Clinical trial · Interventional
Single Versus Conventional Laparoscopy for Benign Adnexal Disease
Single Port Laparoscopy Versus Conventional Laparoscopy for Benign Adnexal Disease - A Randomized Controlled Trial.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cyst | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Single port access laparoscopy
- description
- Single port access laparoscopy for benign adnexal disease.
- interventionNames
- Procedure: Laparoscopic surgery
- type
- ACTIVE_COMPARATOR
- label
- Conventional laparoscopy
- description
- Conventional laparoscopy for benign adnexal disease.
- interventionNames
- Procedure: Laparoscopic surgery
Primary outcomes (1)
- measure
- Postoperative pain
- timeFrame
- 6 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHoyer-Sorensen C, Vistad I, Ballard K. Is single-port laparoscopy for benign adnexal disease less painful than conventional laparoscopy? A single-center randomized controlled trial. Fertil Steril. 2012 Oct;98(4):973-9. doi: 10.1016/j.fertnstert.2012.06.016. Epub 2012 Jul 4. PMID 22769732