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

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Brief Title

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

Official Title

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

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.

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 Type

Interventional

Primary Outcome

The operative time

Secondary Outcome

 weight of the uterus

Condition

Myoma

Intervention

comparison multiple channel port laparoscopic surgery

Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

200

Start Date

January 2011

Completion Date

December 2014

Primary Completion Date

January 2014

Eligibility Criteria

        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

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Yi-Jen Chen, PHD, ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT01564602

Organization ID

VGH2011-03-011IA

Responsible Party

Principal Investigator

Study Sponsor

Taipei Veterans General Hospital, Taiwan

Study Sponsor

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

Verification Date

March 2012