The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06005727
Recruitment Status : Recruiting
First Posted : August 22, 2023
Last Update Posted : August 22, 2023
Sponsor:
Information provided by (Responsible Party):
Singapore General Hospital

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Hemorrhoids Postoperative Pain Postoperative Complications Cryotherapy Effect Device: Transanal ice pack Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Postoperative complications after hemorrhoidectomy [ Time Frame: Within 30 days after surgery ]
    Postoperative bleeding, urinary retention, perianal sepsis, anal stenosis, incontinence

  2. 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.

  3. 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.

  4. 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.

  5. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Hui Lionel Raphael Chen 62223322 ext +65 lionel.raphael.chen.h@singhealth.com.sg

Locations
Layout table for location information
Singapore
Singapore General Hospital Recruiting
Singapore, Singapore, 169608
Contact: Hui Lionel Raphael Chen    6222 3322 ext +65    lionel.raphael.chen.h@singhealth.com.sg   
Sponsors and Collaborators
Singapore General Hospital
Investigators
Layout table for investigator information
Principal Investigator: Isaac Seow-En Singapore General Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhoids
Postoperative Complications
Pathologic Processes
Rectal Diseases
Intestinal Diseases
 Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases