Clinical trial NCT02009228: Single-port LC Might be Preferable for Managing Ovarian Dermoid Cyst.
Official title: Single-Port Compared With Conventional Laparoscopic Cystectomy for Ovarian Dermoid Cysts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Abdominal Pain
Ovarian Spillage
Endobag Rupture
Ovarian Reserve
Keywords: Single-port laparoscopy
Abdominal pain
Ovarian spillage
Endobag rupture
Ovarian reserve
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Yang Ming Chiao Tung University
First posted: 2013-12-11
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The outcome measures and ovarian reserve between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.
timeFrame: The first 48 hours and 4 weeks after the surgery
Secondary outcomes:
measure: Ovarian reserve were compared with single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.
timeFrame: Before and 4 weeks after surgery.
Other outcomes:
measure: Ovarian spillage and endobag rupture rates were compared between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.
timeFrame: During operation.
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
Study officials:
affiliation: Taipei Veterans General Hospital, National Yang Ming University Hosiptal, Ilan, Taiwan
name: Ben-Shian Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taipei Veterans General Hospital, Taiwan
name: Yi-Jen Chen, M.D., Ph D.
role: STUDY_CHAIR
References:
citation: Chen YJ, Wang PH, Ocampo EJ, Twu NF, Yen MS, Chao KC. Single-port compared with conventional laparoscopic-assisted vaginal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2011 Apr;117(4):906-912. doi: 10.1097/AOG.0b013e31820c666a.