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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05666648
Other study ID # IRB/851/CMH Quetta
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date January 31, 2023

Study information

Verified date December 2022
Source Combined Military Hospital Quetta
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure.


Description:

ABSTRACT Objective To compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in Acute Anal Fissure. Study Design Randomized Controlled Trial Place and Duration of Study Department of Surgery Combined Military Hospital, Quetta, from15 January 2019 to 15 August 2021. Patients and Methods Individual patients were randomized to either receive 'sitz baths' or 'no sitz baths' treatment for 4 weeks. Patients were asked to have 'sitz bath' once in morning and again at bedtime, after each week pain scores and healing of fissure were assessed. Main outcome measures were validated. Keywords Acute anal fissure, pain, sitz bath


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 60
Est. completion date January 31, 2023
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria: - Patients of acute anal fissure of both genders between 18 to 60 years Exclusion Criteria: - While the patients with history of recurrent fissure, chronic anal fissure, pregnant woman and patients who were operated previously for any anorectal pathology were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sitz Bath
Individual patients were randomized to either receive 'sitz baths' or 'no sitz baths' treatment for 4 weeks. Patients were asked to have 'sitz bath' once in morning and again at bedtime, after each week pain scores and healing of fissure were assessed. Main outcome measures were validated

Locations

Country Name City State
Pakistan Khalid Pervaiz Quetta

Sponsors (1)

Lead Sponsor Collaborator
Combined Military Hospital Quetta

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary healing of fissure healing of fissure after 4 weeks sitz bath four weeks
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