Stapled Haemorrhoidopexy

Ian Botterill

Powerpoint File

Intro
In 1998 Antonio Longo first reported the use of a trans-anal stapler to correct prolapsing haemorrhoids. Since his initial description the procedure has been variously described as stapled haemorrhoidectomy, circular stapled anoplasty, stapled haemorrhoidopexy, stapled prolapsectomy & procedure for proplase & haemorrhoids (PPH). The current accepted terminology is stapled haemorrhoidopexy.

Since its inception the procedure has prompted considerable interest in colorectal circles. The literature has centred on two main themes: firstly the possibility of performing haemorrhoid surgery in a relatively painless manner (supported by a large number of randomised controlled trials) and secondly the reporting of certain rare but potentially worrying complications (based mainly on case reports).

Premise
The thesis behind the procedure is that haemorrhoids prolapse and become externalised through weakening of the so called suspensory ligament. Given that haemorrhoids are a normal anatomical feature, the premise of the procedure lies in returning the prolapsed haemorrhoid tissue to the anal canal by correction of the weakened mucosa and suspensory ligament. The resection of a cuff of rectal mucosa should, theoretically at least, be less painful than conventional haemorrhoid excision which by definition crosses the dentate line.

Informed consent
The issue of informed consent is every bit as applicable to other types of haemorrhoid surgery as it is to stapled haemorrhoidopexy. It is important to highlight the goals of each type of haemorrhoid operation, the alternatives available, the risks of each and the potential benefits of each. The key risks relating to stapled haemorrhoidopexy are possible urgency of defaecation, the potential for persistent pain, septic sequelae, ano-rectal stricture, retention of urine and bleeding.

Patient selection
The typical patient who undergoes stapled haemorrhoidopexy will have grade 3 haemorrhoids. A smaller proportion have either grade 2 or grade 4 haemorrhoids. The role of stapled haemorrhoidopexy in the treatment of grade 4 haemorrhoids is open to question given concerns that it may not deal with large external components or skin tags.

Absolute contraindications include local ano-rectal sepsis or bleeding diathesis. Relative contraindications include a history of faecal incontinence or prior ano-rectal sphincter disturbance which could lead to faecal incontinece.

1. Technique
2. Positioning: forced lithotomy or prone jack-knife
3. Mode of anaesthesia: LA, regional anaesthesia or GA
4. EUA & rigid proctoscopy to rule out coexistent ano-rectal disease
5. Lubrication of the anal canal & gentle dilation with the obturator alone initially
6. Placement of 4 separate stitches (untied) at 12,3,6,9 o’clock
7. Insertion of the obturator & circular anal dilator (CAD) together after maximal reduction of the haemorrhoids
8. Withdrawal of the obturator & fixation of the CAD using the 4 previously sited stitches at the anal verge.
9. Placement of a circumferential 2/0 prolene pursestring at a consistent height of around 2cm craniad to the upper border of the haemorrhoids. The pursestring is typically commenced in the 3 o’clock position.
10. Insertion of the fully opened PPH03 gun along the axis of the rectum
11. Delivery of the pursestring ends through the housing of the gun using the ‘crochet hook’. It may be useful to add a ‘belt’ stitch in the 9 o’clock position to help incorporate circumferential rectal mucosal prolapse in the resected specimen. If a belt stitch is used it should be placed above and below the staple line then also brought out through the contralateral side of the gun housing. 
12. Tension is applied to the pursestring such that as the gun is closed along the axis of the rectum. The anal verge should ultimately be at the 4cm mark on the housing of the gun when the gun is fully closed. The gun should be fully closed to aid haemostasis.
13. In females it is crucial to ensure that the posterior vaginal wall moves freely with respect to the head of the fully closed gun (to avoid recto-vaginal fistula)
14. The gun is fired
15. The PPH03 gun is removed after a half turn to release the anvil.
16. Haemostasis is ensured by placement of interrupted 4/0 vicyrl sutures. Diathermy should be avoided to negate the risk of staple line necrosis
17. Post-operative care involves stool softeners, non-constipating analgesics & instructions regarding possible bleeding, pelvic pain, retention of urine etc. Patients should be seen at around 2-4 weeks post-operatively to allow assessment and possible digital dilation of the staple line if stenosis has occurred.

Evidence
A number of prospective randomised controlled trials (RCT) have been reported and a systematic review has been performed. A frequent theme of the many RCTs is the association of stapled haemorrhoidopexy with less post-operative pain, possibly shorter in-patient stay, less use of analgesics and earlier return to work when compared to open haemorrhoidectomy. That said it is well established that conventional haemorrhoid surgery can be performed as a day case. The randomised trials reported are summarised below:

Mehigan et al. Lancet 2000;355:782-5. RCT: SH v. open haemorrhoidectomy
Rowsell et al. Lancet 2000;355:779-81. RCT: SH v. open haemorrhoidectomy
Khalil et al. BJS 2000;87:1352-55. RCT: SH v. closed haemorrhoidectomy
Ho et al. DCR 2000;43:1666-75. RCT: SH v. open haemorrhoidectomy
Shalaby et al. BJS 2001;88:1049-53. RCT: SH v open haemorrhoidectomy
Ganio et al. BJS 2001;88:669-74. RCT: SH v. open haemorrhoidectomy.
Hetzer et al. Arch Surg 2002;137:337-40. RCT: SH v. open haemorrhoidectomy
Wilson et al. DCR 2002;45:1437-44. RCT: SH v. open haemorrhoidectomy
Correa-Rovelo et al. DCR 2002;45:1367-74. RCT: SH v. closed haemorrhoidectomy
Ortiz et al. BJS 2002;89:1376-81. RCT: SH v diathermy open haemorrhoidectomy
Pavlidis et al. Int J Col Dis 2002;17:50-3. RCT: SH v. open haemorrhoidectomy
Kairaluoma et al. DCR 2003;46:93-9. RCT: SH v.open haemorrhoidectomy
Peng et al. DCR 2003;46:291-7. RCT: SH v. banding
Palimento et al. World J Surg 2003;27:203-7. RCT: SH v. open haemorrhoidectomy
Senagore et al. DCR 2004;47:1824-36. RCT: SH v. closed haemorrhoidectomy
Nisar et al. DCR 2004;47:1837-45. Systematic review of RCTs.
Gravie et al. Ann Surg 2005;242:29-35. RCT: SH v. open haemorrholidectomy
Chung et al. DCR 2005;48:1213-19. RCT: SH v. harmonic scalpel haemorrhoidectomy
Bikhchandani et al. Am J Surg 2005;189:56-60 RCT: SH v. open haemorrhoidectomy
Kraemer et al. DCR 2005;48:1517-22. RCT: SH v. Ligasure haemorrhoidectomy
Basdanis et al. Surg End 2005;19:235-9. RCT: SH v. Ligasure
Ho et al. Tech Coloproctology 2006;10:193-7. RCT: SH v. closed haemorrhoidectomy

Complications
Although the RCT evidence fails to demonstrate increased morbidity in the stapled haemorrhoidopexy groups there has nevertheless been concern raised about the procedure.

Risks of post-operative bleeding are similar to open haemorrhoidectomy in the published randomised trials. Straightforward complications include stricture, bleeding and residual anal skin tags. The stricture that may arise after stapled haemorrhoidopexy is generally easily dilated digitally (unlike anocutaneous strictures than can occur after over enthusiastic open haemorrhoidectomy). Anal skin tags seem to complicate ~10% of cases. Bleeding has diminished markedly with the advent of the PPH03 stapler.

Those rare but potentially worrying complications reported in case reports or short series include:
-recto-vaginal fistula (undoubted technical error)
-severe persistent pain & urgency (possible technical error)
-retropneumoperitoneum & pneumomediastinum (incorrect use of gun)
-incontinence
-pelvic sepsis
-Fourniers gangrene
-rectal pocket syndrome
As with any form of proctology, the ‘herald’ signs of a major septic complication include severe pelvic/ perineal pain, fevers, inability to pass urine. It is noteworthy that the above reports have broadly speaking arisen during the introductory phase of the procedure when a learning curve would be encountered.

Areas of controversy
Outstanding questions remain about the following

1. is the procedure applicable for 4th degree haemorrhoids?
2. do skin tags require additional / alternative treatment?
3. is the cost – benefit ratio acceptable?
4. can the procedure be used on haemorrhoids in the emergency setting?
5. what is the long term efficacy of the procedure? 

The current data will be presented .

Training & audit
It is self evident that as with any surgical procedure, appropriate training is undertaken. There are a number of established training courses in the UK. After appropriate training it is advisable to undergo the early procedures with a preceptor.

In terms of audit, it is advisable to consider submitting the rectal donut for histology. This may yield unexpected pathology and can act as a useful tool for appraisal of possible complications. At a national level, the ACPGBI encourages surgeons performing stapled haemorrhoidopexy to submit case details to the national audit via the ACPGBI website.

NICE position statement & ACPGBI consensus statement
NICE have approved the procedure of stapled haemorrhoidopexy for centres that ‘have normal arrangements for consent, audit & clinical governance’. Clinicians undertaking the procedure should be ‘trained, mentored and monitored’. The NICE review acknowledged that the procedure was ‘as efficacious in the short term as the conventional operation’. It was acknowledged that most of the safety concerns were ‘theoretical and not supported by the published trials’.

Conclusions
It is inevitable that any new procedure will have its champions and its critics. The procedure is correctly termed stapled haemorrhoidopexy and it is tempting to suggest that certain early adverse reports may have stemmed from injudicious stapled haemorrhoidectomy rather than a stapled haemorrhoidopexy. It is also incorrect to advertise that the procedure is painfree. Such claims may only serve to heighten anxiety in patients if pain is detected post-operatively when they may have expected otherwise.

That said the weight of evidence (reduced pain, analgesic usage, time off work) from randomised studies is favourable albeit in the short and medium term. Equally, one cannot dispute the rare but disturbing severe complications that have been reported in the early stages of stapled haemorrhoidopexy. It is worth considering though that certain of these complications may have stemmed from operator error. There are obvious parallels with the introduction of laparoscopic cholecystectomy or laparoscopic colon surgery in this regard. There is no doubt that stapled haemorrhoidopexy has been introduced in an era of close medical scrutiny and as such it will inevitably be strictly monitored. Finally, it should not be forgotten that there are a number a serious complications in the haemorrhoid literature that have arisen after conventional accepted treatments (banding, open haemorrhoidectomy, injection sclerotherapy).

Areas of future interest will essentially relate to the long term outcomes of stapled haemorrhoidopexy and increased understanding of the true frequency of serious complications.