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

Sponsor

Taipei Veterans General Hospital, Taiwan (Other)

Overall Status

Unknown status

CT.gov ID

NCT01564602

Collaborator

(none)

200

Enrollment

Location

Arm

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Myoma Adenomyosis	Device: comparison multiple channel port laparoscopic surgery	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2011

Anticipated Primary Completion Date :

Jan 1, 2014

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: single port laparoscopic surgery 2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders	Device: comparison multiple channel port laparoscopic surgery to compare 2-channel single port and multiple channel port laparoscopic surgery Other Names: multiple channel port laparoscopic surgery

Arm

Intervention/Treatment

Experimental: single port laparoscopic surgery

2-channel or multiple channel single port laparoscopic surgery in gynecologic disorders

Device: comparison multiple channel port laparoscopic surgery

to compare 2-channel single port and multiple channel port laparoscopic surgery

Other Names:

multiple channel port laparoscopic surgery

Outcome Measures

Primary Outcome Measures

The operative time [We will follow the patients until one month after the surgery.]
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.

Secondary Outcome Measures

weight of the uterus [one month]
blood loss [one month]
hospital length of stay [one month]
morbidity [one month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei		Taiwan	1121

Sponsors and Collaborators

Taipei Veterans General Hospital, Taiwan

Investigators

Study Director: Yi-Jen Chen, PHD, Taipei Veterans General Hospital, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

vghtpe user, Director, Taipei Veterans General Hospital, Taiwan

ClinicalTrials.gov Identifier:

NCT01564602

Other Study ID Numbers:

VGH2011-03-011IA

First Posted:

Mar 28, 2012

Last Update Posted:

Apr 2, 2012

Last Verified:

Mar 1, 2012

Keywords provided by vghtpe user, Director, Taipei Veterans General Hospital, Taiwan

2-channel single port laparoscopy

multiple-channel port laparoscopy

Additional relevant MeSH terms:

Adenomyosis

Study Results

No Results Posted as of Apr 2, 2012