Temporary occlusion of the hypogastric artery to reduce blood loss associated with laparoscopic myomectomy
| ISRCTN | ISRCTN66897343 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66897343 |
- Submission date
- 27/06/2023
- Registration date
- 03/07/2023
- Last edited
- 07/09/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Uterine leiomyomas, or uterine fibroids, are benign tumors in the pelvic region that are commonly found in women. For women of reproductive age experiencing symptoms from these tumors, laparoscopic myomectomy (LM) is the preferred treatment option in which myomas are surgically removed through small incisions in the abdomen. In this study, the authors propose that combining LM with blocking blood flow of arteries in the pelvis, or temporary occlusion of the hypogastric artery (TOHA) using vascular clips, can reduce uterine blood flow during surgery and effectively decrease surgery-related blood loss.
Who can participate?
Adult women aged 18-49 years old diagnosed with intramural uterine leiomyomas larger than 4 cm in diameter, who preferred LM and wished to preserve fertility.
What does the study involve?
Participants were randomized into two parallel groups:
1. Patients undergoing standard LM
2. Patients undergoing LM with TOHA clipping.
What are the possible benefits and risks of participating?
The main benefits regard reduced surgery-associated blood loss. There are no foreseen risks associated with the intervention.
Where is the study run from?
Ob-Gyn Clinic of Emergency Municipal Clinical Hospital in Timisoara, Romania. The clinic is affiliated with "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania.
When is the study starting and how long is it expected to run for?
January 2018 to December 2021
Who is funding the study?
"Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania
Who is the main contact?
Prof Laurentiu Pirtea (Principal investigator), pirtea.laurentiu@umft.ro
Dr Cristina Secosan, secosan.cristina@umft.ro
Contact information
Principal Investigator
Victor Babeș University of Medicine and Pharmacy Timișoara
Piata Eftimie Murgu 2
Timisoara
300041
Romania
 ORCID ID |
0000-0002-4398-2492 |
|---|---|
| Phone | +40756162282 |
| pirtea.laurentiu@umft.ro |
Scientific
Victor Babeș University of Medicine and Pharmacy Timișoara
Piata Eftimie Murgu 2
Timisoara
300041
Romania
| ORCID ID |
0000-0002-0274-1377 |
|---|---|
| Phone | +40722488775 |
| dlungeanu@umft.ro |
Scientific
Victor Babeș University of Medicine and Pharmacy Timișoara
Piata Eftimie Murgu 2
Timisoara
300041
Romania
| ORCID ID |
0000-0003-1355-3790 |
|---|---|
| Phone | +40762647210 |
| secosan.cristina@umft.ro |
Study information
| Study design | Proof-of-concept single-center interventional single-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 43858_PIS.pdf |
| Scientific title | Investigation of bilateral Temporary Occlusion of the Hypogastric Artery in women undergoing laparoscopic myomectomy to minimize consequences of blood loss |
| Study acronym | TOHAs |
| Study objectives | Combining laparoscopic myomectomy with a bilateral temporary occlusion of the hypogastric artery (TOHA) using vascular clips minimizes uterine blood flow during surgery and can significantly reduce surgery-associated blood loss. |
| Ethics approval(s) |
Approved 10/12/2018, Human Ethical Committee of “Victor Babes” University of Medicine and Pharmacy (Piata Eftimie Murgu 2, Timisoara, 300041, Romania; +40 256466001; cecs@umft.ro), ref: 44/10.12.2018 |
| Health condition(s) or problem(s) studied | Laparoscopic myomectomy in adult women |
| 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 placed on the anterior trunk of the hypogastric artery, cranially to the uterine artery emergence. The uterine wall was incised, and the myoma/s are located and then removed using traction and countertraction maneuvers. Next, in-bag morcellation was used to remove the leiomyoma/s. The uterine wall was sutured with a double-layer stitch, utilizing a 29 mm, 3/8 circle needle, and Vicryl 2.0 thread. Once the uterine wall had been closed, hemostatic clips are gently removed by traction using atraumatic Johan fenestrated forceps. Location where the intervention occurred All surgical interventions are performed within the facilities of the Ob-Gyn Clinic of Emergency Municipal Clinical Hospital in Timisoara, Romania. The clinic is a tertiary referral hospital and is affiliated with "Victor Babes" University of Medicine and Pharmacy, Timisoara, Romania. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 01/01/2018 |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 49 Years |
| Sex | Female |
| Target number of participants | 62 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/01/2019 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- Romania
Study participating centre
Timisoara
300231
Romania
Sponsor information
University/education
Piata Eftimie Murgu 2
Timisoara
300041
Romania
| Phone | +40256204400 |
|---|---|
| scr-stin@umft.ro | |
| Website | https://www.umft.ro |
"ROR" |
https://ror.org/00afdp487 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 31/12/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The dataset generated during this study will be made available upon institutional contact and reasonable request from Dr Cristina Secosan, secosan.cristina@umft.ro. These datasets will include individual patient data meta-analysis (IPD meta-analysis). |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Informed consent [English] | 03/07/2023 | No | Yes | |
| Participant information sheet | Informed consent [Romanian] | 03/07/2023 | No | Yes | |
| Statistical Analysis Plan | 03/07/2023 | No | No | ||
| Results article | 22/08/2023 | 07/09/2023 | Yes | No |
Additional files
- 43858_PIS.pdf
- Informed consent [English]
- 43858_SAP.pdf
- 43858_PIS [Ro].pdf
- Informed consent [Romanian]
Editorial Notes
07/09/2023: Publication reference added.
03/07/2023: Trial's existence confirmed by the Human Ethical Committee of “Victor Babes” University of Medicine and Pharmacy (Romania).
