Trial Review

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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] 284638 0
Nil known
Universal Trial Number (UTN)
U1111-1150-7972
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Endometriosis 291954 0
Condition category
Condition code
Surgery 292304 292304 0 0
Surgical techniques
Renal and Urogenital 292305 292305 0 0
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] 289426 0
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] 292174 0
Ovarian reserve assessed using ovarian volume and Antral Follicle Count (AFC) as ultrasound markers
Timepoint [1] 292174 0
At baseline and 1,3 and 6 months after surgery
Secondary outcome [1] 308359 0
Recurrence rate of endometrioma assessed by ultrasound
Timepoint [1] 308359 0
At baseline and 1,3 and 6 months after surgery
Secondary outcome [2] 308360 0
Symptom recurrence assessed by Visual Analogue Scale (VAS)
Timepoint [2] 308360 0
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?
No
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
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 6065 0
Italy
State/province [1] 6065 0

Funding & Sponsors
Funding source category [1] 289265 0
Self funded/Unfunded
Name [1] 289265 0
Unfunded study
Country [1] 289265 0
Primary sponsor type
University
Name
"Sapienza" University of Rome
Address
Viale del Policlinico 155, Rome 00161
Country
Italy
Secondary sponsor category [1] 288080 0
None
Name [1] 288080 0
Address [1] 288080 0
Country [1] 288080 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291037 0
Comitato Etico dell'Universita Sapienza di Roma
Ethics committee address [1] 291037 0
Viale Del Policlinico 155, 00161 Rome
Ethics committee country [1] 291037 0
Italy
Date submitted for ethics approval [1] 291037 0
Approval date [1] 291037 0
10/04/2014
Ethics approval number [1] 291037 0
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 48578 0
Prof Ludovico Muzii
Address 48578 0
Department of Obstetrics, Gynecology and Urologic Sciences, "Sapienza" University of Rome. Viale del Policlinico 155, 00161 Rome
Country 48578 0
Italy
Phone 48578 0
+39 06 4940550
Fax 48578 0
Email 48578 0
[email protected]
Contact person for public queries
Name 48579 0
Prof Ludovico Muzii
Address 48579 0
Department of Obstetrics, Gynecology and Urologic Sciences, "Sapienza" University of Rome. Viale del Policlinico 155, 00161 Rome
Country 48579 0
Italy
Phone 48579 0
+39 06 4940550
Fax 48579 0
Email 48579 0
[email protected]
Contact person for scientific queries
Name 48580 0
Prof Ludovico Muzii
Address 48580 0
Department of Obstetrics, Gynecology and Urologic Sciences, "Sapienza" University of Rome. Viale del Policlinico 155, 00161 Rome
Country 48580 0
Italy
Phone 48580 0
+39 06 4940550
Fax 48580 0
Email 48580 0
[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
SourceTitleYear of PublicationDOI
EmbaseComparison between the stripping technique and the combined excisional/ablative technique for the treatment of bilateral ovarian endometriomas: A multicentre RCT.2016https://dx.doi.org/10.1093/humrep/dev313
N.B. These documents automatically identified may not have been verified by the study sponsor.