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
|
|
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
|
|
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. |