Ovarian CystPhase 4NCT01631253
The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation
A Phase 4 study testing Laparoscopic ovarian cyst enucleation in people with Ovarian Cyst, run by CHA University at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the impact on ovarian reserve after single- port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change. Read more about this study
- Who is it for?
- Ages 21 to 45 years, women only
- Conditions the study is for
- Ovarian Cyst
- What is being tested?
- Laparoscopic ovarian cyst enucleation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2011to Mar 2013
- Phase
- Phase 4
- 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 21 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 21-45 years Ultrasound
- CT, MRI diagnosis as ovarian cyst , need to cyst enucleation
- Size of cyst : between 3cm and 10cm
- Regular menstrual cycles defined as cycle length between 25 and 35 days
- Agreement to be enrolled in the study.
Who cannot join
- Previous ovarian surgery
- suspicious of malignancy
- Postmenopause
- Use of oral contraceptive drug, GnRH agonist /antagonist, or other drugs related with ovarian function in last 3 months
- Known endocrine disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam CHA medical center
Seoul, Gamnamgu
seok ju Seong, sjseongcheil@yahoo.co.kr
About this study
The purpose of this study is to investigate the impact on ovarian reserve after single- port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change.
Read the detailed description
With the recent development of surgical instruments techniques, minimally invasive surgery is more feasible in various field of surgery. Laparoscopic surgery has potential benefit of decreased patient discomfort, short hospital stay, superior cosmetic results and decreased convalescence time. Recently, various efforts have been continued for minimally invasive surgery, one of the recently emerging concepts is single port surgery. Several studies have demonstrated that single-port laparoscopic surgery is feasible and safe in gynecology.
However, some limits could be occurred, such as the occurrence of less freedom degrees between the instruments and limits surgical vision, thus limiting surgeon's movements. So, two-port laparoscopy combined access through umbilical and additional suprapubic incision have been used and reported. In case of single port access laparoscopic ovarian cyst enucleation, due to limits of surgeon's movements, cyst enucleation or bipolar electrocoagulation of the ovarian parenchyma adversely affected ovarian function.
Some studies reported that after laparoscopic cyst enucleation, there had been shown marked reduction of ovarian function compared with surgery by laparotomy. Therefore we attempt to investigate the impact of single port laparoscopy that have limits of surgical procedures on ovarian reserve after ovarian cyst enucleation.
To evaluate ovarian reserve change, we will use the anti-mullerian hormone. It is produced by granulosa cells of preantral and small antral follicles and has been recently acknowledged as the useful, reliable, and sensitive hormonal serum marker of the ovarian primordial follicle pool. In addition, the AMH level represents a stronger independent marker of ovarian reserve without significant fluctuation during the menstrual cycle, which progressively decreases with age.
Therefore, this prospective study is performed to compare the differences in ovarian reserve after single-port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change. Serum anti mullerian hormone is measured at preoperative and at postoperative 1week, 1 and 3 months.
- Conditions
- Ovarian Cyst
- Being tested
- Laparoscopic ovarian cyst enucleation
- Medical subject headings
- Ovarian Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ovarian cyst enucleationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| single-port access laparoscopic ovarian cyst enucleation | Active comparator | Procedure: Operative laparoscopic ovarian cyst enucleation was performed only through an umbilical single port. ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with three 5mm trocars inserted into three fingers was draped around the rim of the wound retractor.) Receives: Procedure: Laparoscopic ovarian cyst enucleation |
| two-port laparoscopic access ovarian cyst enucleation | Active comparator | Procedure: Operative access laparoscopic ovarian cyst enucleation was performed using an umbilical single port ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with two 5mm trocars inserted into two fingers was draped around the rim of the wound retractor.) and one 5-mm trocar in the lower abdomen. Receives: Procedure: Laparoscopic ovarian cyst enucleation |
| four-port access laparoscopic ovarian cyst enucleation | Active comparator | Procedure: : Operative laparoscopic ovarian cyst enucleation was performed through insertion of a 12-mm subumbilical trocar and three 5-mm trocars in the lower abdomen. Receives: Procedure: Laparoscopic ovarian cyst enucleation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preoperative and postoperative changes in anti-mullerian hormone level
The primary outcome of our study is the impact on ovarian reserve determined by AMH after the application of the three laparoscopic techniques for the treatment of ovarian cyst.In all study patients, at preoperation and 1 week, 1 month, 3 month after operation, AMH is serially measured.
Measured: preoperative, postoperative at 1week, 1 and 3 months
Secondary outcomes (1)
postoperative pain scores
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startOct 2011
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
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 Ovarian CystStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seok Ju Seong, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631253
- Sponsor's protocol ID
- SPA001
- Status last verified
- Jun 2012
- First submitted
- 26 Jun 2012
- Last updated
- 3 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Yoon BS, Kim YS, Seong SJ, Song T, Kim ML, Kim MK, Paek JY. Impact on ovarian reserve after laparoscopic ovarian cystectomy with reduced port number: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:34-8. doi: 10.1016/j.ejogrb.2014.02.025. Epub 2014 Feb 20.
PubMed 24630293
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact on Ovarian Reserve After Single-port, Two-port, or Four-port Access Laparoscopic Ovarian Cyst Enucleation
- ClinicalTrials.gov ID
- NCT01631253
- Acronym / sponsor ID
- SPA001
- Conditions
- Ovarian Cyst
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 29 Jun 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 investigate the impact on ovarian reserve after single- port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change.
Detailed description
With the recent development of surgical instruments techniques, minimally invasive surgery is more feasible in various field of surgery. Laparoscopic surgery has potential benefit of decreased patient discomfort, short hospital stay, superior cosmetic results and decreased convalescence time. Recently, various efforts have been continued for minimally invasive surgery, one of the recently emerging concepts is single port surgery. Several studies have demonstrated that single-port laparoscopic surgery is feasible and safe in gynecology.
However, some limits could be occurred, such as the occurrence of less freedom degrees between the instruments and limits surgical vision, thus limiting surgeon's movements. So, two-port laparoscopy combined access through umbilical and additional suprapubic incision have been used and reported. In case of single port access laparoscopic ovarian cyst enucleation, due to limits of surgeon's movements, cyst enucleation or bipolar electrocoagulation of the ovarian parenchyma adversely affected ovarian function.
Some studies reported that after laparoscopic cyst enucleation, there had been shown marked reduction of ovarian function compared with surgery by laparotomy. Therefore we attempt to investigate the impact of single port laparoscopy that have limits of surgical procedures on ovarian reserve after ovarian cyst enucleation.
To evaluate ovarian reserve change, we will use the anti-mullerian hormone. It is produced by granulosa cells of preantral and small antral follicles and has been recently acknowledged as the useful, reliable, and sensitive hormonal serum marker of the ovarian primordial follicle pool. In addition, the AMH level represents a stronger independent marker of ovarian reserve without significant fluctuation during the menstrual cycle, which progressively decreases with age.
Therefore, this prospective study is performed to compare the differences in ovarian reserve after single-port, two-port, or four-port access laparoscopic ovarian cyst enucleation based on serum anti mullerian hormone change. Serum anti mullerian hormone is measured at preoperative and at postoperative 1week, 1 and 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single-port access laparoscopic ovarian cyst enucleation | Active comparator | Procedure: Laparoscopic ovarian cyst enucleationProcedure: Operative laparoscopic ovarian cyst enucleation was performed only through an umbilical single port. ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with three 5mm trocars inserted into three fingers was draped around the rim of the wound retractor.) |
| two-port laparoscopic access ovarian cyst enucleation | Active comparator | Procedure: Laparoscopic ovarian cyst enucleationProcedure: Operative access laparoscopic ovarian cyst enucleation was performed using an umbilical single port ( 2 cm longitudinal incision was made within the umbilicus and an wound retractor (Alexis Wound Retractor XS) was inserted into the wound opening. A surgical glove with two 5mm trocars inserted into two fingers was draped around the rim of the wound retractor.) and one 5-mm trocar in the lower abdomen. |
| four-port access laparoscopic ovarian cyst enucleation | Active comparator | Procedure: Laparoscopic ovarian cyst enucleationProcedure: : Operative laparoscopic ovarian cyst enucleation was performed through insertion of a 12-mm subumbilical trocar and three 5-mm trocars in the lower abdomen. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: 21-45 years Ultrasound
- CT, MRI diagnosis as ovarian cyst , need to cyst enucleation
- Size of cyst : between 3cm and 10cm
- Regular menstrual cycles defined as cycle length between 25 and 35 days
- Agreement to be enrolled in the study.
Key exclusion criteria (5 listed)
- Previous ovarian surgery
- suspicious of malignancy
- Postmenopause
- Use of oral contraceptive drug, GnRH agonist /antagonist, or other drugs related with ovarian function in last 3 months
- Known endocrine disorder
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 ovarian cyst enucleation | Procedure or surgery | four-port access laparoscopic ovarian cyst enucleation, single-port access laparoscopic ovarian cyst enucleation, two-port laparoscopic access ovarian cyst enucleation |
Primary outcome
Preoperative and postoperative changes in anti-mullerian hormone level
Time frame: preoperative, postoperative at 1week, 1 and 3 months
The primary outcome of our study is the impact on ovarian reserve determined by AMH after the application of the three laparoscopic techniques for the treatment of ovarian cyst.In all study patients, at preoperation and 1 week, 1 month, 3 month after operation, AMH is serially measured.
1 secondary outcome
postoperative pain scores
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2012.
- Derived from this study: PubMed 24630293Yoon BS, Kim YS, Seong SJ, Song T, Kim ML, Kim MK, Paek JY. Impact on ovarian reserve after laparoscopic ovarian cystectomy with reduced port number: a randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2014 May;176:34-8. doi: 10.1016/j.ejogrb.2014.02.025. Epub 2014 Feb 20.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic ovarian cyst enucleation in people with Ovarian Cyst, run by CHA University at 1 site in South Korea.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Jul 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preoperative and postoperative changes in anti-mullerian hormone level (time frame: preoperative, postoperative at 1week, 1 and 3 months). 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 NCT01631253, 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 Jul 2012.