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CTRI Number  CTRI/2025/11/097610 [Registered on: 18/11/2025] Trial Registered Prospectively
Last Modified On: 14/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing different methods of uterus removal and effects it has on a womans life  
Scientific Title of Study   Comparison of Types of Hysterectomy on Womens Life 
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 Bhanu Sharma 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9896681095  
Fax    
Email  bhanu.kmcmpl2024@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Rekha Upadhya 
Designation  Associate professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9986143120  
Fax    
Email  rekha.upadhya@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Bhanu Sharma 
Designation  Junior Resident 
Affiliation  Kasturba Medical College, Manipal 
Address  Department of Obstetrics and Gynaecology, Kasturba Medical College, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9896681095  
Fax    
Email  bhanu.kmcmpl2024@learner.manipal.edu  
 
Source of Monetary or Material Support  
Self Kasturba hospital, Manipal, Karnataka 
 
Primary Sponsor  
Name  Dr Bhanu Sharma 
Address  Department of Obstetrics and Gynaecology, Kasturba Medical Hospital, Manipal 
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 Bhanu Sharma  Kasturba Hospital  Department of obstetrics and gynaecology, Kasturba medical college
Udupi
KARNATAKA 		 989661095

bhanu.kmcmpl2024@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  Inclusion Criteria
Females between 40 to 75 years who understand and give informed consent
Diagnosed with benign conditions requiring hysterectomy as a treatment option. 
 
ExclusionCriteria 
Details  Exclusion criteria
- Patient who have not consented for the study.
- Patients who opted for medical management.
- Patients with suspected malignancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome of the study is to find out preferred type of hysterectomy on the basis of the various demographic characteristics and the various questionnaires that are being given to the participants of the study.   Primary outcome of the study is to find out preferred type of hysterectomy on the basis of the various demographic characteristics and the various questionnaires that are being given to the participants of the study. Questionnaires will be given to patient prior to surgery to assess the anxiety of the patient, immediate post surgery to assess the pain, to assess the quality of life after 2 months and 6 months and sexual function will be assessed after 6 months. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="231"
Sample Size from India="231" 
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)   25/11/2025 
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="2"
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   Hysterectomy is one of the most commonly performed surgeries in gynaecology practice. The majority of hysterectomies are performed for benign indications. It is estimated that one in every three women will undergo a hysterectomy at some point in her life. We will be investigation various hysterectomy techniques and determine their influence on patient outcomes like pain levels, anxiety, sexual function and quality of life. This study is unique in its comprehensive evaluation i.e. considering recovery times, patient satisfaction, and various other aspects. This study is unique as such type of study has not been carried out in recent times comparing surgical procedures with its pre and post operative effect on a patient’s life. Various details from the patients undergoing hysterectomy will be collected. Pre-operative anxiety will be scored using Hamilton Anxiety Scale (HAM-A), immediate post-operative pain score will be calculated using Visual Analogue Scale(VAS) and Post-operatively at 2 months follow-up patient will be given SF-36 score to see the quality of life after hysterectomy and at 6 months, on telephonic follow-up FSFI (Female Sexual function index) for measuring changes over time before and after interventions in sexual function of a female and SF-36 (Quality of Life) will be calculated and compared among the 3 study groups - TAH (Total abdominal hysterectomy), LAPAROSCOPIC HYSTERECTOMY and NDVH (Non descendent vaginal hysterectomy). On comparison, preferred mode of hysterectomy will be found out. 
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