xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06005727</url>
    </required_header>
    <id_info>
      <org_study_id>2022/2357</org_study_id>
      <nct_id>NCT06005727</nct_id>
    </id_info>
    <brief_title>Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial</brief_title>
    <official_title>Cryotherapy Post-haemorrhoidectomy (CYPHER) Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Singapore General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Singapore General Hospital</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is&#xD;
        indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have&#xD;
        failed. There have been several surgical techniques described such as the Milligan- Morgan,&#xD;
        Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients&#xD;
        experience different degrees of postoperative pain which may cause anxiety and&#xD;
        dissatisfaction.&#xD;
  &#xD;
        A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy&#xD;
        which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has&#xD;
        few deleterious side effects due to its non-pharmacologic nature and has become widespread in&#xD;
        sports medicine to treat soft tissue damage.&#xD;
  &#xD;
        Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and&#xD;
        outcomes among patients who undergo haemorrhoidectomy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Haemorrhoids is a common problem with an estimated prevalence of 5 to 36%. Surgery is&#xD;
        indicated in patients with grade 3 to 4 piles and in patients whom conservative measures have&#xD;
        failed. There have been several surgical techniques described such as the Milligan- Morgan,&#xD;
        Ferguson haemorrhoidectomy, stapled and laser haemorrhoidectomy. However, most patients&#xD;
        experience different degrees of postoperative pain which may cause anxiety and&#xD;
        dissatisfaction.&#xD;
  &#xD;
        Pain is an unavoidable side effect of any proctology operation. It arises from local&#xD;
        inflammation in traumatized tissues which may cause stimulation of surrounding nociceptors.&#xD;
        While adequate postoperative analgesia promotes patient recovery and satisfaction, narcotics&#xD;
        for postoperative pain are also associated with numerous side effects.&#xD;
  &#xD;
        A relatively non-invasive and cost-effective technique targeting inflammation is cryotherapy&#xD;
        which has been shown to decrease pain secondary to trauma, injury or disease. Cryotherapy has&#xD;
        few deleterious side effects due to its non-pharmacologic nature and has become widespread in&#xD;
        sports medicine to treat soft tissue damage. Ice therapy has previously been shown to be safe&#xD;
        and effect for postoperative analgesia in various procedures such as laparotomy, hernia&#xD;
        repair, tonsillectomy, oral surgery but the evidence for its role in haemorrhoidectomy is&#xD;
        lacking.&#xD;
  &#xD;
        Therefore, we aim to evaluate the role of cryotherapy in improving postoperative pain and&#xD;
        outcomes among patients who undergo haemorrhoidectomy. We hypothesize that intraoperative&#xD;
        trans-anal ice pack insertion for patients after haemorrhoidectomy (conventional &amp;amp;&#xD;
        stapled) will have lower postoperative pain scores with possibly decreased postoperative&#xD;
        complications.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">April 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain score on postoperative day 1 after hemorrhoidectomy</measure>
      <time_frame>Postoperative day 1</time_frame>
      <description>Pain score on postoperative day from scale of 1 to 10 after hemorrhoidectomy.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Postoperative complications after hemorrhoidectomy</measure>
      <time_frame>Within 30 days after surgery</time_frame>
      <description>Postoperative bleeding, urinary retention, perianal sepsis, anal stenosis, incontinence</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who had admission after day surgery or readmission for postoperative complications</measure>
      <time_frame>Within 30 days after surgery</time_frame>
      <description>Proportion of patients who had readmission or required admission after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients who require repeat surgical interventions for postoperative complications: bleeding, perianal sepsis and anal stenosis</measure>
      <time_frame>Within 30 days after surgery</time_frame>
      <description>Proportion of patients who required repeat surgical interventions after surgery.</description>
    </secondary_outcome>
    <secondary_outcome>
      <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.</measure>
      <time_frame>Postoperative day 1, 2, 3, 4, 7, 14, 21 and 28.</time_frame>
      <description>Pain scores are recorded on the postoperative day 1, 2, 3, 4, 7, 14, 21 and 28 and postoperative pain score trends analyzed.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mean time to return to work or regular activity, in days, reported by the patient.</measure>
      <time_frame>Within the first 90 days after the surgery</time_frame>
      <description>The time to return to work or regular activity after surgery as reported by the patient</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Hemorrhoids</condition>
    <condition>Postoperative Pain</condition>
    <condition>Postoperative Complications</condition>
    <condition>Cryotherapy Effect</condition>
    <arm_group>
      <arm_group_label>Transanal ice pack applied to hemorrhoidectomy wound for 1 minute</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Transanal ice pack is applied to hemorrhoidectomy wound for 1 minute. After the surgery, standard postoperative analgesia and medications will be prescribed.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard postoperative care after hemorrhoidectomy</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Standard postoperative analgesia and medications will be prescribed.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Transanal ice pack</intervention_name>
      <description>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.</description>
      <arm_group_label>Transanal ice pack applied to hemorrhoidectomy wound for 1 minute</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age group of patients: 21 to 75 years old&#xD;
  &#xD;
            2. Grade 3 (prolapsed but reducible manually) and Grade 4 (prolapsed but irreducible)&#xD;
               piles that are symptomatic&#xD;
  &#xD;
            3. Patients recruited are to undergo either staple or conventional (Milligan-Morgan or&#xD;
               Ferguson) haemorrhoidectomy&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Grade 1 and 2 haemorrhoids&#xD;
  &#xD;
            2. Thrombosed, irreducible piles that require emergency haemorrhoidectomy&#xD;
  &#xD;
            3. Patients who had undergone any previous anorectal surgery within 5 years from the date&#xD;
               of recruitment&#xD;
  &#xD;
            4. Patients with concurrent anorectal pathology (anal fissures, abscess, fistula, tumour,&#xD;
               inflammatory bowel disease)&#xD;
  &#xD;
            5. Pregnant women&#xD;
  &#xD;
            6. Patients with severe medical comorbidities or assessed as ASA 3 and above&#xD;
  &#xD;
            7. Patients on long term antiplatelets (aspirin, plavix) and anticoagulation (clexane,&#xD;
               warfarin, rivaroxaban, apixaban)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Isaac Seow-En</last_name>
      <role>Principal Investigator</role>
      <affiliation>Singapore General Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hui Lionel Raphael Chen</last_name>
      <phone>62223322</phone>
      <phone_ext>+65</phone_ext>
      <email>lionel.raphael.chen.h@singhealth.com.sg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Singapore General Hospital</name>
        <address>
          <city>Singapore</city>
          <zip>169608</zip>
          <country>Singapore</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui Lionel Raphael Chen</last_name>
        <phone>6222 3322</phone>
        <phone_ext>+65</phone_ext>
        <email>lionel.raphael.chen.h@singhealth.com.sg</email>
      </contact>
    </location>
    <location_countries>
      <country>Singapore</country>
    </location_countries>
    <reference>
      <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>
      <PMID>27960130</PMID>
    </reference>
    <reference>
      <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>
      <PMID>11888463</PMID>
    </reference>
    <reference>
      <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.</citation>
      <PMID>25081937</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hemorrhoids</mesh_term>
      <mesh_term>Postoperative Complications</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06005727
  org study id: 2022/2357
  nct id: NCT06005727
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Pain score on postoperative day 1 after hemorrhoidectomy
  time frame: Postoperative day 1
  description: Pain score on postoperative day from scale of 1 to 10 after hemorrhoidectomy.
  measure: Postoperative complications after hemorrhoidectomy
  time frame: Within 30 days after surgery
  description: Postoperative bleeding, urinary retention, perianal sepsis, anal stenosis, incontinence
  measure: Proportion of patients who had admission after day surgery or readmission for postoperative complications
  time frame: Within 30 days after surgery
  description: Proportion of patients who had readmission or required admission after surgery.
  measure: Proportion of patients who require repeat surgical interventions for postoperative complications: bleeding, perianal sepsis and anal stenosis
  time frame: Within 30 days after surgery
  description: Proportion of patients who required repeat surgical interventions 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.
  time frame: Postoperative day 1, 2, 3, 4, 7, 14, 21 and 28.
  description: Pain scores are recorded on the postoperative day 1, 2, 3, 4, 7, 14, 21 and 28 and postoperative pain score trends analyzed.
  measure: 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
  description: The time to return to work or regular activity after surgery as reported by the patient
  arm group label: Transanal ice pack applied to hemorrhoidectomy wound for 1 minute
  arm group type: Active Comparator
  description: Transanal ice pack is applied to hemorrhoidectomy wound for 1 minute. After the surgery, standard postoperative analgesia and medications will be prescribed.
  arm group label: Standard postoperative care after hemorrhoidectomy
  arm group type: No Intervention
  description: Standard postoperative analgesia and medications will be prescribed.
  intervention type: Device
  intervention name: Transanal ice pack
  description: 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.
  arm group label: Transanal ice pack applied to hemorrhoidectomy wound for 1 minute
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Isaac Seow-En
  role: Principal Investigator
  affiliation: Singapore General Hospital
  last name: Hui Lionel Raphael Chen
  phone: 62223322
  phone ext: +65
  email: lionel.raphael.chen.h@singhealth.com.sg
  facility: 
  status: Recruiting
  contact: 
  country: Singapore
  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.
  PMID: 27960130
  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.
  PMID: 11888463
  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.
  PMID: 25081937
  responsible party type: Sponsor
  mesh term: Hemorrhoids
  mesh term: Postoperative Complications
  sharing ipd: No