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

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ClinicalTrials.gov Identifier: NCT02009228
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Collaborator:
National Yang Ming University
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

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.

Condition or disease Intervention/treatment Phase
Abdominal Pain Ovarian Spillage Endobag Rupture Ovarian Reserve Procedure: Ovarian cystectomy Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single-Port Compared With Conventional Laparoscopic Cystectomy for Ovarian Dermoid Cysts
Study Start Date : June 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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 Name: 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 Name: Dermoid cyst




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009228


Locations
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Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan, 11217
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
National Yang Ming University
Investigators
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Principal Investigator: Ben-Shian Huang, M.D. Taipei Veterans General Hospital, National Yang Ming University Hosiptal, Ilan, Taiwan
Study Chair: Yi-Jen Chen, M.D., Ph D. Taipei Veterans General Hospital, Taiwan

Publications of Results:
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Responsible Party: vghtpe user, Yi-Jen, Chen, M.D., Ph D., Department of Obstetrics and Gynecology, Taipei Veterans General Hospital, Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT02009228     History of Changes
Other Study ID Numbers: 2011-06-004IA
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013
Keywords provided by vghtpe user, Taipei Veterans General Hospital, Taiwan:
Single-port laparoscopy
Abdominal pain
Ovarian spillage
Endobag rupture
Ovarian reserve
Additional relevant MeSH terms:
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Dermoid Cyst
Abdominal Pain
Rupture
Wounds and Injuries
Pain
Neurologic Manifestations
Signs and Symptoms
Signs and Symptoms, Digestive
Cysts
Neoplasms
Teratoma
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type