Temporary occlusion of the hypogastric artery to reduce blood loss associated with laparoscopic myomectomy

Investigation of bilateral Temporary Occlusion of the Hypogastric Artery in women undergoing laparoscopic myomectomy to minimize consequences of blood loss

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN66897343

Enrollment

Registered

2023-07-03

Start date

2019-01-01

Completion date

Unknown

Last updated

2023-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic myomectomy in adult women Surgery

Interventions

Combining laparoscopic myomectomy with temporary bilateral occlusion of the hypogastric artery. Study arms: There are two arms that include participants who are randomly allocated to the following in

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Aged between 18 and 49 years old 2. Preference for laparoscopic myomectomy and their desire to preserve fertility 3. Intramural uterine leiomyomas greater than 4 cm in diameter

Exclusion criteria

Exclusion criteria: 1. Patients who did not agree to the enrollment or did not pass inclusion criteria (such as: age over 50, no preference for fertility preservation, personal option for hysterectomy) 2. Other types of myomas (such as submucosal or sub-serosal location), or intramural myomas under 4 cm which did not have an impact on the uterine cavity 3. Suspected of malignancy

Design outcomes

Primary

Measure	Time frame
Total hemoglobin concentration (g/dL) measured using a blood gas analyzer system (carried out in the CO-oximetry module) within the hospital laboratory before and immediately after the surgery	—

Secondary

Measure	Time frame
1. Required iron perfusion measured using the quantity of iron administered by intravenous infusion after surgery decided by the consultant based on ferritin concentration < 100 µg.I-1 after surgery 2. Required postoperative blood transfusion measured using blood testing and determined by the consultant based on a hemoglobin level of 70-80 g.I-1 measured after surgery 3. Anemia measured using blood testing and diagnosed based on hemoglobin less than 120 g/L (12 g/dL) as a dichotomous variable after surgery 4. Overall operative time measured using medical records as the time elapsed from the initial incision to final skin closure after surgery 5. Twelve-month post-operative spontaneous pregnancy measured using medical records as any pregnancy recorded within 12 months after laparoscopic myomectomy, without assisted reproductive measures at one timepoint at the end of the study 6. Hospital re-admission rate of participants in the trial who return to the hospital within seven days of discharge after laparoscopic myomectomy measured using medical records at one timepoint at the end of the study 7. Reports of death, including in-hospital death, or within 14 days of discharge after laparoscopic myomectomy, measured using medical records at one timepoint at the end of the study	—

Measure

Time frame

1. Required iron perfusion measured using the quantity of iron administered by intravenous infusion after surgery decided by the consultant based on ferritin concentration < 100 µg.I-1 after surgery 2. Required postoperative blood transfusion measured using blood testing and determined by the consultant based on a hemoglobin level of 70-80 g.I-1 measured after surgery 3. Anemia measured using blood testing and diagnosed based on hemoglobin less than 120 g/L (12 g/dL) as a dichotomous variable after surgery 4. Overall operative time measured using medical records as the time elapsed from the initial incision to final skin closure after surgery 5. Twelve-month post-operative spontaneous pregnancy measured using medical records as any pregnancy recorded within 12 months after laparoscopic myomectomy, without assisted reproductive measures at one timepoint at the end of the study 6. Hospital re-admission rate of participants in the trial who return to the hospital within seven days of discharge after laparoscopic myomectomy measured using medical records at one timepoint at the end of the study 7. Reports of death, including in-hospital death, or within 14 days of discharge after laparoscopic myomectomy, measured using medical records at one timepoint at the end of the study

—

Countries

Romania

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 8, 2026