Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial

Singapore Health Services (SingHealth)

Status: Enrolling

Conditions: Postoperative Complications; Postoperative Pain; Cryotherapy Effect; Hemorrhoids

Treatments: Device: Transanal ice pack

Study type: Interventional

Funder types: Other

Identifiers

NCT06005727

2022/2357

Details and patient eligibility

About

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.

Full 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 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 & stapled) will have lower postoperative pain scores with possibly decreased postoperative complications.

Enrollment: 50 estimated patients

Sex: All

Ages: 21 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Transanal ice pack applied to hemorrhoidectomy wound for 1 minute

Active Comparator group

Description:

Transanal ice pack is applied to hemorrhoidectomy wound for 1 minute. After the surgery, standard postoperative analgesia and medications will be prescribed.

Treatment:

Device: Transanal ice pack

Standard postoperative care after hemorrhoidectomy

No Intervention group

Description:

Standard postoperative analgesia and medications will be prescribed.