Save the Ovaries - Surgical Management of Simple Ovarian Cysts in Children and Adolescents

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age1-18
SponsorUniversity Children's Hospital, Zurich

About this trial

The purpose of this study is to evaluate which operative technique should be used for managing simple ovarian cysts in girls and adolescents. The two techniques that are being compared are laparoscopic cyst enucleation and laparoscopic cyst deroofing. The investigators will assess the effect of both techniques on the ovarian reserve and the risk of cyst recurrence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Symptomatic simple cysts ≥ 4 cm with indication for surgical intervention

Asymptomatic cysts ≥ 4 cm, with surgical indication due to persistence or increase in size

Asymptomatic cysts ≥ 4 cm with other pathology as surgical indication, if known preoperatively

Age 12 months - 18 years

Disqualifiers

Neonatal ovarian cysts (age <12 months)

Age >18 years

Complex cysts (with solid components, e.g., Teratoma, risk or suspicion of malignancy)

Paratubar/paraovarian cysts

Trial design

Design model

Parallel

Treatments tested in this trial

  • Laparoscopic ovarian cyst surgery

    Procedure/Surgery

    Laparoscopic ovarian cyst surgery is any surgery with the goal of removal or drainage of an ovarian cyst. The exact surgical technique will be predefined by randomization.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Ovarian Cyst DeroofingExperimental treatment 1 intervention
Group B: Ovarian Cyst EnucleationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative change of AMH level

Change in AMH level postoperatively compared to preoperative AMH levels (measured in pmol/L).

Time frame
8 weeks

Secondary outcomes

1

Postoperative recurrence rate

Postoperative recurrence is defined as an ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms at follow-up 6-8 weeks postoperatively. If the asymptomatic cyst is \< 4cm, a second follow-up will be performed at 10-14 weeks postoperatively. Recurrence is then defined as ipsilateral asymptomatic cyst ≥ 4cm or a cyst of any size that requires a medical or surgical intervention due to symptoms. The outcome will be measured as "recurrence/no recurrence"

Time frame
14 weeks

Other outcomes

1

Intraoperative complications

The investigators will describe any intraoperative complications.

Time frame
2 weeks
2

Operative times

The investigators will measure the operative times in minutes for both techniques.

Time frame
2 weeks
3

Postoperative ipsilateral ovarian volume on ultrasound

The postoperative ipsilateral ovarian volume will be calculated by ultrasound (Ovarian Volume: V (in ml) = long axis in cm x transversal axis x ap diameter x 0.5) and compared to published standard ovarian volumes in ml according to age.

Time frame
14 weeks
4

Postoperative adnexal ratio

The adnexal ratio will be calculated by division of the volume of the affected ovary (in ml) with the volume of the unaffected ovary (in ml). If the adnexal ratio is \<1 postoperatively, this can be a sign of postoperative volume loss.

Time frame
14 weeks

Sponsors and contacts

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University Children's Hospital, Zurich

Lead sponsor

University Children's Hospital Basel

Collaborator