Haemorrhoidectomy 2016

Haemorrhoidectomy-Specific Evidence

Arguments for…

• Diclofenac suppositories administered immediately postoperatively reduced pain scores on the evening of surgery and the morning after and reduced analgesic consumption versus control (n=60; all patients had SA) (Rahimi 2012, LoE 1)

PROSPECT Recommendations

• Based on procedure-specific evidence of analgesic efficacy (LoE 1), systemic NSAIDs/COX-2-selective inhibitors are recommended (Grade A), in the absence of contraindications, administered in time to provide sufficient early post-operative analgesia
• The recommendation has been strengthened since the previous review, which stated:
  • Based on transferable evidence showing analgesic efficacy (LoE 1), it is recommended (Grade B) that systemic conventional NSAIDs should be administered at the appropriate time to provide sufficient analgesia in the early recovery period

Haemorrhoidectomy-Specific Evidence

• There were no procedure-specific studies evaluating paracetamol in this review or the last review

PROSPECT Recommendations  

• Paracetamol is recommended, given its safety and established role in baseline pain management, despite a lack of procedure-specific evidence (Grade B), and it should be administered in time to provide sufficient early post-operative analgesia
• The previous review stated:
  • It is recommended (Grade B) that paracetamol should be administered at the appropriate time to provide sufficient analgesia in the early recovery period, based on transferable evidence showing efficacy for treating pain of moderate intensity (LoE 1)
  • Paracetamol alone is not recommended for high-intensity pain (VAS >/=50 mm) (Grade B), based on transferable evidence (LoE 1) showing a lack of analgesic efficacy

Haemorrhoidectomy-Specific Evidence

Arguments for…

• No additional studies on glucocorticoids were identified since the last review
• Relevant evidence from the previous review:
  • IM betamethasone (12 mg administered 30 min before surgery; n=24) was associated with significantly lower verbal pain scores than placebo when sitting during 5–24 h (p<0.04), but pain scores at rest were not significantly different at any time point (Aasboe 1998; LoE 1)
  • IM betamethasone 12 mg (12 mg administered 30 min before surgery; n=20) provided lower verbal categorical scores compared with diclofenac (200 mg per day administered after surgery; n = 20) (no statistics reported) (Kisli 2005; LoE 2). In addition, significantly fewer patients in the betamethasone group required supplemental analgesia (p<0·05) and significantly more patients were discharged from hospital

PROSPECT Recommendations  

• Pre-operative parenteral glucocorticoids are recommended (Grade B), based on procedure-specific evidence (LoE 1 and 2) for analgesic efficacy
• The previous review stated: Pre-operative parenteral glucocorticoids are recommended (Grade B), based on limited procedure-specific (LoE 1 and 2) and transferable evidence (LoE 1) for analgesic efficacy

Haemorrhoidectomy-Specific Evidence

Arguments for…

• No additional studies on laxatives were identified since the last review
• Relevant evidence from the previous review:
  • VAS pain scores on defecation were significantly lower with lactulose (15 ml three times daily for four days prior to haemorrhoidectomy; n=22) compared with placebo (n=20) on days 2 (p=0.025) and 4 (p=0.02), but not on days 1, 3 and 5, and significantly lower in the first two 24 h periods after defecation (p=0.005) (London 1987; LoE 1). VRS pain scores on defecation were significantly lower with lactulose compared with placebo on days 1 (p=0.03), 2 (p=0.025) and 3 (p=0.04), but not on days 4 and 5, and significantly lower in the first 24 h period after defecation (p=0.03). Patients in both groups received 15 ml lactulose three times daily from admission until discharge
  • VAS pain scores on defecation were significantly lower with Plantago ovata (a laxative herb, administered postoperatively, two sachets of 3.26 g per day for 20 days) compared with control (glycerine oil) (p<0.001) (Kecmanovic 2006; LoE 2)

PROSPECT Recommendations  

• Laxatives are recommended (Grade A), started in the days prior to surgery, as an adjunct to analgesic therapy, based on procedure-specific evidence (LoE 1 and 2)
• This is consistent with the previous review, which stated: Laxatives are recommended (Grade A) in the days prior to surgery, as an adjunct to analgesic therapy, based on procedure-specific evidence (LoE 1 and 2)

Haemorrhoidectomy-Specific Evidence

Arguments against…

• Mechanical bowel preparation prior to haemorrhoidectomy did not improve pain scores at 3 days or with first bowel movement (n=44; all patients received spinal anaesthesia) (Tokac 2013, LoE 1)

PROSPECT Recommendations

• Pre-operative mechanical bowel preparation did not reduce postoperative pain (LoE 1) and is not recommended (Grade A)
• The previous review made no recommendation regarding mechanical bowel preparation as no evidence was identified

Haemorrhoidectomy-Specific Evidence  

Arguments for…

• Oral metronidazole for 7 days after surgery reduced pain, analgesia requirement and time to resumption of daily activities (n=44; all patients received SA) (Solorio-Lopez 2015, LoE 2)
• The previous review found:
  • Three out of four studies (all LoE 1) demonstrated a reduction in pain scores with metronidazole compared with placebo/no treatment (Data table)

Arguments against…

• Prophylactic intravenous antibiotics on anaesthetic induction made no difference to postoperative pain or analgesic consumption between postoperative days 1 and 7 (n=100; patients had SA or GA) (Khan 2014b; LoE 1)

PROSPECT Recommendations

• Oral metronidazole is recommended (Grade A) as an adjunct to analgesic therapy based on procedure-specific evidence (LoE 1)
• Prophylactic intravenous antibiotics did not reduce post-operative pain (LoE 1) and are not recommended (Grade A)
• The recommendation for oral metronidazole is strengthened since the previous review by additional procedure-specific evidence of analgesic benefit
• The previous review made no recommendation regarding prophylactic intravenous antibiotics as no evidence was identified

Haemorrhoidectomy-Specific Evidence

• No procedure-specific evidence was identified in the current or previous literature review

PROSPECT Recommendations  

• Gabapentinoids cannot be recommended (Grade D, LoE 4) because there is no procedure-specific evidence
• This is consistent with the previous review, which stated: Pre-operative/postoperative gabapentinoids cannot be recommended (Grade D, LoE 4) because there is no procedure-specific evidence and because the benefit:risk ratio is not sufficiently favourable for this ambulatory procedure, despite analgesic efficacy in other procedures (transferable evidence, LoE 1)

Haemorrhoidectomy-Specific Evidence

Arguments against…

• A bolus of ketamine (5mg/kg) continuing as an infusion until 2 min after end of surgery (5mg/kg/min) did not have any effect on pain or analgesic requirements (n=78; patients underwent GA) (Spreng 2010, LoE 1)

PROSPECT Recommendations

• Ketamine infusion is not recommended (Grade A) based on procedure-specific evidence showing no analgesic effect (LoE 1)
• The previous review made no recommendation regarding ketamine infusion as no evidence was identified

Haemorrhoidectomy-Specific Evidence

• No additional studies on dextromethorphan were identified since the last review

PROSPECT Recommendations

• Dextromethorphan is not recommended (grade D, LoE 4) due to limited procedure-specific evidence
• The recommendation is consistent with the previous review, which stated: Dextromethorphan is not recommended (Grade D, LoE 4) based on inconclusive procedure-specific evidence and transferable evidence

Haemorrhoidectomy-Specific Evidence

Ischiorectal fossa block

Arguments for…

• Ischiorectal fossa block with 0.25% bupivacaine reduced pain scores at 12h and increased the time to first analgesic demand versus saline and no block at all (n=90; GA in both groups) (Rajabi 2012, LoE 1)
• The previous review found:
  • One study compared the combination of local anaesthetic injection into the ischiorectal fossa and perianal infiltration into the haemorrhoidal complexes versus peri-anal infiltration alone, with the same local anaesthetic solution (Luck 2000; LoE 1). Pain scores were significantly lower for ischiorectal fossa block compared with no block (P = 0·002 – 0·031), but the need for supplemental analgesia and length of hospital stay were comparable

Posterior perineal injection

Arguments for…

• There were no additional studies on posterior perineal injection since the last review.
• The previous review found:
  • Posterior perineal block with ropivacaine was superior to control (no injection) in reducing postoperative pain scores (P = 0·001), need for supplemental analgesia (P < 0·001) and length of recovery room stay (P <0·001), but duration of hospital stay and time to first bowel movement were comparable (GA in both groups) (Brunat 2003; LoE 1)

Pudendal nerve block

Arguments for…

• There were no additional studies on pudendal nerve block since the last review.
• The previous review found:
  • Two studies compared GA plus nerve stimulator-guided bilateral pudendal nerve block versus GA alone (Naja 2005, Naja 2006; both LoE 1). In Naja 2005, a third group received GA plus placebo nerve block. Patients in pudendal block groups had lower pain scores (p<0·001 Naja 2006; p<0·005 Naja 2005) and reduced analgesic consumption (p<0·001 Naja 2006; p<0·05 Naja 2005), as well as a shorter hospital stay (p<0·001 Naja 2006; p<0·05 Naja 2005), earlier resumption of daily activities (p<0·001 Naja 2005, Naja 2006) and higher patient satisfaction (p<0·001 Naja 2006; p<0·001 Naja 2005)

Perianal local anaesthetic infiltration

Arguments for…

• Postoperative liposomal bupivacaine infiltration reduced postoperative pain scores up to 96 h and analgesic requirement compared to plain bupivacaine (n=75; GA in both groups) (Haas 2012, LoE 1)
• Postoperative liposomal bupivacaine infiltration reduced cumulative pain scores for up to 72 hours and reduced analgesic requirement compared with placebo (n=187; GA in both groups) (Gorfine 2011, LoE 1)
• Pre-incisional, perianal intradermal injection of 4ml 1% methylene blue with bupivacaine (n=37) reduced pain scores and paracetamol use on days 1 to 3 compared with bupivacaine plain solution (n=30) (GA in both groups) (Sim 2014, LoE 1)

PROSPECT Recommendations

• Pudendal nerve block under GA or LA is recommended as there is some evidence that it is more effective than perianal infiltration of local anaesthetic (Grade B, LoE 2) (see Anaesthetic techniques)
• Liposomal bupivacaine cannot yet be recommended (Grade D) due to a lack of inclusion of other recommended analgesic techniques, despite extended analgesia compared with plain bupivacaine/placebo, in two studies (LoE 4)
• The recommendations have been updated since the previous review, which stated:
  • Nerve blocks (perineal, pudendal, ischiorectal fossa blocks), as adjuncts to anaesthesia, are recommended for intra- and postoperative analgesia (Grade A) based on procedure-specific evidence for analgesic efficacy (LoE 1)
  • No recommendation can be made regarding the choice of nerve block at this time due to a lack of procedure-specific evidence directly comparing different blocks
  • When used as an adjunct to anaesthesia, perianal LA infiltration is recommended for intra- and postoperative analgesia (Grade A), based on procedure-specific evidence for analgesic efficacy (LoE 1)
  • Perianal LA infiltration may be preferable to nerve blocks because of the simplicity of administration (Grade D, LoE 4) but there is a lack of procedure-specific evidence comparing these techniques
  • No recommendation can be made regarding postoperative local perianal infiltration, due to limited and inconsistent procedure-specific evidence (LoE 4)

Haemorrhoidectomy-Specific Evidence  

Pudendal nerve block versus spinal anaesthesia

Arguments for…

• Local pudendal block reduced both pain scores and analgesic requirement up to 24h compared with spinal anaesthesia (n=74) (Castellvi 2009, LoE 1)
• Pudendal combined with local block resulted in reduced analgesic requirement but not pain scores compared to spinal anaesthesia (n=67) (Anannamcharoen 2008, LoE 2)

Pudendal nerve block versus perianal local anaesthetic infiltration

Arguments for…

• Pudendal nerve block reduced pain scores at 8h and reduced analgesic requirement and length of hospital stay compared with perianal local anaesthetic infiltration (n=120) (Tepetes 2010, LoE 2)

Local anaesthetic infiltration versus spinal anaesthesia

Arguments for…

• There were no additional studies on this comparison since the last review.
• The previous review found:
  • One study (Ong 2005) compared local anaesthesia with 1 per cent lidocaine plus 0·25 per cent bupivacaine plus 1 : 200 000 adrenaline in a 20 – 25-ml volume (infiltrated directly into the anal sphincter, levator ani muscles and surrounding perianal skin) versus spinal anaesthesia (n = 30 per group). The two techniques were comparable with respect to pain scores and supplemental analgesia requirements, as well as incidence of urinary retention.

Local anaesthesia versus general anaesthesia

Arguments against…

• In open haemorrhoidectomy, local block only without general anaesthesia was associated with more pain immediately postoperatively but less pain on day 8 and no difference in mean pain score overall compared with general anaesthesia with preoperative perianal block (n=41) (Kushwaha 2008, LoE 1)

Spinal / Epidural local anaesthetic with or without adjuncts

Arguments for…

• Spinal block with 7mg bupivacaine and 80mcg morphine reduced pain scores at 6h, 12h, and 24h compared with bupivacaine alone (n=40) (Moreira 2014, LoE 2)
• The addition of clonidine (4 mcg/kg) to ropivacaine epidural reduced pain at 4h postoperatively (n=80) (Baptista 2014, LoE 1)
• Spinal anaesthesia with ropivacaine plus clonidine reduced pain up to 24h compared with ropivacaine peridural anaesthesia with or without clonidine (n=80) (Baptista 2008, LoE 2)

Caudal epidural: lidocaine with or without ropivacaine

Arguments for…

• Caudal block with a local anaesthetic solution combining ropivacaine plus lidocaine reduced pain scores up to 6 hours postoperatively compared with lidocaine alone (n=287) (Ye 2007, LoE 1)

PROSPECT Recommendations

• Pudendal block, with or without general anaesthesia, is recommended as the anaesthetic modality of choice (Grade A) based on procedure-specific evidence of analgesic benefit over spinal anaesthesia (LoE 1)
• Adjuncts to spinal anaesthesia (morphine, clonidine) are not recommended, despite a reduction in pain, due to potential side effects (Grade D)
• The previous review stated:
  • No specific recommendation can be made regarding the choice of anaesthetic technique (local, spinal, caudal epidural or general anaesthesia) because of limited procedure-specific evidence.
  • Nevertheless, local anaesthetic infiltration or general anaesthesia may be preferred (Grade D, LoE 4) over spinal and caudal epidural anaesthesia, owing to the potential limitations of the latter for outpatient procedures such as haemorrhoidal surgery. (from paper)
  • No recommendation can be made regarding the choice of anaesthetic technique (local anaesthesia versus spinal anaesthesia [appropriate ‘short-duration’ spinal] versus general anaesthesia), due to limited procedure-specific evidence (from website)

• This review has only included studies relating to excisional haemorrhoidectomy (we did not evaluate studies on stapled haemorrhoidectomy or doppler guided haemorrhoidal artery ligation for instance)
• The opinion of the members of the PROSPECT Haemorrhoidectomy Subgroup and PROSPECT Working Group is that the choice of haemorrhoid procedure should be based on factors other than pain, such as specific aspects of pathology, with patient and surgeon preference and experience taken into account

Haemorrhoidectomy-Specific Evidence  

Closed versus open haemorrhoidectomy

Arguments for…

• Closed haemorrhoidectomy reduced pain at 24h compared to open haemorrhoidectomy (n=213; GA in both groups) (Shaikh 2013, LoE 2)
• The previous review reported 3 papers indicating reduced pain using closed versus open haemorrhoidectomy (Jóhannsson 2006, LoE 1; Arroyo 2004, LoE 1; You 2005) with 3 papers showing no difference in pain between the two methods (Pescatori 2000, LoE 1; Arbman 2000, LoE 1; Ho 1997; LoE 1)

Electrocoagulation versus ligation of the pedicle

Arguments for…

• Electrocoagulation reduced pain scores for the first 6 days after surgery compared to ligation, with decreased analgesia use in the first 24 hours after open haemorrhoidectomy (n=120; SA in both groups) (Bessa 2011, LoE 1)

Sphincterotomy

Arguments for…

• Lateral internal sphincterotomy reduced pain up to day 9 after open haemorrhoidectomy (n=60) (De Luca 2012, LoE 2)
• Internal sphincterotomy was associated with significantly less pain on days 4 to 7 postoperatively when compared with topical diltiazem (n=102; both groups had spinal or caudal anaesthesia) (Chauhan 2009, LoE 1)
• Partial internal sphincter resection (with anal cushion suspension) reduced pain after haemorrhoidectomy (n=192) (Lu 2013, LoE 2)

Arguments against…

• Inducing a “chemical sphincterotomy” using botulinum toxin injection did not reduce pain compared with placebo (n=32) (Singh 2009, LoE 1)
• The addition of lateral internal sphincterotomy may reduce postoperative pain but is clinically counter-intuitive given the concern regarding sphincter injury and continence after haemorrhoidectomy. Longer term follow-up is required to establish the safety of this practice

Energy devices

Arguments for…

• Harmonic scalpel haemorrhoidectomy reduced pain at 24 hours, 7 days and 28 days postoperatively, and analgesic consumption at 24 hours and 7 days, compared with electrocautery (n=151) (Bulus 2014, LoE 2)
• Harmonic scalpel haemorrhoidectomy reduced pain for 28 days and analgesic requirement compared with electrocautery (n=64) (Abo-hashem 2010, LoE 2)
• A high quality meta-analysis published in 2009 demonstrated reduced pain with Ligasure compared with conventional haemorrhoidectomy (Nienhuijs 2009)
• Ligasure haemorrhoidectomy reduced pain compared to open haemorrhoidectomy in 6 studies (Franceschilli 2011, LoE 2; Gentile 2011, LoE 1; Sakr 2010, LoE 1; Bessa 2008, LoE 2; Altomare 2008, LoE 1; Muzi 2007, LoE 1) and in four of these there was an associated reduction in analgesia use.
  • Reduction in severe pain up to 7 days postoperatively (n=210) (Franceschilli 2011, LoE 2)
  • Reduction of pain scores at 1, 3, 4 and 14 days, with lower analgesic consumption (n=52) (Gentile 2011, LoE 1)
  • Reduced pain up to 48 hours postoperatively but not for 14 or 28 days, and reduced parenteral analgesic consumption (n=74) (Sakr 2010, LoE 1)
  • Reduction in pain for up to 6 weeks postoperatively and reduction in analgesic consumption in the first 24 hours (n=110) (Bessa 2008, LoE 2)
  • Reduction of pain from day 3 to day 7 but not for days 8 to 14, 21 or 28, and reduction of analgesic consumption on days 3 and 4 (n=272) (Altomare 2008, LoE 1)
  • Reduced pain at discharge and first bowel motion (n=250) (Muzi 2007, LoE 1)
• Ligasure reduced pain scores compared to closed haemorrhoidectomy on days 1, 7 and 14 but not for 6 weeks, and reduced analgesic requirement on days 1, 3 and 7 (n=80) (Fareed 2009, LoE 2)
• Radiofrequency scalpel (Surgitron) reduced pain compared with closed haemorrhoidectomy at 1 and 2 days after surgery, and reduced analgesic consumption (n=22) (Filingeri 2010, LoE 2)
• Comparison of CO2 laser and cold scalpel technique did not demonstrate a significant difference in pain or analgesia requirement between groups up to 14 days postoperatively, except reduced pain on first bowel movement with CO2 laser (n=40) (Pandini 2006, LoE 2)

Arguments against…

• In two studies with a total of 116 patients, Ligasure did not reduce pain compared to conventional open haemorrhoidectomy (Castellvi 2009, LoE 1; Tan 2008, LoE 1)
• Evidence identified in a meta-analysis was conflicting, and the cost-effectiveness and long term outcomes of energy devices for haemorrhoidectomy have yet to be adequately addressed (Tan 2007, meta-analysis)

PROSPECT Recommendations

• Closed haemorrhoidectomy (Grade B) or open haemorrhoidectomy with electrocoagulation of the pedicle (Grade A) is recommended as the primary procedure for grade 3 and 4 haemorrhoids, based on:
  • Lower level evidence that closed haemorrhoidectomy is less painful than open haemorrhoidectomy (LoE 2)
  • Evidence that open haemorrhoidectomy with pedicle electrocoagulation reduces pain compared with pedicle ligation (LoE 1)
• Injection of botulinum toxin is not recommended (Grade D) due to inconsistent procedure-specific evidence for analgesic benefit in the postoperative period (LoE 4)
  • No change since the previous review
• The use of an anal dilator as an adjunct to haemorrhoid surgery is not recommended for analgesia (Grade D, LoE 4) based on limited procedure-specific evidence
  • No change since the previous review