Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery
Condition: Colonic Diseases; Rectal Diseases
MeSH terms: Colonic Diseases; Rectal Diseases
Study type: Interventional

Summary: 
      The purpose of this research is to compare two different standard of care surgical methods
      for the following large bowel (colon) procedures: laparoscopic right colectomy, total
      colectomy, and left colectomy. The study will compare electrocautery, used with surgical
      clips and/or surgical staplers, and the Ligasure vessel sealer. The investigators will be
      looking at which procedure is faster and more cost efficient and the investigators will
      calculate hospital expenses for the two groups to make comparisons.
    

Detailed description: 
      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.
    

Intervention name(s): Bipolar electrosurgical generator and instruments; Disposable stapling instruments
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic colectomy using the Ligasure device; laparoscopic colectomy using clips, cautery and stapler
Other intervention name(s): Ligasure Device; Staples or Clips
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Ulcerative colitis; Crohn's disease; Colorectal polyps; Colorectal malignancy; Endometriosis; Diverticulitis; Colonic inertia