ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12614000653662

Ethics application status

Approved

Date submitted

11/06/2014

Date registered

23/06/2014

Date last updated

23/06/2014

Type of registration

Retrospectively registered

Titles & IDs

Public title

Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: a multicentric, randomized study

Scientific title

Patients with bilateral endometriomas underwent laparoscopy cystectomy by two different surgical techniques (stripping vs combined technique), using patients themselves as their own controls, to evaluate ovarian reserve as primary outcome.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1150-7972

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Endometriosis

Condition category

Condition code

Surgery

Surgical techniques

Renal and Urogenital

Other renal and urogenital disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Each patient with bilateral endometriomas underwent to a single laparoscopy to remove the cysts. In the same laparoscopy two different techniques were performed: excisional stripping technique on one side versus combined technique (partial stripping and bipolar coagulation on last part on hilus) on the other side. Each patient received both surgical techniques performed at either side after random assignment. The mean duration of surgery was comparable between the two techniques and it was approximately 20 minutes.
Duration of study: one year.

Intervention code [1]

Treatment: Surgery

Comparator / control treatment

The standard treatment was laparoscopic stripping of endometrioma while the comparator treatment was combined technique (partial excisional cystectomy followed by ablative surgery with bipolar coagulation of the final part on the hilus). Each patient received both surgical techniques on different sides. Patients were used as their own controls

Control group

Active

Outcomes

Primary outcome [1]

Ovarian reserve assessed using ovarian volume and Antral Follicle Count (AFC) as ultrasound markers

Timepoint [1]

At baseline and 1,3 and 6 months after surgery

Secondary outcome [1]

Recurrence rate of endometrioma assessed by ultrasound

Timepoint [1]

At baseline and 1,3 and 6 months after surgery

Secondary outcome [2]

Symptom recurrence assessed by Visual Analogue Scale (VAS)

Timepoint [2]

At baseline and 1,3 and 6 months after surgery

Eligibility

Key inclusion criteria

-bilateral ovarian endometriomas larger than 3cm
-pelvic pain
-infertility

Minimum age

18 Years

Maximum age

38 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

-previous ovarian surgery
-medical treatment (GnRH analogs or oral contraceptives) in previous 3 months or during follow-up

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Central randomization by phone/fax/computer

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomization using randomization tables created by computer software

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Safety/efficacy

Statistical methods / analysis

The sample size needed for the study was calculated based on the assumption that the recurrence rate after endometrioma excision is 34% (Vercellini P et al, Acta Ob Gyn Scand 2012;92(1):8-16), and a change of one third in the recurrence rate was considered clinically significant, with an alpha value of 0.05 and a beta value of 0.80.
T student or Mann-Whitney U-test was used for continuous data and chi-square for categorical variables.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/01/2014

Actual

14/04/2014

Date of last participant enrolment

Anticipated

31/12/2014

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Italy

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Unfunded study

Address [1]

Unfunded study

Country [1]

Primary sponsor type

University

Name

"Sapienza" University of Rome

Address

Viale del Policlinico 155, Rome 00161

Country

Italy

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Comitato Etico dell'Universita Sapienza di Roma

Ethics committee address [1]

Viale Del Policlinico 155, 00161 Rome

Ethics committee country [1]

Italy

Date submitted for ethics approval [1]

Approval date [1]

10/04/2014

Ethics approval number [1]

Protocol n. 454/14, Ref. n. 3150

Summary

Brief summary

The primary purpose of the study is to compare laparoscopic excision of endometrioma by stripping technique versus combined technique (stripping plus coagulation/ablation) in terms of ovarian reserve and recurrence of endometrioma

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ludovico Muzii

Address

Department of Obstetrics, Gynecology and Urologic Sciences, "Sapienza" University of Rome. Viale del Policlinico 155, 00161 Rome

Country

Italy

Phone

+39 06 4940550

Fax

[email protected]

Contact person for public queries

Name

Ludovico Muzii

Address

Department of Obstetrics, Gynecology and Urologic Sciences, "Sapienza" University of Rome. Viale del Policlinico 155, 00161 Rome

Country

Italy

Phone

+39 06 4940550

Fax

[email protected]

Contact person for scientific queries

Name

Ludovico Muzii

Address

Department of Obstetrics, Gynecology and Urologic Sciences, "Sapienza" University of Rome. Viale del Policlinico 155, 00161 Rome

Country

Italy

Phone

+39 06 4940550

Fax

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Comparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: A multicentre RCT.	2016	https://dx.doi.org/10.1093/humrep/dev313

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically