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Training does not affect patient outcome: a comparison of 300 elective laparoscopic colonic resections with anastomosis.

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10/03/2009

Training does not affect patient outcome: a comparison of 300 elective laparoscopic colonic resections with anastomosis.

 SJ Dalton, A Ghosh, N Zafar, K Riyad, AR Dixon

Department of Colorectal Surgery, Frenchay Hospital, North Bristol NHS Trust, Bristol, BS16 1LT, UK.

 

Key words: training, laparoscopic fellowships, laparoscopic colorectal surgery

 

Objective: The aim of this retrospective cohort study was to compare outcomes in patients who underwent elective laparoscopic colonic resection with anastomosis performed by a single surgeon or his training fellow.

Methods: A prospectively collected electronic database of all laparoscopic procedures between January 2005 and September 2008 was used. Two groups were compared; those operated upon by the Consultant trainer (C) and those by the fellow (F).  Fellows were either post CCT or in their last year of training. 300 consecutive cases were examined, 150 in each group.  Groups were matched for indication, age, ASA grade, cancer T stage and procedure performed. Preoperative work-up, operative surgery and anaesthesia were identical between groups.

Results: No significant difference was demonstrated in age, mean 67 (26-91) or ASA grade.  Indications for surgery were; cancer (C) 120, (F) 126, diverticular disease (C) 22, (F) 20, Crohn’s disease (C) 8, (F) 7.  Fellow’s median operative time was significantly longer at 126 min (95%CI 117-134) compared to the consultant trainer - 104 min. (95%CI 98-111) (p<0.01).  No significant differences in the complication or conversion rates were demonstrated. Length of stay and the 30day readmission rates were similar.

Discussion: In this retrospective cohort study we have demonstrate that when matched cases are compared, trainee operating time is significantly longer than that of the consultant trainer but without any significant increase in length of stay, complication or readmission rates.  Training takes time but not at the expense of patient care.

 

Introduction:

Colorectal cancer is the third most common malignancy in the UK1 with open surgery remaining the mainstay of treatment2.  Although Jacobs reported the first successful laparoscopic colonic resection, a right hemicolectomy in Miami, Florida in 19903 the uptake of laparoscopic colorectal surgery here in the UK has been painfully slow4, 5 with only about 18% of ACPGBI surgeons undertaking 50% of their practice laparoscopically4. in the 12 month period to March 2007, 8.82% of resections were performed by this method (Nice 2006)6.  Major reasoning for this delayed uptake included early concerns about oncological safety 7,8,9 and the recognition of the relatively long and technically demanding learning curve10-13.  Large, long-term randomized control trials of laparoscopic surgery for colorectal cancer have supported the view that the original concerns were unfounded (MRC CLASSIC14,COST15 and Barcelona16 trials).  Systematic17, Cochrane18 reviews and meta-analysis19 concluded that laparoscopc resection was safe and associated with better short-term outcomes and without any compromise to long-term cancer survival.  NICE updated its guidance in 2006 in favour of NHS trusts providing patients the option of laparoscopic resection as an alternative to open surgery20. More importantly the guidance recommends that laparoscopic surgery should only be performed by surgeons who have completed appropriate training and who perform this procedure often enough to maintain competence. 

Much has been written5,21,22 with regard to the leaning curve and patient/case selection which determines the rates of conversion and clinical outcome, and predictive models have attempted to identify suitable patients13.  That said, the main rate-limiting factor in its adoption is the shortage of surgeons suitably skilled in this technique.  In response to this and the finding that the majority of established UK colorectal surgeons and surgeons completing training programmes are not competent in laparoscopic colorectal surgery4,23 a number of initiatives were introduced (industry funded fellowships and the ALS consultant preceptorship programme).  In 2008, as part of the Cancer Reform Strategy implementation plans the DOH and the National Cancer Action Team developed and funded a programme with an objective of training consultant colorectal surgeons to a level of competence to perform laparoscopic resections independently and safely.   The National Cancer Director recently wrote24 to all CEOs and Medical Directors of the English acute trusts urging that they “support all your colorectal surgeons and their teams already in training or who wish to start training, to enroll in the national programme”.  However, there has been little research looking at the quality of the surgery carried out by “trainees” on such programmes.  Here we describe our centres experience and compare the clinical outcomes of patients who underwent elective laparoscopic colonic resection with anastomosis performed by a single surgeon or his training fellow.

 

Methods:

A prospectively collected electronic database of all colorectal laparoscopic procedures between January 2005 and September 2008 was used to identify patient outcomes.  All patients undergoing elective laparoscopic resection with an anastomosis under the care of the senior author were eligible for inclusion.  Two groups were compared; those operated upon by the consultant trainer and those operated on by the supervised fellow.  Fellows were either post CCT or within their last six months of training.  300 consecutive cases were examined, 150 in each group.  Complex diverticular and Crohn’s fistulating disease or extended en bloc resections were excluded from this study, as these were considered unsuitable for the training fellow.  Otherwise there were no specific exclusion criteria.

Statistics:

The study’s primary endpoints were duration of surgery and complication rates; secondary endpoints were length of stay and readmission rates.  Groups were matched for indication of surgery, patient age, ASA grade, cancer T stage and operative procedure performed. Matching was performed from the complete prospectively collected database with the researcher performing the matching blinded to the final outcome data.

Instat prism software® was used to test normality of data and to perform analysis. Differences between percentages in contingency tables were evaluated by the Pearson ?2 test or Fisher’s exact probability test.  Differences between means of normally distributed variables were assessed by the t test; the Mann Whitney test was used for non-normal data.  The sample size of 150 patients per group gives an 80% power to detect a significant difference of 0.05 between groups.  The patients’ data were held on a Microsoft Excel database (Microsoft ® Corporation, Redmond, Washington, USA).

Peri-operative care:

Patients received a phosphate enema on the morning of surgery.  Volatile agents provided anaesthesia; epidurals were never used, with peri/postoperative analgesia provided by a combination of short acting opiods, intravenous paracetamol and a pre-operatively placed transabdominalis plane block (TAP block), supplemented by an oral opiate25.  Catheters were removed in theatre and patients were actively mobilised and allowed diet as tolerated.

Surgical technique:

Patients for left-sided resection were positioned in the dorsi-lithotomy position, hips extended in 30 degrees of Trendelenburg.  Patients for right-sided resections were placed supine.  A medial or lateral approach was used as the anatomy/pathology dictated; dissection was performed using harmonic scalpel (Ethicon Endosurgery, Bracknell, UK) and pedicles ligated with either Hem-o-Lok clips (Teleflex Medical, High Wycombe, UK) or vascular linear staplers (Ethicon Endosurgery, Bracknell, UK).  Three ports were used for most resections.  Drains were not used routinely.

 

Results:

300 consecutive elective none-complicated colorectal resections with anastomosis were performed over the four-year study period: 150 in each cohort.  The demographics of the two groups were well matched; the mean age was 66.9, (range 26-91). There were 78 men in the Fellows’ group and 62 in the Consultant group.  The mean ASA was 2.20 in the Fellows’ group and 2.29 in the Consultant group (Table 1).  Mean BMI was 26.4 for the Fellows’ group (range14-39) and 26.7 (range 16-55) in the Consultant group.  Indications for surgery included: cancer (Fellow) 126, (Consultant) 120, diverticular disease (F) 20, (C) 22, Crohn’s disease (F) 7, (C) 8.  The cancer T-stages were T1 (12), T2 (21), T3 (56) and T4 (17) for the patients operated upon by the supervised Fellows and T1 (10), T2 (22), T3 (64), T4 (12) for the Consultant operated group.  The average nodal yields for cancer was 15.4 in the Fellows’ cohort and 16 in those operated upon by the Consultant.

The training Fellows’ group comprised 55 right/extended right hemicolectomies, 60 high anterior resections and 31 TME resections (18 with covering ileostomies); in the Consultant group there were 55 right/extended right hemicolectomies, 55 high anterior resections, 40 TME resections (22 with covering ileostomies).  A conversion was defined as “an unplanned additional or extended incision”; there were three conversions (2%) in the Fellows group and none in the Consultant group.

There was no significant difference in the 30-day mortality between the groups with four deaths (2.6%) occurring in the Consultant cohort - septic complications following anastomotic leaks (2) and myocardial infarctions (2); three patients (2%) died in the Fellows’ group (complications following an anastomotic leak and an “off screen” enterotomy and a case of Clost. Difficile colitis with acute renal failure).  There was no significant difference in the complication rates between groups.  Six leaks (4%) - clinical and radiological were seen in the Fellows’ group and four (2.6%) in the Consultant group.  The Fellows median operative time was significantly longer at 126 min. (95%CI 117-134) compared to the Consultant group; 104 min. (95%CI 98-111) (p<0.01).  The length of postoperative hospital stay was similar between groups with a mean length of stay of 4.6 days (95%CI 2.2-5.6) for the Fellows’ group and 4.46 days (95%CI 2.0-5.9) for the Consultant operated group.

There was no difference in the rate of post-operative complications between groups. 26 (17%) complications developed in the Fellows’ group: anastomotic leak (6), “off screen enterotomy” (3), ureteric injury (1), abscess (1), ileus (4), wound infection (3), Clost. Diff (1), AF (2), PE (1), cerebral oedema (1), retention of urine (1), headache (2), UTI (1), perforated DU (1).  The Consultant operated group contained 34 (22%) complications: anastomotic leak (3), “off screen enterotomy” (1), ileus (9), wound infection (3), myocardial infarct (2), AF (4), Clost. Diff (1), abscess (2), retention urine (5) and anastomotic bleed (2).   Major surgical injuries/errors were more common on the Fellows’ group (4) than when the Consultant trainer operated (1).

Finally, readmission rates were not significantly different between groups.  The Fellows’ group had six readmissions; adhesional small bowel obstruction (1), anastomotic leak (1), faecal impaction (1), wound complications (2) and one with diarrhoea and new onset AF.  There were 10 readmissions in the Consultant cohort: urinary retention post TME (4), delayed anastomotic leak at day 30 (1), wound infection (2), Norwalk virus (1), pancreatitis/hypercalcaemia (1) and one for reassurance.  Two readmitted patients died; one from each group.

Discussion:

Surgical training has traditionally been an apprenticeship and when available training in laparoscopic surgery has followed this well trodden path. However, laparoscopic surgery also requires additional cognitive and motor skills, with the requirement of long periods of continuous concentration, image interpretation and adjustment to the loss of a degree of tactile feedback and altered anatomical view26. Whilst data suggests that laparoscopic surgery can be complemented by focused simulator training27, the role of such training for a senior trainee or training consultant is limited. The relatively long and technically demanding learning curve of laparoscopic colorectal surgery is established11,12,13 and the central role of a preceptor in this training is recognised28.  Estimations of the number of cases required before embarking on safe independent practice range from 20-6029.

Whether patients are at risk from increased complications or a greater length of stay when operated upon by surgeons during this learning curve is not known.  Lordan et al have suggested22 that the change from open to laparoscopic dissection is safe even during the initial learning curve.  Their series however is small and includes only 77 laparoscopic cases with 32 conversions.  Renwick et al demonstrated no difference for open colorectal resection when closely supervised trainees were compared with their consultant trainer; patient groups were not matched and were operated upon in different hospitals30.   Evidence from other specialities suggests that preceptoring of trainees does not result in increased patient risk; Skrecas et al demonstrated that a mentoring program allows safe introduction of laparoscopic radical prostatectomy31.  There is little data however, supporting the safety of such a program for laparoscopic colorectal surgery. 

The combination of the emergence of new technology and patients’ intuitive belief that a minimally invasive procedure offers significant advantages has meant that training programs have had to work hard to prepare surgical trainees for performing these operations. To date, we do not have a standard requirement for either volume let alone the diversity and potential for laparoscopic colorectal practice.  Our results suggest that this learning curve does not result in patient harm when an experienced trainer is involved. This is important as with the growing need for trained laparoscopic colorectal surgeons the preceptorship of trainees and established consultants is set to increase.  All of our fellows exceeded the “ideal” case volume suggested by a survey of US MIS fellows31 and have, like their Ethicon Endosurgery funded Fellowship counterparts achieved competency upon completion of their six-month post.  All as newly appointed consultants, now provide a comprehensive laparoscopic colorectal service.  Hopefully the hard won lessons that followed the introduction of laparoscopic cholecystectomy in the UK are taken on board and acted upon.  “Off screen” enterotomy (not seen on “playback”) with potential for adverse outcome can and do occur, even when the operator/trainer is experienced; approx 1/1000 (trainer) versus 1:50 trainee.  Their mechanism of causation remains debalable.

This paper does have its flaws; a single trainer is compared to a number of laparoscopic fellows with the data grouped to allow analysis. Though this heterogeneity weakens the study, it reflects current practice and allows for a meaningful comparison.  The possible selection bias generated by the easier cases being performed by the laparoscopic fellows or by the trainer completing cases where the trainee failed to progress has been considered; however, cases were only included in the Fellows group if the whole operation was completed by the fellow and cases were matched to avoid a selection bias.  The significance of a shorter operative time for the trainer is debateable.  Chen et al have shown that operating time is a poor surrogate for the learning curve in laparoscopic colorectal resections34 and argued that case difficulty increases as experience increases and therefore operative time in a case series yields little information.  In our study cases were matched and so the shorter operative time of the preceptor compared to the trainee is a true, although not a particularly surprising finding.  Though the time differences were significant the actual increase in operative time was small and hence the clinical effect on the patients is likely to be minimal.  However, the accumulative effect of a supervised trainee performing three consecutive resections is significant and would if sufficient beds were available have a financial and target implication to the hospital trust.

In this review of a prospectively collected database we demonstrate that when matched cases are compared trainee-operating time is significantly longer than that of the preceptor however no significant increase in complication rate, length of stay or readmission rate is demonstrated. Training and preceptorship takes time but not at the expense of patient care.

 

 References

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 wwwstatisticsgovuk/downloads/theme_health/cancertrendsupdatepdf.

2. National institute of Clinical Excellence Guidance on the use of Laparoscopic Surgery for colorectal surgery. Technology appraisal guidance no.17.

  http://www.nice.org.uk/pdf/guidancelapcolcanc.pdf.

3. Jacobs M, Verdeja JC, Goldstein HS. Minimally invasive colon resection (laparoscopic colectomy). Surg Laparosc Endosc 1991;1:144-50.

4. Schwab KE, Dowson HM, Van Dellen J, Marks CG, Rockall TA. The Uptake of Laparoscopic Colorectal Surgery in Great Britain and Ireland: A questionnaire survey of consultant members of the ACPGBI.  Colorectal Dis 2009; 11: 318-322

5. Harinath G, Shah PR, Haray PN, Foster ME. Laparoscopic colorectal surgery in Great Britain and Ireland--where are we now? Colorectal Dis 2005;7:86-9.

6. NICE implementation uptake report: laparoscopic surgery for colorectal cancer.  NICE technology appraisal 105.

http://www.nice.org.uk/media/411/18/ImplUptakeReportColorectalResectionsLaparoscopic.pdf

7. Akle CA. Early parietal recurrence of adenocarcinoma of the colon after laparoscopic colectomy. Port site metastasis after laparascopic colorectal surgery for cure of malignancy. Br J Surg 1996;83:427.

8. Molenaar CBH, Bijnen AB, Ruiter AB.  Indications for laparoscopic colorectal surgery. 

Results from the Medical Centre Alkmaar, The Netherlands.  SurgEndosc. 1998; 12: 42-5.

9. Jenkins J, Roth J, Johnson W, Pofahl N.  Laparoscopic Colorectal Surgery: Indications and Techniques.  Current Surgery, Vol 62, Issue 3, 319 - 323.

10. Pandey S, Slawik S, Cross K, Soulsby R, Pullyblank AM, Dixon AR. Laparoscopic appendicectomy: a training model for laparoscopic right hemicolectomy? Colorectal Dis 2007;9:536-9.

11.. Choi DH, Jeong WK, Lim SW, Chung TS, Park JI, Lim SB, Choi HS, Nam BH, Chang HJ, Jeong SY. Learning curves for laparoscopic sigmoidectomy used to manage curable sigmoid colon cancer: single-institute, three-surgeon experience. Surg Endosc 2008.

12. Shah PR, Joseph A, Haray PN. Laparoscopic colorectal surgery: learning curve and training implications. Postgrad Med J 2005;81:537-40.

13. Tekkis PP, Senagore AJ, Delaney CP.  Conversion rates in laparoscopic colorectal surgery.  A predictive model with 1253 patients.  Surg Endosc 2005; 19: 47-54.

14. Guillou PJ, Quirke P, Thorpe H, Walker J, Jayne DG, Smith AMH, Heath RM, Brown JM, MRC CLASSIC trial group.  Short-term endpoints of conventional versus laparoscopic-assisted surgery in patients with colorectal cancer (MRC CLASICC trial): multicentre, randomised controlled trial. Lancet 2005;365:1718-26.

15. The Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer.  N Engl J Med 2004;350:2050-9.

16. Lacey AM, Garcia-Valdecasas JC, Delgado S et al., Laparoscopy-assisted colectomy versus open colectomy for treatment of non-metastatic colon cancer; a randomized trial.  Lancet 2002; 359: 2224-2229.

17. Reza MM, Blasco JA, Andradas E, Cantero R, Mayol J.  Systematic review of laparoscopic versus open surgery for colorectal cancer.  Br.J.Surg 2006; 93: 921-8.

18 Schwenk W, Haase O, Neudecker J, Muller JM.  Short term benefits for laparoscopic colorectal resection. Cochrane Database of Systematic Reviews 2008, Issue 3.

19. Bonjer HJ, Hop WC, Nelson H, Sargent DJ, Lacy AM, Castells A, Guillou PJ, Thorpe H, Brown J, Delgado S, Kuhrij E, Haglind E, Pahlman L. Laparoscopically assisted vs open colectomy for colon cancer: a meta-analysis. Arch Surg 2007;142:298-303.

20. National Institute for Health and Clinical Excellence (NICE).  Laparoscopic surgery for colorectal cancer.  London (UK): National Institute for `health and Clinical Excellence (NICE); 2006 Aug. 25 p. (Technology appraisal guidance; No. 105).

http://www.nice.org.uk/nicemedia/pdf/2006039LaparoscopicSurgeryForColorectalCancer.pdf

21. Bennett CL, Stryker SJ, Ferreira MR, Adams J, Beart RW jr.  The learning curve for laparoscopic colorectal surgery.  Preliminary results from a prospective analysis of 1194 laparoscopic-assisted colectomies.  Arch Surg 1997; 132: 41-5.

22.  Lordan JT, Tilney HS, Shirol S, Jourdan I, Gudgeon AM.  Does the laparoscopic colorectal learning curve adversely affect the results of colorectal cancer resection? A 3-year prospective study in a district general hospital. Colorectal Disease 2008; 10: 363-369.

23. Charron P, Campbell R, Dejesus S, Gallagher J, Williamson P, Ferrara A. The gap in laparoscopic colorectal experience between colon and rectal and general surgery residency training programs. Dis Colon Rectum 2007;50:2023-31; discussion 31.

24. Richards M, Coleman M.  National Training Programme (NTP) in laparoscopic colorectal cancer surgery: supporting NICE Technology Appraisal (2006) recommendations for laparoscopic resection for colorectal cancer. 

http://www.dh.gov.uk/en/Publicationsandstatistics/Lettersandcirculars/Dearcolleagueletters/DH_091954

25. Zafar N,  Davies R, Greenslade GLG, Dixon AR.  The evolution of analgesia in an "Accelerated" recovery programme for resectional  laparoscopic  colorectal surgery with an anastomosis. Colorectal Dis. 2009 Jan 16. [Epub ahead of print]

26. Way LW, Stewart L, Gantert W, Liu K, Lee CM, Whang K, Hunter JG. Causes and prevention of laparoscopic bile duct injuries: analysis of 252 cases from a human factors and cognitive psychology perspective. Ann Surg 2003;237:460-9.

27. Gurusamy K, Aggarwal R, Palanivelu L, Davidson BR. Systematic review of randomized controlled trials on the effectiveness of virtual reality training for laparoscopic surgery.

Br J Surg 2008;95:1088-97.

28. Pigazzi A, Anderson C, Mojica-Manosa P, Smith D, Hernandez K, Paz IB, Ellenhorn JD.

Impact of a full-time preceptor on the institutional outcome of laparoscopic colectomy.

Surg Endosc 2008;22:635-9.

29. Tekkis PP, Senagore AJ, Delaney CP, Fazio VW. Evaluation of the learning curve in laparoscopic colorectal surgery: comparison of right-sided and left-sided resections. Ann Surg 2005;242:83-91.

30. Renwick AA, Bokey EL, Chapuis PH, Zelas P, Stewart PJ, Rickard MJ, Dent OF. Effect of supervised surgical training on outcomes after resection of colorectal cancer. Br J Surg 2005;92:631-6.

31. Skrekas T, Mochtar CA, Lagerveld BW, de Reijke TM, van Velthoven RF, Peltier A, de la Rosette JJ, Laguna MP. Mentor-initiated approach in laparoscopic radical prostatectomy. J Endourol 2006;20:831-5.

32. Tichansky DS, Taddeucci RJ, Harper J, Madan AK.  Minimally invasive surgery fellows would perform a wider variety of cases in their "ideal" fellowship.  Surg.Endosc 2008; 22: 650-654.

33. Williams G, McAllister I, Sagar P.  The Laparoscopic Colorectal Fellowships: popular, educational and produce competent laparoscopic surgeons.  Br.J.Surg 2008; 95 (S3); 43.

34. Chen W, Sailhamer E, Berger DL, Rattner DW. Operative time is a poor surrogate for the learning curve in laparoscopic colorectal surgery. Surg Endosc 2007;21:238-43.

 

Table 1.  ASA grades of two cohort groups

 

ASA

No of patients

Trainer group

 

No of patients

Fellow group

I

21

 

23

II

70

 

76

III

56

 

48

IV

5

 

0

 

 

 


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