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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary: 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).
Sponsor: Taipei Veterans General Hospital, Taiwan

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Ovarian reserve were compared with single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts. [ Time Frame: Before and 4 weeks after surgery. ]

Original Secondary Outcome: Same as current

Information By: Taipei Veterans General Hospital, Taiwan

Dates:
Date Received: December 8, 2013
Date Started: June 2011
Date Completion:
Last Updated: December 8, 2013
Last Verified: December 2013