Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12607000241437
Ethics application status
Approved
Date submitted
28/04/2007
Date registered
7/05/2007
Date last updated
7/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laparoscopy versus laparoscopic-guided minilaparotomy in large adnexal masses.
Scientific title
Laparoscopic guided MiniLaParoTomy (LpsMLPT) versus operative laparoscopy (Lps) for large adnexal cysts: analysis of operative and postoperative data and evaluation of efficacy in terms of intraperitoneal spillage.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adnexal masses. 1778 0
Condition category
Condition code
Reproductive Health and Childbirth 1865 1865 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The comparator is laparoscopic guided minilaparotomy.

Cyst will be removed by minilaparotomy after laparoscopic evaluation in the comparator group. A 3 to 7 cm transverse skin incision 1 to 2 cm below the pubic hair line and 2 to 4 cm above the pubic symphisis is carried out after diagnostic laparoscopy. Excision of the ovarian cyst is performed in the standard fashion and the ovarian edges approximated with a suture stitch avoiding the ovarian cortex.
Duration of the treatment is strictly limited to surgery.
Follow up duration is limited to 1 month after discharge in order to verify short term complications and patient satisfaction.
Intervention code [1] 1728 0
Treatment: Surgery
Comparator / control treatment
The control group is Laparoscopy
Control group
Active

Outcomes
Primary outcome [1] 2647 0
Cyst rupture.
Timepoint [1] 2647 0
During surgery through direct observation.
Secondary outcome [1] 4498 0
Surgical difficulty.
Timepoint [1] 4498 0
A global impression at the end of intervention.
Secondary outcome [2] 4499 0
Operative and postoperative results.
Timepoint [2] 4499 0
During intervention, after 12 and 24 hours after surgery has been completed.
Secondary outcome [3] 4500 0
Short and long term complications.
Timepoint [3] 4500 0
Within 1 month after operation.
Secondary outcome [4] 4501 0
Short-term patients satisfaction.
Timepoint [4] 4501 0
3 months after intervention.

Eligibility
Key inclusion criteria
Cyst largest diameter between 7 and 18 cm, no ultrasonographic suspect of endometriosis or malignancy (thick papillary projections, solid areas, central flow, and velocimetric features of high velocity and low resistance (9)), serum CA125 within normal range, Body Mass Index (BMI) below 29 kg/m2, American Society of Anesthesiologists’ physical status classification (ASA) class 0–2, no acute or chronic pelvic known disease, no sign of acute abdomen, no previous laparotomies, no requirement of other associated surgical procedures, possibility of placing an intrauterine manipulator and signed informed consent to the surgical procedure and to traditional surgical staging in case of unexpected malignancy.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Endometriosis, patients with a contralateral cyst with greatest diameter larger than 7 cm.

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)
concealed envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2012 0
University
Name [1] 2012 0
Department of Gynecology, University of Rome
Country [1] 2012 0
Italy
Primary sponsor type
Individual
Name
Pierluigi Benedetti Panici, Italy.
Address
Country
Italy
Secondary sponsor category [1] 1823 0
Individual
Name [1] 1823 0
Roberto Angioli, Italy.
Address [1] 1823 0
Country [1] 1823 0
Italy

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3740 0
"Dipartimento Assistenziale Integrato" of the Department of Gynecology of the University of Rome "La Sapienza"
Ethics committee address [1] 3740 0
Ethics committee country [1] 3740 0
Italy
Date submitted for ethics approval [1] 3740 0
Approval date [1] 3740 0
22/12/2004
Ethics approval number [1] 3740 0

Summary
Brief summary
The objective of the present study was to assess if laparoscopic guided minilaparotomy could reduce the rupture rate of operative laparoscopy for the treatment of large non endometriotic ovarian cysts with no other risk factor for malignancy other than size
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27831 0
Address 27831 0
Country 27831 0
Phone 27831 0
Fax 27831 0
Email 27831 0
Contact person for public queries
Name 10917 0
Ludovico Muzii
Address 10917 0
Campus Biomedico University
Via Longoni 69
Rome 00100
Country 10917 0
Italy
Phone 10917 0
0039-225411
Fax 10917 0
Email 10917 0
[email protected]
Contact person for scientific queries
Name 1845 0
Ludovico Muzii
Address 1845 0
Campus Biomedico University
Via Longoni 69
Rome 00100
Country 1845 0
Italy
Phone 1845 0
0039-225411
Fax 1845 0
Email 1845 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
No additional documents have been identified.