Digestive System Diseases

All Conditions

Symptoms and General Pathology

Diverticulitis

Diverticulum

Diverticular Diseases

Gastroenteritis

Gastrointestinal Diseases

Pathological Conditions, Anatomical

Herbal and Botanical

All Drugs and Chemicals

Cola

During left-sided colonic resections, anastomosis perfusion will be estimated by the visual appreciation of the surgeon and the ICG fluorescence-based enhanced reality. These two approaches will be compared.

During interventions, anastomosis perfusion will be estimated (outcomes: visual appreciation of the surgeon, ICG fluorescence-based enhanced reality and series of peri-operative samplings) in order to validate the accuracy of ICG fluorescence-based enhanced reality technique.

In any case, the resection will be performed according to the surgeon's appreciation.

Left-sided colonic resection

Didier Mutter, MD, PhD

Michele Diana, MD

The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

Accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. Anastomotic leakage is the most dreadful complication of colorectal resections.

Intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. This is subjective and based on the experience of the surgeon.

Fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, Indocyanine Green (ICG), which is administered by intravenous injection. Fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion.

The hypothesis is that ICG-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections.

In patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by :

* the visual appreciation of the surgeon
* the fluorescence-based enhanced reality, after injection of ICG and digital process.

A series of peri-operative samplings will also be carried out. In any case, the resection will be performed according to the surgeon's appreciation.

Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

The perfusion evaluated by the ICG fluorescence-based enhanced reality, obtained by the digital process of the fluorescence dynamic signal, will be correlated to the metabolic state of the intestine, assessed by the measure of biological markers on several points of the intestine.

The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage.

The distance between the resection site based on the surgeon's clinic appreciation and the resection site based on the digital analysis and the level of capillary lactates and mitochondria respiratory rate on different sites will be measured.

IHU Strasbourg

Tissue Adhesions

Cicatrix

Fibrosis

Hematinics

Liver Extracts

Patients who will undergo liver resection who have a laparoscopically performed colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.

Patients who will undergo liver resection who have an open colorectal resection in history. Assignment to cohort is on intention to treat of the primary operation.

Liver resection performed for metastatic disease from colorectal carcinoma

Liver resection

Harry P van Goor, MD, PhD

Rationale: Adhesion formation is a frequent complication after abdominal surgery. Adhesion formation might be reduced by laparoscopic surgery, however sound evidence is lacking. Colorectal surgery would be a good clinical model to investigate adhesion formation between open and laparoscopic surgery because of the adhesion formation propensity of colorectal surgery. However, a randomized controlled study to provide direct evidence is unlikely because of large numbers of patients needed for such a trial and the difficulty to check for adhesion formation at second surgery. Therefore we investigate adhesion formation after laparoscopic and open colorectal surgery for malignancy at liver surgery for metastases.

Objective: The aim of our study is to compare the incidence of adhesions after laparoscopic versus open surgery for colorectal malignancies during liver resection for colorectal metastases.

Study design: The study is designed as a prospective observational cohort study.

Study population: All consecutive, adult patients undergoing laparotomy or laparoscopy for intended liver resection or radio frequency ablation for liver metastases of a colorectal malignancy in whom inspection of the middle and lower abdomen is possible to map adhesions.

Main study parameters/endpoints:

* Primary endpoint is incidence of adhesions to the ventral abdominal wall around the site of the original incision.
* Secondary endpoints are episodes of bowel obstruction between index surgery and liver surgery; total incidence of adhesions; extent of adhesions; Zühlke classification of adhesions; performance of adhesiolysis; duration of adhesiolysis; peroperative complications: enterotomy, seromuscular injury, inadvertent organ injury during adhesiolysis; postoperative complications: delayed diagnosed perforation, SAE's.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study is an observational study. The existence of adhesions will be assessed during laparotomy or laparoscopy for the treatment of liver metastases. The laparotomy is indicated for medical treatment and should not be enlarged solely for the assessment of adhesions nor will the operating time be influenced for this purpose.

Adhesions and peroperative complications have to be scored by the operating surgeon during or directly after surgery. The postoperative complications have to be scored during the postoperative course by the doctors on the ward. These assessments do not interfere with the treatment of the patients.

Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection

Patient has episode of small bowel obstruction in medical history

To compare the incidence of adhesions to the ventral abdominal wall in patients undergoing laparotomy or laparoscopy for intended liver resection for colorectal metastases after open versus laparoscopic resection of the primary tumour.

Inadvertent bowel injury made during operation

Incidence of predetermined postoperative complications:

* mortality
* incisional wound infection
* abdominal sepsis
* pneumonia
* urinary tract infection

Radboud University Medical Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Endometriosis

Colonic Diseases

Polyps

Rectal Diseases

Intestinal Diseases

laparoscopic colectomy using the Ligasure device

Bipolar electrosurgical generator and instruments

laparoscopic colectomy using clips, cautery and stapler

Disposable stapling instruments

Conor P. Delaney, MD, PhD

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.

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.

Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery

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

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 staples. Safety, cost, operative time, time to pedicle ligation and hemostasis will be objectively measured in each treatment group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis	NCT02626091	Sigmoid Diverti... Sigmoid Diverti... Colorectal Mali...	Left-sided colo...	18 Years -	IHU Strasbourg
Adhesions After Open Versus Laparoscopic Resection of Colorectal Malignancies Detected During Liver Resection	NCT01720966	Adhesions	Liver resection	18 Years - 100 Years	Radboud University Medical Center
Random Comparison of LigaSure and Disposable Staples for Laparoscopic Surgery	NCT00487409	Colonic Disease... Rectal Diseases	Bipolar electro... Disposable stap...	18 Years - 80 Years	University Hospitals Cleveland Medical Center

Spots Global Cancer Trial Database for colorectal malignancy