Postoperative Pain Clinical Trial
Official title:
Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | December 31, 2024 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Age group of patients: 21 to 75 years old 2. Grade 3 (prolapsed but reducible manually) and Grade 4 (prolapsed but irreducible) piles that are symptomatic 3. Patients recruited are to undergo either staple or conventional (Milligan-Morgan or Ferguson) haemorrhoidectomy Exclusion Criteria: 1. Grade 1 and 2 haemorrhoids 2. Thrombosed, irreducible piles that require emergency haemorrhoidectomy 3. Patients who had undergone any previous anorectal surgery within 5 years from the date of recruitment 4. Patients with concurrent anorectal pathology (anal fissures, abscess, fistula, tumour, inflammatory bowel disease) 5. Pregnant women 6. Patients with severe medical comorbidities or assessed as ASA 3 and above 7. Patients on long term antiplatelets (aspirin, plavix) and anticoagulation (clexane, warfarin, rivaroxaban, apixaban) |
Country | Name | City | State |
---|---|---|---|
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Singapore,
Hetzer FH, Demartines N, Handschin AE, Clavien PA. Stapled vs excision hemorrhoidectomy: long-term results of a prospective randomized trial. Arch Surg. 2002 Mar;137(3):337-40. doi: 10.1001/archsurg.137.3.337. — View Citation
Medina-Gallardo A, Curbelo-Pena Y, De Castro X, Roura-Poch P, Roca-Closa J, De Caralt-Mestres E. Is the severe pain after Milligan-Morgan hemorrhoidectomy still currently remaining a major postoperative problem despite being one of the oldest surgical techniques described? A case series of 117 consecutive patients. Int J Surg Case Rep. 2017;30:73-75. doi: 10.1016/j.ijscr.2016.11.018. Epub 2016 Nov 15. — View Citation
Watkins AA, Johnson TV, Shrewsberry AB, Nourparvar P, Madni T, Watkins CJ, Feingold PL, Kooby DA, Maithel SK, Staley CA, Master VA. Ice packs reduce postoperative midline incision pain and narcotic use: a randomized controlled trial. J Am Coll Surg. 2014 Sep;219(3):511-7. doi: 10.1016/j.jamcollsurg.2014.03.057. Epub 2014 May 23. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Postoperative complications after hemorrhoidectomy | Postoperative bleeding, urinary retention, perianal sepsis, anal stenosis, incontinence | Within 30 days after surgery | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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. | |
Secondary | 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 |
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