Condition category
Digestive System
Date applied
27/11/2008
Date assigned
02/01/2009
Last edited
29/06/2010
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 David Parés

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

001

Study information

Scientific title

Sitz bath for acute anal pain: cold or warm? A randomised controlled trial

Acronym

FRI.CA study

Study hypothesis

A warm sitz bath is better than a cold one to relieve acute anal pain.

Ethics approval

Received from the local medical ethics board on the 2nd February 2006 (ref: 2005/2203/I)

Study design

Randomised controlled, two-arm 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

Acute anal pain from haemorrhoids or anal fissure

Intervention

Treatment 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Pain control, evaluated using the VAS during the first 7 days of the study.

Secondary outcome measures

Outcome of disease (haemorrhoids or fissure), measured during the first 7 days of the study.

Overall trial start date

01/01/2007

Overall trial end date

31/12/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients aged over 18 years, either sex
2. Acute anal pain for haemorrhoids or anal fissure
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. No acceptance
2. Previous anal surgery

Recruitment start date

01/01/2007

Recruitment end date

31/12/2008

Locations

Countries of recruitment

Spain

Trial participating centre

Hospital del Mar
Barcelona
08003
Spain

Sponsor information

Organisation

Hospital del Mar (Spain)

Sponsor details

Passseig Maritim 25 - 29
Barcelona
08003
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.hospitaldelmar.cat/

Funders

Funder type

Hospital/treatment centre

Funder name

Hospital del Mar (Spain)

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/20580349 [in Spanish]

Publication citations

  1. Maestre Y, Parés D, Salvans S, Ibáñez-Zafón I, Nve E, Pons MJ, Martínez-Casas I, Pascual M, Pera M, Grande L, [Cold or hot sitz baths in the emergency treatment of acute anal pain due to anorectal disease? Results of a randomised clinical trial]., Cir Esp, 2010, 88, 2, 97-102, doi: 10.1016/j.ciresp.2010.04.007.

Additional files

Editorial Notes