Role of rectal Misoprostol along with intramyometrial Vasopressin in reducing blood loss during Laparoscopic removal of fibroids.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Patients planned for laparoscopic myomectomy and meeting the inclusion and exclusion criteria
- Registration Number
- CTRI/2017/09/009677
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
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)
Exclusion Criteria
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Intraoperative blood loss in vasopressin plus misoprostol group versus only vasopressin group.Timepoint: Measured immediately after the end of surgery
- Secondary Outcome Measures
Name Time Method Intraoperative: <br/ ><br>1.Ease of myoma separation/enucleation <br/ ><br>2.Need of any additional haemostatic measure <br/ ><br>3.Need for blood transfusion <br/ ><br>4.No. and type of sutures used <br/ ><br>5.Rate of conversion to laparotomy <br/ ><br>6.Need for hysterectomy <br/ ><br>7.Duration of surgery <br/ ><br>8.Any other complication <br/ ><br> <br/ ><br>Postoperative <br/ ><br>1.Hb drop and change in other blood counts <br/ ><br>2.Morbidity like pyrexia (temp 100 °F), diarrhoea <br/ ><br>3.Need for blood transfusion <br/ ><br>4.Length of hospital stay <br/ ><br>5.Evaluation on f/up visits at 1 and 6 wksTimepoint: till 48 hrs postoperative