“SAPIENZA” UNIVERSITA’ di ROMA

UOC CHIRURGIA GENERALE G Direttore: Prof. Adriano Redler

I SIMULATORI VIRTUALI LAPAROSCOPICI E LA CHIRURGIA BARIATRICA:

CONSTRUCT VALIDITY TEST

G. Casella, D. Giannotti, G. Patrizi, G. Di Rocco, M. Marchetti, E. Soricelli, A. Redler

XXI CONGRESSO NAZIONALE SICOB

ATTUALITA’ E NUOVE PROSPETTIVE

IN CHIRURGIA BARIATRICA E METABOLICA

Strumento valido e sicuro per l’acquisizione ed implementazione delle competenze laparoscopiche.

I SIMULATORI LAPAROSCOPICI

Simulatore laparoscopico dotato di force feedback con visualizzazione realistica della cavità addominale.

.

Lap MentorTM

Basic skill tasks:

• manipulation of a 0 and 30-degree camera

• eye-hand coordination

• clipping and grasping leaking hoses

• two-handed maneuvers

• cutting

• electrocauterization

• objects traslocation.

Full procedures:

• Cholecistectomy

• gastric by-pass

• hernia repair

OBJECTIVE ASSESSMENT

Total time

Accuracy rate

Economy of movements of left instrument

Economy of movements of right instrument

Average speed of instrument

Total path lenght of instrument

Safe dissection,

Time of unsafe coagulation

Complications

Bleeding

Non cauterized bleeding

Perforations

Etc...........

Capacità di discriminare tra i diversi livelli di esperienza dei soggetti esaminati.

CONSTRUCT VALIDITY1. Face validity2. Content validity3. Construct validity4. Concurrent validity5. Predictive validity

NOVICE EXPERT

Construct validity: fondamentale per valutare il simulatore come strumento di training e certificazione

• Ruolo comprovato nella valutazione delle procedure laparoscopiche di base.

•Discussa la possibilità di distinguere la reale esperienza del chirurgo in procedure di maggiore complessità come il LRYGBP.

Verificare la capacità del simulatore Lap-Mentor (Simbionix) di riconoscere il diverso

grado di esperienza in procedure di laparoscopia avanzata e valutarne il ruolo

nella certificazione del chirurgo nella chirurgia bariatrica.

AIMS

BACKGROUND

As a results of the growing diffusion of bariatric surgery and of increased patients’ demands, more and more surgeons even without a specific training began to perform bariatric advanced laparoscopic

surgical procedures.

Objective Structured Clinical Examination (OSCE)

Objective Structured Assessment of Technical Skills (OSATS)

using a global rating scale which consists of seven evaluation items scored on a five point scale:

Reznick R, Regehr G, MacRae H, Martin J, McCulloch W. Testing technical skill via an innovative ‘bench station’ examination. Am J Surg. 1997;173:226-230.

1. respect for tissue2. time/motion3. Instrument handling4. flow of operation, 5. knowledge of instruments 6. knowledge of procedure 7. use of assistants.

A system for reviewing unedited videotapes of laparoscopic nephrectomies or adrenalectomies by utilizing simplified criteria

to assess the laparoscopic surgical skills of urologists

Matsuda T, Ono Y, Terachi T, et al. The endoscopic surgical skill qualification system in urological laparoscopy: a novel system in Japan. J Urol. 2006;176:2168-2172

•Validated system of proficiency assessment

•Two blinded experts

•Subjective evaluation

•Loss of attention

OBJECTIVE ASSESSMENT

Total time

Accuracy rate

Economy of movements of left instrument

Economy of movements of right instrument

Average speed of instrument

Total path lenght of instrument

Safe dissection,

Time of unsafe coagulation

Complications

Bleeding

Non cauterized bleeding

Perforations

Etc...........

20 CHIRURGHI

10 BARIATRIC GROUP 10 GENERAL GROUP

EYE-HAND COORDINATION TASK

CONFEZIONAMENTO GASTRIC POUCH (TASK 1)

ANASTOMOSI GASTRO-DIGIUNALE (TASK 2)

STUDIO PROSPETTICO

No VRLS experience

EYE-HAND COORDINATION TASK

General Group Bariatric Group

Performance

metric

Median IQR Median IQR P-value

total time (s) 53.5 (41.7-55.2) 52.5 (34.7-60.2) 0.8498

accuracy rate (%) 84.6 (69.3-90.0) 84.1 (72.9-89.9) 0.7050

EMRI 67.2 (59.0-70.6) 66.3 (55.4-69.6) 0.5453

EMLI 67.4 (54.6-75.6) 66.1 (57.0-71.4) 0.8205

IQR: Interquartile range; EMRI: economy of movement of right instrument; EMLI: economy of movement of left instrument

RISULTATI:

CONFEZIONAMENTO GASTRIC POUCH (TASK 1)

General Group Bariatric Group

Performance metric Median IQR Median IQR P-value

Total time (s) 901.5 (711.2-1161.5) 820.0 (606.7-1443.5) 0.7913

Pouch volume (cc) 48.3 (32.9-56.2) 22.1 (19.1-27.8) 0.0034

Unsafe dissection (%) 47.2 (39.2-63.8) 51.0 (40.8-59.5) 0.9397

Times the linear cutter was fired (n)

3.5 (2.7-5.0) 3.0 (3.0-4.0) 0.5408

Fundus included in the pouch (%)

29.4 (18.8-42.2) 8.4 (2.9-14.9) 0.0034

Time of unsafe coagulation (s)

26.5 (14.5-43.7) 3.5 (2.0-10.7) 0.0006

Complications (n)0.0 (0.0-0.2) 0.0 (0.0-0.0) 0.1462

Bleeding (n)5.5 (2.0-8.0) 0.0 (0.0-1.0) 0.0003

Non cauterized bleeding (n)

1.0 (1.0-1.2) 0.0 (0.0-0.0) 0.0006

YES NO YES NO P-value

Dissection of His angle 3 7 10 0 0.003

Pouch separated 8 2 10 0 0.474

1 20

102030405060

Pouch volume

General Group Bariatric Group

Pouc

h vo

lum

e(cc

)

1 205

101520253035

Fundus included in the pouch

General Group Bariatric Group

Fund

us in

clud

ed (%

)

1 205

1015202530

Time of unsafe coagulation

General Group Bariatric Group

Tim

e of

uns

afe

coag

ulati

on (s

)

General Group Bariatric Group

Performance metric Median IQR Median IQR P-value

Total time (s) 306.0 (265.7-

518.2)

385.5 (291.5-454.0) 0.8501

Jejunum injurie (n) 3.5 (0.7-7.5) 5.5 (2.7-7.2) 0.3053

Punctures >1cm (n) 1.0 (0.0-1.0) 0.0 (0.0-0.2) 0.0285

Punctures not used (n) 0.0 (0.0-0.2) 0.0 (0.0-0.0) 0.1462

ANASTOMOSI GASTRO-DIGIUNALE (TASK 2)

IQR: Interquartile range

CONCLUSIONI

•Il chirurgo bariatrico risulta più accurato durante l’esecuzione del GBP negli accorgimenti che influenzano i risultati della procedura stessa come la preparazione dell’angolo di His ed il volume della pouch.

•Il simulatore Lap-Mentor (Simbionix) è in grado di riconoscere l’esperienza in procedure di chirurgia laparoscopica avanzata e potrebbe essere proposto quale strumento di certificazione.

•L’ analisi dei parametri in cui si sono registrate le differenze più significative tra i due gruppi, potrebbe suggerire quali esercizi risultino più utili nei programmi di training per la formazione del chirurgo bariatrico.

CONCLUSIONI