Trial Information

A Randomized Trial Comparing Outcomes for the LigaSure and Disposable Stapling Instruments for Laparoscopic Surgery

The application of laparoscopic surgery has expanded over the last decade to include many
complex abdominal procedures that have traditionally been performed through a laparotomic
incision. The widespread acceptance and utilization of laparoscopy has directly resulted in
a continuing need to develop both new techniques and ancillary surgical instrumentation.

Laparoscopic instruments that provide adequate hemostasis and allow for precise dissection
of tissues are needed for a safe and efficient operation. Furthermore, as new devices
emerge and the volume of laparoscopic cases increases the importance of cost and
ergonomically sound instrumentation have become apparent.

The safety and efficacy of laparoscopic colectomy for benign disease has been demonstrated
by several case series over the last decade. The advantages of smaller wounds, shorter
ileus, earlier resumption of dietary intake, and reductions in hospital stay have been
consistently reported as the major benefits of this approach. More recently, in a
multi-center randomized prospective trial laparoscopic colectomy for curable cancer resulted
in equivalent cancer related survival to open colectomy when performed by experienced
surgeons. Adherence to standard cancer resection techniques including but not limited to
complete exploration of the abdomen, adequate proximal and distal margins, ligation of the
major vessels at their respective origins, containment and careful tissue handling, and en
bloc resection with negative tumor margins using the laparoscopic approach resulted in
acceptable outcomes.

The advantages of standardized surgical technique's for laparoscopic colectomy that were
discussed in this multicenter trial were well outlined in one previous study. This study
retrospectively reviewed a consecutive series of patients undergoing laparoscopic sigmoid
colectomy from 1999 to 2001 at a single institution. The potential benefits of a
standardized technique included 1) standardization of surgical instrument sets, 2)
definition of benchmarks for the decision to convert before inappropriate investments in
time and equipment, and 3) provision of an easily transferred skill set for residents in
training.

Despite the obvious value of this standardized approach, a variety of techniques and
laparoscopic instruments for tissue dissection and coagulation are currently utilized.
These options include laparoscopic staplers, lap clip appliers, suture ligature,
electrothermal bipolar vessel sealers, electric cautery, and ultrasonic shears. Dissection,
coagulation, and the division of the mesocolon and mesorectum during laparoscopy, continue
to represent a technical and hemostatic challenge. When dealing with inflamed tissues, as
in diverticulitis or inflammatory bowel disease, or when the mesocolon and mesorectum are
fatty, reliable hemostasis is not always easy to obtain. Concerning tissue dissection and
coagulation, electrosurgery, widely implemented in open surgery, has displayed some
complications and limits related to minimally invasive techniques. The search for safer
multidimensional instruments has led to the development of both the ultrasonic
dissector(UCS), (Harmonic Scalpel, Ultracision, Ethicon Endosurgery Inc., Cincinnati, OH)
and the endoscopic Ligasure (LIG or EBVS), (Valleylab, Boulder, CO).

Use of ultrasonic dissection in colorectal laparoscopic surgery has recently been reviewed
retrospectively in two studies. Both studies concluded that ultrasonic dissection was safe
and effective. A prospective randomized clinical trial also demonstrated that use of UCS
provided the advantage of a decreased blood loss when compared with ES without and any
increase in morbidity.

Recently an electrothermal bipolar vessel sealer, (EBVS) (Ligasure, Valleylab, Boulder, CO,
USA) was developed for both laparoscopic and open procedures as an alternative to suture
ligatures, hemoclips, staplers and ultrasonic coagulator's for ligating vessels, and tissue
bundles. The EBVS is approved by the Food and Drug Administration to seal vessels up to 7mm
in diameter. It does so by applying high current and low voltage, which differs from the
energy used in standard monopolar and bipolar cautery. This unique form of energy denatures
collagen and elastin within the vessel wall and surrounding connective tissue. The addition
of extreme pressure applied by the instrument, which also differs from other energy sources,
causes the denatured protein to reform, with the vessel walls in apposition. Clinically,
the result is a nearly translucent "seal" that may be transected. The Ligasure device has
been used in all types of gastrointestinal surgery including small and large bowel
resection, gastrectomy, pancreatectomy, splenectomy, esophagogastric devascularization for
portal hypertension, and transplantation. To date, the device appears to be cost effective
in teaching institutions when used in difficult open and laparoscopic surgery.

The initial results with the EBVS and colorectal surgery were from a prospective review of
98 cases by a single surgeon from 1998 to 2000. These included both laparoscopic and open
cases and involved 53 colon resections. No postoperative hemorrhagic complication occurred
and there was an estimated mean reduction in operative time of 39 minutes. Additionally,
the same authors' applied the ligasure technology to a pig animal model and consistently
reported no evidence of postoperative bleeding. They concluded that the EBVS was safe and
effective and may potentially reduce operative times.

A second study, also a retrospective analysis, compared Ligasure to an ultrasonic coagulator
for total abdominal colectomy in 15 patients with ulcerative colitis. The procedure using
Ligasure reduced the operating time, intraoperative bleeding and operator's stress in
comparison with ultrasonic coagulation.

A third study, another retrospective comparative model, was conducted to address the
differences between EBVS and ultrasonic shears for laparoscopic transverse and sigmoid
colectomy. The study included 30 patients and found that the incidence of rebleeding was
significantly lower in the EBVS group than in the the UCS group for both surgical
procedures. In addition the required time for mesocolon dissection was also significantly
shorter when the EBVS was used.

The only prospective randomized study with Ligasure and laparoscopic colorectal surgery
addressed the speed, reliability and cost to guide surgeons in their choice for
intracorporeal pedicle ligation. This study involved both straight laparoscopy and
hand-assisted laparoscopy and compared laparoscopic vascular staplers and disposable clip
appliers with the Ligasure Atlas during elective right, left, and total colectomy. Cases
were stratified by procedure and failure was defined as any bleeding after pedicle ligation.
100 patients were included in the study and the Ligasure atlas was found to be more cost
effective and associated with lower failure rates.

Significance and Purpose The utilization and safety of surgical staplers and disposable
clips for laparoscopic colectomy is established and has been adopted by the majority of
surgeon's performing these procedures. Although the growing evidence supporting the
application of Ligasure to laparoscopic colorectal surgery has demonstrated its safety and
efficiency, most of the studies have been limited by sample size and their retrospective
nature. There also have been several questions left unanswered. A standardized approach for
laparoscopic right, total, and left colectomy has never been substantiated by any
prospective study. Furthermore, the difficult and somewhat dangerous steps involved with
division of the mesorectum during both laparoscopic sigmoid colectomy and low anterior
resection have not been appropriately evaluated.

The objective of this study is to determine the best technical approach to laparoscopic
right, total, and left colectomy by comparing the utilization of the Ligasure device to
electrocautery with the application of surgical clips and/or surgical stapler's. To answer
this question the investigators will compare each approach regarding tissue dissection,
colonic mobilization and pedicle ligation. Safety, cost, operative time, time to pedicle
ligation and hemostasis will be objectively measured in each treatment group.