Benign Ovarian or Tubal DiseaseNCT01679509
Study of Laparoendoscopic Single Site Adnexal Surgery for Benign Ovarian and Tubal Disease
A study testing Single-port laparoscopic adnexal surgery and Three-port laparoscopic adnexal surgery in people with Benign Ovarian or Tubal Disease, run by Asan Medical Center at 1 site in South Korea.
Trial summary
To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Benign Ovarian or Tubal Disease
- What is being tested?
- Single-port laparoscopic adnexal surgery and Three-port laparoscopic adnexal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Jul 2017
- 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 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease
- Benign teratoma
- Endometrioma
- Mucinous cystadenoma
- Serous cystadenoma
- Benign Brenner tumor
Show all 12Show fewer
- Ectopic pregnancy(cornual, tubal, ovarian pregnancy, etc.)
- paratubal cyst, parovarian cyst
- Risk reducing bilateral salpingooophorecotmy due to familial breast/ovarian cancer syndrome
- Other benign adnexal disease requiring surgery
- American Society of Anesthesiologist Physical Status classification I-II.
- Patient who have signed written informed consent
Who cannot join
- Uncontrolled medical disease
- Active infectious disease
- Previous pelvic radiation therapy
- Patient who requires further procedure excluding adnexal surgery
- Patient who has other pain source excluding adnexal disease
- Pregnant and lactating woman
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Universit of Ulsan College of Medicine, Asan Medical Center
Seoul, 138-736
Joo-Hyun Nam, M.D., Ph.D., 82-2-3010-3633, jhnam@amc.seoul.kr
About this study
Official title: Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery
To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease
- Conditions
- Benign Ovarian or Tubal Disease
- Being tested
- Single-port laparoscopic adnexal surgery, Three-port laparoscopic adnexal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-port laparoscopic adnexal surgeryProcedure or surgery
Three-port laparoscopic adnexal surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Single-port surgery group | Experimental | Single-port laparoscopic adnexal surgery Receives: Procedure: Single-port laparoscopic adnexal surgery |
| Three-port surgery group | Active comparator | Three-port laparoscopic adnexal surgery Receives: Procedure: Three-port laparoscopic adnexal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hospital stay
Measured: within 1 week after surgery
Secondary outcomes (7)
postoperative pain
Measured: within 1 week after surgery
postoperative analgesics requirement
Measured: within 1 week after surgery
quality of life
Measured: within 6 months aftr surgery
surgical stress response
Measured: within 2 days after surgery
operating time
Measured: immediately ater surgery
transfusion requirement and amount
Measured: within 1 week after surgery
postoperative complication
Measured: within 1 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Ovarian or Tubal DiseaseStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joo-Hyun Nam, Asan Medical Center
- Investigators
- Joo-Hyun Nam, M.D., Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01679509
- Sponsor's protocol ID
- LESS-A
- Status last verified
- May 2017
- First submitted
- 3 Sep 2012
- Last updated
- 31 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Single-port and Three-port Laparoscopic Adnexal Surgery
- ClinicalTrials.gov ID
- NCT01679509
- Acronym / sponsor ID
- LESS-A
- Conditions
- Benign Ovarian or Tubal Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 6 Sep 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.
To compare the safety and efficacy between single-port and three-port adnexal surgery in patients with benign ovarian and tubal disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single-port surgery group | Experimental | Procedure: Single-port laparoscopic adnexal surgerySingle-port laparoscopic adnexal surgery |
| Three-port surgery group | Active comparator | Procedure: Three-port laparoscopic adnexal surgeryThree-port laparoscopic adnexal surgery |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patient who undergo laparoscopic adnexal surgery due to following benign adenxal disease
- American Society of Anesthesiologist Physical Status classification I-II.
- Patient who have signed written informed consent
Key exclusion criteria (6 listed)
- Uncontrolled medical disease
- Active infectious disease
- Previous pelvic radiation therapy
- Patient who requires further procedure excluding adnexal surgery
- Patient who has other pain source excluding adnexal disease
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 |
|---|---|---|
| Single-port laparoscopic adnexal surgery | Procedure or surgery | Single-port surgery group |
| Three-port laparoscopic adnexal surgery | Procedure or surgery | Three-port surgery group |
Primary outcome
postoperative hospital stay
Time frame: within 1 week after surgery
7 secondary outcomes
postoperative pain
Time frame: within 1 week after surgery
postoperative analgesics requirement
Time frame: within 1 week after surgery
quality of life
Time frame: within 6 months aftr surgery
surgical stress response
Time frame: within 2 days after surgery
operating time
Time frame: immediately ater surgery
transfusion requirement and amount
Time frame: within 1 week after surgery
postoperative complication
Time frame: within 1 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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.
Joo-Hyun Nam, M.D., Ph.D. principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-port laparoscopic adnexal surgery and Three-port laparoscopic adnexal surgery in people with Benign Ovarian or Tubal Disease, run by Asan Medical Center 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 12 inclusion and 6 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 31 May 2017. 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.
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?
Contact Joo-Hyun Nam, M.D., Ph.D. (82-2-3010-3633, jhnam@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative hospital stay (time frame: within 1 week after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2017.