| Study Summary: |
|
Introduction: Natural Orifice Translumenal Endoscopic Surgery (NOTES) describes a new field
of investigational surgery which uses the endoscope as the primary operative tool. The
insertion sites for the endoscope include natural orifices such as the mouth, anus, vagina,
or urethra. Multiple animal studies utilizing similar techniques are ongoing at several
institutions, including Baystate Medical Center. These multidisciplinary teams consist of
surgeons and gastroenterologists who are collaborating to develop safe and effective
surgical techniques via the natural orifice route in order to avoid surgical incisions.
The NOTES team at Baystate began animal studies in May, 2006. Multiple procedures,
including but not limited to uterine horn resection (simulating appendectomy),
cholecystectomy, nephrectomy, splenectomy, distal pancreatectomy, small bowel resection,
mediastinal exploration, and sleeve gastrectomy have been completed successfully by the
team. This work has led to a separate, IRB-approved protocol to perform NOTES pancreatic
pseudocystgastrostomy in human patients. To date, 2 patients have successfully undergone
entirely transluminal, endoscopic cystgastrostomy with a third case upcoming. The focus of
much of our research (as well as that of many other investigators), is to develop a secure
closure method for the stomach. Unfortunately, key scientific questions remain regarding
this technique and thus have limited human trials to date. Given this, we have begun to
explore other access techniques.
Gynecologists have long considered transvaginal access to the peritoneum as a safe route of
entry into the abdomen. Transvaginal hysterectomy and transvaginal tubal ligation have
indeed become a regular part of the gynecologic armamentarium. NOTES surgeons have learned
from this access approach and have begun to employ it as a safe route into the abdomen. In
fact, investigators in New York1,2; San Diego3; Strasbourg, France4; Mallorca, Spain5;
Hamburg, Germany6, Milan, Italy7; and Rio de Janeiro8,9 and São Paulo10, Brazil have all
announced transvaginal NOTES procedures involving the gallbladder. All of these approaches,
to date, have utilized one or more laparoscopic trocars for safety reasons.
Primary Objective: The primary objective of this pilot study is to demonstrate that the
Natural Orifice Translumenal Endoscopic Surgery (NOTES) transvaginal cholecystectomy
technique is as safe and effective as standard laparoscopic surgical technique for the
resection of gallbladder.
Hypothesis: Patients who undergo Natural Orifice Translumenal Endoscopic Surgery for
treatment of their gallbladder disease will experience effective treatment with less
discomfort and with quicker recovery than standard surgical techniques.
Introduction: The NOTES team (surgeon and gastroenterologist) at Baystate has extensive
experience with animal work in developing novel techniques with commercially available
products. Despite performing cholecystectomies in porcine models both through a
transgastric and transvaginal approach, we have yet to perform a human case. The surgeons
on the team have performed well over a thousand laparoscopic cholecystectomies; the
gastroenterologist is a recognized advanced therapeutic endoscopist; and the gynecologist is
an expert in transvaginal surgery. We believe that our combination of human experience and
animal research will lead to safe attempts to perform the procedure described herein.
Methods: There will be a total of 3 patients undergoing this experimental surgical
procedure once meeting all entry criteria and subsequent to obtaining informed consent
These patients will be recruited from the Baystate ambulatory surgery clinics..
Preoperative laboratory testing, such as blood work (liver function tests, amylase and
lipase, a white blood cell count, and a pregnancy test), as well as ultrasound of the liver
to document gallbladder disease will be performed as is the standard for patients undergoing
surgical removal of the gallbladder. In this procedure, after the induction of general
anesthesia and creation of a culdotomy, a sterile endoscope would be inserted into the
vagina and then into the abdomen. Following the insertion of the endoscope, a retraction
stitch will be passed through the abdominal wall and into the gallbladder to retract the
fundus of the gallbladder in a cephalad direction. A 5-mm trocar will be placed in the
umbilicus and will serve two functions: one, to allow for a laparoscope in case the view
becomes compromised or substandard; and two, to allow a clip applier to be placed in the
abdomen for clipping the cystic artery and cystic duct. Dissection of the gallbladder can
commence using endoscopic tools and removal of the specimen will be directly through the
culdotomy and out through the vagina. Utilizing this technique, as many as three surgical
incisions can be avoided.
Postoperatively, the patient will be kept in the hospital overnight. After discharge,
follow-up examination will be conducted at 3-5 days (by telephone), 1 week, and 6 weeks
following the procedure to determine the success of the procedure. Longer term follow-up
will be determined by the patient's overall condition. For at least the first 3 procedures,
a laparoscopic camera will be available on the sterile field and at least one laparoscopic
trocar will be employed. As with any operation, we would revert to the next least invasive
modality should patient safety and/or degree of difficulty dictate that it be so. In this
case, should we encounter difficulties during transvaginal cholecystectomy, we would have a
low threshold to revert to laparoscopic cholecystectomy or even to open cholecystectomy as
needed.
Safety Monitoring: Due to the novelty of the procedure, safety information will be
monitored on a continuous basis. Complications that deviate from expected outcomes from
standard laparoscopic cholecystectomy would result in, the study being terminated
prematurely or temporarily suspended while we assess the events. A member of the general
surgery department will be appointed as a safety monitor and will review all the cases and
report to the IRB after the first and third case.
Risks and Benefits: The anticipated risks associated with this type of surgery include:
Bleeding, infection, need for open surgery, bile leak, bile duct injury, and bowel injury.
Risks specific to the transvaginal NOTES approach include infection of the vagina,
dyspareunia. A vaginal incision has no known adverse effects on either fertility or
subsequent childbirth, even within a few weeks of the procedure. The anticipated benefits
include a decrease in the amount of pain experienced with laparoscopic cholecystectomy, as
well as a more cosmetically acceptable result.
Statistics: As this is a purely descriptive study of feasibility of a new technique, there
are no specific statistics to be monitored.
Data Storage: The identifiable data collected will be kept in a locked filing cabinet in
the primary investigator's office. Only the PI will have access to this file.
It is anticipated that there will be more similar "natural orifice-type" surgeries in the
future for a variety of procedures and a multitude of reasons (no incision, less pain, and
less time in the hospital). These surgeries will be some of the first transvaginal
cholecystectomies performed in the world.
|