Assessment of bleeding reduction technique in laparoscopic myomectomy (keyhole surgery to remove fibroids)

ISRCTN	ISRCTN89994856
DOI	https://doi.org/10.1186/ISRCTN89994856
ClinicalTrials.gov number	NCT05994560
Secondary identifying numbers	324-19

Submission date: 11/11/2023
Registration date: 22/11/2023
Last edited: 09/04/2024

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The aim of this study is to determine whether patients who underwent laparoscopic fibroid removal and temporary placement of a metallic mechanism (called a “clip”), which acts as a clamp on the uterine arteries and utero-ovarian ligaments, have decreased bleeding during surgery, compared to patients who underwent laparoscopic myomectomy without said clips.

Who can participate?
Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a desire to preserve the uterus.

What does the study involve?
This is a study in which patients who underwent laparoscopic myomectomy with temporary placement of "clips" in the uterine arteries and utero-ovarian ligaments, which are removed at the end of the intervention, are compared with another control group of patients who underwent laparoscopic myomectomy with the traditional technique (without "clips) usually performed in other centers.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
University Hospital Ramon y Cajal (Spain)

When is the study starting and how long is it expected to run for?
January 2020 to December 2022

Who is funding the study?
University Hospital Ramon y Cajal (Spain)

Who is the main contact?
Dr Enrique Moratalla Bartolome, enrique.moratalla@salud.madrid.org

Contact information

Dr Enrique Moratalla Bartolome
Public, Scientific, Principal Investigator

M-607, 9, 100
Madrid
28034
Spain

ORCID ID	0000-0002-2653-2043
Phone	+34 913368105
Email	enrique.moratalla@salud.madrid.org

Study information

Study design	Longitudinal prospective randomized controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	44575 PIS v2.pdf
Scientific title	Value of temporary occlusion of the uterine arteries in laparoscopy myomectomy
Study objectives	The objective of this study is to determine whether patients undergoing laparoscopic myomectomy with temporary occlusion of the uterine arteries and utero-ovarian ligaments using clips experience a decrease in blood loss during surgery compared to patients who undergo laparoscopic myomectomy without clips.
Ethics approval(s)	1. Approved 24/02/2020, Medicine Research Ethics Committee University Hospital Ramon y Cajal (M-607, 9, 100, Madrid, 28034, Spain; +34 913368322; ceic.hrc@salud.madrid.org), ref: 324-19 2. Approved 12/02/2020, MEDICINE RESEARCH ETHICS COMMITTEE HM HOSPITALS (Avda. Montepríncipe, 25., Boadilla del Monte, 28660, Spain; -; secretariaceic@hmhospitales.com), ref: 20.01.1492-GHM
Health condition(s) or problem(s) studied	Laparoscopic myomectomy with temporary occlusion of the uterine arteries and utero-ovarian ligaments
Intervention	Patients who underwent laparoscopic myomectomy with temporary occlusion of the uterine arteries and utero-ovarian ligaments using clips will be analyzed with a control group of patients who underwent laparoscopic myomectomy with the traditional technique (surgery without temporary occlusion of uterine arteries). Patients with symptomatic fibroids who require surgery to treat them, from the Gynecology Service of the Ramón y Cajal Hospital and HM Hospitals. Patients will be randomized into 2 groups: exposed (patients with temporary occlusion of the uterine arteries by clips during surgery) and non-exposed (patients without temporary occlusion of the uterine arteries during surgery). A patient will be recruited in the pre-surgical consultation when laparoscopic myomectomy is indicated, randomizing both groups by simple random sampling. An informed consent will be delivered to the patients, who have to accept and sign in order to participate in the study. The diagnosis of the presence of fibroids will be made by abdominal and/or transvaginal gynecological ultrasound and/or nuclear magnetic resonance. Fibroids will be quantified, measured and their location described. The patients included in the study will have their pre-surgical hemoglobin determined by preoperative analysis and another post-surgical hemoglobin sample will be determined the day after surgery. The need for transfusion, blood loss during surgery (aspirate the blood content), surgical time, hospital stay, symptom improvement and complications will be assessed. In addition, clinical data on the patients will be collected: age, height, weight, race, concomitant diseases and treatment, family history, age at menarche, tobacco and alcohol consumption, main clinic where the surgery is performed.
Intervention type	Procedure/Surgery
Primary outcome measure	Blood loss (by assessing pre- and postoperative hemoglobin in g/dL and intraoperative blood aspirate in milliliters) measured using the amount of aspirated fluid at the end of the procedure minus the amount of fluid used for irrigation in ml.
Secondary outcome measures	Measured using patient records unless noted: 1. Surgical time (minutes) 2. Need for transfusion (yes/no) 3. Length of hospital stay (days) 4. Preoperative hemoglobin (g/dl) was obtained within 24 hours before surgery, and postoperative hemoglobin was collected on postoperative day 1 5. Surgical complications were documented
Overall study start date	11/01/2020
Completion date	31/12/2022

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	Female
Target number of participants	80
Total final enrolment	80
Key inclusion criteria	Patients with uterine fibroids requiring surgical treatment via laparoscopy and with a desire to preserve the uterus.
Key exclusion criteria	1. Patients who do not meet the inclusion criteria. 2. Women with symptomatic fibroids who are not candidates for laparoscopic surgery and/or have no desire to preserve the uterus. 3. Patients for whom technical placement of clips during the intervention is not possible.
Date of first enrolment	12/02/2020
Date of final enrolment	21/12/2022

Locations

Countries of recruitment

Spain

Study participating centres

University Hospital HM Monteprincipe

Avenida de Montepríncipe nº 25
Boadilla del Monte
28660
Spain

University Hospital Ramon y Cajal

M-607, 9, 100
Madrid
28034
Spain

University Hospital HM Sanchinarro

Calle Oña 10
Madrid
28050
Spain

Sponsor information

Hospital Universitario Ramón y Cajal
Hospital/treatment centre

M-607, 9, 100
Madrid
28034
Spain

Phone	+34 913368000
Email	ceic.hrc@salud.madrid.org
Website	https://www.comunidad.madrid/hospital/ramonycajal/
"ROR"	https://ror.org/050eq1942

Funders

Funder type

Hospital/treatment centre

Hospital Universitario Ramon y Cajal

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 datasets generated during and/or analysed during the current study will be available upon request from Dr. Enrique Moratalla, emoratallab@gmail.com

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	version 2		22/11/2023	No	Yes
Results article		25/03/2024	09/04/2024	Yes	No

Additional files

44575 PIS v2.pdf

Editorial Notes

09/04/2024: Publication reference and total final enrolment added.
22/11/2023: Trial's existence confirmed by MEDICINE RESEARCH ETHICS COMMITTEE HM HOSPITALS.