Brief Title
Transvaginal Cholecystectomy Using Endoscopic Assistance
Official Title
Laparoscopic Cholecystectomy Using Transvaginal Endoscopic Assistance
Brief Summary
Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The
procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall.
Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The
space in the abdominal cavity can then be seen on a video screen. Thin retractors and
dissecting instruments are placed through the other cannula and the gallbladder is removed
using the video screen for vision. The gallbladder duct and the artery are usually occluded
with clips or stitches.
In this study we propose to do the procedure though a single 5 mm incision placed at the
umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder
will be retracted using strings (sutures) attached to the gallbladder. The dissection will be
done using laparoscopic instruments (scissors, knives, dissectors) placed through the
laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction.
An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the
abdomen through the vagina.
This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision
and one vaginal incision. This will provide the basis for future studies evaluating decreased
pain and costs with transvaginal assisted cholecystectomy.
Detailed Description
BACKGROUND When doing laparoscopic cholecystectomy, there are generally four ports placed
through four separate skin incisions. One port is used for a rigid laparoscope, two for
retraction, and one for dissecting. We have recently started to reduce the number of
incisions for laparoscopic cholecystectomy to one umbilical incision. Three ports are used
through one incision by suspending the gallbladder to the abdominal wall using sutures. This
allows the surgeon to eliminate incisions and the patients have reduced postoperative wound
pain and improved cosmesis. However, by using standard laparoscopic rigid instruments and
optic systems it is challenging to perform this operation via a single incision.
Recently, natural orifice transluminal endoscopic surgery (NOTES) has been used in females to
reduce the size and number of fascial incisions of the anterior abdominal wall. This vaginal
approach has generally been done with the aid of laparoscopy (hybrid procedure). The vaginal
assistance may allow small abdominal wall incisions resulting in less pain and faster
recovery than after the standard laparoscopic approach.
We propose a phase I study of a laparoscopic cholecystectomy using a single 5 mm port and
transvaginal endoscopic assistance in 10 female patients. The procedure will have at least
one 5 mm laparoscopic port for safety and assistance. Conversions to conventional
laparoscopic surgery will be done if difficulties are encountered.
OBJECTIVE Reduction in the number of ports required in laparoscopic cholecystectomy.
Null hypothesis: Laparoscopic cholecystectomy requires two or more fascial port sites to
perform.
Alternative hypothesis: Laparoscopic cholecystectomy can be done with a single 5 mm
laparoscopic port with transvaginal assistance of flexible endoscopy.
The standard laparoscopic procedure will be used as the control.
STUDY DESIGN This study will be conducted as a prospective, single site, non-randomized,
single-arm study among elective surgery patients. Subjects will be enrolled from a population
of otherwise healthy females undergoing laparoscopic surgery for cholelithiasis,
cholecystitis, or biliary dyskinesia. Patients enrolled in the study will have a flexible
transvaginal endoscopy used during laparoscopic cholecystectomy. Subjects enrolled will be
told that the primary purpose of the study is to try to reduce the number of laparoscopic
ports and skin incisions that are necessary to perform their cholecystectomy. Subjects will
be followed for approximately 6 weeks post treatment for purposes of the study.
STUDY PROCEDURE At surgery, the patient will be placed in the dorsal lithotomy position.
Sterile prep and drape of the anterior abdominal wall, perineum, and vagina will be
obtained.. A 7-8 mm umbilical skin incision will be made. Using standard techniques, a Veress
insufflation needle will be placed at the umbilicus to establish pneumoperitoneum. A 5 mm
laparoscopic port will then be placed at the umbilicus. Pressure will be set from 6 to 15 mm
of mercury to obtain an adequate working space.
Patients will then undergo a pelvic exam by a gynecologist followed by placement of a
weighted speculum into the vagina. Forceps or tenaculum will then be used to grasp the
posterior lip of the cervix and the cervico-vaginal junction identified. A uterine
manipulator will be placed into the uterus to allow manipulation of the uterus. A 10 mm
incision will be made though the posterior vaginal wall 1 cm from the cervix. The patient
will then be placed into deep Trendelenburg positioning. A 10mm trocar will be placed against
the posterior vaginal fornix creating a point of pressure on the pelvic peritoneum visible by
laparoscopy. This point will be in the midline of posterior fornix between the utero-sacral
ligaments. The weighted speculum will be removed and gently steady pressure will be applied
to the vaginal trocar until entry into the posterior cul-de-sac is directly visualized by the
laparoscope. Alternatively, the colpotomy will be performed without using a trocar, under
direct vision. One of two Olympus flexible scopes will be used. An 8.7 mm sterile Olympus
flexible single channel gastroscope can be placed though the vaginal port. A 2 channel scope
requires removal ofthe10 mm vaginal port and placement of the 2 channel scope over a wire.
All scope insertions will be observed under laparoscopy for safety.
The gallbladder will then have 1-4 sutures or endoloops attached to the gallbladder and
placed through the anterior abdominal wall using a 1 mm suture passer (GraNee). Dissection
will be done around the cystic duct using commercially available laparoscopic dissectors. For
dissection of the gallbladder and cystic duct/artery, the flexible instruments will be used
via the endoscope as alternative to laparoscopic instruments where appropriate. The cystic
duct will be clipped with laparoscopic clips and divided. The cystic artery will be dissected
clipped and divided in a similar fashion. The gallbladder will then be dissected from the
gallbladder bed.
If indicated by the surgeon to facilitate or complete the procedure, laparoscopic ports will
be added through additional abdominal wall incision sites. Laparoscopic instruments will
assist in the procedure as needed by the judgment of the surgeon. The addition of
laparoscopic ports and/or instruments will be documented. Rarely the gallbladder cannot be
removed in a laparoscopic fashion and must be removed in an open manner. This same risk is
present for any laparoscopic cholecystectomy.
Once the gallbladder is detached, the traction sutures will be cut. An endoscopic snare or
grasper will be used to grasp the gallbladder and remove it from the abdomen through the
vagina. Should an endocatch bag be needed to extract the gallbladder, it will be placed via
the vaginal port and visualized by laparoscopy. The gallbladder bed will be inspected and
irrigated. The skin is closed in a subcuticular manner. The laparoscopic fascial port will
not be closed which is standard for 5 mm ports. The posterior vagina will be closed with a
running absorbable suture. The pelvic peritoneum will not be closed which is standard in many
pelvic operations. Post operative care with be identical to laparoscopic cholecystectomy.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Reduction in the number of laparoscopic ports
Secondary Outcome
Cost analysis comparison of surgical procedures.
Condition
Cholelithiasis
Intervention
cholecystectomy.
Study Arms / Comparison Groups
Surgical Procedure
Description: Laparoscopic transvaginal cholecystectomy with endoscopic assistance.
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
0
Start Date
January 2009
Completion Date
May 2011
Primary Completion Date
May 2011
Eligibility Criteria
Inclusion Criteria:
- Female age ≥ 18 yrs
- Diagnosis of cholelithiasis, cholecystectomy, choledocholithiasis or biliary
dyskinesia and scheduled for laparoscopic cholecystectomy
- Have an indication for a standard laparoscopic procedure cholecystectomy
- Not pregnant
Exclusion Criteria:
- Any significant co-morbidities, including significant cardiac disease, history of
stroke, severe pulmonary disease, hypertension with a diastolic greater than 100,
pancreatitis.
- Patients that are immunosuppressed or on immunosuppression therapy.
- An unacceptable psychological or medical risk as determined by the primary
investigators.
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Brent Miedema, MD, ,
Administrative Informations
NCT ID
NCT00815438
Organization ID
1125518
Responsible Party
Sponsor
Study Sponsor
University of Missouri-Columbia
Study Sponsor
Brent Miedema, MD, Principal Investigator, University of Missouri-Columbia
Verification Date
September 2016