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Is it safe to have major surgery performed in the PRIVATE sector?

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08/02/2009

A consultant lead integrated care pathway in the private sector allows for an earlier and safe discharge.  A comparison of 300 laparoscopic colonic resections

Dalton SJ, Ghosh AK, Greenslade GL*, Dixon AR.

 

Departments of Colorectal Surgery and Anaesthesia*

SPIRE Bristol Hospital & North Bristol NHS Hospital Trust, Bristol, UK

 

Abstract

Objective: The aim of this cohort study was to compare immediate outcomes of patients undergoing laparoscopic colonic resection performed by a single surgeon and anaesthetist in NHS and private hospital settings.

Methods: A prospective electronic database of all colorectal laparoscopic procedures between April 2001 and September 2008 was used to identify outcomes of patients undergoing laparoscopic resection with anastomosis.  Two groups of 150 patients were compared: NHS and private patients (PP).  Groups were matched for indication of surgery, age, ASA grade, cancer T stage and operation.  Patients with social delays were excluded.  The only difference was the insitution, its care pathway and its implementation.

Results: No difference was demonstrated in age, mean 64.5 (19-93) or ASA grade between groups.  Indications for surgery were: cancer NHS (83), PP (75), diverticular disease NHS (42), PP (51), inflammatory bowel disease NHS (20), PP (16) and other NHS (5), PP (8).  Operative time was significantly longer in the NHS group, 118min (95%CI 110-125) compared to the PP group 103min (95%CI 94-111) (p<0.01).  Postoperative stay in the NHS was significantly longer, mean 5.8 median 5 days (95%CI 5.1-6.5) compared to a mean 3.1 and median of 3 days (95%CI 2.7-3.6) (p<0.01).  Total number of bed days was 851 (NHS) and 452 (PP).  No differences in 30-day mortality, surgery specific complication and readmission rates (5.3%) were demonstrated.  Infections developed in 12 NHS patients (one fatal) and two PP (?2 test =6.83; 1 df, p=0.009).  Two PP patients were transferred to NHS for critical care support.  

Discussion: Clinical pathways improve outcome by providing a mechanism to coordinate care and so reduce fragmentation and costs.  Our results demonstrate that it is possible to achieve these goals in the private setting.  Although controversial, a consultant directed pathway has a positive impact on efficiency and quality.  The challenge is to achieve this in the NHS.

 

Key Words; Laparoscopic colorectal surgery, ERAS, Integrated Care Pathways, NHS and private care provision.

 

Introduction:

Colorectal cancer is the third commonest malignancy in the UK1 and surgery remains the mainstay of treatment; open surgery remaining by far the most common method for resection 2. The uptake of laparoscopic surgery has been slow, largely through concerns about its oncological safety3 and the long and technically demanding learning curve4 5, 6.  The results of large long-term randomized trials of laparoscopic surgery for colorectal cancer have demonstrated that it is not only an acceptable alternative to open resection7, 8 but it brings added short-term clinically relevant benefits9-11.  NICE updated its guidance in 2006 in favour of NHS Trusts providing patients the option of laparoscopic resection as an alternative to open surgery12.   Laparoscopic surgery results in reduced pain,13 nausea and vomiting14, earlier return of gut function14, 15, earlier discharge, a demonstrable reduction in infection16, 17 and minimal cost implications18, 19.

Over recent years there has been a paradigm shift in the management of patients undergoing colonic surgery; from remaining in hospital until the likelihood of complications had passed, to early mobilisation and discharge with community support and readmission should any post operative complications develop.  The shift to early mobilisation and discharge has been championed as ‘Enhanced Recovery After Surgery’ (ERAS) protocols20; with multimodal clinical pathways to accelerate recovery after colonic resection.  ERAS was first described in open surgery and showed an impressive reduction in both postoperative stay20 and complication rates21.  Its multifaceted approach has also been shown to enhance recovery post laparoscopic colorectal surgery11; length of stay for major colonic resection has been reduced to 23 hours in appropriately selected and supported patients 22,23.  However, a recent multi centre trial concluded that an ERAS protocol is not enough in itself to enable discharge of patients on the day of functional recovery and that more experience and better organization of care may be required24.  Some authors have questioned whether ERAS protocols actually result in a shorter recovery period or whether the reduced length of stay simply reflects improved organisation of care25. 

Integrated Patient Care Pathways (ICP) have been shown to streamline patient care27.  However, in many hospitals the addition of such pathways has amounted to little more than introducing unwelcome paperwork without a demonstrable improvement in patient care. We hypothesize that the role of the operating consultant and anaesthetist in constructing and refining the whole patient pathway and their relationship with like-minded nurses is key to the effective running of an ICP and a positive outcome

The aim of this study was to compare the outcome measures of matched patient groups undergoing laparoscopic resectional surgery in two settings - NHS and private.  Multimodal care pathways were established in each place of work.  Both senior authors championed and encouraged ERAS in both hospital settings.  The NHS pathway was driven by hospital protocol and delivered by the junior surgical (with regular consultant input) and nursing staff.  In the private setting it was directly consultant led.  Outcome measures were duration of surgery, length of stay, complication and readmission rates.

 

Methods:

A prospectively collected, institutionally approved password protected electronic database of all elective colorectal laparoscopic procedures between April 2001 and September 2008 was used to identify patient outcomes.  All patients undergoing elective laparoscopic resection with anastomosis under the care of the senior authors were eligible for inclusion.  Two groups were compared: 150 operated upon in an NHS hospital and 150 who had their surgery carried out in a private institution. Groups were matched for age, ASA grade, indication, cancer T stage, operative procedure and year of surgery.  There were no specific exclusion criteria for offering a laparoscopic approach or declining a wish to have the surgery carried out in a private institution.  Patients with delayed discharge for social reasons were excluded from the study.

Statistics

The primary endpoint of the trial was length of stay; secondary endpoints were complication and readmission rates. Matching was performed from the full prospective database with the researcher performing the matching blinded to the 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 and 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).

 Pre-operative care:

Both groups underwent nurse lead pre-operative assessment with investigations limited in the PP setting to those requested by the consultant.  Unexpected abnormal results from PP patients were fed back to and discussed directly with the supervising consultant.  NHS pre-assessment clinics followed Trust protocols and the supervising junior doctor managed any queries.  PPs were admitted (booked admission for a defined number of days with posted orders) two hours prior to surgery (Friday morning) having been asked to fast for 6hrs and drink water up to admission; each received a two phosphate enema bowel prep (administered by a senior nurse) and 400mls of a carbohydrate pre-load drink.  The NHS group were admitted the Monday afternoon prior to surgery, “clerked” by a junior doctor and prescribed similar bowel preparation (early evening) and fasted from midnight.  PP patients anticipated to need a covering stoma were seen at home by an independent stoma nurse; NHS patients were seen on the ward and often on the morning of surgery.

 Peri-operative care

The private institution provided a dedicated and fully trained laparoscopic theatre team.  Operative procedure and anaesthetic technique were identical between groups; all received antibiotic and thrombo-embolic prophylaxis and were kept normothermic throughout.   Anaesthesia comprised short acting volatile agents. Epidurals were not used.  Peri-operative analgesia evolved through the study period from PCA systems, IV paracetamol plus oral analgesia, through to bilateral 0.375% bupivacaine transabdominalis plane blocks24 (TAP-block) supplemented with short acting opioids, paracetamol and a single dose of intravenous NSAID.  This was supplemented as necessary in the recovery ward by aliquots of short duration intravenous opioids.   PPs were offered a cup of tea/biscuit/toast in the recovery ward by the anaesthetist.  Post-operative analgesia was provided by multimodal oral analgesia.  Paracetamol was always administered as an intravenous infusion in the private institution.

 Surgical technique

Abdominal wall trauma was minimised by using three laparoscopic ports and extracting the specimen through the already incised umbilicus.  Drains were not used routinely and urinary catheters were removed in theatre (excluding full rectal resections).

 Postoperative management

Patients were allowed diet as tolerated and encouraged to mobilise.  PPs were offered light snacks and meals at scheduled times throughout the day.  Ward staff were encouraged to offer NHS patients a light snack on the evening of surgery and toast the next morning.  All nursing concerns (PPs) were directed to the appropriate consultant. The supervising surgeon and anaesthetist visited the PPs twice daily; documentation was made in the ICP notes and any decisions conveyed to the accompanying senior nurse.  Drips, drains catheters etc were removed at the time of asking.  NHS patients were seen on daily junior Dr - nurse in charge ward rounds.  PP stoma patients were visited once or twice on the ward followed by two or three times at home.  All NHS stoma care was conducted on an inpatient basis.  Patients were discharged when it was considered appropriate.


Results:

300 elective colorectal resections with anastomosis were performed; 150 in each study group.  Demographics in the two patient groups were well matched, the mean age was 66.9, (range 26-91).  There were 67 men in the NHS group and 45 in the PP group.  The mean ASA was 2.01 in the NHS group and 2.01 in the PP group (Table 1).  The mean BMI in the NHS group was 26.3 (range 14-44) and 27 (range 16-55) for the PPs.

Indications for surgery comprised; cancer NHS (83), PP (75), complicated diverticular disease NHS (42), PP (51), inflammatory bowel disease NHS (20), PP (16).  The final cancer T-stage was T1 (10), T2 (22), T3 (64), T4 (12) in the PP group and T1 (12), T2 (21), T3 (56), T4 (17) in the NHS group. The average nodal yield for cancer was 15.4 (NHS) and 16 (PP).

The NHS operations comprised 31 TME rectal resections (9 with covering ileostomies), 82 high anterior resections, 11 extended right hemicolectomies or segmental resections and 31 right hemicolectomies.  In the PP group there were 31 TME rectal resections (11 with covering ileostomies), 69 high anterior resections, 9 extended right hemicolectomies or segmental resections and 41 right hemicolectomies.  Operative/anaesthetic time was significantly longer in the NHS group 118min (95%CI 110-125) compared to the PP group 103min (95%CI 94-111) (p<0.01).

An open conversion was defined as ‘an unplanned incision or extension of an incision’; three (2%) were necessary in both groups.  23% of NHS patients and 17% of the PP group had a complication.  Two leaks in the NHS group and three in the PP group required surgical intervention; two PPs required hospital transfer and NHS ITU support.  Complications arising within the NHS comprised ileus (4), wound infection (7), retention of urine (3), cardiac (3), c-difficile colitis (1), chest (1), phlebitis (1), UTI (2) cf the PP group - retention of urine (5), chest infection (1) wound (1) and cardiac (1).  Infections were seen in 12 NHS patients and two PPs (?2 test =6.83; 1 df, p=0.009).   The 30-day mortality was 4 (2.7%) in the NHS group (leak, MI, respiratory failure and c-difficile colitis) and one (0.7%) in the PP group (followed a leak).

Postoperative stay in the NHS was significantly longer - mean 5.8, median 5 days (95%CI 5.1-6.5) compared to a mean 3.1 and median of 3 days (95%CI 2.7-3.6) (p<0.01).  PPs were admitted within two hours of surgery whilst the NHS patients were admitted the afternoon before hand. The total number of bed days used was 851 (NHS) and 452 (PP).   There were 8 (5.3%) readmissions in both groups.

 

 Discussion:

Integrated care pathways (ICPs) are structured multidisciplinary care plans which detail essential steps in the care of patients with a specific clinical problem and have been proposed as a way of encouraging the translation of national evidence-based guidelines from a clinical and nursing practice viewpoint into local protocols and their application to clinical practice.  They have the potential to improve continuity of patient care.  From the patients' perspective there is evidence that ICPs by defining the patient journey improves patients’ confidence and understanding of the treatment they are about to receive27.  

ICPs also improve data collection, as they require each participant to keep good records.  This allows for easier abstraction of clinical data and audit with the potential for promoting change.  It is also useful medico-legally.  However, for them to be effective requires that they are implemented and used and then revised in the light of experience.  Whilst standardisation of care can improve patient outcome, guidelines developed by “experts” often fail to consider the views of the many professionals caring for individual patients and the realities of the local institution(s).  Failure to consider local facilities and resources coupled with consultation and education makes local acceptance and implementation unlikely.  ?When working they can improve team communication and overall patient-staff interaction, allowing increased autonomy and possibly reduced bureaucracy.  Unless the staff are engaged and empowered to suggest refinements the ICP is likely to gather dust rather than be used.

Standardised treatment of common high cost procedures such as a laparoscopic colorectal resection allows increased accuracy in planning patient stay and prediction of bed and theatre requirements. This in turn improves cost estimation, resource management and budget planning. In the private sector cost and efficiency translate to the “bottom line”.  Reduction in hospital bed utilisation is a key factor in controlling spiralling costs28 and the length of stay can be used as a surrogate for hospital efficiency29,30.  Early and appropriate post-operative discharge not only improves bed utilisation29and reduces the numbers of nosocomial infections31 - it is also preferred by patients32.  Most surgical ICPs, when implemented, reduce hospital stay with associated cost savings and without any detrimental impact on patient care33-35.

Hanning et al showed significant variation in post operative length of stay for comparable patients managed in different private hospitals29 and Ham et (REF) al demonstrated improved bed utilisation in the Californian Medicare system when compared to the NHS31. ?No such studies have looked at matched patient groups in the UK.  We have demonstrated a significant decrease in the length of stay of matched patients undergoing laparoscopic colorectal resections in the private as compared to the NHS setting.  In this study patients in the PP group were admitted on the day of surgery and those in the NHS hospital the night before, though this would by definition result in a reduction in overall length of stay it does not explain the magnitude of the difference (851 vs 452).  Even taking this into account, the reduction in the length of stay remains statistically significant.

The reason for this observed reduction in length of stay within the private setting is likely to be multifactorial, but the role of the operating consultant and anaesthetist in providing continuity of post operative care and their interaction with senior nursing staff is central, as is their combined interaction with the patient and the resultant effect on the expectation of the patient.  In the private setting, patient expectation is all in the hands of the senior clinicians through their provision of pre-operative information (verbal and written), defined planned/booked period of admission etc., whereas in the NHS it comes from several sources, each providing an opportunity for potential conflict.  Integrated care pathways were established in both the PP and NHS settings of this study.  However, in the NHS it was the junior surgical and nursing staff that directed patient progression along the pathway up to and including discharge.  In a recent multi centre trial, Matheson et al., concluded that a protocol is not enough to enable discharge of patients on the day of functional recovery and that more experience and better organization of care may be required24.  In this study we believe that we have demonstrated the clear advantage of a consultant directed integrated care pathway.  The implementation of the EWTD in August 2009 has the potential to further worsen the situation for NHS patients with further erosion of the surgical unit’s ability to provide continuity of care and professional responsibility.

NHS Trusts observe!  ICPs should not be considered a means of laying down strict guidelines, which have the potential to constrain surgeons and stifle individual clinical assessment and skill, but rather allow for formal documentation of what is already, informally, accepted as best practice.  This provides a framework within which care can be changed in an evidence-based fashion rather than anecdotally.  The individual surgeon has a central role in fashioning the type of care that they wish to provide, acknowledging international best practice.  When this works it allows management and clinicians a framework within which to plan service delivery.  By clinically defining these parameters, the surgeon creates and controls care with their patient at the centre and with optimisation of care been upheld at the forefront.  Surgeons have a duty and a responsibility to be instrumental in the design and implementation of ICPs and so allow the development of a quality driven service where audit occurs regularly and results are open for review.

 

 References

 

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2. National institute of Clinical Excellence Guidance on the use of Laparoscopic Surgery for colorectal surgery. Technology appraisal guidance no.17. Available at http://www.nice.org.uk/pdf/guidancelapcolcanc.pdf.

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22. Scala A, Huang A, Dowson HM, Rockall TA. Laparoscopic colorectal surgery - results from 200 patients. Colorectal Dis 2007;9:701-5.

 

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24. Zafar N, Rhiyad K, R Davies, GL Greenslade, AR Dixon.  The evolution of analgesia in an accelerated recovery programme "Tap, Lap and Go".  2008; Colorectal Disease

 

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28. Malcolm L. Trends in hospital bed utilisation in New Zealand 1989 to 2006: more or less beds in the future? N Z Med J 2007;120:U2772.

 

29. Hanning BW. Length of stay benchmarking in the Australian private hospital sector. Aust Health Rev 2007;31:150-8.

 

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31. Tess BH, Glenister HM, Rodrigues LC, Wagner MB. Incidence of hospital-acquired infection and length of hospital stay. Eur J Clin Microbiol Infect Dis 1993;12:81-6.

 

32. Lehmann HP, Fleisher LA, Lam J, Frink BA, Bass EB. Patient preferences for early discharge after laparoscopic cholecystectomy. Anesth Analg 1999;88:1280-5.

 

33. Miller PR, Fabian TC, Croce MA et al. Improving outcomes following penetrating colon wounds: application of a clinical pathway. Ann Surg 2002; 235(6): 775-81

 

34. Calland JF, Tanaka K, Foley E et al. Outpatient laparoscopic cholecystectomy: patient outcomes after implementation of a clinical pathway. Ann Surg 2001; 233(5): 704-15

 

35. Calligaro KD, Dougherty MJ, Raviola CA et al. Impact of clinical pathways on hospital costs and early outcome after major vascular surgery. J Vasc Surg 1995; 22(6): 649-57; discussion 657-60

 

 

 


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