Clinical protocol levels are required in laboratory animal surgery when using medical devices: experiences with ureteral replacement surgery in goats.

It is common to test medical devices in large animal studies that are or could also be used in humans. In this short report we describe the use of a ureteral J-stent for the evaluation of biodegradable tubular constructs for tissue reconstruction, and the regeneration of ureters in Saanen goats. Similarly to a previous study in pigs, the ureteral J-stent was blindly inserted until some resistance was met. During evaluation of the goats after three months, perforation of the renal cortex by the stent was observed in four out of seven animals. These results indicated that blind stent placement was not possible in goats. In four new goats, clinical protocols were followed using X-ray and iodinated contrast fluids to visualize the kidney and stent during stent placement. With this adaptation the stents were successfully placed in the kidneys of these four new goats with minimal additional effort. It is likely that other groups in other fields ran into similar problems that could have been avoided by following clinical protocols. Therefore, we would like to stress the importance of following clinical protocols when using medical devices in animals to prevent unnecessary suffering and to reduce the number of animals needed.

Best practices for IACUCs in the evaluation of multiple major operative procedures.

Evaluation of multiple major operative procedures can be a daunting task for IACUCs. Committee members need to know what a major operative procedure is, when multiple major operative procedures are permitted under the Animal Welfare Act, when permission from the Administrator of the US Department of Agriculture's Animal and Plant Health Inspection Service is required for multiple major operative procedures, and what information must be included when requesting such permission. The author discusses the intent and requirements for multiple major operative procedures under the Animal Welfare Act and describes best practices that IACUCs may use in evaluating multiple major operative procedures both within and across protocols.

El conejo como modelo experimental de entrenamiento en cirugía laparoscópica pediátrica / The rabbit as an experiemntal model for training in pediatric laparoscopic surgery

La cirugía laparoscópica ofrece nuevos retos para el cirujano pediatra, de ahí la necesidad de lograr un adecuado entrenamiento antes de intervenir directamente a los pacientes. Se han diseñado distintos modelos para el entrenamiento, tanto In vitro, como In vivo. Evaluar la utilidad del conejo como modelo experimental de entrenamiento en cirugía laparoscópica pediátrica. Se incluyeron en el estudio 19 conejos de la especie Oryctolagus cuniculus, 16 hembras y 3 machos. Se realizaron 65 procedimientos quirúrgicos de nivel I, II y III, distribuidos de la siguiente manera: 16 laparoscopias diagnósticas, 12 esterilizaciones, 12 ooforectomías, 8 apendicetomías, 10 gastrostomías, 2 rafias gástricas, 2 gastroenteroanastomosis y 3 anastomosis intestinales. El tiempo medido para realizar la laparoscopia diagnóstica incluyó la colocación y fijación de los tres trocares, así como la revisión sistemática de todos los cuadrantes de la cavidad abdominal. El tiempo del resto de los procedimientos se cronometró sin tomar en cuenta la colocación de los trocares. Los promedios de tiempo para realizar cada procedimiento quirúrgico fueron: laparoscopia diagnóstica: 29,17 min., esterilización: 4,33 min., ooforectomía: 4,47 min., apendicectomía: 22,17 min., gastrostomía: 32,10 min., rafia gástrica: 15,05 min., gastroenteroanastomosis: 49,05 min. y anastomosis intestinal: 106,67 min. Los costos del material quirúrgico, anestésico y conejos, se estimo en 160 BsF por cada animal, para un total de 3040 BsF invertidos. El conejo constituye un adecuado modelo para entrenamiento en cirugía laparoscópica pediátrica, ya que es posible realizar y simular un gran número de procedimientos quirúrgicos, además de ser económico y disponible

Laparoscopic surgery offers new challenges for the general surgeon and pediatric surgeon, hence the need for an adequate training before intervening patients directly. There are different models designed in vitro as well as in vivo. To evaluate the utility of the rabbit as an experimental model for pediatric laparoscopic surgery training. Nineteen rabbits of the species Oryctolagus cuniculus were included in the study, 16 females and 3 males. Sixty five surgical procedures of Level I, Level II and Level III were distributed as follows: 16 diagnostic laparoscopies, 12 surgical sterilizations, 12 oophorectomy, 8 appendectomies, 10 gastrostomies, 2 gastric sutures, 2 gastroenteroanastomosis and 3 intestinal anastomosis. The measured time to perform the diagnostic laparoscopy included the placement and trocars fixation as well as the rabbit systematic revision of all abdominal cavity quadrants, while the time for the remaining procedures was timed without considering the placement of the trocar. The average times for each surgical procedure were: diagnostic laparoscopy: 29.17 min., surgical sterilization: 4.33 min., oophorectomy: 4.47 min., appendectomy: 22.17 min., gastrostomy: 32.10 min., gastric suture: 15.05 min., gastroenteroanastomosis: 49.05 min., and intestinal anastomosis: 106.67 min. The cost of surgical material, anesthetics and rabbits, was estimated in 160 BsF per animal involved, for a total investment of 3.040 BsF. We conclude that the rabbit is an adequate model for pediatric laparoscopic surgery training because it is possible to simulate a large number of surgical procedures, besides its low costs and availability

Laboratory guidelines for animal care.

Animal research is a controversial subject because of the ethical and moral implications of using unwilling research subjects in potentially painful or distressful procedures usually ending in euthanasia. As such, it must be conducted in a compassionate and responsible manner geared toward maximizing the animals' quality of life prior to and during experimentation. Because of its contentious nature, the conduct of animal research is highly regulated at the federal, state, city, and institutional levels. It is essential that researchers acquire a working knowledge of the procedures and regulations in order to protect themselves and their staff from occupational hazards as well as protect their labs from criticism or attack from animal rights organizations. Perhaps the best way to protect from the latter is to avoid inadvertent instances of noncompliance with their research protocol or applicable regulations. Regulatory noncompliance can also have serious negative consequences on investigators' research ranging from temporary suspension of their protocols to loss of funding or principal investigator status. To minimize such events, it is advised that researchers build positive and collaborative relationships, trust and rapport with key institutional players, such as the veterinary staff, the Institutional Animal Care and Use Committee (IACUC), and top administrators. Guidance is provided regarding the appropriate handling of regulatory noncompliances.

Effects of wire-bottom caging on heart rate, activity and body temperature in telemetry-implanted rats.

Some experimental procedures are associated with placement of animals in wire-bottom cages. The goal of this study was to evaluate stress-related physiological parameters (heart rate [HR], body temperature [BT], locomotor activity [LA], body weight [BW] and food consumption) in rats under two housing conditions, namely in wire-bottom cages and in bedding-bottom cages. Telemetry devices were surgically implanted in male Sprague-Dawley rats. HR, BT and LA were recorded at 5 min intervals. Analysis under each housing condition was performed from 16:00 to 08:00 h of the following day (4 h light, 12 h dark). During almost all of the light phase, the HR of rats housed in wire-bottom cages remained high (371 ± 35 bpm; mean ± SD; n = 6) and was significantly different from that of rats housed in bedding-bottom cages (340 ± 29 bpm; n = 6; P < 0.001; Student's t-test). In general, BT was similar under the two housing conditions. However, when rats were in wire-bottom cages, BT tended to fluctuate more widely during the dark phase. LA decreased when animals were housed in wire-bottom cages, in particular during the dark phase. Moreover, there was a significant difference with respect to the gain in BW: BW of rats housed in bedding-bottom cages increased 12 ± 2 g, whereas that of rats in wire-bottom cages decreased by 2 ± 3 g (P < 0.001). Our results demonstrate that housing rats in wire-bottom cages overnight leads to immediate alterations of HR, BW and LA, which might be related to a stress response.

Intestinal resection and anastomosis in neonatal gnotobiotic piglets.

We describe a surgical method for ileal resection and anastomosis in newborn germfree piglets that was undertaken to establish a model that can be used for immunologic research and other applications. A preliminary experiment indicated that neonatal piglets with resection of approximately 60 cm of their ileum (removal of approximately 90% of the continuous ileal Peyer patches; group A) and those in which the ileum was transected (group B) could be maintained germfree for 35 d, colonized with defined gut flora, and maintained in a clean room until 70 d of age. In the final study, 12 piglets (4 each for groups A and B and 4 untreated controls), were monitored for postoperative feeding behavior, malaise, evidence for contamination with pathogenic bacteria, and weight gain. All surgical animals were free from incidental contamination from pathogens and environmental organisms with atypical colony types for 35 d. Two piglets in group B died postoperatively (1 during the preliminary experiment and 1 during the final study). Control (group C) piglets gained significantly more weight than did those in group A. These studies demonstrated that surgical resection of the ileal Peyer patches under germfree conditions can be accomplished successfully without compromising piglet health or introducing pathogens and with only a modest reduction in weight gain.