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

Category Primary study
Registry of TrialsISRCTN registry
Year 2023
INTERVENTION: 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 interventions: LM ‐ laparoscopic myomectomy with no hypogastric artery clipping LM + TOHA ‐ laparoscopic myomectomy with temporary occlusion of the hypogastric artery Method of randomization: Randomization was single‐blind and performed with the R package "blockrand" version 1.5. Intervention providers: All surgical procedures are performed by a single and highly proficient surgeon with over a decade of experience in laparoscopic surgery. Modes of delivery Prior to the surgery, neither Gonadotropin‐Releasing Hormone (GnRH) agonists nor any intra‐operative hemostatic drugs, such as vasopressin injections, are employed. Before initiating surgical procedures, general anesthesia was induced concomitantly with orotracheal intubation. Abdominal access was obtained via a direct trocar entry technique. CO2 insufflation was used to create a pneumoperitoneum with a low intra‐abdominal pressure of up to 12 mmHg. A 10 mm trocar was positioned on the median line, 8 cm away from the umbilicus, while two 5 mm trocars are situated on each side of the lower abdomen. The patient was then reclined in a Trendelenburg position. The parietal peritoneum was incised below the lumbo‐ovarian ligament. The ureter and anterior trunk of the hypogastric artery are identified in the area where these two structures run parallel. The ureter and hypogastric artery are identified using blunt dissection. A metallic clip was then place CONDITION: Laparoscopic myomectomy in adult women ; Surgery PRIMARY OUTCOME: 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 OUTCOME: ; 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; 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
Epistemonikos ID: 4f592c3ae82096773bca92111a1d8552fd780009
First added on: Aug 26, 2024