Dermoid Ovarian CystsNCT01590030
Ovarian Mesial Incision: a New Safe and Fertility-sparing Technique
A study testing Laparoscopic dermoid cystectomy in people with Dermoid Ovarian Cysts, run by University Magna Graecia at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and fertility-sparing of mesial incision for laparoscopic dermoid cystectomy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Dermoid Ovarian Cysts
- What is being tested?
- Laparoscopic dermoid cystectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2004to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- reproductive age
- pre-operative findings suggestive for benign tumor
- regular menstrual cycles at least six months before surgery
Who cannot join
- previous pelvic surgery
- known endocrine disease
- estrogen-progestin use before surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique
The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.
- Conditions
- Dermoid Ovarian Cysts
- Being tested
- Laparoscopic dermoid cystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic dermoid cystectomyProcedure or surgery
Laparoscopy will be performed by pneumoperitoneum with CO2. A complete pelvic examination will be performed to exclude malignant disease. Ovarian capsule will be incised by scissors on mesial side in study group and antimesial side in control group. After cleavage plane identification the cyst enucleation will be completed by atraumatic dissection.
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic mesial incision | Experimental | Not described Receives: Procedure: Laparoscopic dermoid cystectomy |
| Laparoscopic antimesial incision | Active comparator | Not described Receives: Procedure: Laparoscopic dermoid cystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spillage of intracystic content rate
Measured: Intraoperative
Operative times
Operative times will be assessed when surgeons will end the laparoscopy, specifically when he will end the suture of the last skin scar.
Measured: Immediately at the end of the laparoscopy
Chemical peritonitis rate
Measured: 1 week after surgery
Intraoperative blood loss
The first patient blood sample will be taken the morning of the surgery, at h 8 am. The day after, it will be taken the second blood sample. Intraoperative blood loss wil be calculated by deducting Hb values of the second hemocrome by the first one.
Measured: The morning after laparoscopy
Secondary outcomes (1)
Ovarian reserve
Measured: 3 months and 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startSep 2004
- Primary completionDec 2009
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermoid Ovarian CystsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Magna Graecia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fulvio Zullo, University Magna Graecia
- Investigators
- Fulvio Zullo, MD, PhD, Principal investigator, University Magna Graecia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590030
- Sponsor's protocol ID
- Mesial Dermoid Incision
- Status last verified
- May 2012
- First submitted
- 30 Apr 2012
- Last updated
- 3 May 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Morelli M, Mocciaro R, Venturella R, Imperatore A, Lico D, Zullo F. Mesial side ovarian incision for laparoscopic dermoid cystectomy: a safe and ovarian tissue-preserving technique. Fertil Steril. 2012 Nov;98(5):1336-40.e1. doi: 10.1016/j.fertnstert.2012.07.1112. Epub 2012 Aug 11.
PubMed 22884658
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesial Incision for Laparoscopic Dermoid Cystectomy: a New Safe and Fertility-sparing Technique
- ClinicalTrials.gov ID
- NCT01590030
- Acronym / sponsor ID
- Mesial Dermoid Incision
- Conditions
- Dermoid Ovarian Cysts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University Magna GraeciaUniversity, hospital or other
- Study start
- Sep 2004
- Primary completion
- Dec 2009 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety and efficacy in terms of spillage risk and fertility-sparing of mesial incision for laparoscopic dermoid cystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic mesial incision | Experimental | Procedure: Laparoscopic dermoid cystectomy |
| Laparoscopic antimesial incision | Active comparator | Procedure: Laparoscopic dermoid cystectomy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- reproductive age
- pre-operative findings suggestive for benign tumor
- regular menstrual cycles at least six months before surgery
Key exclusion criteria (3 listed)
- previous pelvic surgery
- known endocrine disease
- estrogen-progestin use before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic dermoid cystectomyLaparoscopy will be performed by pneumoperitoneum with CO2. A complete pelvic examination will be performed to exclude malignant disease. Ovarian capsule will be incised by scissors on mesial side in study group and antimesial side in control group. After cleavage plane identification the cyst enucleation will be completed by atraumatic dissection. | Procedure or surgery | Laparoscopic antimesial incision, Laparoscopic mesial incision |
Primary outcome
Spillage of intracystic content rate
Time frame: Intraoperative
Operative times
Time frame: Immediately at the end of the laparoscopy
Operative times will be assessed when surgeons will end the laparoscopy, specifically when he will end the suture of the last skin scar.
Chemical peritonitis rate
Time frame: 1 week after surgery
Intraoperative blood loss
Time frame: The morning after laparoscopy
The first patient blood sample will be taken the morning of the surgery, at h 8 am. The day after, it will be taken the second blood sample. Intraoperative blood loss wil be calculated by deducting Hb values of the second hemocrome by the first one.
1 secondary outcome
Ovarian reserve
Time frame: 3 months and 1 year after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2012.
- Derived from this study: PubMed 22884658Morelli M, Mocciaro R, Venturella R, Imperatore A, Lico D, Zullo F. Mesial side ovarian incision for laparoscopic dermoid cystectomy: a safe and ovarian tissue-preserving technique. Fertil Steril. 2012 Nov;98(5):1336-40.e1. doi: 10.1016/j.fertnstert.2012.07.1112. Epub 2012 Aug 11.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fulvio Zullo, MD, PhD principal investigator
University Magna Graecia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic dermoid cystectomy in people with Dermoid Ovarian Cysts, run by University Magna Graecia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spillage of intracystic content rate (time frame: Intraoperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01590030, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2012.