Evaluation of the National Training Programme for Laparoscopic Colorectal Surgery of England (Lapco)

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Evaluation of the National Training Programme for Laparoscopic Colorectal Surgery of England (Lapco) Mr Hugh Mackenzie, Dr Melody Ni, Mr Danilo Miskovic, Mr Mark Coleman, Professor George Hanna

National Training Programme for Laparoscopic Colorectal Surgery Lapco Aims:» Disseminate LCS» Shorten the learning curve» Minimise patient morbidity and mortality Incorporates:» Expert supervised intraoperative training» Formative competency assessment monitoring of training progression» Summative competency assessment at end of training» Continuous clinical audit of patient outcomes

Competency Assessment Formative assessment of training progression 1 - Not performed, step had to be done by trainer 2 - Partly performed, step had to be partly done by trainer 3 - Performed, with substantial verbal support 4 - Performed with minor verbal support 5 - Competent performance, safe (without guidance) 6 - Proficient performance, couldn t be better

Competency Assessment Summative assessment sign-off Assessor 1 Trainer/ trainee agree to enter sign off process Trainee is invited to submit 2 videos of independently performed procedures Educational centre (Imperial College) Assessor 2 If positive result, recommend solo training, if negative, recommend further supervised training Aim: safe and solid technique for straight forward case (R/Hemi and L/Hemi)

Competency Assessment Summative assessment Competency Assessment Tool

Study Objectives Clinical Safety» Prospectively collected, clinical outcomes for the supervised NTP training Efficiency» Learning CUSUM curves, derived from a Global Assessment Score (GAS) Efficacy» Influence of training volume on CAT score» Impact of technical performance in sign-off on clinical outcomes» Analysis of clinical outcomes of cases performed independently within 12 months of sign-off

Clinical Safety Training clinical outcomes Clinical Outcome NTP Training Cases Number of cases 1560 Conversion 76 (4.9%) Complications Overall 217 (13.9%) Overall Surgical 190 (12.2%) Leak 34 (2.2%) Re-operation 61 (3.9%) Re-admission 47 (3.0%) Median Hospital Stay 5 (4-7) Mortality 8 (0.5%)

Clinical Safety Clinical Learning curves

CUSUM (Obs Exp) 10 Efficiency Competency Learning Curves 5 0-5 -10-15 -20-25 -30 Set up Exposure Vascular Pedicle Mobilisation of Colon Flexure Mesorectal Dissection Transection and Anastomosis -35 1 3 5 7 9 11 13 15 17 19 21 23 25 27 29 31 Procedure Number Regime shift detection - competency (GAS score of 5) is reached: - theatre set-up case 6 - exposure case 11 - transection and anastomosis case 25 - mobilisation of colon case 30, - vascular pedicle case 31. - Flexure and mesorectal dissection do not reach a plateau.

Efficacy Sign-off outcomes 89 trainees have submitted videos for sign-off 63 have been signed off. Pass rate is 71%

Efficacy Sign-off outcomes

Efficacy Sign-off outcomes CAT score< 2.69 P-value CAT score 2.69 3.09 P-value CAT score > 3.09 Number of Cases 38 76 57 Complications 11 (25.0%) 0.049 9 (12.9%) 0.031 2 (3.5%) Surgical Complication 8 (18.2%) 0.104 7 (10.0%) 0.029 1 (1.8%) Lymph node count 13 (8 20) 0.101 15 (11 22) 0.001 20 (16 25) Distal Resection Margin (cm) 4.0 (2.0 6.0) 0.097 4.0 (3.0 7.0) 0.178 5.0 (3.0 6.3) Number of NTP Cases 9 (2 13) 0.002 15 (6 23) 0.012 20 (13 28) Total Number of Laparoscopic Colorectal Cases 40 (27 60) 0.261 37 (26 48) 0.492 34 (27 54)

Efficacy Post-program clinical outcomes Clinical Outcome NTP Training Cases Post Sign-off Cases P-Value Number of cases 1560 603 Conversion 76 (4.9%) 72 (11.9%) <0.001 Complications Overall 217 (13.9%) 80 (13.3%) 0.697 Overall Surgical 190 (12.2%) 72 (11.9%) 0.878 Leak 34 (2.2%) 13 (2.2%) 0.973 Re-operation 61 (3.9%) 32 (5.3%) 0.151 Re-admission 47 (3.0%) 24 (4.0%) 0.258 Mean Hospital Stay 5 (4-7) 5 (4-7) 0.381 Mortality 8 (0.5%) 4 (0.7%) 0.673

Efficacy Case Complexity Demographic Category NTP Training Cases Post Sign-off Independent cases P-Value No. of Cases - 1560 603 Lapco Risk Score No. of High Risk Cases 123 (8.3%) 71 (11.8%) 0.012 Age Mean (S.D) 66.7 (13.8) 66.7 (13.0) 0.273 Gender Male 833 (53.4%) 309 (51.2%) 0.543 BMI Mean (S.D) 27.4 (5.0) 27.0 (3.4) 0.068 Urgency Emergency 31 (2.0%) 17 (2.8%) 0.239 1 307 (19.7%) 124 (24.4%) ASA grade 2 988 (63.3%) 265 (52.2%) 3 261 (16.7%) 114 (22.4%) <0.001 4 4 (0.3%) 5 (1.0%) Prior abdominal Surgery Yes 395 (25.3%) 97 (16.1%) <0.001 Right colectomy 589 (37.8%) 206 (34.2%) Resection Left Colectomy/ High AR/ Sigmoid Colectomy 675 (43.3%) 219 (36.3%) <0.001 Diagnosis Low AR /APER 165 (10.6%) 130 (21.6%) Other 131 (8.4%) 48 (8.0%) Cancer 1252 (80.3%) 480 (79.6%) Diverticular disease 82 (5.3%) 57 (9.5%) IBD 94 (6.0%) 26 (4.3%) Benign Polyp 117 (7.5%) 33 (5.5%) Other 0.002

Conclusions Structured supervised intraoperative training in laparoscopic colorectal surgery was safe for patients The learning curve is reduced Training improves technical performance and clinical outcomes in sign-off Clinical outcomes are maintained in independent practice