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CTRI Number  CTRI/2017/10/010193 [Registered on: 25/10/2017] Trial Registered Prospectively
Last Modified On: 17/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of blood loss between saline injection and classical technique during vaginal surgery for pelvic organ prolapse  
Scientific Title of Study   Comparison of blood loss between hydrodissection and conventional dissection during vaginal surgery for pelvic organ prolapse - a Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Shemeena PS 
Designation  Junior resident 
Affiliation  Jawaharlal Institute of post graduate medical education and research 
Address  Department of Obstetrics and Gynaecology JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9539667616  
Fax    
Email  shemeenasayed9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Gowri Dorairajan 
Designation  Professor 
Affiliation  Jawaharlal Institute of post graduate medical education and research 
Address  Department of Obstetrics and Gynaecology JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9894348518  
Fax    
Email  gowridorai@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Shemeena PS 
Designation  junior resident 
Affiliation  Jawaharlal Institute of post graduate medical education and research 
Address  Department of Obstetrics and Gynaecology JIPMER

Pondicherry
PONDICHERRY
605006
India 
Phone  9539667616  
Fax    
Email  shemeenasayed9@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Jawaharlal institute of Post graduate medical education and research 
Address  Dhanvantary Nagar, JIPMER,Puducherry,605006 
Type of Sponsor  Research institution and hospital 
 
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 Shemeena PS  Jawaharlal Institute of Post Graduate Medical Education and Research  Department of Obstetrics and Gynaecology 2nd floor WCH JIPMER puducherry
Pondicherry
PONDICHERRY 
9539667616

shemeenasayed9@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institute Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Women between 30 and 75 years of age with pelvic organ prolapse undergoing vaginal surgery ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  hydrodissection using saline in vaginal dissection for prolapse surgery  After cleaning and draping the case randomized to the study group will receive 60- 80 ml of saline injected around cervix into vaginal mucosa anteriorly before vaginal wall dissection is carried out. An additional 60 ml will be instilled for posterior vaginal wall dissection 
Comparator Agent  vaginal dissection without hydrodissection during prolapse surgery  normal vaginal dissection will be carried out without hydodissection 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  a. Women between 30 and 75 years of age with pelvic organ prolapse undergoing vaginal surgery that includes apical component (hysterectomy) and at least one morecompartment (anterior or posterior repair).

b.Operations performed by senior registar or consultant
 
 
ExclusionCriteria 
Details  1. Women with recurrent prolapse
2. Women with intra operative blood loss due to slippage of ligature.
3. Women undergoing non descent vaginal hysterectomy.
4. Conservative surgery for prolapse
5. Abdomino vaginal repair surgery for prolapse
6. Additional procedures like Tension free vaginal tape (TVT) or sacrospinal fixation(SSF)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
to compare the blood loss between hydrodissection and conventional incision without hydrodissection during vaginal surgery for pelvic organ prolapse.

 
blood loss in milli litre during duration of surgery around 2 hours 
 
Secondary Outcome  
Outcome  TimePoints 
to compare the post operative complications like reactionary or secondary haemorhage and infection  5 to 7 days after surgery 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="44" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2017 
Date of Study Completion (India) 17/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   Hydrodissection incorporating saline alone or with different types of vasoconstrictors has been tried in vaginal prolapse surgery. Vasoconstrictors may subject the patient to unnecessary risk. hydrodissection using saline alone has not been compared with conventional incision. so this comparative study is being undertaken. Women undergoing prolapse surgery are usually multiparous and likely to have underlying anemia or poor iron stores. It will help in long run by reducing blood loss and preventing further anemia. 
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