Business case for PPH and STARR

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NORTH BRISTOL

NHS Trust

Day Case PPH
& STARR

Case of Need for the continuation of Stapled Haemorrhoidopexy* (PPH)

& Stapled TransAnal Rectal Resection (STARR)

CONTENTS

PAGE

1. EXECUTIVE SUMMARY

1.1 Haemorrhoids are a distressing condition affecting 2/3 of the population. Severe symptoms curtail people’s quality of life (pain, bleeding, and embarrassment).

1.2 Excision haemorrhoidectomy has a well earned reputation for generating excruciating postoperative pain. Because of this, surgery (for both patient and clinician) has always been the last option.

1.3 Longo described (1998) an innovative procedure PPH (Procedure for Prolapse & Haemorrhoids). This is the first operation to focus logically on treating the cause of the symptoms. Patients with operative grade III/IV haemorrhoids are primarily suitable for this operation. Patients with Grade II Haemorrhoids can also benefit if their symptoms are severe or if other treatment options (banding) have failed.

1.4 PPH has been subject to extensive clinical trials and was introduced into the UK in 1998. The rapid worldwide uptake (500,000 cases to date) has been mirrored in the UK, where nearly 11,000 procedures have been performed.

1.5 PPH instrumentation can also be used (Stapled TransAnal Rectal Resection) to treat patients with outlet obstruction syndrome, rectal anal intussusceptions, mucosal prolapse and occult rectal prolapse. Traditional surgical treatment of these conditions involves a difficult per-anal rectal mucosectomy requiring about two hours of operating time and a 3-5 day admission. STARR can usually be performed as a day case and takes 30 minutes.

1.6 The reported advantages of PPH and STARR are:

• Cost savings (>80% performed as a day case here at Frenchay)
• 9 PPH cases/list (cf 4 Milligan-Morgan Haemorrhoidectomies/list)
• 5 STARR/list (cf 2 internal DeLormes rectal mucosectomies/list)
• Reduced post operative pain & earlier return to normal activity
• Durable results & High Patient satisfaction

1.7 In 2003, The National Institute for Clinical Excellence (NICE) issued guidance on PPH and concluded that current evidence supports its use. www.nice.org.uk/IP106overview

1.8 The introduction of PPH within this Trust 5 years ago (approx 80 cases/year) has saved 320 bed days or £23,552 per year. This saving is substantially higher when one takes into account NBTs financial need to reduce beds. One less bed required for an overnight stay frees up a bed to clear a 4hr A&E breach/long waiter etc.

1.9 Additional funding from Day Case budget of £28,000 will be required to fund the anticipated number of cases.

1.10 Conservative data suggests that HRG reimbursement for PPH is £13,788 higher than traditional excision haemorrhoidectomy; £31,348 may be more realistic.

1.11 STARR requires an additional day case funding of £18,000

1.12 STARR was introduced 3 ½ years ago. 30 cases/year has allowed a saving of 142 bed days or £52,256 per year. The excess HRG income of STARR over traditional per-anal rectal mucosectomy is £ 45,702 (F32 or F34).

1.13 PPH & STARR allow NBT to achieve/implement the high impact changes identified by the NHS modernisation agency.

· Access to modern surgical intervention

· Reduced length of stay

· Avoid unnecessary follow-up (predictable outcomes)

· Increased reliability of therapeutic interventions (outcome, complications)

· Day case surgery as the norm

· Little requirement for an in-patient bed

· Significant patient benefit (Quality of Life/QUALYS)

1.14 PPH & STARR afford NBT significant FINANCIAL advantages when choose/book & payment by results implemented. HRGs generate profit.

1.15 Under payment by results, high levels of day case surgery provision are necessary to maintain income against tariff. There is a large demand for day case provision in the choice initiative.

1.16 Haemorrhoidectomy is an Audit Commission “Basket Case”. PPH allows NBT to achieve 80% as Day Case cf 24% for excision haemorrhoidectomy at NBT (16% nationally).

1.17 PPH & STARR are attractive interventions for ISTCs. A second wave ISTC within the AGW area exacerbates the above risks to NBT.

1.18 Rather than throwing the baby out with the bath water, NBT should concentrate on the final three modernisation agenda objectives

· Improve access

· Reduce the queues

· Optimise patient flow through bottle necks.

1.19 PCT costs will be reduced through

· More effective treatment; fewer GP appointments and re-referrals for recurrent symptoms.

· Simpler post-operative care; less pain, no open wound, lower rates of faecal impaction, urinary retention etc

· Day case excision haemorrhoidectomy requires lots of community nursing input (up to 9 visits). The readmission rate is >10%.

1.20 Increased volumes of patients with anorectal symptoms are now being seen as an unintended consequence of the two-week wait cancer initiative. Our duty of care requires us to offer these patients effective treatment.

1.21 Ethicon Endosurgery would like NBT to become the teaching centre for PPH & STARR in the South of England. As a result the instrumentation will be discounted further.

2. HAEMORRHOIDAL DISEASE

2.1 The prevalence of Haemorrhoids is estimated at between 4% and 34% ^1.

2.1 Symptoms include bleeding, faecal soiling, itching, pain and prolapse ^2,3.

2.3 The majority can be treated through lifestyle change (diet, increased fluid intake & exercise). Whilst outpatient banding can be effective in ¾ patients with stage II disease, 20% suffer severe pain, 12% develop urinary problems and 5% faint in clinic. 7% have major complications (bleeding, sepsis, ulceration, thrombosis). 25% of patients fail banding and require surgical treatment. >150 patients undergo banding in Mr Dixon’s clinics each year.

2.4 80-90 patients/year have historically undergone M-M haemorrhoidectomy here in Frenchay. Nationally only 16% of haemorrhoidectomies are carried out as day cases. 84% of PPHs are carried out as day cases here in NBT.

2.5 The two-week wait cancer initiative generates a high volume of symptomatic patients sufficient to warrant either a haemorrhoidectomy or rectal mucosectomy.

Physiopathology

2.4 External and internal haemorrhoidal cushions are normal anatomical structures that assist in the discrimination of flatus and faeces. For this reason their preservation is viewed as an important factor in maintaining continence.

2.5 For many years haemorrhoidal disease was seen as a vascular problem that could be resolved by excision/ligation. More recently it has been demonstrated that a distal displacement of the rectal mucosa and haemorrhoidal tissues leads to venous drainage difficulties resulting in swollen and prolapsed haemorrhoids ⁴. The theory of prolapse is universally accepted as well as its classification:

1^st Degree: Internal mucous prolapse that does not go beyond the anal verge

2^nd Degree: Spontaneously reducible prolapse

3^rd Degree: Manually reducible prolapse

4^th Degree: Irreducible external prolapse

Rationale and Description of PPH

2.6 Following the acceptance that mucosal prolapse is the main predisposing factor for haemorrhoidal complications; efforts to treat the cause of the condition rather than purely the symptoms were investigated leading to the development of the PPH procedure in 1998⁴.

2.7 Using this procedure a circumferential section of redundant rectal mucosa is excised, simultaneously preserving the haemorrhoidal tissues and relocating them to their normal anatomical position. This is performed using a dedicated circular stapler (PPH03 Ethicon Endo-Surgery), which excises the prolapse and staples the remaining tissues into place. The prolapse is reduced and the haemorrhoids shrink to their normal size. The entire operation is conducted within the anal canal away from the highly sensitive anal tissues resulting in significantly reductions in pain and discomfort.

3. OUTLET OBSTRUCTION SYNDROME (OOS)

3.1 A significant number of patients are seen in a colorectal clinic with symptoms of OOS. Most of these patients are referred via the Two-week wait pathway.

3.2 The patients, usually female, complain of incomplete evacuation with painful effort, unsuccessful attempts with long periods of time in the bathroom, use of perineal support and/or odd posture, insertion of fingers into the vagina and/or the anal canal, bleeding and poor quality of life.

3.3 In a very small number of OOS patients, symptoms relate to the development of an uncoordinated inhibitory pattern within the muscles of the pelvic floor. In these patients biofeedback can achieve the reactivation of the inhibitory capacity of all muscles of the pelvic floor during defecation

3.4 In the majority of patients, OOS develops in response to intussusceptions of the rectal wall extending into the anal canal, defined as an internal prolapse and frequently combined with a rectocele.

3.5 STARR tackles both the intussusceptions and the rectocele using circular staplers and corrects the abdominal wall and excises the intussusceptions.

3.6 Many patients with rectocele are operated on by gynaecologists. However, Gynaecologists never deal with the intussusceptions. A lot of these patients represent via the two-week wait initiative with a “change in bowel habit”. STARR avoids the need for a perineal and vaginal wound and the potential problems of delayed healing, dyspareunia etc.

3.7 In many patients STARR is inappropriate. The intussusception is either too large amounting to an occult full thickness prolapse, the rectocele is large, gynaecologists have already had a failed attempt at repair, and there is an associated vault /vaginal prolapse, an enterocele or a cystocoele. In these patients the correct approach is a ventral rectopexy whereby everything can be sorted out in one 90 mins operation with a 23hr stay.

4. PATIENT OUTCOMES

4.1 Traditional Milligan-Morgan haemorrhoidectomy is acknowledged as being particularly painful during the post-operative period. Patients requires strong analgesia that can lead to decreased intestinal motility and increasing length of hospital stay due to pain and fear of defecation by the patient.

4.2 Current practise requires on average a 3-4 day post-operative hospital stay ¹⁹, or until patients have their first bowel movement. The majority of patients undergoing traditional haemorrhoidectomy are therefore treated as in-patients.

4.3 PPH can reduce the patient length of hospital stay to less than 1 day ^5,6.

4.4 PPH also reduces post-operative pain ^4-17, which improves the quality of recovery and reduces the need for powerful and costly analgesia.

4.5 The patient has a quicker return to normal activity (1 versus 5 weeks) ^{7-9, 11-14, 16,17}.

4.6 PPH has been shown to provide safe and effective control of the symptoms associated with haemorrhoids ^7-17.

4.7 STARR is faster (45mins) than conventional surgery, involves a short hospital stay, requires only one surgeon (no gynaecologist) has few complications and is associated with very good outcomes²⁰.

5. TREATMENT COSTS

5.1 The cost of post-operative pain and distress to the patient following haemorrhoidectomy is indefinable. Improving the quality of patient care through introducing new technologies is a commitment within the UK, thus allowing patients a right to the most modern, effective and least invasive methods of treatment.

5.2 Studies have shown that when day case excision haemorrhoidectomy is performed, there is high impact on community nursing requirements with upwards of 9 home visits being required. Hospital readmission is necessary in 10%. The excision wounds usually take 4-5 weeks to heal.

5.3 As hospital waiting lists remain long, more effective methods of treating elective conditions such as haemorrhoids must be employed as outlined in the NHS plan and the modernisation agenda.

5.4 The introduction of PPH/STARR will allow cost savings to be made in terms of reduced length of hospital stay, better utilisation of day-case wards, savings on analgesics and more importantly, follow-up requirements (community and surgical OPD)

5.5 The procedure requires the use of a dedicated kit (PPH03 for PPH & PPH01 for STARR-Ethicon Endo-Surgery), which will need to be purchased from Theatre budget. The overall savings more than compensate for the cost of the stapling device.

5.6 In terms of the patient and society as a whole, additional cost benefits accrue through a speedier and more reliable return to normal activities.

5.7 Conversion from traditional haemorrhoidectomy to PPH and traditional operations for OOS to STARR will have a positive effect on waiting list times. PPH/STARR performed on a morning list enables the patient episode to be classified as day-case helping the move to increased day-case surgery (80% here at Frenchay) as outlined in the NHS plan.

6a TREATMENT COST COMPARISON PPH*

* PPH can be carried out as a day case procedure thus reducing total costs. The data below represents comparisons for In-Patient treatment. In-patient costs are based on “Netten & Curtis, Unit costs of health & social care 2002"

Financial Impact Summary

At total increase in day case budget of £28,000 would be required to cover the Instrument costs for an anticipated 80 cases per year.

Based on 80 Patient procedures this investment would allow a saving of 320 bed days or £23,520 per year.

The excess HRG income of PPH over traditional excision-ligation haemorrhoidectomy lies between £17,000 and £31,000

6b. TREATMENT COST COMPARISON STARR*

* STARR can be carried out as a day case procedure thus reducing total costs. The data below represents comparisons for In-Patient treatment. In-patient costs are based on “Netten & Curtis, Unit costs of health & social care 2002"

Financial Impact Summary

At total increase in day case budget of £18,000 would be required to cover the instrument costs for the anticipated 30 cases per year.

Based on 30 Patient procedures this investment would allow a saving of 142 bed days or £52,256 per year.

The excess HRG income of STARR over traditional per-anal rectal mucosectomy (internal De’Lormes) is £ 45,702 however operation coded (F32 or F34)

7. CLINICAL EVIDENCE

7.1 To date there have been over 500,000 PPH procedures performed worldwide and nearly 11,000 in the UK (Ethicon Endo-Surgery).

7.2 The outcomes from the clinical data below support the submission that PPH is associated with a significant reduction in pain, hospital stay, and a quicker recovery time.

7.3 National Institute for Clinical Evidence (NICE) Guidance supports the published data on safety and efficacy of the procedure ¹⁸.

Table 1. Results of Randomised Controlled Trials. It should be noted that some of the above RCTs kept patients in hospital for the same period of time as part of their research methods.

8. REFERENCES

1. Welton ML, Vaema MG, Amerhauser A. Colon, Rectum and Anus in SURGERY Basic Science and Clinical Evidence. Ed. By Norton JA, Bbolinger RR, Chag AE, Lowry SF, Mulvill SJ, Pass HI adThompso RW. New York, Springer-Verlag. 2001.

2. Loder PB, Kamm MA, Nicholls RJ, Phillips RKS. Haemorrhoids: pathology, pathophysiology and aetiology. British Journal of Surgery 1994; 81:946-954.

3. Polglase A. Haemorrhoids: A clinical update. Medical Journal of Australia 1997; 167: 85-88.

4. Longo A. Treatment of haemorrhoid disease by reduction of mucosa and haemorrhoid prolapse with a circular-suturing device: a new procedure. Proceedings of the 6^th World Congress of Endoscopic Surgery. Rome, Italy, June 3-6,1998, pp 777-84.

5. Guy RJ, Cho Eng Ng, Kong-Weng Eu. Stapled anoplasty for haemorrhoids: a comparison of ambulatory vs. in-patient procedures. Colorectal Disease 2003; 5: 29-32.

6. Beattie GC, Lam JPH, Louden MA. A prospective evaluation of the introduction of circumferential stapled anoplasty in the management of haemorrhoids and mucosal prolapse. Colorectal Disease 2000; 2: 1-6.

7. Mehigan BJ, Monson JR, Hartley JE. Stapling procedure for hemorrhoids versus Milligan-Morgan haemorrhoidectomy: randomized controlled trial. Lancet 2000; 355: 782-5.

8. Rowsell M, Belio M, Hemingway DM. Circumferential mucosectomy (stapled haemorrhoidectomy) versus conventional haemorrhoidectomy: randomized controlled trial. Lancet 2000; 355: 779-81.

9. Ho Y-H, Cheong W-K, Tsang C et al. Stapled haemorrhoidectomy-cost and effectiveness. Randomized controlled trial including incontinence scoring, anorectal manometry, and endoanal ultrasound assessments at up to three months. Dis Colon Rectum 2000 Dec;43:1666-75.

10. Ganio E, Altomare DF, Gabrielli F, et al. Prospective randomized multicentre trial comparing stapled with open haemorrhoidectomy. Br J Surg 2001: 88: 669-74.

11. Shalaby R, Desoky A. Randomized clinical trial of stapled versus Milligan-Morgan haemorrhoidectomy. Br J Surg 2001: 88: 1049-53.

12. Boccasanta P, Capretti G, Venturi M et al. Randomized controlled trial between stapled circumferential mucosectomy and conventional haemorrhoidectomy in advanced haemorrhoids with external mucosal prolapse. Am J Surg 2001: Jul;182(1):64-8.

13. Pavlidis T, Papaziogas B, Souparis A, Patsas A et al. Modern stapled Longo procedure vs. conventional Milligan-Morgan haemorrhoidectomy: a randomized controlled trial. Int J Colorectal Dis. 2002 Jan;17(1):50-3.

14. Hetzer FH, Demartines N, Handschin AE et al. Stapled vs excision haemorrhoidectomy: long term results of a prospective randomized controlled trial. Arch Surg 2002 Mar;137(3):337-40.

15. Kairaluoma M, Nuorva K, Kellokumpu I. Day- case stapled (circular) vs diathermy haemorrhoidectomy: a randomized, controlled trial evaluating surgical and functional outcome. Dis Colon Rectum 2003 Jan;46(1):93-99.

16. Palimento D, Picchio M, Attanasio U et al. Stapled and open haemorrhoidectomy: Randomized controlled trial of early results. World J Surg 2003 Feb;27(2):203-7.

17. Cheetham MJ, Cohen CR, Kamm MA et al. A randomized, controlled trial of diathermy haemorrhoidectomy vs stapled haemorrhoidectomy in an intended day-care setting with longer-term follow-up. Dis Colon Rectum 2003 Apr;46(4):491-7.

18. National Institute for Clinical Evidence. Circular Stapled Haemorrhoidectomy. Interventional Procedure Guidance 34. December 2003.

19. Monson JRT, Mortensen NJ, Hartley J. Consensus document for Association of Coloproctology of Great Britain and Ireland. Procedure for Prolapse and Haemorrhoids (PPH) or Stapled Anopexy. May 2002.

20. Boccasanta P, Venturi M, Stuto A, Bottini C, Caviglia A, Carriero A, Mascagni D, Mauri R, Sofo L, Landolfi V. Stapled Transanal Rectal Resection for outlet obstruction: a prospective multicentre trial. Dis.Colon & Rectum 2004; 47: 1285-97.