics approval(s)Received from the local medical ethics board on the 2nd February 2006 (ref: 2005/2203/I)
Health condition(s) or problem(s) studiedAcute anal pain from haemorrhoids or anal fissure
InterventionTreatment with sitz bath every 12 hours during 7 days. Follow-up will be performed every day during the first 7 days of the study. Recommendations of temperature for sitz bath, diary record of temperature and pain (Visual Analogue Scale [VAS]) will be assessed.
Intervention typeOther
Primary outcome measurePain control, evaluated using the VAS during the first 7 days of the study.
Secondary outcome measuresOutcome of disease (haemorrhoids or fissure), measured during the first 7 days of the study.
Overall study start date01/01/2007
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants60
Key inclusion criteria1. Adult patients aged over 18 years, either sex
2. Acute anal pain for haemorrhoids or anal fissure
3. Written informed consent
Key exclusion criteria1. No acceptance
2. Previous anal surgery
Date of first enrolment01/01/2007
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Spain

Study participating centre

Hospital del Mar
Barcelona
08003
Spain

Sponsor information

Hospital del Mar (Spain)
Hospital/treatment centre

Passseig Maritim 25 - 29
Barcelona
08003
Spain

Website http://www.hospitaldelmar.cat/
ROR logo "ROR" https://ror.org/03a8gac78

Funders

Funder type

Hospital/treatment centre

Hospital del Mar (Spain)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2010 Yes No