CompletedPhase 3

Single Versus Conventional Laparoscopy for Benign Adnexal Disease

Norway40 participantsStarted 2011-01

Plain-language summary

Keyhole surgery for adnexal disease has traditionally been performed using three or four small incisions. The last years a new operating method has been introduced. This method makes use of only one incision of 2 cm in the umbilicus. This method is less invasive, and it might benefit the patient through less postoperative pain and a higher satisfaction with the cosmetic result. So far, many studies have shown that this new method is feasible for adnexal disease, but its superiority compared to conventional laparoscopy is to be proven. This study aims to show this difference. The investigators aim to compare experienced postoperative pain and use of analgesics in patients undergoing single port laparoscopy for benign adnexal disease with conventional laparoscopy. The investigators hypothesize that the patients will experience less postoperative pain and use less analgesic in the single port laparoscopy group. Further, the investigators aim to compare the satisfaction with the cosmetic results in the two groups. In addition, blood loss, operating time, complications and conversion to conventional laparoscopy will be registered in the two groups.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Women ≥ 18 years. * ASA score 1 or 2. * Presumed benign ovarian disease or a hereditary cancer risk. * Ovarian cyst ≤ 6 cm. Exclusion Criteria: * Ovarian cyst \> 6 cm. * Endometrioma. * Endometriosis. * History of chronic pelvic pain. * Known severe intra abdominal adhesions. * Daily use of analgesics. * Inability to understand Norwegian or English.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain

Timeframe: 6 hours

Trial details

NCT IDNCT01288599

SponsorSorlandet Hospital HF

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2011-09

View on ClinicalTrials.gov More Ovarian Cyst trials