Sitz Bath vs no Sitz Bath in Acute Anal Fissure Treatment | NCT05666648

Studies
Sitz Bath vs no Sitz Bath in Acute Anal Fissure Treatment

NCT05666648

Sponsor

Combined Military Hospital Quetta

Status

Unknown status

Last Update Posted

Dec 28, 2022Actual

Enrollment

60Actual

Phase

Not provided

Conditions

Pain, Postoperative

Interventions

Sitz Bath

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Jan 31, 2023Estimated

First Submitted Date

Dec 11, 2022

First Submission Date that Met QC Criteria

Dec 18, 2022

First Posted Date

Dec 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2022

Last Update Posted Date

Dec 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Dr Zeeshan Ayub, Associate Professor, Combined Military Hospital QuettaPrincipal Investigator

Lead Sponsor

Combined Military Hospital QuettaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

4 Weeks

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sixty patients completed trial in two groups			Other: Sitz Bath

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sitz Bath	Other	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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zeeshan Ayub, FCPS	CMH Quetta	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Khalid Pervaiz		Quetta		52280	Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Plan to work further

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D010146	Pain

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009461	Neurologic Manifestations

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