Skip to main content
OpenTrials
Completed

NCT Number: NCT02009228

Single-port LC Might be Preferable for Managing Ovarian Dermoid Cyst.

Minimally invasive surgery has become the standard treatment for many gynecologic disease processes. In the last decade, numerous studies have demonstrated that laparoscopic approaches to various gynecologic oncology conditions-particularly for early-stage endometrial and cervical cancers as well as select pelvic masses-is feasible and results in shorter hospital stays, improved quality of life and comparable surgical and oncologic outcomes to abdominal staging.For instance, the typical gynecologic robotic surgical procedure will require Two to three 5-mm ports and one 12-mm laparoscopic ports. Recently, an even less invasive alternative to conventional laparoscopy surgery has been developed: laparoendoscopic single-site surgery (LESS), also known as single-port surgery. Single port laparoscopy is an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions. Preliminary advances in LESS as applied to urologic and gastrointestinal surgery demonstrate that the techniques are feasible provided that both optimal surgical technical expertise with advanced skills and optimal instrumentation are available. Recently, several publication showed the single port laparoscopic surgery is feasibility in gynecologic surgery including oophorectomy, cystecomty, and myomecomty. To our knowledge, the sample size of recent publication about single port surgery including cystectomy and myomecomty is small. Furthermore, these studies lack the comparison of single port and convectional laparoscopic surgery. Base on our recent study demonstrated that either the single-port or the conventional approach can be used for LAVH, but the single-port LAVH technique yielded less postoperative pain (Chen et al., Obestet Gynecol, 2011). The purpose of this study was to assess the feasibility of single port laparoscopic surgery in the treatment of benign gynecologic disease.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Taipei Veteran General Hospital

Taipei, Taiwan, 11217

About this study

This study was designed as a retrospective case-control study, and port placement was one of the differences in operative procedures between the two groups. Patients with ovarian dermoid cysts were evaluated at Taipei Veterans General Hospital from June 13, 2011 through June 12, 2013. Approval for the study was obtained from the hospital's ethics committee, and informed consent was obtained from all patients (VGHIRB 2011-06-004IA).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • the patient received cystectomy for ovarian dermoid cysts (even while pregnant), the cyst received an American Society of Anesthesiologists physical status classification of I or II, and the patient provided signed informed consent.

Exclusion criteria

  • patients who received an oophorectomy for dermoid cyst or had a dermoid ovarian cyst with malignant potential and concomitant surgeries for uterine lesion, pelvic organ prolapse or urodynamic urinary incontinence were excluded.

Treatment and study plan

Ovarian cystectomy

Procedure

Other names: Dermoid cyst

Primary outcomes

  1. The outcome measures and ovarian reserve between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.

    Time frame: The first 48 hours and 4 weeks after the surgery

    The outcome measures included operative time, blood loss, postoperative pain, and analgesic use in the first 48 hours after surgery.

Secondary outcomes

  1. Ovarian reserve were compared with single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.

    Time frame: Before and 4 weeks after surgery.

    Ovarian reserve markers include serum estrogen (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), and anti-Mullerian hormone (AMH) before and 4 weeks after surgery.

Other outcomes

  1. Ovarian spillage and endobag rupture rates were compared between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.

    Time frame: During operation.

    The ovarian spillage and endobag rupture rates were compared between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts during operation.

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Collaborators

  • National Yang Ming Chiao Tung University

Registry information

Official study title

Single-Port Compared With Conventional Laparoscopic Cystectomy for Ovarian Dermoid Cysts

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Dec 11, 2013
Registry last updated
Dec 11, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.