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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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 

 
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