Health TrialsbyHealthPanel

Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy

ConditionsUterine Fibroids (Leiomyoma)MyomectomyMyomectomy; Surgical Blood Loss
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorAlexandria University

About this trial

The current study is a multiple-arm, single blinded, and controlled randomized trial. It will be conducted in two gynecological endoscopy centers: • ElShatby University Hospital, a tertiary level hospital in Alexandria, Egypt. • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt. Patient selection: women with uterine leiomyomata and planning for laparoscopic myomectomy will be assessed for eligibility then will be enrolled in the trial according to the following inclusion and exclusion criteria, after providing a written informed consent of participation. Outcome variables of the study: The primary outcome is intraoperative blood loss and the change in postoperative hemoglobin. The secondary outcomes of this study are the operative time of performing uterine arteries occlusion and the postoperative ovarian reserve.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

women with uterine fibroids and complaining of either abnormal uterine bleeding, infertility, urinary or rectosigmoid pressure manifestations.

Fibroid size from 3 - 10 cm in diameter and with

a maximum number of 3 fibroids.

Disqualifiers

contraindication to pneumoperitoneum and laparoscopy,

patients with BMI > 30 kg/m2,

history of midline abdominal incisions,

women with history of prior ovarian surgery,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Temporary clipping of uterine artery

    Procedure/Surgery

    Both uterine arteries will be temporary clipped with a Titanium clip till the end of the myomectomy procedure

  • Temporary occlusive suturing of uterine artery

    Procedure/Surgery

    A "Shoelace" suture will be applied to both uterine arteries and the sutures will be removed at the end of the myomectomy procdure

  • Bipolar coagulation of uterine arteries

    Procedure/Surgery

    Permanent coagulation of both uterine arteries will be performed by Bipolar forceps before the start of the myomectomy procedure

  • Laparoscopic myomectomy only

    Procedure/Surgery

    No occlusion of uterine arteries will be performed. Only Laparoscopic myomectomy will be performed

Treatment groups

60 Participants
are divided into 4 treatment groups
Group A: Temporary clipping of uterine arteriesActive comparator 1 intervention
Group B: Temporary occlusive suturing of uterine arteryActive comparator 1 intervention
Group C: Bipolar coagulation of uterine arteriesActive comparator 1 intervention
Group D: No occlusion of uterine arteryActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intraoperative blood loss

The amount of intraoperative blood loss measured at the end of the procedure by estimation of the total volume of fluid in the suction machine.

Time frame
Within 40 minutes of end of the myomectomy procedure
2

Postoperative Hemoglobin shift

Postoperative hemoglobin level will be measured 24 hours after the procedure and the shift in hemoglobin from the preoperative level will be recorded

Time frame
24 hours after the procedure

Secondary outcomes

1

Operative time of uterine artery occlusion

Duration from accessing the retroperitoneum to occlusion of both uterine arteries

Time frame
Time lapsed from intraperitoneal laparoscopic entry till completion of bilateral uterine artery occlusion (in minutes)
2

Total operative time

The total time lapse from the peritoneal entry till the end of the myomectomy procedure

Time frame
Time lapsed from intraperitoneal laparoscopic entry till completion of the myomectomy procedure and abdominal exit (in minutes)
3

Impact on ovarian reserve

Serum AMH will be measured 3 months postoperative and compared with the preoperative level

Time frame
3 months postoperatively
4

Intraoperative complications

The incidence of any intraoperative complications such as, blood transfusion, vascular injury, bowel injury, conversion to laparotomy, conversion to hysterectomy will be recorded in the four study arms.

Time frame
40 minutes, 90 minutes, 120 minutes Intraoperative and 24 hours, 48 hours, 7 days Postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alexandria University

Lead sponsor

Source ClinicalTrials.gov
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