Trial Information

To Compare to Single-port Access Laparoscopic-assisted Vaginal Hysterectomy (LAVH) and Multiple Ports LAVH: A Randomized Controlled Trial

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