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

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

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.

Study Overview

• Status: Completed
• Conditions: Abdominal Pain; Ovarian Reserve; Ovarian Spillage; Endobag Rupture
• Intervention / Treatment: Procedure: Ovarian cystectomy

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).

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Taipei Veteran General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single-port laparoscopy; The three-channel single-port: a 1.5-cm horizontal intraumbilical skin incision, a 1.5-cm to 2-cm rectus fasciotomy to open the peritoneal cavity, and the insertion of an Alexis small wound retractor (Applied Medical, Rancho Santa Margarita, CA). The wrist portion of a size 6.5 surgical glove was fixed to the outer ring of the wound retractor. A 12-mm trocar was inserted through a small hole made in one of the fingertips of the glove and advanced into the abdominal cavity. Two additional holes for the accessory channels were made in another fingertip of the glove, and two conventional 5-mm trocars were inserted through the holes.	Procedure: Ovarian cystectomy; Other Names: Dermoid cyst
Active Comparator: Conventional laparoscopy; The 12-mm main troca was inserted via subumbilical incision after fully insufflation by verness needle and other 3 working 5-mm trocas were inserted under vision at right middle abdominal, left middle abdominal and suprapubic incisions.	Procedure: Ovarian cystectomy; Other Names: Dermoid cyst

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The outcome measures and ovarian reserve between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.	The outcome measures included operative time, blood loss, postoperative pain, and analgesic use in the first 48 hours after surgery.	The first 48 hours and 4 weeks after the surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovarian reserve were compared with single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.	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.	Before and 4 weeks after surgery.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovarian spillage and endobag rupture rates were compared between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts.	The ovarian spillage and endobag rupture rates were compared between single-port and conventional laparoscopic cystectomy in managing ovarian dermoid cysts during operation.	During operation.

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Yang Ming University
• Investigators: Principal Investigator: Ben-Shian Huang, M.D., Taipei Veterans General Hospital, National Yang Ming University Hosiptal, Ilan, Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: December 8, 2013
• First Submitted That Met QC Criteria: December 8, 2013
• First Posted (Estimate): December 11, 2013

Study Record Updates

• Last Update Posted (Estimate): December 11, 2013
• Last Update Submitted That Met QC Criteria: December 8, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Abdominal pain; Ovarian reserve; Single-port laparoscopy; Ovarian spillage; Endobag rupture
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Wounds and Injuries; Cysts; Signs and Symptoms, Digestive; Neoplasms, Germ Cell and Embryonal; Teratoma; Rupture; Abdominal Pain; Dermoid Cyst
• Other Study ID Numbers: 2011-06-004IA