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

Learn more about:
Related Clinical Trial
Factors Associated With Adenomyosis and a Clinical Scoring System for the Diagnosis Quality of Life After Hysterectomy (AdenoQOL) Low Molecular Weight Heparin on the Adenomyosis Patients’IVF-ET Outcome Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI Clinical and Molecular Study of Endometriosis and Adenomyosis Surgical Success After Laparoscopic vs Abdominal Hysterectomy Electronic Catheter Stethoscope Ovarian Reserve Modification After Lps Hysterectomy With Bilateral Salpingectomy Does 3D Laparoscopy Improve Vaginal Cuff Suture Time? Single-port Access Laparoscopic-assisted Vaginal Hysterectomy Uterine Artery Embolization for Symptomatic Fibroids Oxytocin in MRI-HIFU To Compare to 2-channel and Multiple-channel Single Port Laparoscopic-assisted Vaginal Hysterectomy Effect of Addition of Steroids on Duration of Analgesia Paracervical Block in Laparoscopic Hysterectomy Use of Dexamethasone in Uterine Artery Embolization Treatment of Benign Uterine Disorders Using High Intensity Focused Ultrasound (MR-HIFU) Comparison of Estrogen-progestin Therapy in Continuous Regimen Versus Combination Estrogen-progestin Therapy in Continuous Regimen Plus Levonorgestrel-releasing Intrauterine System (LNG-IUS) Dienogest for Treatment of Adenomyotic Uteri Health-Related QoL Among Women Receiving Hysterectomy in NTUH Development and Validation of EHP-30 (Hong Kong Chinese Version) for Patients With Endometriosis and Adenomyosis Adenomyosis and Ulipristal Acetate Efficacy of Acupuncture on Chronic Pelvic Pain in Women With Endometriosis or Adenomyosis LNG-IUS for Treatment of Dysmenorrhea Benefit of GnRH Agonist Before Frozen Embryo Transfer in Patients With Endometriosis and/or Adenomyosis Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis Adenomyosis: Genomic Mechanisms and Biological Response What Are we Missing? Diagnosing Uterine Adenomyosis Using Ultrasound Elastography Comparing Efficacy of Microwave vs Embolization Treatment for Adenomyosis Role of Dienogest in the Treatment of Patient With Symptomatic Adenomyosis Comparison of the Operation and Medical Treatment of Endometriosis and Adenomyosis A Prospective Study of Diagnostic Accuracy of Ultrasound Placebo-controlled Proof of Concept Study of Epelsiban in Women With Adenomyosis A Multi-omics Study of Adenomyosis Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis Levonorgestrel Intrauterine System and Adenomyosis Validation of the Adenomyosis Calculator Levonorgestrel-releasing Intrauterine System Versus a Low-dose Combined Oral Contraceptive for Management of Adenomyosis Uteri Modified Downregulation for Women With Adenomyosis of the Uterus Prior to Frozen-thawed Embryo Transfer. New Inflammation Markers for Distinguishing Uterine Adenomyosis and Leiomyoma The Association Between Adenomyosis/Uterine Myoma and Lower Urinary Tract Symptoms High-intensity Focused Ultrasound in Treatment of Uterine Adenomyosis Evaluation of Therapeutic Effect and Safety of Mifepristone in the Treatment of Adenomyosis Norwegian Adenomyosis Study III: Peristalsis Histopathological Diagnosis of Adenomyosis Norwegian Adenomyosis Study I Vaginal Bromocriptine for Treatment of Adenomyosis Levonorgestrel-releasing Intrauterine System for the Treatment of Symptomatic Adenomyosis

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