Single-port Access Laparoscopic-assisted Vaginal Hysterectomy
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Uterine Myomas Adenomyosis |
Procedure: single-port LAVH |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | To Compare to Single-port Access Laparoscopic-assisted Vaginal Hysterectomy (LAVH) and Multiple Ports LAVH: A Randomized Controlled Trial |
- 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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- To evaluate the cosmetic outcome. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2010 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: single-port LAVH
single port LAVH
|
Procedure: single-port LAVH
single-port LAVH
Other Name: single-port LAVH
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 30 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)
- American Society of Anesthesiologists (ASA) physical status of patient: classification I-II
Exclusion Criteria:
- The procedure will be required to conversion to laparotomy.
- Cancer
Contacts and Locations| Contact: Yi-Jen Chen, MD | 886-2-28757566 | chenyj@vghtpe.gov.tw |
| Taiwan | |
| Veterans General Hospital -Taipei | Recruiting |
| Taipei, Taiwan, 11217 | |
| Contact: Yi-Jen Chen, MD 886-2-28757566 chenyj@vghtpe.gov.tw | |
| Principal Investigator: Yi-Jen Chen, MD | |
| Study Chair: | Yi-Jen Chen, MD | Taipei Veterans General Hospital,Taiwan |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Chen-Hsen Lee, MD, Chairman, Taipei Veterans General Hospital,Taiwan |
| ClinicalTrials.gov Identifier: | NCT01048931 History of Changes |
| Other Study ID Numbers: | VGHIRB 98-10-03 |
| Study First Received: | January 12, 2010 |
| Last Updated: | January 13, 2010 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by Taipei Veterans General Hospital,Taiwan:
|
Single-port, laparoscopic-assisted, vaginal hysterectomy |
Additional relevant MeSH terms:
|
Myoma Leiomyoma Myofibroma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Connective Tissue Connective Tissue Diseases |
ClinicalTrials.gov processed this record on June 17, 2013