| CTRI Number |
CTRI/2017/09/009677 [Registered on: 07/09/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/09/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
Role of rectal Misoprostol along with intramyometrial Vasopressin in reducing blood loss during Laparoscopic removal of fibroids. |
|
Scientific Title of Study
|
To compare the efficacy of Intramyometrial Vasopressin plus Rectal Misoprostol with Intramyometrial Vasopressin alone to decrease blood loss during Laparoscopic Myomectomy: A Randomised Clinical Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Alka Kriplani |
| Designation |
Head of Department |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room No. 3076, 3rd floor,Dept of Obstetrics & Gynaecology,AIIMS,New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9810828717 |
| Fax |
01126588663 |
| Email |
kriplanialka@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonal Srivastava |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9962722166 |
| Fax |
01126588663 |
| Email |
drsonal2808@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Srivastava |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9968722166 |
| Fax |
01126588663 |
| Email |
drsonal2808@gmail.com |
|
|
Source of Monetary or Material Support
|
|
All India Institute of Medical Sciences, Ansari Nagar East, New Delhi, Delhi 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
AIIMS, Ansari Nagar East, New Delhi, 110029 |
| 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 Sonal Srivastava |
All India Institute of Medical Sciences |
Room No.3076,3rd floor,Dept of Obstetrics & Gynaecology AIIMS,New Delhi 110029
New Delhi
DELHI |
9968722166
01126588663
drsonal2808@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POSTGRADUATE RESEARCH,AIIMS,NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients planned for laparoscopic myomectomy and meeting the inclusion and exclusion criteria, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Only intra operative vasopressin |
20 units |
| Intervention |
Preoperative per rectal misoprostol 600 mcg |
Plus Intraoperative vasopressin (20 units) |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Women between 16-45 years of age
2. Myomatous uterus corresponding to 28 weeks size or less
3. Largest fibroid less than 15 cm
4. Haemoglobin level equal to or greater than 9 g/dL
5. No contraindication to use of vasopressin or misoprostol (renal/heart
disease)
|
|
| ExclusionCriteria |
| Details |
1. Previous myomectomy
2. Significant medical condition such as heart, renal or pulmonary disease
3. Hb < 9 g/dL
4. Pregnancy
5. History of any bleeding disorder
6. Concurrent anticoagulation therapy
7. Grade 0 submucosal fibroid
8. Patient not fit for laparoscopic surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intraoperative blood loss in vasopressin plus misoprostol group versus only vasopressin group. |
Measured immediately after the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Intraoperative:
1. Ease of myoma separation/enucleation
2. Need of any additional haemostatic measure
3. Need for blood transfusion
4. No. and type of sutures used
5. Rate of conversion to laparotomy
6. Need for hysterectomy
7. Duration of surgery
8. Any other complication
Postoperative
1. Hb drop and change in other blood counts
2. Morbidity like pyrexia (temp 100 °F), diarrhoea
3. Need for blood transfusion
4. Length of hospital stay
5. Evaluation on f/up visits at 1 and 6 wks |
till 48 hrs postoperative |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
03/03/2014 |
| Date of Study Completion (India) |
13/08/2015 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Uterine
leiomyomas are the most common benign tumors of the uterus in women of
reproductive age group, with a cumulative incidence of 70%. Symptomatic fibroids can b treated either by medical or surgical management. Fibroids
are the leading indication for hysterectomy worldwide.
Myomectomy,
however, remains the gold standard for symptomatic women who desire uterine
preservation. A major problem that myomectomy poses is excessive
blood loss from the increased uterine vasculature.
A
number of interventions have been used to decrease the blood loss during
myomectomy. Signiï¬cant
reductions in blood loss with misoprostol, vasopressin, bupivacaine plus epinephrine,
tranexamic acid, pericervical tourniquet and gelatin-thrombin matrix have been
demonstrated in various clinical trials.
In
India, no studies have been conducted to compare the efficacy of different
combination regimens to control haemorrhage during laparoscopic myomectomy.
Thus, we proposed to investigate the efficacy of a single preoperative dose of
per rectal misoprostol along with intramyometrial vasopressin over
intramyometrial vasopressin alone to decrease blood loss in patients undergoing
laparoscopic myomectomy. |