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Home No. 17: Is a laparoscopic serial liver biopsy considered 'major' animal surgery?

Aug 02

No. 17: Is a laparoscopic serial liver biopsy considered 'major' animal surgery?

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Is a laparoscopic serial liver biopsy considered 'major' animal surgery?

Reader Question: We would like to use laparoscopic procedures to obtain serial biopsy samples from an animal's liver before introduction of an infection agent, and again at two intervals after infection. A member of our Institutional Animal Care and Use Committee (IACUC) says the biopsy penetrates the body cavity, so it's "major" surgery. That's not my reading of guidelines from the Office of Laboratory Animal Welfare (OLAW), which says the body cavity must be exposed and/or the biopsy must "substantially" impair the animal physically or physiologically. Who is right?

Reader Question: The simple answer is that it is indeed a "major" procedure because, based on the information you've given, your IACUC has made that determination. According to this statement from OLAW, the IACUC has discretion to classify a surgery as major or minor, following OLAW guidelines:

“OLAW would consider the IACUC, in its review of the unique circumstances of the research activity, as the determiner of whether the procedure is major or minor. From the description of the proposed procedures, they are related components of a research project and would be permitted by the Animal Welfare Act regulations [9 CFR, Part 2, Section 2.31 (d)(1)(x)] and the Guide for the Care and Use of Laboratory Animals if determined to be major procedures and approved by the IACUC.”

OLAW's guidelines to help IACUCs decide whether to classify a procedure as major or minor include the following:

• The PI must provide a detailed description of the procedure, along with anticipated or actual consequences, to the IACUC.

• The IACUC determines if the surgical procedures only penetrate the body cavity but don't expose it.

• The IACUC then determines if the procedure produces substantial physical or physiological impairment.

• If the answer to both IACUC determinations is No — i.e., it doesn't expose the body cavity and, No, it won't cause substantial physical or physiological impairment — then the IACUC may classify the surgery as "minor." If the answer to either question is “Yes,” it must be considered a "major" operative procedure.

While your IACUC determined the procedure is major surgery, it might have to reclassify the procedure based on the actual clinical outcome. And whether it's classified as major or minor, the IACUC will have to make sure you employ appropriate pain relief, sterility, and peri-operative monitoring.

Expert comments: by a professor of comparative medicine at a major university in the Northeast

Comments (1)
Professor, University of Pittsburgh
written by Bill Yates, August 06, 2010
The Animal Welfare Act Regulations also specify that a procedure must penetrate AND expose a body cavity, or produce impairment of physiological functions, to be considered a major surgery. The word AND was included purposefully. Unfortunately, the word "expose" was not defined, so we are not sure what constitutes an exposure of a body cavity.

The 2010 revision of the Guide also provides an IACUC more discretion in evaluating whether a procedure is major or minor. The following paragraph from the 2010 Guide makes it clear that a laparoscopic surgery can be deemed to be a minor surgery:

Procedures such as laparoscopic surgeries and some procedures associated with neuroscience research (e.g., craniotomy, neurectomy), may be classified as major or minor surgery, depending on the impact of the procedure on the animal (Devitt et al. 2005; Hancock et al. 2005; NRC 2003b; Perret-Gentil et al. 1999, 2000). For example, laparoscopic techniques with minimal associated trauma and sequelae could be considered minor (such as avian sexing and oocyte collection), while others should be considered major (e.g. hepatic lobectomy and cholecystectomy). Although minor laparoscopic procedures are often performed on an “outpatient” basis, appropriate aseptic technique and instruments and appropriate anesthesia and analgesia are necessary. Whether a laparoscopic procedure is deemed to be major or minor should be evaluated on a case-by-case basis, as determined by the veterinarian and IACUC.

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