Fibroids Cancer Other benign neoplasms of uterus
Conditions
Interventions
Current interventions as of 15/09/2008:
Patients with symptomatic fibroids requiring open myomectomy will be randomised to treatment with either GnRH analogues pre-operatively for 3 months or intra-op
the drain will stay in situ for a minimum of 48 hours, and will be removed once the drainage is less than 100 ml in 24 hours. Temperature will be monitored in the usual way every 4 - 6 hours. Haemoglo
blood transfusion will be given if Hb is less than 8 g/dl or if it is clinically indicated for other reasons. Prior to discharge from hospital patients will undergo doppler studies of uterine blood fl
Sponsors
Record Provided by the NHSTCT Register - 2005 Update - Department of Health (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 15/09/2008: Intra-operative blood loss, assessed by the standard method of meticulous measurement of blood loss during surgery, measured at conclusion of surgery. Initial primary outcome measures: 1. Post-operative blood loss + FPC need for blood transfusion 2. Febrile mortality 3. Ovarian function 4. Uterine blood flow 5. General health 6. Menstrual blood loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Added as of 15/09/2008: 1. Post-operative blood loss, assessed by amount collected in surgical drains and by post-operative changes in haemoglobin, measured after removing the drain, i.e. on average this will be at day 2 post-operatively 2. Intra- and post-operative blood transfusion rates. Blood transfusion rate is measured (if it is required) intra-operatively plus (if required) post-operatively. 3. Intra- and post-operative morbidity: immediate post-operative morbidity measured within the first week after surgery. Late morbidity (complications) measured at post- operative check-up at 6 weeks, then 3 months and then 6 months. 4. Ovarian function, assessed by serial serum FSH concentrations: measured pre-operatively and again at follow-up at 6 weeks, then 3 months and then 6 months | — |
Countries
United Kingdom
Outcome results
None listed