Comparison of intraoperative blood loss with rectal misoprostol along with intramyometrial vasopressin and intramyometrial vasopressin alone in women undergoing laparoscopic myomectomy – a double blinded randomized placebo controlled trial.

Myomectomy, is indicated in symptomatic women who wish to conserve the uterus , may be performed by hysteroscopy, laparoscopy, or laparotomy, according to their size, location, number, and the experience of the surgeon. In women who wish to conserver their uterus for reproductive function or otherwise, laparoscopic myomectomy is preferable to abdominal myomectomy because it provides more rapid recovery, fewer postoperative adhesion, less blood loss, and less postoperative pain. Perioperative complications, reproductive outcomes, and risk of uterine rupture are similar to those obtained with open myomectomy. The most common complication of myomectomy is hemorrhage. Currently, during myomectomy, the myometrium overlying the fibroids is injected with a diluted solution of vasopressin (20 units in 100 mL of normal saline) as it diminishes blood flow locally and regionally at the level of the uterine arteries.

This study is a randomized controlled study that aims to compare the use of rectal misoprostol with intramyometrial vasopressin and intramyometrial vasopressin alone in reducing the blood loss during myomectomy. Misoprostol exerts its effect on the uterus by inducing myometrial contractions and causes vasoconstriction of the uterine arteries, restricting the vascular supply and hence reducing the blood flow to the leiomyomas. It is also safe, effective and cheap. The minor side effects of Tab. Misoprostol are fever, chills, loose stools , abdominal pain, nausea , vomiting and dyspepsia.

Patient in this study will be recruited from outpatient department and general wards under department of gynecology units 1 and 2, Christian medical college, Vellore from October 2023 to October 2025. This will be a randomized controlled trial.

The protocol will be submitted to the Institutional review board for approval. Once approved, women planned for myomectomy for symptomatic leiomyoma based on previous transvaginal ultrasound, transabdominal ultrasound or MRI will be enrolled. Based on the imaging – fibroid mapping – once the number, size and location of the fibroid is known, inclusion and exclusion criteria will be applied, and patients will be recruited for the study after informed written consent.

The patients will be randomly allocated into 2 groups, Group 1 – Rectal misoprostol 800mcg + Intramyometrial vasopressin (n = 65 ) and Group 2 – Intramyometrial vasopressin only (n=65 ), via a computer generated randomization list. A physician not directly involved in the study will prepare the sequentially – numbered sealed envelopes, containing either group 1 or group 2, labelled A and B respectively. After the informed consents are signed, the investigator will open the envelope and the randomization will be ensured by giving the drug to the doctor assigned. Misoprostol tablets 600mcg will be administered per rectally (per rectal examination is not done, only the drug is placed per rectally) by the doctor to the patient based on the randomization, 90 minutes prior to surgery, according to the set protocol. The surgeon is blinded and unaware of which group the patients are randomized into.

Only assigned surgeons from each unit will be performing all the myomectomies. The myometrium overlying the fibroids is injected with a diluted solution of vasopressin (1 unit/ml of saline). Once the surgery is complete, the surgeon will fill the details in the Performa regarding the blood loss and ease of enucleation. Patients will be monitored postoperatively in the recovery for minimum of 2 hours and then in the ward until discharge for any postoperative complications.

Data entry will be done using Epidata and Statistical analysis will be performed using SPSS version 25 (IBM Inc., Armonk, NY, USA)