Clinical trial NCT06005727: Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
Official title: Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhoids
Postoperative Pain
Postoperative Complications
Cryotherapy Effect
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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: 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.

Eligibility 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)

Primary outcomes:
measure: Pain score on postoperative day 1 after hemorrhoidectomy
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Postoperative complications after hemorrhoidectomy
timeFrame: Within 30 days after surgery
measure: Proportion of patients who had admission after day surgery or readmission for postoperative complications
timeFrame: Within 30 days after surgery
measure: Proportion of patients who require repeat surgical interventions for postoperative complications: bleeding, perianal sepsis and anal stenosis
timeFrame: Within 30 days after surgery
measure: Changes in the mean pain score 1 month after surgery assessed by telephone interviews on POD1, 2, 3, 4, 7, 14, 21 and 28.
timeFrame: Postoperative day 1, 2, 3, 4, 7, 14, 21 and 28.
measure: Mean time to return to work or regular activity, in days, reported by the patient.
timeFrame: Within the first 90 days after the surgery
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: Singapore General Hospital
name: Isaac Seow-En
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.