Single-port Access Laparoscopic-assisted Vaginal Hysterectomy

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Brief Title

Single-port Access Laparoscopic-assisted Vaginal Hysterectomy

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 Description

      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. Next, carbon dioxide was
      insufflated to maintain intra-abdominal pressure at 12-14 mmHg, depending on age and
      condition of the patient. Five- or 10-mm laparoscopes were used as needed. These laparoscopes
      have an incorporated light source within the camera head that does not compete for the very
      limited space in the port site. One or two additional 5-mm trocar sleeves were introduced
      through the single port system to make an imaginary triangle with the previous port for the
      camera to avoid clashing and to maximize surgical movement. A uterine manipulator was
      inserted to optimize visualization and accessibility in the surgical field . Then the
      laparoscopic assisted vaginal hysterectomy was perform as usual. Finally, the approach to the
      fascia and peritoneum is easier via the umbilicus than an extra-umbilical area; the
      peritoneum and fascia were approximated and closed layer by layer with 2-0 Vicryl suture and
      the skin was selectively sutured .

      In the control group: 50 patients receive the multiple ports-access laparoscopic-assisted
      vaginal hysterectomy (traditional LAVH, usually 3-4 ports) as previous described.

      Objectives and outcomes:

      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. The rate of multiple ports laparoscopy convert to transabdominal hysterectomy
      will be record. The rate of single ports laparoscopy convert to multiple ports laparoscopy or
      transabdominal hysterectomy will be record.

      The morbidity (wound infection, hernia, fever...) associated with surgery will be noted, too.

      Randomization process:

      Treatment allocation was performed in accordance with a computer-generated randomization
      sequence using numbered, sealed envelopes.

      Main Inclusion/ Exclusion Criteria Inclusion

        1. Patients receive laparoscopic-assisted vaginal hysterectomy (LAVH)

        2. American Society of Anesthesiologists (ASA) physical status of patient: classification
           I-II

      Exclusion

        1. The procedure will be required to conversion to laparotomy.

        2. Any cardio-vascular diseases.

        3. Malignant disease

      Number of subjects: 100 Methods: In the intervention group : 50 patients receive the single
      port-access laparoscopic-assisted vaginal hysterectomy.

      In the control group : 50 patients receive the multiple ports-access laparoscopic-assisted
      vaginal hysterectomy (traditional LAVH, usually 3-4 ports).

      Planned Study Timelines:

      (submission date to Health authority in 1st country, dates of start and end of subject
      enrolment, end of study) Dates of start: Aug., 2009 End of study: Aug., 2011

      Evaluation of efficacy:

      Sample size:

      In calculating the sample size required, the primary assessment was the post-operative time
      and blood loss. We determined a required sample size of 50 patients per group for a
      two-tailed X2 test with 80% power and a P level of .05. Thus a total of 100 analyzable
      patients were obtained for this study.

      Endpoints:

      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.

      Statistical analysis plan:

      Normality was assessed by means of the Kolmogorov-Smirnov test. Differences between the
      groups were analyzed by using an unpaired two-tailed t test for continuous variables and the
      X2 test for binomial outcomes (Stata 10 Edition for Windows, StataCorp LP, College Station,
      TX). The pain scores over time and their interaction with the intervention were analyzed by
      means of the analysis of variance for repeated measures (SPSS 15.0.0, SPSS Inc., Chicago,
      IL). Effects were considered statistically significant for P<.05
    

Study Phase

Phase 3

Study Type

Interventional


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.

Secondary Outcome

 To evaluate the cosmetic outcome.

Condition

Uterine Myomas

Intervention

single-port LAVH

Study Arms / Comparison Groups

 single-port LAVH
Description:  single port LAVH

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

Procedure

Estimated Enrollment

100

Start Date

October 2009

Completion Date

October 2010

Primary Completion Date

October 2010

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.

          -  Cancer
      

Gender

Female

Ages

30 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

Yi-Jen Chen, MD, 886-2-28757566, [email protected]

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations


NCT ID

NCT01048931

Organization ID

VGHIRB 98-10-03



Study Sponsor

Taipei Veterans General Hospital, Taiwan

Collaborators

 National Yang Ming University

Study Sponsor

Yi-Jen Chen, MD, Study Chair, Taipei Veterans General Hospital, Taiwan


Verification Date

January 2010