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CTRI Number  CTRI/2025/07/091496 [Registered on: 23/07/2025] Trial Registered Prospectively
Last Modified On: 21/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Prospective Study 
Study Design  Other 
Public Title of Study   Comparing Robotic and Laparoscopic Surgery for Removing the Uterus in Non-Cancerous Conditions : A Study of Patient Outcomes. The research compares the following between laparoscopic and robotic hysterectomy : - Surgical outcomes (like complication rates, hospital stay) - Cost 
Scientific Title of Study   Robotic versus laparoscopic hysterectomy Comparison of perioperative outcomes in benign gynecological diseases 
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 Soofia Jamal 
Designation  Secondary DNB Resident 
Affiliation   
Address  Department of obstetrics and gynecology, Max Smart super speciality hospital, Saket, New Delhi

South
DELHI
110017
India 
Phone  7500608933  
Fax    
Email  soofiajamal20@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manju Khemani 
Designation  PRINICPAL DIRECTOR AND CONSULTANT  
Affiliation   
Address  G1 OPD, Department of obstetrics & gynecology, Max Smart Hospital, Saket, New Delhi

South
DELHI
110017
India 
Phone  9810611598  
Fax    
Email  manju.khemani@maxhealthcare.com  
 
Details of Contact Person
Public Query  
Name  Dr Soofia Jamal 
Designation  MBBS, DGO, Secondary DNB Resident 
Affiliation  Max Smart, Saket, New Delhi 
Address  G1, Department of obstetrics & gynecology, Max Smart super speciality hospital, Saket, New Delhi

South
DELHI
110017
India 
Phone  7500608933  
Fax    
Email  soofiajamal20@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Max Smart  
Address  Max Smart Superspeciality Hospital, Saket, New Delhi 
Type of Sponsor  Private hospital/clinic 
 
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 Soofia Jamal  Max Smart super speciality Hospital   Room number G1, Department of obstetrics and gynecology
South
DELHI 		 7500608933

soofiajamal20@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Max Healthcare Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N889||Noninflammatory disorder of cervixuteri, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  89.00 Year(s)
Gender  Female 
Details  All the patients above the age of 40 years undergoing laparoscopic hysterectomy or robotic hysterectomy for benign gynecological diseases and willing to be a part of the study will be included. 
 
ExclusionCriteria 
Details  - The patient who are not willing to be a part of the study will be excluded.
- Patients with malignant gynecological disease
- Patient undergoing additional surgeries like cholecystectomy, breast surgery.
- Patients with coagulation disorders
- Patients with severe endometriosis (stage 3 and 4)
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare early surgical outcomes between robotic and laparoscopic hysterectomy.
To compare following between robotic and laparoscopic hysterectomy
- Intra operative complications
- Conversion to open surgery
- Estimated blood loss
- Post operative pain as per visual analogue scale and need for extra analgesics
- First gas discharge
- Hospital stay 		 8 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="102"
Sample Size from India="102" 
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)   01/08/2025 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response (Others) - 
  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 01-05-2026 and end date provided 01-01-2029?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Hysterectomy is one of the commonest gynecological procedure done for benign conditions apart from malignant conditions. There is rising trend of minimally invasive surgeries worldwide. Robotic hysterectomy can be safely performed and has perioperative outcomes equivalent to Laparoscopic hysterectomy and superior to Total Abdominal hysterectomy.  Robotic hysterectomy is an alternative tool for minimally invasive hysterectomy. However there is a relative dearth of Indian literature with regard to this modality. More studies are required to assess patient safety and identify specific sub groups who would benefit from robotic approach. 
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