| Literature DB >> 31290167 |
Christelle M Follette1, Michelle A Giuffrida1, Ingrid M Balsa1, William T N Culp1, Philipp D Mayhew1, Michelle L Oblak2, Ameet Singh2, Michele A Steffey1.
Abstract
OBJECTIVE: To evaluate reporting of surgical complications and other adverse events in clinical research articles describing soft tissue and oncologic surgery in dogs and cats. STUDYEntities:
Mesh:
Year: 2019 PMID: 31290167 PMCID: PMC6973234 DOI: 10.1111/vsu.13279
Source DB: PubMed Journal: Vet Surg ISSN: 0161-3499 Impact factor: 1.495
Definitions of terms commonly used to classify the time frame of complications provided in clinical research articles of surgical interventions in dogs and cats
| Term | Definition | No. of articles |
|---|---|---|
| Intraoperative | During surgery | 2 |
| During anesthesia | 2 | |
| Not postoperative | 1 | |
| Recorded at the time of surgery | 1 | |
| Perioperative | During anesthesia | 2 |
| Time from hospital admission until discharge or death | 2 | |
| During hospitalization | 1 | |
| Time from induction of anesthesia until discharge | 1 | |
| During surgery or at extubation | 1 | |
| <7 days | 1 | |
| <14 days | 1 | |
| Postoperative | Not intraoperative | 2 |
| Not perioperative | 2 | |
| Within 2 weeks of surgery | 2 | |
| After recovery from general anesthesia | 1 | |
| Within 72 hours of surgery | 1 | |
| <1 week | 1 | |
| Within 10 days of surgery | 1 | |
| Directly related to the surgical procedure | 1 | |
| Within the same hospital stay as the surgical procedure | 1 | |
| Related to surgery and occurring after surgery until suture removal | 1 | |
| Short term | ≤2 weeks after the procedure | 3 |
| 7–30 days | 3 | |
| Within 30 days after surgery | 2 | |
| During the hospitalization period | 1 | |
| 10–14 days postsurgery | 1 | |
| 14–30 days after the procedure | 1 | |
| ≥2 weeks | 1 | |
| ≤15 postoperative days | 1 | |
| <4 weeks after surgery | 1 | |
| Occurring at or before suture removal | 1 | |
| Between surgery and the 2‐week recheck | 1 | |
| Long term | >30 days after the procedure | 6 |
| >2 weeks after the procedure | 2 | |
| Noted among those with follow‐up | 1 | |
| From surgery until death or last date of contact | 1 | |
| After discharge from the hospital | 1 | |
| >15 postoperative days | 1 | |
| >4 weeks | 1 | |
| Occurring after suture removal | 1 |
Proposed terminology for defining adverse events, complications, and major reporting time frames in clinical studies of small animal soft tissue and oncologic surgery
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The Accordion Severity Classification of Postoperative Complications: Contracted Classificationa
| Level | Definition |
|---|---|
| 1 | Mild complication: Requires only minor invasive procedures that can be performed at bedside such as insertion of intravenous lines, urinary catheters, nasogastric tubes, and drainage of wound infections. Physiotherapy and the following drugs are allowed: antiemetics, antipyretics, analgesics, diuretics, and electrolytes |
| 2 | Moderate complication: Requires pharmacologic treatment with drugs other than those allowed for minor complications (eg, antibiotics); blood transfusions and total parenteral nutrition are also included |
| 3 | Severe complication: All complications requiring endoscopic or interventional radiologic procedures or reoperation as well as complications resulting in failure of one or more organ systems |
| 4 | Death: Postoperative death |
An expanded classification in the area of “severe” complications is available and recommended for large studies of very complex procedures.6
Proposed definitions and grading of three commonly reported intraoperative complications
| Intraoperative incidents | |||||
|---|---|---|---|---|---|
| Adverse event | Grade | ||||
| 1 | 2 | 3 | 4 | 5 | |
| Iatrogenic tissue injury | Incidents managed with minimal change in operative tactics and without further consequences for the patient | Incidents managed with change in operative tactics but without further consequences for the patient | Incidents with further non–life‐threatening consequences for the patient | Incidents with further life‐threatening consequences for the patient | Incidents resulting in death |
| Technical failure | Incidents managed with minimal change in operative tactics and without further consequences for the patient | Incidents managed with changes in operative tactics but without further consequences for the patient | Incidents with further non–life‐threatening consequences for the patient | Incidents with further life‐threatening consequences for the patient | Incidents resulting in death |
| Conversion from laparoscopic or thoracoscopic approach | Strategic conversion to hand‐assisted or open approach due to anticipated operative difficulty | Reactive extension of an incision or conversion to hand‐assisted approach because of operative difficulty or non–life‐threatening operative error | Reactive conversion to open approach because of operative difficulty or non–life‐threatening operative error | Reactive conversion to open approach due to life‐threatening operative error | … |
Abbreviation: …, Grade 5 severity is not defined for the complication of operative conversion. If an animal died as a result of an event that required conversion, the conversion would be grade 4 and the underlying event would be the cause of death.
Injury to tissues adherent or adjacent to the intended operative site.
Malfunction of operative equipment, instruments, or implantable materials, whether due to operator error or not.
Intraoperative switch from laparoscopic or thoracoscopic approach to hand‐assisted or open laparotomy or thoracotomy. A strategic conversion is made directly after feasibility assessment of completing the operation with the intended technique because of anticipated operative difficulty or logistic considerations. A reactive conversion is made in response to an operative error or operative difficulty after intracorporeal procedures or dissection have begun.12
Classification of Intraoperative Complications (CLASSIC) criteriaa
| Grade | Definition |
|---|---|
| 0 | No deviation from the ideal operative course |
| I | Any deviation from the ideal operative course |
| Without the need for any additional treatment or intervention | |
| II | Any deviation from the ideal operative course |
| With the need for any additional treatment or intervention | |
| Not life threatening and not leading to permanent disability | |
| III | Any deviation from the ideal operative course |
| With the need for any additional treatment or intervention | |
| Life threatening and/or leading to permanent disability | |
| IV | Any deviation from the ideal operative course |
| With the death of the patient |
Sequelae, failures of cure, events related to underlying disease, wrong‐site or wrong‐patient surgery, and errors in indication are not defined as intraoperative complications.7
Sample table for reporting postoperative complicationsa
| Patients assessed for complications | ||
|---|---|---|
| Complications | Group 1, N = 100, n (%) | Group 2, N = 50, n (%) |
| Grade 1 | ||
| Vomiting | 9 (9) | 5 (10) |
| Diarrhea | 11 (11) | 5 (10) |
| Seroma | 4 (4) | 2 (4) |
| Fever | 1 (1) | 2 (4) |
| Total grade 1 complications | 25 (25) | 14 (28) |
| Grade 2 | ||
| Vomiting | 4 (4) | 1 (2) |
| Laryngeal edema | 0 (0) | 1 (2) |
| Total grade 2 complications | 4 (4) | 2 (4) |
| Grade 3 | ||
| Esophagitis | 1 (1) | 0 (0) |
| Total grade 3 complications | 1 (1) | 0 (0) |
| Grade 4 | ||
| Acute kidney injury | 0 (0) | 1 (2) |
| Septic peritonitis | 5 (5) | 5 (10) |
| Total grade 4 complications | 5 (5) | 6 (12) |
| Grade 5 | ||
| Death due to septic peritonitis | 2 (2) | 2 (4) |
| Total grade 5 complications | 2 (2) | 2 (4) |
Adapted from Strasberg et al.6