| CTRI Number |
CTRI/2025/03/081881 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
06/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [variation in traditional sitz bath technique ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Traditional sitz bath vs Hot-Cold-Hot (HCH) sitz bath- A Randomized controlled trial. |
|
Scientific Title of Study
|
Effects of Traditional sitz bath vs Hot-Cold-Hot (HCH) sitz bath in post anal sphincterotomy patients with chronic anal fissure- A Randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mayank Badkur |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 526, General Surgery OPD, AIIMS Jodhpur, Jodhpur Rajasthan India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9981121554 |
| Fax |
|
| Email |
drmayankbadkur@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Badkur |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 526, General Surgery OPD, AIIMS Jodhpur, Jodhpur Rajasthan India
RAJASTHAN
342005
India |
| Phone |
9981121554 |
| Fax |
|
| Email |
drmayankbadkur@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Badkur |
| Designation |
Associate Professor |
| Affiliation |
AIIMS Jodhpur |
| Address |
Room no 526, General Surgery OPD, AIIMS Jodhpur, Jodhpur Rajasthan India
RAJASTHAN
342005
India |
| Phone |
9981121554 |
| Fax |
|
| Email |
drmayankbadkur@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Jodhpur, Jodhpur, Rajasthan, India, 342005 |
|
|
Primary Sponsor
|
| Name |
AIIMS Jodhpur |
| Address |
AIIMS Jodhpur, Jodhpur, Rajasthan, India. 342005 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Myank Badkur |
Room no 526, Surgery OPD, Department if General SurgeryAIIMSJodhpur |
AIIMS Jodhpur, Jodhpur, Rajasthan, India. 342005
Jodhpur
RAJASTHAN |
9981121554
drmayankbadkur@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe (Clinical Trial))e |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K602||Anal fissure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hot-Cold-Hot Sitz Bath |
Patients will be instructed to sit in a tub containing lukewarm water (the prescribed temperature of the water was to be equal to what they would have preferred for a whole-body bath (37 to 40°C)) for 5 min, followed by cold water (water temperature to temperature (15 to 20°C)) for 5 min. and again a lukewarm water sitz bath follows it for 5 min. Patients were advised not to add anything to the water used for the sitz bath. |
| Comparator Agent |
Traditional Sitz bath |
Patients will be instructed to sit in a tub containing lukewarm water (the waters prescribed temperature was equal to what they would have preferred for a whole-body bath (37 to 40°C)) for 15 min each time. Patients were advised not to add anything to the water used for the sitz bath. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Post operative patients of anal fissure.
2. Mental Ability to understand and follow the intervention
3. Physical ability to perform the intervention.
|
|
| ExclusionCriteria |
| Details |
1. Sever Cardiovascular diseases.
2. Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the mean Post defecation pain on POD 7 |
post operative day (POD) 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the post defecation Pain score on POD 1st & 7th POD.
2. To compare the mean Post defecation perianal burning sensation on POD 1st & 7th POD.
3. To evaluate the patient satisfaction level at 7th POD.
4. To evaluate the duration of oral analgesia required in post operative period up to 7th POD.
5. To evaluate the quality of life (SF-36) at 7th POD.
|
post operative day 1
post operative day 7 |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Traditional Sitz bath, an age-old therapeutic process widely used in perianal pathologies. Many modifications of the sitz bath have been tried. With the help of our current study, we are trying to compare the effect of traditional sitz bath vs Hot-Cold-Hot (HCH) sitz bath in post-anal sphincterotomy patients with chronic anal fissure
Research Question: Is Hot-Cold-Hot (HCH) sitz bath superior to traditional sitz bath in post anal sphincterotomy patients with chronic anal fissure?
|