| CTRI Number |
CTRI/2024/09/074338 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
fecal continence after surgical correction techniques in female patients with absent anal opening. |
|
Scientific Title of Study
|
Comparison of continence in female patients with Anorectal
Malformations (ARM) undergoing placement of neoanus based on Caudal
Termination of the Striated Muscle Complex (SMC) vs anal dimple - An open-
label randomized control 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 AMIT KUMAR |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
ROOM NO-231
DEPARTMENT OF PEDIATRIC SURGERY
AIIMS PATNA PHULWARISHARIF
PIN 801507
ROOM NO-231
DEPARTMENT OF PEDIATRIC SURGERY
AIIMS PATNA PHULWARISHARIF
Patna
BIHAR
801507
India |
| Phone |
6201762578 |
| Fax |
|
| Email |
dramitkumar@aiimspatna.org |
|
Details of Contact Person
Scientific Query
|
| Name |
DR AMIT KUMAR |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
ROOM NO-231
DEPARTMENT OF PEDIATRIC SURGERY
AIIMS PATNA PHULWARISHARIF
ROOM NO-231
DEPARTMENT OF PEDIATRIC SURGERY
AIIMS PATNA PHULWARISHARIF
Patna
BIHAR
801507
India |
| Phone |
6201762578 |
| Fax |
|
| Email |
dramitkumar@aiimspatna.org |
|
Details of Contact Person
Public Query
|
| Name |
DR AMIT KUMAR |
| Designation |
Associate Professor |
| Affiliation |
AIIMS PATNA |
| Address |
ROOM NO-231
DEPARTMENT OF PEDIATRIC SURGERY
AIIMS PATNA PHULWARISHARIF
ROOM NO-231
DEPARTMENT OF PEDIATRIC SURGERY
AIIMS PATNA PHULWARISHARIF
Patna
BIHAR
801507
India |
| Phone |
6201762578 |
| Fax |
|
| Email |
dramitkumar@aiimspatna.org |
|
|
Source of Monetary or Material Support
|
|
AIIMS PATNA
PHULWARISHARIF
PATNA,BIHAR
INDIA
PIN CODE-801507
|
|
|
Primary Sponsor
|
| Name |
Amit kumar |
| Address |
DR AMIT KUMAR
ROOM NO-231
DEPTT OF PEDIATRIC SURGERY
AIIMS PATNA
PHULWARISHARIF,PATNA,BIHAR
PIN-801507 |
| Type of Sponsor |
Research institution |
|
|
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 |
| AMIT KUMAR |
AIIMS PATNA |
ROOM NO-231
DEPARTMENT OF PEDIATRIC SURGERY
AIIMS PATNA PHULWARISHARIF
Patna
BIHAR |
6201762578
amitsandilya1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC,AIIMS,PATNA |
Approved |
| IEC,AIIMS,PATNA |
Not Applicable |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
HEALTHY INDIVIDUALS |
| Patients |
(1) ICD-10 Condition: Q419||Congenital absence, atresia and stenosis of small intestine, part unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
application of muscle stimulator during posterior saggital anorectoplasty |
THE INTERVENTION GROUP WILL UNDERGO RECONSTRUCTION OF NEO ANUS BASED ON MUSCLE STIMULATOR.THIS MUSCLE STIMULATOR WILL EXACTLY LOCALISE THE MUSCLE COMPLEX WHEREIN THE NEOANUS CAN BE PLACED FOR BEST POSSIBLE RESULTS. IT WILL ONLY BE USED INTRAOPERATIVELY FOR MAXIMUM TIME OF 30 SECONDS. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
6.00 Year(s) |
| Gender |
Female |
| Details |
ALL FEMALES IN THIS AGE GROUP WITH ANOVESTIBULAR FISTULA UNDERGOING PSARP. |
|
| ExclusionCriteria |
| Details |
Redo PSARP
Severe perineal malformations
Poorly developed Anal dimple
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative fecal continence in patients with anorectal malformations undergoing placement of neoanus based on the anal dimple versus the caudal termination of the striated muscle complex during PSARP. |
3month,6month,9months and 12 months 1 year post surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the relationship between striated muscle complex and anal dimple.
|
3month,6month,9month and 12 month |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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)
|
09/10/2024 |
| 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="5"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
the study aims at a novel technique of attaining good fecal continence in operated cases of anorectal malformations. It will utilise specialised surgical techniques to see how it affects the clinical outcomes in terms of fecal continence.
|