Sitz Bath vs no Sitz Bath in Acute Anal Fissure Treatment

Comparison of Sitz Bath and no Sitz Bath Treatments in Patients With Acute Anal Fissure

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 Overview

• Status: Active, not recruiting
• Conditions: Pain, Postoperative
• Intervention / Treatment: Other: Sitz Bath

Detailed 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

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Pakistan
  • Quetta, Pakistan, 52280
    • Khalid Pervaiz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of acute anal fissure of both genders between 18 to 60 years

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sixty patients completed trial in two groups	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
healing of fissure	healing of fissure after 4 weeks sitz bath	four weeks

Collaborators and Investigators

• Sponsor: Combined Military Hospital Quetta
• Investigators: Study Director: Zeeshan Ayub, FCPS, Cmh Quetta

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: December 11, 2022
• First Submitted That Met QC Criteria: December 18, 2022
• First Posted (Estimate): December 28, 2022

Study Record Updates

• Last Update Posted (Estimate): December 28, 2022
• Last Update Submitted That Met QC Criteria: December 18, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Acute anal fissure, pain, sitz bath
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Anus Diseases; Pain, Postoperative; Fissure in Ano
• Other Study ID Numbers: IRB/851/CMH Quetta

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Plan to work further

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No