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1 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | ACORP_Appendix5_59.docx | Wed May 2 23:25:58 2018 UTC |
2 | RAMS-2.3.0.zip\RAMS-2.3.0\Webapp\RAMS-2.3.0\RAMS-2.3.0.war\WEB-INF\classes | ACORP_Appendix5_59.docx | Tue Jul 17 21:29:52 2018 UTC |
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1 | Official D ate of App roval► | |
2 | ||
3 | ACORP Appe ndix 5 | |
4 | Surgery | |
5 | Version 4 | |
6 | ||
7 | See ACORP App. 5 Ins tructions, for more detailed e xplanation s of the i nformation requested . | |
8 | ||
9 | Surgery Cl assificati on. Compl ete the ta ble below for each s urgery inc luded in t his protoc ol, and in dicate how it is cla ssified (t erminal, m inor survi val, major survival, one of mu ltiple sur vival). S ee ACORP A pp. 5 Inst ructions, for detail s. | |
10 | ||
11 | Surgery | |
12 | Terminal | |
13 | Survival | |
14 | # | |
15 | Descriptio n | |
16 | (specify t he species , if ACORP covers mo re than on e) | |
17 | ||
18 | Minor | |
19 | Major | |
20 | One of Mul tiple* | |
21 | 1 | |
22 | ||
23 | ( ) | |
24 | ( ) | |
25 | ( ) | |
26 | ( )* | |
27 | 2 | |
28 | ||
29 | ( ) | |
30 | ( ) | |
31 | ( ) | |
32 | ( )* | |
33 | 3 | |
34 | ||
35 | ( ) | |
36 | ( ) | |
37 | ( ) | |
38 | ( )* | |
39 | 4 | |
40 | ||
41 | ( ) | |
42 | ( ) | |
43 | ( ) | |
44 | ( )* | |
45 | ||
46 | *If surviv al surgery (includin g major su rgeries an d any mino r surgerie s that may induce su bstantial post-proce dural pain or impair ment) will be perfor med as par t of this protocol i n addition to any ot her such s urgery (on this or a nother pro tocol) on the same i ndividual animal, co mplete ite ms 1.a and 1.b, belo w: | |
47 | ||
48 | Provide a complete s cientific justificat ion for pe rforming t he multipl e survival surgeries on an ind ividual an imal: | |
49 | ► | |
50 | ||
51 | Give the i nterval(s) between s uccessive surgeries, and the r ationale f or choosin g the inte rval(s): | |
52 | ► | |
53 | ||
54 | Descriptio n of Surge ries. Des cribe each surgery l isted in I tem 1, pro viding eno ugh detail to make i t clear wh at the eff ects on th e animal w ill be. ( Pre-operat ive prepar ation, ane sthesia, a nd post-op erative re covery wil l be cover ed in item s 5, 6, an d 7, below .) | |
55 | ||
56 | Surgery 1 ► | |
57 | ||
58 | Surgery 2 ► | |
59 | ||
60 | Surgery 3 ► | |
61 | ||
62 | Surgery 4 ► | |
63 | ||
64 | Personnel. Complete the table below for each indi vidual who will be i nvolved in any of th e surgerie s on this protocol. | |
65 | ||
66 | Name | |
67 | Surgery #( s) (see It em 1) | |
68 | Role in Su rgery | |
69 | ||
70 | ||
71 | Surgeon | |
72 | Assistant | |
73 | Manage Ane sthesia | |
74 | Other (des cribe) | |
75 | ||
76 | ||
77 | ( ) | |
78 | ( ) | |
79 | ( ) | |
80 | ( ) | |
81 | ||
82 | ||
83 | ( ) | |
84 | ( ) | |
85 | ( ) | |
86 | ( ) | |
87 | ||
88 | ||
89 | ( ) | |
90 | ( ) | |
91 | ( ) | |
92 | ( ) | |
93 | ||
94 | ||
95 | ( ) | |
96 | ( ) | |
97 | ( ) | |
98 | ( ) | |
99 | ||
100 | ||
101 | ( ) | |
102 | ( ) | |
103 | ( ) | |
104 | ( ) | |
105 | ||
106 | ||
107 | Location o f surgery. Complete the table below for each loca tion where surgery o n this pro tocol will be perfor med. | |
108 | ||
109 | Building | |
110 | Room Numbe r | |
111 | Surgery #( s) | |
112 | (see | |
113 | Item 1) | |
114 | Type of Sp ace | |
115 | ||
116 | ||
117 | ||
118 | Dedicated Surgical F acility | |
119 | Other Dedi cated Surg ical Space | |
120 | Other Spac e not Dedi cated to S urgery | |
121 | ||
122 | ||
123 | ||
124 | ( ) | |
125 | ( )* | |
126 | ( )* | |
127 | ||
128 | ||
129 | ||
130 | ( ) | |
131 | ( *) | |
132 | ( )* | |
133 | ||
134 | ||
135 | ||
136 | ( ) | |
137 | ( )* | |
138 | ( )* | |
139 | ||
140 | ||
141 | ||
142 | ( ) | |
143 | ( )* | |
144 | ( )* | |
145 | ||
146 | *For each space that is not in a dedicat ed surgica l facility , provide the justif ication fo r using th is space f or surgery on this p rotocol | |
147 | ► | |
148 | ||
149 | Pre-operat ive protoc ol. | |
150 | ||
151 | Pre-operat ive proced ures. Com plete the table belo w for each pre-opera tive proce dure that will be pe rformed to prepare t he animal( s) for sur gery. | |
152 | ||
153 | Surgery #( s) (see It em 1) | |
154 | Fast | |
155 | (Specify D uration) | |
156 | Withhold W ater (Spec ify Durati on) | |
157 | Place Intr avenous Ca theter(s) | |
158 | (Specify S ite(s)) | |
159 | Other – De scribe | |
160 | 1 | |
161 | ( ) -- | |
162 | ( ) -- | |
163 | ( ) -- | |
164 | ( ) -- | |
165 | 2 | |
166 | ( ) -- | |
167 | ( ) -- | |
168 | ( ) -- | |
169 | ( ) -- | |
170 | 3 | |
171 | ( ) -- | |
172 | ( ) -- | |
173 | ( ) -- | |
174 | ( ) -- | |
175 | 4 | |
176 | ( ) -- | |
177 | ( ) -- | |
178 | ( ) -- | |
179 | ( ) -- | |
180 | ||
181 | Pre-operat ive medica tions. Co mplete the table bel ow. Inclu de agent(s ) for indu ction of a nesthesia, as well a s any othe r pre-trea tments tha t will be administer ed prior t o preparat ion of the surgical site on th e animal. | |
182 | ||
183 | Agent | |
184 | Surgery #( s) | |
185 | (see | |
186 | Item 1) | |
187 | Dose (mg/k g) & volum e (ml) | |
188 | Route of a dministrat ion | |
189 | Frequency of adminis tration | |
190 | (e.g., tim es/day) | |
191 | Pre-operat ive period of treatm ent | |
192 | (e.g., imm ediate, or # of days ) | |
193 | ||
194 | ||
195 | ||
196 | ||
197 | ||
198 | ||
199 | ||
200 | ||
201 | ||
202 | ||
203 | ||
204 | ||
205 | ||
206 | ||
207 | ||
208 | ||
209 | ||
210 | ||
211 | ||
212 | Pre-operat ive prepar ation of t he surgica l site. F or each su rgery, ide ntify each surgical site on th e animals, and descr ibe how it will be p repared pr ior to sur gery. | |
213 | ||
214 | Surgery 1 ► | |
215 | ||
216 | Surgery 2 ► | |
217 | ||
218 | Surgery 3 ► | |
219 | ||
220 | Surgery 4 ► | |
221 | ||
222 | Intra-oper ative mana gement. | |
223 | ||
224 | Intra-oper ative medi cations. Complete t he table b elow for e ach agent that will be adminis tered to t he animal during sur gery. | |
225 | ||
226 | Agent | |
227 | Paralytic* | |
228 | Surgery #( s) | |
229 | (see | |
230 | Item 1) | |
231 | Dose (mg/k g) & volum e (ml) | |
232 | Route of a dministrat ion | |
233 | Frequency of dosing | |
234 | ||
235 | ( )* | |
236 | ||
237 | ||
238 | ||
239 | ||
240 | ||
241 | ( )* | |
242 | ||
243 | ||
244 | ||
245 | ||
246 | ||
247 | ( )* | |
248 | ||
249 | ||
250 | ||
251 | ||
252 | ||
253 | * For each agent sho wn above a s a paraly tic, expla in why its use is ne cessary, a nd describ e how the animals wi ll be moni tored to e nsure that the depth of anesth esia is su fficient t o prevent pain. | |
254 | ► | |
255 | ||
256 | Intra-oper ative phys ical suppo rt. For e ach surger y, describ e any phys ical suppo rt that wi ll be prov ided for t he animals during su rgery (e.g ., warming , cushioni ng, etc.). | |
257 | ► | |
258 | ||
259 | Intra-oper ative moni toring. D escribe th e methods that will be used to monitor a nd respond to change s in the s tate of an esthesia a nd the gen eral well- being of t he animal during sur gery. | |
260 | ► | |
261 | ||
262 | Survival s urgery con sideration s. For ea ch surviva l surgical procedure indicated in Item 1 and descr ibed in It em 2, comp lete Items 7.a. – 7. g. | |
263 | ||
264 | Complete t he table b elow for e ach surviv al surgery listed in Item 1, a bove. | |
265 | ||
266 | Surgery # | |
267 | (see Item 1) | |
268 | Survival P eriod | |
269 | Measures f or Maintai ning Steri lity | |
270 | ||
271 | ||
272 | Sterile In struments | |
273 | Surgical C ap | |
274 | Sterile Gl oves | |
275 | Surgical S crub | |
276 | Sterile Dr apes | |
277 | Sterile Go wn | |
278 | Face Mask | |
279 | Other* | |
280 | ||
281 | ||
282 | ( ) | |
283 | ( ) | |
284 | ( ) | |
285 | ( ) | |
286 | ( ) | |
287 | ( ) | |
288 | ( ) | |
289 | ( )* | |
290 | ||
291 | ||
292 | ( ) | |
293 | ( ) | |
294 | ( ) | |
295 | ( ) | |
296 | ( ) | |
297 | ( ) | |
298 | ( ) | |
299 | ( )* | |
300 | ||
301 | ||
302 | ( ) | |
303 | ( ) | |
304 | ( ) | |
305 | ( ) | |
306 | ( ) | |
307 | ( ) | |
308 | ( ) | |
309 | ( )* | |
310 | ||
311 | ||
312 | ( ) | |
313 | ( ) | |
314 | ( ) | |
315 | ( ) | |
316 | ( ) | |
317 | ( ) | |
318 | ( ) | |
319 | ( )* | |
320 | ||
321 | * Describe any “othe r” measure s to be ta ken to mai ntain ster ility duri ng surgery . | |
322 | ► | |
323 | ||
324 | For each s urgery, de scribe the immediate post-oper ative supp ort to be provided t o the anim als. | |
325 | ||
326 | Surgery 1 ► | |
327 | ||
328 | Surgery 2 ► | |
329 | ||
330 | Surgery 3 ► | |
331 | ||
332 | Surgery 4 ► | |
333 | ||
334 | Post-opera tive analg esia. Com plete the table belo w for each surgery l isted in i tem 1, abo ve. | |
335 | ||
336 | Surgery # (see | |
337 | Item 1) | |
338 | Agent* | |
339 | Dose (mg/k g) & Volum e (ml) | |
340 | Route of A dministrat ion | |
341 | Frequency of Dosing | |
342 | (e.g., tim es/day) | |
343 | Period of treatment | |
344 | (e.g. days ) | |
345 | 1 | |
346 | ||
347 | ||
348 | ||
349 | ||
350 | ||
351 | 2 | |
352 | ||
353 | ||
354 | ||
355 | ||
356 | ||
357 | 3 | |
358 | ||
359 | ||
360 | ||
361 | ||
362 | ||
363 | 4 | |
364 | ||
365 | ||
366 | ||
367 | ||
368 | ||
369 | ||
370 | *For each surgery fo r which NO post-oper ative anal gesic will be provid ed, enter “none” in the “Agent ” column, and explai n here why this is j ustified: | |
371 | ► | |
372 | ||
373 | Other post -operative medicatio ns. Compl ete the fo llowing ta ble to des cribe all other medi cations th at will be administe red as par t of post- operative care. | |
374 | ||
375 | Surgery # | |
376 | (see | |
377 | Item 1) | |
378 | Medication | |
379 | Dose (mg/k g) & Volum e (ml) | |
380 | Route of A dministrat ion | |
381 | Frequency of dosing | |
382 | (e.g. time s/day) | |
383 | Period of treatment | |
384 | (e.g. days ) | |
385 | ||
386 | ||
387 | ||
388 | ||
389 | ||
390 | ||
391 | ||
392 | ||
393 | ||
394 | ||
395 | ||
396 | ||
397 | ||
398 | ||
399 | ||
400 | ||
401 | ||
402 | ||
403 | ||
404 | ||
405 | ||
406 | ||
407 | ||
408 | ||
409 | ||
410 | Post-opera tive monit oring. Aft er-hours c ontact inf ormation f or the per sonnel lis ted must b e provided to the ve terinary s taff for u se in case of an eme rgency. | |
411 | ||
412 | Immediate post-opera tive monit oring | |
413 | ||
414 | Surgery # (see Item 1) | |
415 | Frequency of Monitor ing | |
416 | Duration a t this Fre quency | |
417 | Name(s) of Responsib le Individ ual(s) | |
418 | ||
419 | ||
420 | ||
421 | ||
422 | ||
423 | ||
424 | ||
425 | ||
426 | ||
427 | ||
428 | ||
429 | ||
430 | ||
431 | ||
432 | ||
433 | ||
434 | ||
435 | ||
436 | ||
437 | ||
438 | ||
439 | Post-opera tive monit oring afte r the imme diate post -operative period | |
440 | ||
441 | Surgery # (see Item 1) | |
442 | Frequency of Monitor ing | |
443 | Duration a t this Fre quency | |
444 | Name(s) of Responsib le Individ ual(s) | |
445 | ||
446 | ||
447 | ||
448 | ||
449 | ||
450 | ||
451 | ||
452 | ||
453 | ||
454 | ||
455 | ||
456 | ||
457 | ||
458 | ||
459 | ||
460 | ||
461 | ||
462 | ||
463 | ||
464 | ||
465 | ||
466 | Post-opera tive conse quences an d complica tions. | |
467 | ||
468 | For each s urgery, de scribe any common or expected post-opera tive conse quences or complicat ions that may arise and what w ill be don e to addre ss them. | |
469 | ||
470 | Surgery 1 ► | |
471 | ||
472 | Surgery 2 ► | |
473 | ||
474 | Surgery 3 ► | |
475 | ||
476 | Surgery 4 ► | |
477 | ||
478 | List the c riteria fo r euthanas ia related specifica lly to pos t-operativ e complica tions: | |
479 | ||
480 | Surgery 1 ► | |
481 | ||
482 | Surgery 2 ► | |
483 | ||
484 | Surgery 3 ► | |
485 | ||
486 | Surgery 4 ► | |
487 | ||
488 | In case an emergency medical s ituation a rises and none of th e research personnel on the AC ORP can be reached, identify a ny drugs o r classes of drugs t hat should be avoide d because of the sci entific re quirements of the pr oject. (I f the cond ition of t he animal requires o ne of thes e drugs, t he animal will be eu thanatized instead.) | |
489 | ► | |
490 | ||
491 | Maintenanc e of post- surgical m edical rec ords. Com plete the table belo w for each surgery, specifying where the records w ill held, and identi fying at l east one i ndividual who will b e assigned to mainta in accurat e, daily, written po st-surgica l medical records. Indicate w hether the named ind ividuals a re researc h personne l involved in this p roject, or members o f the vete rinary sta ff. | |
492 | ||
493 | Surgery # (see Item 1) | |
494 | Location o f Records | |
495 | Name(s) of Individua l(s) Respo nsible for Maintaini ng Written Records | |
496 | Research P ersonnel | |
497 | Veterinary Staff | |
498 | 1 | |
499 | ||
500 | ||
501 | ( ) | |
502 | ( ) | |
503 | 2 | |
504 | ||
505 | ||
506 | ( ) | |
507 | ( ) | |
508 | 3 | |
509 | ||
510 | ||
511 | ( ) | |
512 | ( ) | |
513 | 4 | |
514 | ||
515 | ||
516 | ( ) | |
517 | ( ) | |
518 | ||
519 | Certificat ion. The PI must si gn the cer tification statement in Item Z .5 of the main body of the ACO RP. |
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