Reducing blood loss in laparoscopic and open myomectomy: a prospective randomised controlled trial comparing the benefit of triple tourniquets against gonadotropin releasing hormone (GnRH) analogues

Completed

• Conditions: Fibroids; Cancer; Other benign neoplasms of uterus

• Registration Number: ISRCTN64355848
• Lead Sponsor: Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-30
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Current inclusion criteria as of 15/09/2008:
Inclusion criteria for open myomectomy:
1. Symptomatic multiple fibroids (more than three fibroids)
2. Uterine size less than 24 weeks gestation equivalent

Inclusion criteria for laparoscopic myomectomy:
1. Uterine size up to 16 - 18 weeks gestation equivalent
2. No more than three fibroids, with maximum diameter of 15 cm 3. Mostly intramural fibroids

Initial inclusion criteria:
Patients will be referred from the GP to our fibroid clinic and have symptomatic fibroids. They will have chosen to have a myomectomy and agreed to be in the study.

Exclusion Criteria

Added as of 15/09/2008:
Exclusion criteria for open myomectomy:
1. Large uterus more than 24 weeks gestation equivalent
2. Women with a bleeding disorder
3. Women on anticoagulants
4. Treatment with GnRH analogues within the previous six months
5. Women with a haemoglobin level of less than 10.5 g/dl

Exclusion criteria for laparoscopic myomectomy:
1. Uterine size of more than 16 - 18 weeks gestation equivalent
2. Women with a bleeding disorder
3. Women on anticoagulants
4. Women with a haemoglobin level of less than 10.5 g/dl
5. Mostly subserous fibroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified