Using cryotherapy to reduce pain after hemorrhoid surgery
Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
This study is testing if using ice packs after hemorrhoid surgery can help reduce pain and complications for patients with severe hemorrhoids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Singapore General Hospital Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06005727 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of cryotherapy in alleviating postoperative pain and complications in patients undergoing hemorrhoidectomy for grade 3 and 4 hemorrhoids. The study involves applying transanal ice packs to target inflammation and reduce pain, which is a common issue following such surgeries. By comparing outcomes between patients receiving cryotherapy and those who do not, the trial aims to provide evidence for a non-invasive, cost-effective pain management technique. The study is conducted at Singapore General Hospital, focusing on a specific patient demographic.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 75 with symptomatic grade 3 or 4 hemorrhoids scheduled for surgical intervention.
Not a fit: Patients with grade 1 or 2 hemorrhoids, those requiring emergency surgery, or individuals with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve postoperative pain management and patient satisfaction after hemorrhoid surgery.
How similar studies have performed: Previous studies have shown cryotherapy to be effective in postoperative pain management for various surgical procedures, but its application in hemorrhoidectomy is less established.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Singapore
- Singapore General Hospital — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Isaac Seow-En — Singapore General Hospital
- Study coordinator: Hui Lionel Raphael Chen
- Email: lionel.raphael.chen.h@singhealth.com.sg
- Phone: 62223322
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.