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/NCT05982028</url>
    </required_header>
    <id_info>
      <org_study_id>PC1 - 4</org_study_id>
      <nct_id>NCT05982028</nct_id>
    </id_info>
    <brief_title>Patients' Quality of Life After Pilonidal Cyst Operations.</brief_title>
    <official_title>Evaluation of Patients' Quality of Life and Treatment Outcomes After Pilonidal Cyst Operations.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lithuanian University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lithuanian University of Health Sciences</source>
    <oversight_info>
      <has_dmc>No</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>
        Biomedical research consists of two main parts. In the first part, the pilonidal&#xD;
        cyst-specific quality of life questionnaire is compiled, adapted, validated, tested for&#xD;
        suitability in assessing patients after pilonidal cyst operations.&#xD;
  &#xD;
        The second part will compare two pilonidal cyst operations. A prospective, comparative,&#xD;
        randomized clinical study will be conducted.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The first part includes the creation, adaptation, validity and suitability of the pilonidal&#xD;
        cyst-specific quality of life questionnaire in assessing patients after pilonidal cyst&#xD;
        operations, verification and evaluation of the quality of life and its dynamics after these&#xD;
        operations. A survey of patients operated on for acute and chronic pilonidal cysts will be&#xD;
        conducted. The main evaluation criteria of the first part will be the internal consistency of&#xD;
        the questionnaire, the stability of the measurements, the construct validity and the&#xD;
        frequency of patients with moderate and severe symptoms according to the specific quality of&#xD;
        life questionnaire after pilonidal cyst surgery and the SF36v2 quality of life questionnaire.&#xD;
  &#xD;
        The second part will compare two pilonidal cyst operations. A prospective, comparative,&#xD;
        randomized clinical study will be conducted. This part of the study will study patients&#xD;
        scheduled for surgery for chronic pilonidal cyst. Patients will be randomized into two&#xD;
        groups, a group that will undergo radical excision of the pilonidal cyst without suturing the&#xD;
        wound and a group that will undergo minimally invasive &quot;pit picking&quot; surgery. Patients will&#xD;
        be interviewed before surgery, as well as on the first and second day after surgery.&#xD;
        Discharged patients will complete quality-of-life questionnaires at 1, 2 weeks, and 2 months.&#xD;
        Patients will be invited for a visit after 1 and 6 months, wound healing, disease recurrence&#xD;
        and quality of life will be evaluated. The main evaluation criteria of the second part will&#xD;
        be objective data - postoperative complications, wound healing time, duration of incapacity&#xD;
        for work, frequency of disease recurrence and subjective data - changes in pain (VAS 10 cm&#xD;
        scale) and quality of life total points according to SF36v2 and the specific life&#xD;
        questionnaire created after radical pilonidal cyst excision and &quot;pit picking&quot; operations.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">September 1, 2020</start_date>
    <completion_date type="Anticipated">March 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>One week after surgery</time_frame>
      <description>Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain at rest on a specified 100 mm scale at the specified time.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of disease recurrence</measure>
      <time_frame>Recurrence will be assessed 6 months and 2 years after surgery</time_frame>
      <description>Disease recurrence will be assessed by clinical examination.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>One day after surgery</time_frame>
      <description>Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>Two days after surgery</time_frame>
      <description>Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>Two weeks after surgery</time_frame>
      <description>Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>One month after surgery</time_frame>
      <description>Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>Two months after surgery</time_frame>
      <description>Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain after surgery</measure>
      <time_frame>Six months after surgery</time_frame>
      <description>Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Postoperative complications</measure>
      <time_frame>1 months after surgery</time_frame>
      <description>Patients will report past complications.</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of life according to the 36-Item Short Form Survey (SF-36).</measure>
      <time_frame>Before surgery, 1 and 2 days after surgery, 1 and 2 weeks after surgery, 1, 2 and 6 months after surgery. Change from baseline in quality of life scores over a 6-month period will be assessed.</time_frame>
      <description>Patients fill out the the 36-Item Short Form Survey (SF-36). All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table. The scores from those questions that address each specific area of functional health status are then averaged together, for a final score within each of the 8 dimensions measured (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well being, social functioning, pain, general health). All 8 categories are scored in the same way.</description>
    </other_outcome>
    <other_outcome>
      <measure>Duration of disability</measure>
      <time_frame>1 month after surgery</time_frame>
      <description>Patients will note the duration of incapacity for work.</description>
    </other_outcome>
    <other_outcome>
      <measure>Wound healing time</measure>
      <time_frame>Six months after surgery</time_frame>
      <description>Patients will note the time when the wound healed.</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of life total scores according to a specific life questionnaire developed by the researcher.</measure>
      <time_frame>Before surgery, 1 and 2 days after surgery, 1 and 2 weeks after surgery, 1, 2 and 6 months after surgery. Change from baseline in quality of life scores over a 6-month period will be assessed.</time_frame>
      <description>Patients fill out a specific life questionnaire. This questionnaire consists of 20 questions, the value of each question is from 1 to 5 points. The minimum score value is 20, the maximum score value is 100. A lower score value indicates a better quality of life.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Pilonidal Cyst</condition>
    <condition>Pain Postoperative</condition>
    <condition>Quality of Life</condition>
    <arm_group>
      <arm_group_label>Pit picking group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Minimally invasive pilonidal cyst surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Excision group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Radical surgical pilonidal cyst excision without suturing</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Minimally invasive pit-picking surgery</intervention_name>
      <description>Midline pits and secondary fistula openings were probed to determine the direction and length of any associated sinus tracts, followed by an excision with a 3 or 5 mm punch biopsy needle, depending on the size of the pit. A 2 cm lateral incision was made parallel to the pilonidal cyst. Hair and granulations within the sinus tracts were removed, and the cyst cavity was drained through the incision. Nonabsorbable monofilament sutures were used to close the excisional wounds of the pits and secondary fistula. Once haemostasis was achieved, the wound was covered with a sterile gauze with 10 % povidone-iodine solution.</description>
      <arm_group_label>Pit picking group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Radical surgical excision without suturing</intervention_name>
      <description>Under the guidance of brilliant green, the cavity of the pilonidal cyst, along with the sinus tracts and fistulas, was marked. A symmetric elliptical incision was made to excise the pits and secondary fistula openings. The pilonidal cyst was removed from the healthy subcutaneous tissue and sacrococcygeal fascia using monopolar electrocautery. The wound was not sutured and was left open to heal by secondary intention. After haemostasis was achieved, the wound was covered with sterile gauze with 10 % povidone-iodine solution.</description>
      <arm_group_label>Excision group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients aged 18-75 (men and women)&#xD;
  &#xD;
            2. Chronic symptomatic (primary or recurrent) pilonidal cyst&#xD;
  &#xD;
            3. American Society of Anesthesiologists physical status I to III&#xD;
  &#xD;
            4. Signed the person's information and consent form to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Acute pilonidal cyst&#xD;
  &#xD;
            2. Patients who do not speak Lithuanian&#xD;
  &#xD;
            3. Cognitive, visual, auditory and locomotor system disorders&#xD;
  &#xD;
            4. Insufficiency of kidneys, liver, cardiopulmonary system&#xD;
  &#xD;
            5. Refuses to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Lithuanian University of Health Sciences, Clinic of General Surgery</name>
        <address>
          <city>Kaunas</city>
          <zip>LT-47144</zip>
          <country>Lithuania</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Lithuania</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>July 30, 2023</last_update_submitted>
    <last_update_submitted_qc>July 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Lithuanian University of Health Sciences</investigator_affiliation>
      <investigator_full_name>Edvinas Dainius</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cysts</mesh_term>
      <mesh_term>Pilonidal Sinus</mesh_term>
      <mesh_term>Pain, Postoperative</mesh_term>
    </condition_browse>
    <!-- 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/NCT05982028
  org study id: PC1 - 4
  nct id: NCT05982028
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Biomedical research consists of two main parts. In the first part, the pilonidal
        cyst-specific quality of life questionnaire is compiled, adapted, validated, tested for
        suitability in assessing patients after pilonidal cyst operations.
  
        The second part will compare two pilonidal cyst operations. A prospective, comparative,
        randomized clinical study will be conducted.
  The first part includes the creation, adaptation, validity and suitability of the pilonidal
        cyst-specific quality of life questionnaire in assessing patients after pilonidal cyst
        operations, verification and evaluation of the quality of life and its dynamics after these
        operations. A survey of patients operated on for acute and chronic pilonidal cysts will be
        conducted. The main evaluation criteria of the first part will be the internal consistency of
        the questionnaire, the stability of the measurements, the construct validity and the
        frequency of patients with moderate and severe symptoms according to the specific quality of
        life questionnaire after pilonidal cyst surgery and the SF36v2 quality of life questionnaire.
  
        The second part will compare two pilonidal cyst operations. A prospective, comparative,
        randomized clinical study will be conducted. This part of the study will study patients
        scheduled for surgery for chronic pilonidal cyst. Patients will be randomized into two
        groups, a group that will undergo radical excision of the pilonidal cyst without suturing the
        wound and a group that will undergo minimally invasive "pit picking" surgery. Patients will
        be interviewed before surgery, as well as on the first and second day after surgery.
        Discharged patients will complete quality-of-life questionnaires at 1, 2 weeks, and 2 months.
        Patients will be invited for a visit after 1 and 6 months, wound healing, disease recurrence
        and quality of life will be evaluated. The main evaluation criteria of the second part will
        be objective data - postoperative complications, wound healing time, duration of incapacity
        for work, frequency of disease recurrence and subjective data - changes in pain (VAS 10 cm
        scale) and quality of life total points according to SF36v2 and the specific life
        questionnaire created after radical pilonidal cyst excision and "pit picking" operations.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Pain after surgery
  time frame: One week after surgery
  description: Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain at rest on a specified 100 mm scale at the specified time.
  measure: Rate of disease recurrence
  time frame: Recurrence will be assessed 6 months and 2 years after surgery
  description: Disease recurrence will be assessed by clinical examination.
  measure: Pain after surgery
  time frame: One day after surgery
  description: Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
  measure: Pain after surgery
  time frame: Two days after surgery
  description: Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
  measure: Pain after surgery
  time frame: Two weeks after surgery
  description: Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
  measure: Pain after surgery
  time frame: One month after surgery
  description: Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
  measure: Pain after surgery
  time frame: Two months after surgery
  description: Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
  measure: Pain after surgery
  time frame: Six months after surgery
  description: Postoperative pain will be assessed on a VAS 100 mm scale. Patients will mark their pain
  measure: Postoperative complications
  time frame: 1 months after surgery
  description: Patients will report past complications.
  measure: Quality of life according to the 36-Item Short Form Survey (SF-36).
  time frame: Before surgery, 1 and 2 days after surgery, 1 and 2 weeks after surgery, 1, 2 and 6 months after surgery. Change from baseline in quality of life scores over a 6-month period will be assessed.
  description: Patients fill out the the 36-Item Short Form Survey (SF-36). All questions are scored on a scale from 0 to 100, with 100 representing the highest level of functioning possible. Aggregate scores are compiled as a percentage of the total points possible, using the RAND scoring table. The scores from those questions that address each specific area of functional health status are then averaged together, for a final score within each of the 8 dimensions measured (physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/ fatigue, emotional well being, social functioning, pain, general health). All 8 categories are scored in the same way.
  measure: Duration of disability
  time frame: 1 month after surgery
  description: Patients will note the duration of incapacity for work.
  measure: Wound healing time
  time frame: Six months after surgery
  description: Patients will note the time when the wound healed.
  measure: Quality of life total scores according to a specific life questionnaire developed by the researcher.
  time frame: Before surgery, 1 and 2 days after surgery, 1 and 2 weeks after surgery, 1, 2 and 6 months after surgery. Change from baseline in quality of life scores over a 6-month period will be assessed.
  description: Patients fill out a specific life questionnaire. This questionnaire consists of 20 questions, the value of each question is from 1 to 5 points. The minimum score value is 20, the maximum score value is 100. A lower score value indicates a better quality of life.
  arm group label: Pit picking group
  arm group type: Experimental
  description: Minimally invasive pilonidal cyst surgery.
  arm group label: Excision group
  arm group type: Experimental
  description: Radical surgical pilonidal cyst excision without suturing
  intervention type: Procedure
  intervention name: Minimally invasive pit-picking surgery
  description: Midline pits and secondary fistula openings were probed to determine the direction and length of any associated sinus tracts, followed by an excision with a 3 or 5 mm punch biopsy needle, depending on the size of the pit. A 2 cm lateral incision was made parallel to the pilonidal cyst. Hair and granulations within the sinus tracts were removed, and the cyst cavity was drained through the incision. Nonabsorbable monofilament sutures were used to close the excisional wounds of the pits and secondary fistula. Once haemostasis was achieved, the wound was covered with a sterile gauze with 10 % povidone-iodine solution.
  arm group label: Pit picking group
  intervention type: Procedure
  intervention name: Radical surgical excision without suturing
  description: Under the guidance of brilliant green, the cavity of the pilonidal cyst, along with the sinus tracts and fistulas, was marked. A symmetric elliptical incision was made to excise the pits and secondary fistula openings. The pilonidal cyst was removed from the healthy subcutaneous tissue and sacrococcygeal fascia using monopolar electrocautery. The wound was not sutured and was left open to heal by secondary intention. After haemostasis was achieved, the wound was covered with sterile gauze with 10 % povidone-iodine solution.
  arm group label: Excision group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  country: Lithuania
  responsible party type: Principal Investigator
  investigator affiliation: Lithuanian University of Health Sciences
  investigator full name: Edvinas Dainius
  investigator title: Principal Investigator
  mesh term: Cysts
  mesh term: Pilonidal Sinus
  mesh term: Pain, Postoperative