Operative notes do not reflect reality in laparoscopic cholecystectomy

Original article

Operative notes do not reflect reality in laparoscopic cholecystectomy L. S. G. L. Wauben1,3 , W. M. U. van Grevenstein5 , R. H. M. Goossens2,3 , F. H. van der Meulen4 and J. F. Lange1 Departments of 1 Surgery and 2 Neuroscience, Erasmus University Medical Centre, Rotterdam, 3 Department of Applied Ergonomics and Design, Faculty of Industrial Design Engineering and 4 Department of Mathematics and Computer Science, Faculty of Electrical Engineering, Delft University of Technology, Delft, and 5 Department of Oncological and Gastrointestinal Surgery, University Medical Centre Utrecht, Utrecht, The Netherlands Correspondence to: Dr L. S. G. L. Wauben, Department of Applied Ergonomics and Design, Faculty of Industrial Design Engineering, Delft University of Technology, Landbergstraat 15, 2628 CE Delft, The Netherlands (e-mail: [email protected])

Background: Operative notes represent an essential element in safe patient care and should therefore

be clear and accurate. This comparative study examined whether operative notes accurately represented the laparoscopic cholecystectomy (LC) as performed. Methods: Nine Dutch teaching and non-teaching hospitals were invited to record 20 successive LCs each and to collect the corresponding operative notes. The main outcome measures were overall differences and correspondence between video recordings and notes based on the Dutch guideline for LC and the occurrence of iatrogenic gallbladder perforation. A comparison was made of the cumulative results of recordings and operative notes, and individual recordings were compared with the corresponding notes. Results: Seven hospitals participated in the study; 125 video recordings and operative notes were fully analysed. Recordings showed more steps of the procedure than did notes. Individual comparisons showed significant differences (P ≤ 0·001) between the recording and the corresponding note for the steps ‘Introducing trocars under vision’, ‘Condition of the gallbladder’, ‘Critical view of safety’ and ‘Removing first and second trocar under vision’. Iatrogenic gallbladder perforation with spilled bile occurred in 31 patients (24·8 per cent), and was both recorded and reported in 29 patients. Iatrogenic gallbladder perforation with spilled bile and spilled stones occurred in 15 patients (12·0 per cent), and was recorded and reported in 11 patients. Conclusion: Operative notes do not adequately represent the actual LCs performed as they describe fewer important procedural steps. It is suggested that operative notes should include video recordings. Paper accepted 30 March 2011 Published online 1 June 2011 in Wiley Online Library (www.bjs.co.uk). DOI: 10.1002/bjs.7576

Introduction

Operative notes are standard for all surgical disciplines for the systematic documentation of an operation and are thus an essential element in safe patient care. Operative notes should be clear, accurate and timely written1 – 3 . Furthermore, notes are useful for research, education, medicolegal cases and quality assurance3 – 9 . In contrast with the extensive developments in surgery and related disciplines in the past few centuries, the operative note has remained much the same: it is often a subjective, non-standardized testimony, dictated to a transcription service or secretary6,9 – 11 . Usually, operative notes are dictated or written immediately after the operation, but  2011 British Journal of Surgery Society Ltd Published by John Wiley & Sons Ltd

delays are not exceptional2 – 4,7,10,11 . Although written or dictated notes are familiar to the surgeon, and are flexible and easy to adapt, recent studies have shown some disadvantages. For instance, notes may include inadequate or incomplete information on the operation performed, the indication for surgery and postoperative instructions, and the time frame between surgery and documentation may not be clear1,2,4,7,9,11,12 . Methods for writing operative notes, such as electronic templates or database management systems for generating notes, seem to improve record-keeping1,2,4,7,8,10,11 . Furthermore, video registration for documentation of the operation has been introduced. Currently, no operative documentation is based solely on video recordings. British Journal of Surgery 2011; 98: 1431–1436

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However, images portray more information than the written word. Studies have shown that video recordings provide additional information regarding anatomical and pathological changes and surgical outcome, give better insight into potential problems, enable earlier detection of complications, and facilitate future surgery or treatment of the patient5,13,14 . Potential concerns are physicians’ acceptance of information technology, liability, privacy, initial costs and file storage5 . Current video technology might improve and support the process of producing operative notes. This study focused on the possible added value of making video recordings in addition to operative notes, and examined whether notes actually represent the operations performed. Laparoscopic cholecystectomy (LC) was chosen as an index operation because this procedure is easy to record. Furthermore, an official guideline of the Dutch Society of Surgery15,16 recommends image registration by photographing the obtained critical view of safety (CVS)17 . Methods

In August 2007, nine Dutch teaching and non-teaching hospitals were invited to participate in the study. Presentations were given to the participants, explaining the aim of the study. Each hospital had to record 20 successive LCs on digital video disc (DVD) in at least standard quality. The surgeons and residents who participated were not blinded to the study. The image recording was to start when the abdomen was entered, and to be discontinued when the endoscope was disconnected. All operative notes were to be collected as well. Most data were received anonymously without patient information or the name of the surgeon and institution, or were anonymized before the data were analysed. All DVDs were copied to a hard disk, and the operative notes were retyped. Each recording and corresponding note was given an identification number. First the recordings were viewed on a Mac or PC, and analysed by a researcher and a surgeon based on the stepwise LC guideline of the Dutch Society of Surgery16 . If consensus could not be reached, a second surgeon analysed the image recordings. The six analysed steps of the LC guidelines included: 1, Introducing trocars under vision; 2, Condition of the gallbladder; 3, Establishing CVS; 4, Placing of the clips; 5, Haemostasis of the liver bed; and 6, Removing trocars under vision. CVS was defined as completely unfolding Calot’s triangle by mobilizing the gallbladder neck from the gallbladder bed of the liver before clipping and transecting the cystic artery and duct18 . ‘Adequate placing of the clips’ was defined as  2011 British Journal of Surgery Society Ltd Published by John Wiley & Sons Ltd

‘clips encircling the entire tubular structure’, and ‘adequate haemostasis of the liver bed’ was defined as either ‘checking actively by pulling up the liver by lifting of gallbladder’ or ‘pushing up the liver edge by means of an instrument’. The steps were rated as ‘performed according to the guidelines’ or ‘not performed according to the guidelines’. Additional comments could be added to all steps. Iatrogenic gallbladder perforations were also recorded. The operative notes were analysed in a similar way. The cumulative ratings for the video recordings were compared with those for the operative notes.

Statistical analysis Individual video recordings and operative notes were compared assuming the probability that a specific aspect of the procedure was the same for both the recording and the note. McNemar’s test for marginal homogeneity was used, excluding missing values19 . A generalized likelihood ratio test, including missing data, was performed20,21 . Bonferroni correction was applied for multiple comparisons, making P < 0·005 statistically significant. Statistical software R version 2.9.2 for Mac (http://www.r-project.org) was used for analyses. Results

Seven of nine contacted hospitals participated in the study, six teaching and one non-teaching hospital. One teaching hospital failed to collect the data before the inclusion date and another wanted to wait until a new operating room was fully functional. The total number of cholecystectomies performed in 2007 in the participating hospital ranged from 161 to 564. Approximately 80 per cent of the cholecystectomies were performed laparoscopically. The non-teaching hospital performed 189 LCs and the teaching hospitals performed a mean of 283 LCs. In total, 139 DVDs and operative notes were received for analysis. However, five DVDs could not be analysed as they could not be viewed on the Mac or PC. Conversion to open operation was entailed in eight recordings. As the endoscope was disconnected with no image being recorded, these cases could not be analysed. Reasons for conversion were unclear anatomy in seven patients and bile duct injury in one patient. One recording could not be compared with the operative note, as this had not been dictated when the hospital’s data were received for analysis. Hence, 125 recordings and operative notes were fully analysed. The notes were dictated in six hospitals, in two of which a dictation template was used. All notes were checked after transcription. The non-teaching hospital www.bjs.co.uk

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used a standardized computer-based template for writing the notes. For some operations the video recording started too late, so that the procedure was mistakenly not recorded from the start, or the recording ended too soon, or both. Consequently, the recordings had missing data. For some specific steps, for example the introduction of trocars under vision, the proportion of operations with missing data was quite large. Cumulative scores of the comparison between the recordings and notes showed that, in majority of cases, the recordings depicted steps 1 through 6 of the guideline (Table 1). The operative notes also described these steps in most patients, except for step 1, which was documented in less than half of the operations. Furthermore, analysis of data from the notes

showed that in 51 patients (40·8 per cent) CVS was not described adequately. In these 51 patients, the majority of the notes described ‘dissection of the cystic duct and cystic artery’ (25 patients) and ‘Calot’s triangle’ (12). In four patients, CVS was not accomplished owing to the use of a different surgical approach or bleeding. Nevertheless, the recordings showed that CVS was accomplished in 36 of these 51 patients. The recordings showed that in eight patients the clips were placed inadequately. In one patient the clips were placed and replaced, leaving six clips on the cystic duct, and one clip was dropped in the abdomen and not retrieved. In another patient partial resection of the gallbladder was performed resulting in no structures being clipped or cut, and in a third patient the clips did not encircle the entire

Table 1 Comparison of recordings and operative notes with overall cumulative scores in 125 patients undergoing laparoscopic cholecystectomy Step

Means of documentation

Recorded/described

Not recorded/not described

Missing data

1 Introducing trocars under vision*

Recordings Notes

86 (68·8) 58 (46·4)

4 (3·2) 67 (53·6)

35 (28·0) 0 (0)

2 Condition of the gallbladder

Recordings Notes

121 (96·8) 83 (66·4)

0 (0) 42 (33·6)

4 (3·2) 0 (0)

3 CVS

Recordings Notes

99 (79·2) 74 (59·2)

26 (20·8) 51 (40·8)

0 (0) 0 (0)

4 Placement of clips

Recordings Notes

117 (93·6) 116 (92·8)

8 (6·4) 9 (7·2)

0 (0) 0 (0)

5 Haemostasis of the liver bed

Recordings Notes

91 (72·8) 89 (71·2)

33 (26·4) 36 (28·8)

1 (0·8) 0 (0)

6 Removing trocars under vision*

Recordings Notes

91 (72·8) 80 (64·0)

25 (20·0) 44 (35·2)

9 (7·2) 1 (0·8)

Values in parentheses are percentages. *Mean number of procedures in which the three trocars (epigastric and two working trocars) were introduced and removed under vision. CVS, critical view of safety. Table 2 Comparison of the six operative steps of laparoscopic cholecystectomy observed in the video recording and described in the corresponding operative note P

Step no. 1

2 3 4 5 6

Step

Cases compared

Described but not seen

Seen but not described

Missing values

McNemar test‡

Likelihood ratio test

Introducing first trocar* Introducing second trocar* Introducing third trocar* Condition of the gallbladder CVS Placement of clips Haemostasis of the liver bed Removing first trocar*† Removing second trocar*† Removing third trocar*†

86 91 93 121 125 125 124 118 116 114

3 1 4 0 11 6 18 7 11 23

39 49 47 40 36 7 20 34 32 23

39 34 32 4 0 0 1 6 8 10

< 0·001 < 0·001 < 0·001 < 0·001 < 0·001 0·782 0·746 < 0·001 0·001 1·000

< 0·001 < 0·001 < 0·001 < 0·001 < 0·001 0·776 0·664 < 0·001 < 0·001 0·982

*Under vision. †For one operation, the operative note was not available; missing data were omitted and the McNemar test was performed using the remaining 124 operations. ‡Without continuity correction. CVS, critical view of safety.

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cystic duct. Two notes described that ‘the common bile duct was clipped and cut’, which was actually not the case. The recordings showed more steps than were described in the notes: 327 (26·2 per cent) of the total of 1250 steps were seen but not described (Table 2). Only a small majority of all steps analysed (705 (56·4 per cent) of 1250) were observed in both the individual note and its recording. Comparisons showed significant differences (P ≤ 0·001) between the recordings and the notes for the steps: ‘Introducing first, second and third trocar under vision’, ‘Condition of the gallbladder’, ‘CVS’, and ‘Removing first and second trocar’. In 31 patients (24·8 per cent) perforation with spilled bile occurred; this was recorded and reported in 29 patients. However, two recordings showed perforations with spilled bile that were not described in the corresponding notes. In 15 patients (12·0 per cent) perforation with spilled bile and stones occurred; this was recorded and reported in 11 patients. Four recordings showed perforation with spillage that was not described in the corresponding note: the perforation and not the spilled stones was described in two patients, and no perforation was documented in the other two patients.

Discussion

This study showed significant differences in the accuracy of reported intraoperative data for LC between video recordings and the corresponding operative notes. In approximately one-quarter of the steps analysed the recordings showed more data than the notes. Furthermore, in some cases the notes described steps of the procedure that could not be verified in the recordings. The step of LC that most often could not be verified was ‘removing trocars under vision’. This is of importance as potentially dangerous portsite bleeding may occur22 . Nevertheless, recordings were occasionally incomplete as well. In particular, the introduction of the trocars was often not recorded. Reasons for inaccuracy in operative notes relate partly to practical problems. Dictating notes for several, possibly identical, procedures at the end of the day makes the testimony less accurate10,12,23 . Subjective notes lead to underreporting, and thereby preclude qualitative and quantitative analysis of technical errors24 – 28 . Furthermore, lack of information impedes communication with other healthcare providers1,24,28 . Common bile duct injury is the main severe complication encountered in LC14,29 – 31 . Although the Dutch Healthcare Inspectorate and the Dutch Society of Surgery advise that CVS be established and recorded photographically, a live video image of the procedure is advantageous in  2011 British Journal of Surgery Society Ltd Published by John Wiley & Sons Ltd

assessing the achievement of CVS. Recording the procedure also permits analysis of the circumstances under which the error occurred14,28,32 . However, it is advisable to add time-markers for recordings during surgery in order to improve review and to add comments on specific steps of the procedure. An important problem in LC is iatrogenic gallbladder perforation with leak of bile and gallstones26,30,31 , and the possibility of subsequent septic complications, although the risk of sepsis as described in the literature is low (0·08–0·3 per cent)30,31 . The rates of iatrogenic gallbladder perforation (24·8 per cent) and perforation with gallstone spillage (12·0 per cent) in the present study were at the high end of the range reported in the literature (13–40 and 5–19 per cent respectively)26,31 . This can be explained by the fact that gallstone spillage is often underreported26 . Although no studies have shown any actual harm inflicted on patients as a result of inadequate operative notes, a lack of clear description of actual intraoperative events could affect the patient’s postoperative treatment and delay the diagnosis of late complications26,30 . Future documentation of surgical procedures could be suggested to include video recordings combined with operative notes5,28 . The accuracy of notes can be assisted by structured and electronic templates. International studies have shown that templates improve the record-keeping of surgeons in terms of efficiency, comprehensiveness, completeness, accuracy, effectiveness and uniformity1,7,10,11 . However, it is important that the templates are not so rigid that important information is lost9 . Video recording of operative procedures has some distinct advantages over written notes. Recording data objectively can provide a critical piece of evidence in medicolegal cases, and furthermore is more transparent when a specific procedure is discussed after surgery with the patient or other physicians4 – 6,8,11,13,25,28,29 . Besides being beneficial for the individual patient, video recordings might prevent future complications as they enable study of how complications such as biliary injury might occur14,28,32 . Conversely, challenges are met within the field of investment, privacy and liability5,32 . However, in a comparable setting, Groenen and colleagues33 showed that the financial benefit from the investment was gained within 5 years. Although other elements of the operative procedure are of importance for the outcome of an operation, this study focused only on the operative technique of LC. The assumption was that the video recording might provide an added value to the operative notes for documentation of the operation. This study included surgeons and residents willing to be analysed and recorded anonymously, although www.bjs.co.uk

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no surgeon declined participation for this particular reason. Nevertheless, the participants were not blinded; they knew the procedure was being recorded and that the notes would be compared with the recordings. Thus, a Hawthorne effect – better performance owing to the fact that the subject is being studied – could have led to slightly deviant results. This study has shown that, at present, operative notes do not accurately represent the actual LC being performed, as they describe fewer important procedural steps. It is suggested that documentation of an operative procedure such as LC should involve a combination of notes and video recordings. Recordings add important information, which can be used for quality assurance, information for patients, evidence in medicolegal cases, and teaching purposes, and might help to prevent future complications. Acknowledgements

The authors would like to thank the contact persons at each hospital for providing the recordings and operative notes: J. P. C. M. Oomen, R. Vree, P. Plaisier, N. D. Bouvy, H. A. Prins, E. G. J. M. Pierik, B. A. Van Wagensveld and A. Doeksen. They also thank MediRisk for providing one Sony DV-1000MD recorder to record the procedures. The authors declare no conflict of interest. References 1 Edhemovic I, Temple WJ, de Gara CJ, Stuart GC. The computer synoptic operative report – a leap forward in the science of surgery. Ann Surg Oncol 2004; 11: 941–947. 2 Parikh JA, Yermilov I, Jain S, McGory ML, Ko CY, Maggard MA. How much do standardized forms improve the documentation of quality of care? J Surg Res 2007; 143: 158–163. 3 Vergis A, Gillman L, Minor S, Taylor M, Park J. Structured assessment format for evaluating operative reports in general surgery. Am J Surg 2008; 195: 24–29. 4 Lefter LP, Walker SR, Dewhurst F, Turner RW. An audit of operative notes: facts and ways to improve. ANZ J Surg 2008; 78: 800–802. 5 Houkin K, Kuroda S, Abe H. Operative record using intraoperative digital data in neurosurgery. Acta Neurochir (Wien) 2000; 142: 913–919. 6 Borchert D, Harshen R, Kemps M, Lavelle M. Operative notes teaching: re-discovery of an effective teaching tool in surgical training. The Internet Journal of Surgery 2006; 8. http://www.ispub.com/journal/the_internet_journal_of_ surgery/volume_8_number_1/article/operative_notes_ teaching_re_discovery_of_an_effective_teaching_tool_ in_surgical_training.html [accessed 3 May 2011]. 7 Currall VA, Chesser TJ. Computer generated operation notes. Stud Health Technol Inform 2008; 137: 51–55.

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Commentary

Operative notes do not reflect reality in laparoscopic cholecystectomy (Br J Surg 2011; 98: 1431–1436) Recent surveys have documented concerns about completeness of operative reports and conformity to guidelines published by organizations such as the Royal College of Surgeons. The report of Wauben and colleagues adds a troubling dimension to the operative reporting of laparoscopic cholecystectomy: video recording of the operation does not always confirm what is stated in the operative note. Somewhat disturbing are the omissions of reference to the critical view of safety in a significant number of operative reports and, in two cases, the erroneous description of a common duct being ‘clipped and cut’. The authors also note unverifiable claims of withdrawal of trocars under vision and failures to report bile spillage or retrieval of dropped gallstones. Whether or not such operative records were completed by trainees or the attending surgeons, they stand in patient records as the surgeons’ official versions of the conduct of these operations. This report has implications for clinical practice and residency training, and will be read with introspection by anyone who worries about patients undergoing major surgical procedures. In 1895, two newly minted graduates of Harvard Medical School set out to be the best surgeons they could be. Harvey Cushing became known for meticulous documentation of surgical indications, operative strategy and his own mishaps1 . He also made detailed diagrams of pathological and operative anatomy for many of his cases. Verbal and visual documentation were crucial to the way Cushing learned, improved and communicated. His classmate, Ernest A. Codman, became known for insisting on improvement through structured documentation and unsparing analysis of operative events, postoperative complications and out-of-hospital recovery. He argued that surgeons’ obligations to their patients could be discharged only by integration of such systems into their hospital’s culture2 . This report from the Dutch group is the future envisioned by Cushing and Codman. D. I. Soybel Harvard Medical School, Boston, and General and Gastrointestinal Surgery, Brigham and Women’s Hospital, 75 Francis Street, Boston, Massachusetts 02115, USA (e-mail: [email protected]) DOI: 10.1002/bjs.7569

References ˜ 1 Latimer K, Pendleton C, Olivi A, Cohen-Gadol AA, Brem H, Quinones-Hinojosa A. Harvey Cushing’s open and thorough documentation of surgical mishaps at the dawn of neurologic surgery. Arch Surg 2011; 146: 226–232. 2 Codman EA. A Study in Hospital Efficiency. 1917. Reprinted by the Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, 1996.

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