To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy

Adenomyosis Clinical Trial

Official title:

Prospective Cohort Study to Compare to 2-channel and Multiple Channel Single Port Laparoscopic-assisted Vaginal Hysterectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01564602
• Other study ID #: VGH2011-03-011IA
• Status: Recruiting
• Phase: N/A
• First received: February 20, 2012
• Last updated: March 28, 2012
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: March 2012
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to assess the efficacy and safety of single port-access laparoscopic-assisted vaginal hysterectomy. The operative time, weight of the uterus, blood loss and hospital stay will be record, respectively. The pain score is based on the visual analogue scale in which patients record the intensity of their pain 12, 24, and 48 hours after surgery.

Description:

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, Lee et al. performed the multiple channel single port-access laparoscopic-assisted vaginal hysterectomy (SPA-LAVH) in 24 patient. All cases but 3 were performed exclusively through a single port. The median operative time, weight of the uterus, and estimated blood loss were 119 minutes (range 90 to 255 minutes), 347 g (range 225 to 732 g), and 400 mL (range 100 to 1000 mL), respectively. The median hospital stay (postoperative day) was 3 days (range 3 to 7). Although there are a limited number of studies demonstrating the feasibility of single-port access laparoscopic-assisted vaginal hysterectomy (LAVH), single-port surgery is "new-old" (i.e., a revisited and unstandardized technique) because the major disadvantage of limited movement caused by collisions of the laparoscopic instruments has been mitigated by the development of multi-channel approaches. Therefore, the investigators used a 2-channel single-port system, which was different from the previously published 3-channel single-port technique11,12 to reduce collisions and aid the assistant in controlling the scope without interfering with the surgeon's instruments. To our knowledge, there are no randomize control trial to evaluate of 2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders. The purpose of this study was to assess the feasibility of 2-channel and multiple-channel single port laparoscopy in the treatment of benign uterine disease.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

• Any cardio-vascular diseases.

• Malignant disease

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenomyosis
• Myoma

Intervention

Device:
• comparison multiple channel port laparoscopic surgery
to compare 2-channel single port and multiple channel port laparoscopic surgery

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The operative time	We will follow the patients until one month after the surgery. The primary outcome measure of this trial is the effect and safety of single port-access laparoscopic-assisted vaginal hysterectomy.	We will follow the patients until one month after the surgery.	Yes
Secondary	weight of the uterus		one month	Yes
Secondary	blood loss		one month	Yes
Secondary	hospital length of stay		one month	Yes
Secondary	morbidity		one month	No