| CTRI Number |
CTRI/2025/03/081916 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Follow-up study of Rahman’s technique of uterine scar defect repair |
|
Scientific Title of Study
|
Laparoscopic isthmocele repair by Rahman’s technique: A prospective observational multicentric 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 |
Dr Hafeez Rahman |
| Designation |
HOD Obstetrics and Gynaecology |
| Affiliation |
Sunrise Institute of Medical Sciences Pvt. Ltd. |
| Address |
Department of Gynaecology and Obstetrics
Seaport Airport Road, Kakkanad
Ernakulam
KERALA
682030
India |
| Phone |
9847047780 |
| Fax |
|
| Email |
drhafeezsims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sonia Farhan |
| Designation |
Consultant Gynecologist |
| Affiliation |
Sunrise Institute of Medical Sciences Pvt. Ltd. |
| Address |
Department of Gynaecology and Obstetrics
Seaport Airport Road, Kakkanad
Ernakulam
KERALA
682030
India |
| Phone |
9847047780 |
| Fax |
|
| Email |
soniafarhanph@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sonia Farhan |
| Designation |
Consultant Gynecologist |
| Affiliation |
Sunrise Institute of Medical Sciences Pvt. Ltd. |
| Address |
Seaport Airport Road, Kakkanad
Ernakulam
KERALA
682030
India |
| Phone |
9645349136 |
| Fax |
|
| Email |
soniafarhanph@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sunrise Institute of Medical Sciences Pvt Ltd, Seaport Airport Road, Kakkanad, Ernakulam, 682030 |
|
|
Primary Sponsor
|
| Name |
Dr Hafeez Rahman |
| Address |
Sunrise Institute of Medical Sciences Pvt Ltd, Seaport Airport Road, Kakkanad, Ernakulam, 682030 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poornima J |
KIMS Sunrise Hospital |
Department of Gynaecology and Obstetrics
Ashwini Nagar, Kasaragod, Kerala, 61121
Kasaragod
KERALA |
8762545283
jpoornima900@gmail.com |
| Dr Abdul Rasheed |
Sunrise Institute of Medical Sciences Pvt Ltd |
Department of Gynaecology and Obstetrics Railway Station Road, near Railway Station, Palayam, Kozhikode, Kerala, 673002
Kozhikode
KERALA |
8086858911
abdulrasheednest@gmail.com |
| Dr Hafeez Rahman |
Sunrise Institute of Medical Sciences Pvt Ltd |
Department of Gynaecology and Obstetrics
Seaport Airport Road, Kakkanad, Kochi, 682030
Ernakulam
KERALA |
9847047780
04842428917
drhafeezsims@gmail.com |
| Dr KU Raghavendra Prasad |
Sunrise Institute of Medical Sciences Pvt Ltd |
Department of Gynaecology and Obstetrics Kushavankunnu, Ramnagar Road, Kanhangad, Kerala, 671531
Kasaragod
KERALA |
9895120439
rpogdoc@yahoo.co.in |
| Dr Leena Naduvalath |
Sunrise Institute of Medical Sciences Pvt Ltd |
Department of Gynaecology and Obstetrics Thrissur Kunnamkulam Road, near Petrol Pump, Changaramkulam, Nannammukku, Kerala, 679575
Thrissur
KERALA |
9645034545
leenanaduvalathu@gmail.com |
| Dr Sonia Farhan |
Sunrise Institute of Medical Sciences Pvt Ltd |
Department of Gynaecology and Obstetrics Seaport Airport Road, Kakkanad, Kochi, 682030
Ernakulam
KERALA |
9645349136
04842428917
soniafarhanph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUNRISE HOSPITAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. All symptomatic patients diagnosed with Isthmocele or uterine nische on
imaging.
2. All Patients diagnosed with uterine Isthmocele on imaging.
3. Patients with uterine niche planning for VBAC |
|
| ExclusionCriteria |
| Details |
Patients with extremes of age
avoided |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
The fertility outcome and the rate of recurrence of symptoms following Isthmocele repair.
The Pelvic pain and Quality of life outcomes after Isthmocele
repair. |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The Pelvic pain and Quality of life outcomes after Isthmocele
repair.
repair |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
18/03/2025 |
| 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="0"
Months="6"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
This study will be used to fabricate a new concept to reinforce more targeted management of the Isthmocele or uterine niche using Rahman’s surgical technique which will enable not only the correction of the physical defect but also the excision of the entire abnormal mucosa lining the uterine diverticulum. This method of Laparoscopic Isthmocele repair is proposed to give better symptomatic fertility and quality of life outcomes. |