Pain, PostoperativeNCT05666648
Sitz Bath vs no Sitz Bath in Acute Anal Fissure Treatment
An observational study of Pain, Postoperative, run by Combined Military Hospital Quetta at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Sitz Bath
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 31 Jan 2023
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients of acute anal fissure of both genders between 18 to 60 years
Who may be able to join
- Patients of acute anal fissure of both genders between 18 to 60 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Pain, Postoperative
- Being tested
- Sitz Bath
- Keywords
- Acute anal fissure, pain, sitz bath
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Sixty patients completed trial in two groups | Not described Receives: Other: Sitz Bath |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of fissure
healing of fissure after 4 weeks sitz bath
Measured: four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 60 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Combined Military Hospital Quetta
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zeeshan Ayub, Combined Military Hospital Quetta
- Investigators
- Zeeshan Ayub, FCPS, Study director, Combined Military Hospital Quetta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666648
- Sponsor's protocol ID
- IRB/851/CMH Quetta
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Plan to work further
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sitz Bath and no Sitz Bath Treatments in Patients With Acute Anal Fissure
- ClinicalTrials.gov ID
- NCT05666648
- Acronym / sponsor ID
- IRB/851/CMH Quetta
- Conditions
- Pain, Postoperative
- Keywords
- Acute anal fissure, pain, sitz bath
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Combined Military Hospital QuettaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 28 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sixty patients completed trial in two groups | – | Other: Sitz Bath |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients of acute anal fissure of both genders between 18 to 60 years
Key inclusion criteria (1 listed)
- Patients of acute anal fissure of both genders between 18 to 60 years
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sitz BathIndividual 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 | Other | Sixty patients completed trial in two groups |
Primary outcome
healing of fissure
Time frame: four weeks
healing of fissure after 4 weeks sitz bath
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No. Plan to work further
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeeshan Ayub, FCPS study director
Combined Military Hospital Quetta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative, run by Combined Military Hospital Quetta at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of fissure (time frame: four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.