HemorrhoidsNCT06005727
Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
A study testing Transanal ice pack in people with Hemorrhoids and Postoperative Pain, run by Singapore General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Hemorrhoids, Postoperative Pain, Postoperative Complications
- What is being tested?
- Transanal ice pack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Singapore General Hospital
Singapore, 169608
Hui Lionel Raphael Chen, 6222 3322 ext. +65, lionel.raphael.chen.h@singhealth.com.sg
About this study
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.
Read the 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 \& stapled) will have lower postoperative pain scores with possibly decreased postoperative complications.
- Being tested
- Transanal ice pack
- Medical subject headings
- Hemorrhoids, Pain, Postoperative, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transanal ice packDevice
A condom is filled with 100ml of water and frozen to serve as a transanal ice pack. It is covered by sterile plastic dressing and applied to the hemorrhoidectomy wound for 1 minute after surgery is completed.
| Study group | Role | What they receive |
|---|---|---|
| Transanal ice pack applied to hemorrhoidectomy wound for 1 minute | Active comparator | Transanal ice pack is applied to hemorrhoidectomy wound for 1 minute. After the surgery, standard postoperative analgesia and medications will be prescribed. Receives: Device: Transanal ice pack |
| Standard postoperative care after hemorrhoidectomy | No intervention | Standard postoperative analgesia and medications will be prescribed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on postoperative day 1 after hemorrhoidectomy
Pain score on postoperative day from scale of 1 to 10 after hemorrhoidectomy.
Measured: Postoperative day 1
Secondary outcomes (5)
Postoperative complications after hemorrhoidectomy
Postoperative bleeding, urinary retention, perianal sepsis, anal stenosis, incontinence
Measured: Within 30 days after surgery
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.
Measured: Within 30 days after surgery
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.
Measured: Within 30 days after surgery
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.
Measured: Postoperative day 1, 2, 3, 4, 7, 14, 21 and 28.
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
Measured: Within the first 90 days after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isaac Seow-En, Principal investigator, Singapore General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005727
- Sponsor's protocol ID
- 2022/2357
- Status last verified
- Aug 2023
- First submitted
- 15 Aug 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27960130Hetzer 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.
PubMed 11888463Watkins 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.
PubMed 25081937Seow-En I, Chen LRH, Zhao Y, Ng YY, Tan EK. Cryotherapy reduces pain post-hemorrhoidectomy (CYPHER): a randomized, controlled, superiority trial of intra-anal ice after surgery for grade III hemorrhoids. Ann Coloproctol. 2025 Dec;41(6):537-544. doi: 10.3393/ac.2025.00549.0078. Epub 2025 Dec 24.
PubMed 41486911
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06005727
- Acronym / sponsor ID
- 2022/2357
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 \& stapled) will have lower postoperative pain scores with possibly decreased postoperative complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transanal ice pack applied to hemorrhoidectomy wound for 1 minute | Active comparator | Device: Transanal ice packTransanal ice pack is applied to hemorrhoidectomy wound for 1 minute. After the surgery, standard postoperative analgesia and medications will be prescribed. |
| Standard postoperative care after hemorrhoidectomy | No intervention | –Standard postoperative analgesia and medications will be prescribed. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transanal ice packA condom is filled with 100ml of water and frozen to serve as a transanal ice pack. It is covered by sterile plastic dressing and applied to the hemorrhoidectomy wound for 1 minute after surgery is completed. | Device | Transanal ice pack applied to hemorrhoidectomy wound for 1 minute |
Primary outcome
Pain score on postoperative day 1 after hemorrhoidectomy
Time frame: Postoperative day 1
Pain score on postoperative day from scale of 1 to 10 after hemorrhoidectomy.
5 secondary outcomes
Postoperative complications after hemorrhoidectomy
Time frame: Within 30 days after surgery
Proportion of patients who had admission after day surgery or readmission for postoperative complications
Time frame: Within 30 days after surgery
Proportion of patients who require repeat surgical interventions for postoperative complications: bleeding, perianal sepsis and anal stenosis
Time frame: Within 30 days after surgery
Changes in the mean pain score 1 month after surgery assessed by telephone interviews on POD1, 2, 3, 4, 7, 14, 21 and 28.
Time frame: Postoperative day 1, 2, 3, 4, 7, 14, 21 and 28.
Mean time to return to work or regular activity, in days, reported by the patient.
Time frame: Within the first 90 days after the surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 27960130Medina-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.
- Background: PubMed 11888463Hetzer 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.
- Background: PubMed 25081937Watkins 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.
- Derived from this study: PubMed 41486911Seow-En I, Chen LRH, Zhao Y, Ng YY, Tan EK. Cryotherapy reduces pain post-hemorrhoidectomy (CYPHER): a randomized, controlled, superiority trial of intra-anal ice after surgery for grade III hemorrhoids. Ann Coloproctol. 2025 Dec;41(6):537-544. doi: 10.3393/ac.2025.00549.0078. Epub 2025 Dec 24.
- Individual participant dataSharing planned: No
Related trials for Hemorrhoids
Not yet recruiting
Auricular Indwelling Needles Added to Diosmin/Hesperidin for Grade I-II Internal Hemorrhoids With Heat-Toxin Syndrome
Internal Haemorrhoids
Enrolling by invitation
Ultrasound-Guided Versus Landmark-Guided Pudendal Block for Post-Hemorrhoidectomy Pain
Hemorrhoids, Postoperative Pain
Not yet recruitingObservational study
Bleeding Reduction in Grade II-III Haemorrhoids Through Embolization Treatment
Hemorrhoid, Hemorrhoid Bleeding
Recruiting
Ligasure Versus Conventional Diathermy in Hemorrhoidectomy
Hemorrhoids
Enrolling by invitationObservational study
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Arteriovenous Malformation, Gastrointestinal Bleed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Seow-En principal investigator
Singapore General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transanal ice pack in people with Hemorrhoids and Postoperative Pain, run by Singapore General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Lionel Raphael Chen (62223322 ext. +65, lionel.raphael.chen.h@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score on postoperative day 1 after hemorrhoidectomy (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06005727, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.