Single-port Access Laparoscopic-assisted Vaginal Hysterectomy

NCT01048931 | Unknown Phase 3 DMC

• 1 other identifier: VGHIRB 98-10-03
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 \[1-5\].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. However, to our knowledge, there are no randomize control trial to evaluate of single port or multiple ports laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of SPA-LAVH in the treatment of benign uterine disease.

Conditions

Uterine Myomas; Adenomyosis

Keywords

Single-port, laparoscopic-assisted, vaginal hysterectomy

Outcome Measures

Primary Outcomes (1)

• To assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The pain score and morbidity associated with surgery will be noted.

  1 year

Secondary Outcomes (1)

• To evaluate the cosmetic outcome.

  1 year

Study Arms (1)

single-port LAVH

EXPERIMENTAL

single port LAVH

Procedure: single-port LAVH

Interventions

single-port LAVH PROCEDURE

single-port LAVH

single-port LAVH

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
• American Society of Anesthesiologists (ASA) physical status of patient: classification I-II

You may not qualify if:

• The procedure will be required to conversion to laparotomy.
• Cancer

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Yang Ming Chiao Tung University: collaborator

Study Sites (1)

Veterans General Hospital -Taipei

Taipei, 11217, Taiwan

RECRUITING

Related Publications (2)

• Lee YY, Kim TJ, Kim CJ, Kang H, Choi CH, Lee JW, Kim BG, Lee JH, Bae DS. Single-port access laparoscopic-assisted vaginal hysterectomy: a novel method with a wound retractor and a glove. J Minim Invasive Gynecol. 2009 Jul-Aug;16(4):450-3. doi: 10.1016/j.jmig.2009.03.022. Epub 2009 May 31.

  PMID: 19487164 BACKGROUND

• 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.

  PMID: 21422864 DERIVED

MeSH Terms

Conditions

Adenomyosis

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Yi-Jen Chen, MD

  Taipei Veterans General Hospital, Taiwan

  STUDY CHAIR

Central Study Contacts

Yi-Jen Chen, MD

CONTACT

886-2-28757566; chenyj@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: January 12, 2010
• First Posted: January 14, 2010
• Study Start: October 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

TW (1)