| CTRI Number |
CTRI/2025/10/095829 [Registered on: 09/10/2025] Trial Registered Prospectively |
| Last Modified On: |
09/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Comparing the imaging findings with biopsy findings in children with Hirschsprungs disease. |
|
Scientific Title of Study
|
Radiographic transition zone as a predictor of aganglionic extent in Hirschsprungs Disease :A prospective observational study. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akshay Hiremath |
| Designation |
Senior resident |
| Affiliation |
Bangalore medical collage and research institute |
| Address |
Pediatric Surgery OPD, 3rd flood, PMSSY building,
Bangalore medical college and research institute, K R road, Kalasipalyam, bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9482343833 |
| Fax |
|
| Email |
akshayhiremath7904@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Raghunath BV |
| Designation |
Associate Professor |
| Affiliation |
Bangalore medical collage and research institute |
| Address |
Pediatric Surgery OPD, 3rd flood, PMSSY Building,
Bangalore medical college and research institute, K R road, Kalasipalyam, bangalore
Bangalore KARNATAKA 560002 India |
| Phone |
9686665230 |
| Fax |
|
| Email |
bvraghunath9@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Akshay Hiremath |
| Designation |
Senior resident |
| Affiliation |
Bangalore medical collage and research institute |
| Address |
Pediatric Surgery OPD, 3rd floor, PMSSY building, Bangalore medical college and research institute, K R road, Kalasipalyam, bangalore.
Bangalore KARNATAKA 560002 India |
| Phone |
9482343833 |
| Fax |
|
| Email |
akshayhiremath7904@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bangalore medical collage and research institute K R Road Kalasipalyam 560002 |
|
|
Primary Sponsor
|
| Name |
Akshay Hiremath |
| Address |
Bangalore medical collage and research institute K R Road Kalasipalyam 560002 |
| Type of Sponsor |
Other [Self] |
|
|
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 Akshay Hiremath |
Bangalore medical college and research institute |
Pediatric surgery OPD, 3rd floor, PMSSY building, Victoria hospital campus, Bangalore - 560002. Bangalore KARNATAKA |
09482343833
akshayhiremath7904@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bangalore medical college and research institute Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K638||Other specified diseases of intestine, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
PROSPECTIVE OBSERVATIONAL STUDY |
|
| ExclusionCriteria |
| Details |
Children with history of anorectal surgery |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the accuracy of radiographic transition zone as a predictor of aganglionic extent in Hirschsprung’s disease. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="29" Sample Size from India="29"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2025 |
| 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
|
Hirschsprung disease is a congenital disorder characterized by the absence of ganglion cells in the Meissners plexus of the submucosa and the Auerbachs plexus of the muscularis in the terminal rectum extending variably proximally The prevalence of HD ranges from 1 to 1.63 per 10,000 births occurring in approximately 1 in 5000 live births with a male predominance of 4:1 About 65% of HD cases are diagnosed before 1 month of age, and 95% before 1 year of age . The presence of a transition zone on contrast enema, as defined by Swenson, is the most accurate radiological finding for HD, observed in approximately 80% of cases . Several studies have shown that the location of the transition zone correlates well with the level of aganglionosis, while other studies have found discrepancies in this correlation . Traditionally, surgical correction involved an initial diverting colostomy with confirmation of the level of aganglionosis by full-thickness biopsy, followed by a definitive pull-through procedure at a later date . Recently single-stage procedures have become routine avoiding initial colostomy and reducing the number of hospitalizations . Single-stage trans-anal endorectal pull-through and laparoscopy-assisted pull-through procedures are safe and effective offering better cosmesis reduced postoperative pain and shorter hospital stays . However accurate knowledge of the anticipated transition zone is essential for performing a single-stage procedure . Therefore, a study is planned to evaluate the accuracy of the radiological transition zone in identifying the level of aganglionosis in children with Hirschsprungs disease |