NCT05666648

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
3 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

December 28, 2022

Status Verified

December 1, 2022

Enrollment Period

4 years

First QC Date

December 11, 2022

Last Update Submit

December 18, 2022

Conditions

Pain, Postoperative

Keywords

Acute anal fissure, pain, sitz bath

Outcome Measures

Primary Outcomes (1)

  • healing of fissure

    healing of fissure after 4 weeks sitz bath

    four weeks

Study Arms (1)

Sixty patients completed trial in two groups

Other: Sitz Bath

Interventions

Sitz BathOTHER

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

Sixty patients completed trial in two groups

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khalid Pervaiz

Quetta, 52280, Pakistan

Location

MeSH Terms

Conditions

Pain, PostoperativePain

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Zeeshan Ayub, FCPS

    CMH Quetta

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Target Duration
4 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 11, 2022

First Posted

December 28, 2022

Study Start

January 1, 2019

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

December 28, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Plan to work further

Locations

PA(1)