Surgical procedures evaluation

Esophageal manometry to evaluate motility should be performed in any patient who is a candidate for antireflux surgery. It is useful in determining which surgical procedure is best for the patient. 

However evaluation of safety in animal models of disease may be difficult to conduct with strict adhere to current good laboratory practices (cGLPs) due to novel routes of administration, limited animal numbers, uniqueness of the animal model of disease, and/or novel surgical procedures. In such cases the principles of the regulation can still be followed, and where deviations occur, they should be evaluated for their impact on the expected clinical application and discussed. An in-depth discussion should be provided to support a regulatory submission. 

As with the evaluation of corneal abrasions, the application of one or two drops of 0.5% proparacaine is often necessary to allow adequate examination of the eye with a corneal or conjunctival foreign body, ft is advisable to obtain informed consent, preferably written, before proceeding with any minor surgical procedure. 

Esophageal manometry to evaluate motility should be performed in any patient who is a candidate for antireflux smgery. Esophageal manometry is useful in determining which surgical procedure is best for the patient. To perform manometry, a multilumen tube is passed into the stomach and the pressures are measured as the tube is pulled back across the lower esophageal sphincter, esophagus, and pharynx. 

Measurements of Platelet Consumption. A baboon AV shunt model was used to assess quantitatively the effects of physicochemical properties associated with polyacrylamide grafted substrates. In this model, measurements of platelet consumption using 51Cr-labeled platelets were steady state, reproducible between test animals, and unaffected by the surgical procedure (8,10). The methodology involved in the use of AV baboon shunts has been described previously (8,10). We concluded that this primate model simulates arterial thrombotic processes in humans and is suitable for the in vivo evaluation of biomaterial thrombogenesis (10). 

One unanswered question is if these minor ischemic insults could lead to delayed complications such as stricture formation. Bandi et al. [6] reported no clinically significant complications in their group of 48 patients with follow-up out to 10 years. They had ten patients with clinical follow-up and 25 with objective post-procedure evaluation (endoscopy or surgical pathology). No patient had any symptoms of an ischemic complication including six patients who had minor signs of ischemia identified at endoscopy. 

In most patients with diffuse PAVMs, improvement of dyspnea, oxygenation, and shunt fraction is not complete [12]. The residual shunt is believed to represent the shunt through small PAVMs [12]. Even if clinical and radiological evaluation is necessary, oxygen saturation tests are equally important to predict recurrence. It is recommended that patients with diffuse or non treated PAVMs be given antibiotic prophylaxis before dental and surgical procedures to avoid seeding of PAVMs and subsequent development of brain abscess. 

Evaluate each preoperative patient in light of his or her planned surgical procedure for the risk of surgical site infection, and implement appropriate antibiotic prophylaxis and other preventive measures based on that evaluation. 

Most patients evaluated for repeated abortions and found to have a uterine anomaly will have a septate uterus [27]. Avascular fibrous septa can be safely resected hysteroscopically, whereas vascularized myometrial tissue within the septum requires metroplasty as a surgical procedure for treatment of this anomaly and may enhance fetal survival, with one report indicating that 95% of patients became pregnant, 73% carried to term, and 77% delivered a liveborn baby [36]. 

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