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CTRI Number  CTRI/2025/03/081894 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 13/09/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   Comparing Laparoscopic Versus Vaginal Repair of Uterine Prolapse 
Scientific Title of Study   Comparing Total Laparoscopic Hysterectomy with Rahman’s Technique of Sacrocolpopexy with Vaginal Hysterectomy with Sacrospinous Fixation – A Multi-Centric Prospective Cohort Study for Symptomatic Uterovaginal Prolapse. 
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  MBBS, MD, DNB, FCLS - HOD Obstetrics and Gynecology 
Affiliation  Sunrise Institute of Medical Sciences Pvt. Ltd. 
Address  Seaport-Airport Road, Kakkanad

Ernakulam
KERALA
682030
India 
Phone  9847047780  
Fax  04862428917  
Email  drhafeezsims@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sonia Farhan 
Designation  MBBS, MS - Consultant Gynecologist 
Affiliation  Sunrise Institute of Medical Sciences Pvt. Ltd. 
Address  Seaport-Airport Road, Kakkanad

Ernakulam
KERALA
682030
India 
Phone  9645349136  
Fax  04862428917  
Email  soniafarhanph@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sonia Farhan 
Designation  MBBS, MS - Consultant Gynecologist 
Affiliation  Sunrise Institute of Medical Sciences Pvt. Ltd. 
Address  Seaport-Airport Road, Kakkanad

Ernakulam
KERALA
682030
India 
Phone  9645349136  
Fax  04862428917  
Email  soniafarhanph@gmail.com  
 
Source of Monetary or Material Support  
Sunrise Institute of Medical Sciences, 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  
Name  Address 
NIL  NIL 
 
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 , Kasaragod  Ashwini Nagar, Kasaragod, Kerala 671121
Kasaragod
KERALA 		 8762545283
04862428917
jpoornima900@gmail.com 
Dr Abdul Rasheed  PVS Sunrise Institute of Medical Sciences  Railway Station Rd, near Railway Station, Palayam, Kozhikode, Kerala 673002
Kozhikode
KERALA 		 8086858911
04862428917
abdulrasheednest@gmail.com 
Dr Raghavendra Prasad  Sunrise Hospital, Kanhangad  Kushavankunnu, Ramnagar Rd, Kanhangad, Kerala 671531
Kasaragod
KERALA 		 9895120439
04862428917
rpogdoc@yahoo.co.in 
Dr Hafeez Rahman  Sunrise Institute of Medical Sciences  Seaport-Airport Road, Kakkanad, 682030.
Ernakulam
KERALA 		 9847047780
04862428917
drhafeezsims@gmail.com 
Dr Leena Naduvalath  Sunrise Institute of Medical Sciences  Thrissur, Kunnamkulam Rd, Near Petrol Pump, Changaramkula, Nannammukku, 6795575.
Thrissur
KERALA 		 9645035656
04862428917
leenanaduvalath@gmail.com 
Dr Sonia Farhan  Sunrise Institute of Medical Sciences  Seaport-Airport Road, Kakkanad, 682030.
Ernakulam
KERALA 		 9645349136
04862428917
soniafarhanph@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUNRISE INSTITUTE OF MEDICAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N812||Incomplete uterovaginal prolapse,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1)Patients with symptomatic uterine prolapse ( stage 2 and above )
2)Age from 45 to 70 years will be selected 
 
ExclusionCriteria 
Details 
1)Patients with uncontrolled Diabetes Mellitus
2)Patients with suspicion of malignancy.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
the anatomical and functional outcome following total laparoscopic hysterectomy with sacrocolpopexy to vaginal hysterectomy with sacrospinous fixation in terms of rate of recurrence of vault prolapse.  3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Quality of life outcome following total laparoscopic hysterectomy with sacrocolpopexy to vaginal hysterectomy with sacrospinous fixation in terms of rate of recurrence of vault prolapse.  3 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)   15/03/2025 
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="3"
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  

A Multicentric Prospective cohort study will be conducted in the Sunrise group of hospitals, including Sunrise Hospital - Kakkanad, Kanhangad, Kasargod and Changaramkulam. The study aims to analyze the anatomical and functional outcome following total laparoscopic hysterectomy with sacrocolpopexy to vaginal hysterectomy with sacrospinous fixation in terms of rate of recurrence of vault prolapse and quality of life.

 

 
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