Clinical Trial: Single-port Access Laparoscopic-assisted Vaginal Hysterectomy

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: To Compare to Single-port Access Laparoscopic-assisted Vaginal Hysterectomy (LAVH) and Multiple Ports LAVH: A Randomized Controlled Trial

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.

Detailed Summary:

Overall Study Design:

Participants:

This clinical controlled trial will be undertaken among patients who will receive laparoscopic-assisted vaginal hysterectomy.

Interventions:

All the patients will receive laparoscopic surgery using CO2 gas as distension medium. At the end of the surgery, in the control group, CO2 was removed by passive exsufflation through the port site. The patients will be placed in the Trendelenburg position (30 degrees).

In the intervention group: 50 patients receive the single port-access laparoscopic-assisted vaginal hysterectomy. Under general anesthesia, the patient was positioned in the supine position with the legs extended, and prepped and draped in the routine sterile fashion. The legs were protected with foam padding. At the start of surgery, a 2-cm intraumbilical incision was made. Adhesiolysis was performed if adhesions between the viscera and peritoneum existed from prior abdominal surgery or past abdominopelvic infection. The single-port system was made based on a modification of Lee et al. procedure [8]. After insertion of the wound protractor (Alexis X-small for 2-4 cm incisions, Applied Medical, CA, USA) into the abdominal cavity, the extraabdominal portion of the wound protractor was rolled up with the wrist portion of a surgical glove (TriflexLP, 7-0; Cardinal Health, OH, USA; Fig. 1). The finger portion of the glove was resected and tied to prevent leakage of carbon dioxide. The first trocar sleeve for laparoscopy was created after a small incision in the upper portion of the glove was made in the midline. After insertion of a trocar sleeve, the surrounding glove was lifted up with two mosquito forceps and tied to the trocar sleeve. N
Sponsor: Taipei Veterans General Hospital, Taiwan

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: To evaluate the cosmetic outcome. [ Time Frame: 1 year ]

Original Secondary Outcome: Same as current

Information By: Taipei Veterans General Hospital, Taiwan

Dates:
Date Received: January 12, 2010
Date Started: October 2009
Date Completion: October 2010
Last Updated: January 13, 2010
Last Verified: January 2010