Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial
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ClinicalTrials.gov Identifier: NCT06005727 |
Recruitment Status :
Recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
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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.
Condition or disease | Intervention/treatment | Phase |
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Hemorrhoids Postoperative Pain Postoperative Complications Cryotherapy Effect | Device: Transanal ice pack | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial |
Actual Study Start Date : | April 1, 2023 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2024 |
Arm | Intervention/treatment |
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Active Comparator: Transanal ice pack applied to hemorrhoidectomy wound for 1 minute
Transanal ice pack is applied to hemorrhoidectomy wound for 1 minute. After the surgery, standard postoperative analgesia and medications will be prescribed.
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Device: Transanal ice pack
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. |
No Intervention: Standard postoperative care after hemorrhoidectomy
Standard postoperative analgesia and medications will be prescribed.
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- 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.
- Postoperative complications after hemorrhoidectomy [ Time Frame: Within 30 days after surgery ]Postoperative bleeding, urinary retention, perianal sepsis, anal stenosis, incontinence
- 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 had readmission or required admission 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 ]Proportion of patients who required repeat surgical interventions 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. ]Pain scores are recorded on the postoperative day 1, 2, 3, 4, 7, 14, 21 and 28 and postoperative pain score trends analyzed.
- 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 ]The time to return to work or regular activity after surgery as reported by the patient
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Ages Eligible for Study: | 21 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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 Criteria:
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06005727
Contact: Hui Lionel Raphael Chen | 62223322 ext +65 | lionel.raphael.chen.h@singhealth.com.sg |
Singapore | |
Singapore General Hospital | Recruiting |
Singapore, Singapore, 169608 | |
Contact: Hui Lionel Raphael Chen 6222 3322 ext +65 lionel.raphael.chen.h@singhealth.com.sg |
Principal Investigator: | Isaac Seow-En | Singapore General Hospital |
Responsible Party: | Singapore General Hospital |
ClinicalTrials.gov Identifier: | NCT06005727 |
Other Study ID Numbers: |
2022/2357 |
First Posted: | August 22, 2023 Key Record Dates |
Last Update Posted: | August 22, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hemorrhoids Postoperative Complications Pathologic Processes Rectal Diseases Intestinal Diseases |
Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases |