Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial

Study Overview
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Brief Summary
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Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have failed. There have been several surgical techniques described such as the Milligan- Morgan, Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients experience different degrees of postoperative pain which may cause anxiety and dissatisfaction. A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has few deleterious side effects due to its non-pharmacologic nature and has become widespread in sports medicine to treat soft tissue damage. Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and outcomes among patients who undergo haemorrhoidectomy.

Detailed Description
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Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have failed. There have been several surgical techniques described such as the Milligan- Morgan, Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients experience different degrees of postoperative pain which may cause anxiety and dissatisfaction. Pain is an unavoidable side effect of any proctology operation. It arises from local inflammation in traumatized tissues which may cause stimulation of surrounding nociceptors. While adequate postoperative analgesia promotes patient recovery and satisfaction, narcotics for postoperative pain are also associated with numerous side effects. A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has few deleterious side effects due to its non-pharmacologic nature and has become widespread in sports medicine to treat soft tissue damage. Ice therapy has previously been shown to be safe and effect for postoperative analgesia in various procedures such as laparotomy, hernia repair, tonsillectomy, oral surgery but the evidence for its role in haemorrhoidectomy is lacking. Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and outcomes among patients who undergo haemorrhoidectomy. We hypothesize that intraoperative trans-anal ice pack insertion for patients after haemorrhoidectomy (conventional &amp; stapled) will have lower postoperative pain scores with possibly decreased postoperative complications.

Official Title
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Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial

Conditions
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Hemorrhoids, Postoperative Pain, Postoperative Complications, Cryotherapy Effect

Intervention / Treatment
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* Device: Transanal ice pack


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age group of patients: 21 to 75 years old Grade 3 (prolapsed but reducible manually) and Grade 4 (prolapsed but irreducible) piles that are symptomatic Patients recruited are to undergo either staple or conventional (Milligan-Morgan or Ferguson) haemorrhoidectomy Exclusion Criteria: Grade 1 and 2 haemorrhoids Thrombosed, irreducible piles that require emergency haemorrhoidectomy Patients who had undergone any previous anorectal surgery within 5 years from the date of recruitment Patients with concurrent anorectal pathology (anal fissures, abscess, fistula, tumour, inflammatory bowel disease) Pregnant women Patients with severe medical comorbidities or assessed as ASA 3 and above Patients on long term antiplatelets (aspirin, plavix) and anticoagulation (clexane, warfarin, rivaroxaban, apixaban)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transanal ice pack applied to hemorrhoidectomy wound for 1 minute<br>Transanal ice pack is applied to hemorrhoidectomy wound for 1 minute. After the surgery, standard postoperative analgesia and medications will be prescribed. | Device: Transanal ice pack<br>* A condom is filled with 100ml of water and frozen to serve as a transanal ice pack. It is covered by sterile plastic dressing and applied to the hemorrhoidectomy wound for 1 minute after surgery is completed.<br>|
| No Intervention: Standard postoperative care after hemorrhoidectomy<br>Standard postoperative analgesia and medications will be prescribed. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on postoperative day 1 after hemorrhoidectomy | Pain score on postoperative day from scale of 1 to 10 after hemorrhoidectomy. | Postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications after hemorrhoidectomy | Postoperative bleeding, urinary retention, perianal sepsis, anal stenosis, incontinence | Within 30 days after surgery | 
| Proportion of patients who had admission after day surgery or readmission for postoperative complications | Proportion of patients who had readmission or required admission after surgery. | Within 30 days after surgery | 
| Proportion of patients who require repeat surgical interventions for postoperative complications: bleeding, perianal sepsis and anal stenosis | Proportion of patients who required repeat surgical interventions after surgery. | Within 30 days after surgery | 
| Changes in the mean pain score 1 month after surgery assessed by telephone interviews on POD1, 2, 3, 4, 7, 14, 21 and 28. | Pain scores are recorded on the postoperative day 1, 2, 3, 4, 7, 14, 21 and 28 and postoperative pain score trends analyzed. | Postoperative day 1, 2, 3, 4, 7, 14, 21 and 28. | 
| Mean time to return to work or regular activity, in days, reported by the patient. | The time to return to work or regular activity after surgery as reported by the patient | Within the first 90 days after the surgery |