Status:
UNKNOWN
Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
Lead Sponsor:
Singapore General Hospital
Conditions:
Hemorrhoids
Postoperative Pain
Eligibility:
All Genders
21-75 years
Phase:
NA
Brief Summary
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 b...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
April 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06005727
Start Date
April 1 2023
End Date
December 31 2024
Last Update
August 22 2023
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608