<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/NCT04423510</url>
  </required_header>
  <id_info>
    <org_study_id>KonyaTRH01</org_study_id>
    <nct_id>NCT04423510</nct_id>
  </id_info>
  <brief_title>Nonoperative Treatment of Recurrent Pilonidal Sinus Disease</brief_title>
  <official_title>Previously Operated Recurrent Pilonidal Sinus Treated With Crystallized Phenol: Twenty Years Experience</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Osman DOĞRU</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konya Meram State Hospital</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>
      Postoperative recurrent pilonidal sinus disease is troublesome and its treatment is&#xD;
      challenge. Many treatment modalities have been advocated in the treatment of recurrent&#xD;
      pilonidal sinus disease; however, there is still no consensus in the literature. Some&#xD;
      minimally invasive techniques are used alone or as an adjunct to surgery. Crystallized phenol&#xD;
      is the most popular method in the nonoperative treatment of primer pilonidal sinus disease.&#xD;
      But its long term effect in the postoperative recurrent cases is unclear. Investigators aimed&#xD;
      to present the long-term efficacy of crystallized phenol treatment on postoperative recurrent&#xD;
      pilonidal sinus disease through our results collected within the last 20 years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study data were collected prospectively and analyzed retrospectively. The demographic data of&#xD;
      the patients, other parameters such as smoking, whether they sit a lot due to occupation&#xD;
      (sitting at work for at least 6 hours a day), skin tone (whiter, darker), presence of&#xD;
      positive family history, BMI (kg/m2, patients were divided into BMI &lt;30 and BMI&gt; 30),&#xD;
      pilosity levels (mild,moderate, severe) were also recorded. In addition, the time from the&#xD;
      recurrence to admission, the number and type of previous operations, and the status of the&#xD;
      sinus at presentation (acute, chronic) were recorded. The presence of purulent discharge from&#xD;
      the sinus opening and the presence of signs of inflammation or abscess formation in this&#xD;
      region were evaluated as acute pilonidal sinus disease (PSD). The presence of serous&#xD;
      discharge from the sinus opening and absence of abscess formation were evaluated as chronic&#xD;
      PSD. Investigators investigated whether the factors mentioned above affect the number of&#xD;
      applications and recurrence after crystallized phenol treatment (CPT).&#xD;
&#xD;
      The treatment procedure was applied to all patients by one surgical team. One day before the&#xD;
      procedure, patients were asked to clean the hair from the waist to the middle of the thighs&#xD;
      with depilatory creams or epilation. After local anesthesia was performed around the holes, a&#xD;
      thin mosquito clamp was inserted into the sinus and the hairs were removed and the skin&#xD;
      around the hole was covered by nitrofurantoin pomade to prevent chemical irritation. Then&#xD;
      crystallized phenol was introduced into the sinus with the same clamp. Patients were allowed&#xD;
      to return to their daily activities after the procedure. This procedure was performed every 3&#xD;
      weeks. If there was discharge from the wound during the follow-up examination, the procedure&#xD;
      was repeated. The closure of the sinus hole and the complete disappearance of the discharge&#xD;
      were accepted as healing. After the treatment, follow-up was started. Follow up was done&#xD;
      first yearly than five years intervals. All of our patients' contact information was recorded&#xD;
      by us and we tried to reach the patients every 5 years by any means (phone or e-mail).&#xD;
      Investigators tried to follow them up by contacting them periodically, whether they contact&#xD;
      us or not. According to this follow-up, patients were analyzed by divided into 3 groups(1-5&#xD;
      years, 5-10 years, 10-20 years). Patients who could not be reached by any means of&#xD;
      communication were included in the unreachable group. Patients were recommended to have hair&#xD;
      removal at the wound site once a month for 6 years.&#xD;
&#xD;
      Number of crystallized phenol application, presence of recurrence and number of recurrence&#xD;
      after CPT and follow-up data were evaluated. Recurrence of the sinus hole which was found to&#xD;
      occur again at least 6 months after being determined to be closed was considered as&#xD;
      recurrence. If no recurrence was observed during the follow-up or if post-CPT recurrence was&#xD;
      healed after treatment, CPT was considered successful.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 1995</start_date>
  <completion_date type="Actual">February 1, 2016</completion_date>
  <primary_completion_date type="Actual">February 1, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Long term effect of crystallized phenol treatment in recurrent pilonidal sinus</measure>
    <time_frame>January 1995-February 2015</time_frame>
    <description>All participants we applied to crystallized phenol treatment (CPT) were contacted via e-mail, telephone or face-to-face interview and questioned whether there was a recurrence. The number of CPT applications and sinus characteristics (primer openings, seconder openings, sinus presentation etc.) were compared between recurrent participants and non-recurrent participants. The number of CPT application and sinus characteristic features was obtained patients files that were recorded in first consult.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The effects of factors playing a role in the etiology of pilonidal sinus on treatment results</measure>
    <time_frame>January 1995-February 2016</time_frame>
    <description>All participants we applied to crystallized phenol treatment were contacted via e-mail, telephone or face-to-face interview and questioned whether there was a recurrence. The relationship between relapsed participants and non-relapsed participants was investigated between the factors accused in etiology (gender, BMI, family history, pilosity levels, skin tone etc.). Factors accused in etiology were obtained patients files that were recorded in first consult.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">227</enrollment>
  <condition>Pilonidal Sinus</condition>
  <arm_group>
    <arm_group_label>Recurrent pilonidal sinus</arm_group_label>
    <description>Postoperative recurrent pilonidal sinus disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Crystallized phenol treatment</intervention_name>
    <arm_group_label>Recurrent pilonidal sinus</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients who previous operated recurrent pilonidal sinus disease and who accepted&#xD;
        crystallized phenol treatment were included in the study. Patients who at least one year of&#xD;
        treatment and contacting later were included in our study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Previous operated recurrent pilonidal sinus disease&#xD;
&#xD;
          -  Follow-up period of more than 12 months&#xD;
&#xD;
          -  The patients who connection by e-mail or telephone&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primer pilonidal sinus disease&#xD;
&#xD;
          -  Follow-up period of less than 12 months&#xD;
&#xD;
          -  The patients who can't connection by e-mail or telephone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ersin TURAN, 3</last_name>
    <role>Study Chair</role>
    <affiliation>Konya Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ramazan Saygın KERİMOĞLU, 4</last_name>
    <role>Study Chair</role>
    <affiliation>Konya Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emet Ebru NAZİK, 5</last_name>
    <role>Study Chair</role>
    <affiliation>Konya Education and Research Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ebru Esen, 6</last_name>
    <role>Study Chair</role>
    <affiliation>Konya Education and Research Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Lund JN, Leveson SH. Fibrin glue in the treatment of pilonidal sinus: results of a pilot study. Dis Colon Rectum. 2005 May;48(5):1094-6. doi: 10.1007/s10350-004-0905-4.</citation>
    <PMID>15868239</PMID>
  </reference>
  <reference>
    <citation>Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.</citation>
    <PMID>28056720</PMID>
  </reference>
  <reference>
    <citation>Othman I. Skin glue improves outcome after excision and primary closure of sacrococcygeal pilonidal disease. Indian J Surg. 2010 Dec;72(6):470-4. doi: 10.1007/s12262-010-0170-9. Epub 2010 Nov 16.</citation>
    <PMID>22131657</PMID>
  </reference>
  <results_reference>
    <citation>Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.</citation>
    <PMID>29449548</PMID>
  </results_reference>
  <results_reference>
    <citation>Doll D, Luedi MM, Wysocki AP. Pilonidal sinus disease guidelines: a minefield? Tech Coloproctol. 2016 Apr;20(4):263-4. doi: 10.1007/s10151-015-1398-y. Epub 2015 Dec 17. No abstract available.</citation>
    <PMID>26681445</PMID>
  </results_reference>
  <results_reference>
    <citation>Dag A, Colak T, Turkmenoglu O, Sozutek A, Gundogdu R. Phenol procedure for pilonidal sinus disease and risk factors for treatment failure. Surgery. 2012 Jan;151(1):113-7. doi: 10.1016/j.surg.2011.07.015. Epub 2011 Oct 6.</citation>
    <PMID>21982072</PMID>
  </results_reference>
  <results_reference>
    <citation>Kaymakcioglu N, Yagci G, Simsek A, Unlu A, Tekin OF, Cetiner S, Tufan T. Treatment of pilonidal sinus by phenol application and factors affecting the recurrence. Tech Coloproctol. 2005 Apr;9(1):21-4. doi: 10.1007/s10151-005-0187-4.</citation>
    <PMID>15868494</PMID>
  </results_reference>
  <results_reference>
    <citation>Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. doi: 10.1007/s10350-004-0720-y.</citation>
    <PMID>15622588</PMID>
  </results_reference>
  <results_reference>
    <citation>Aygen E, Arslan K, Dogru O, Basbug M, Camci C. Crystallized phenol in nonoperative treatment of previously operated, recurrent pilonidal disease. Dis Colon Rectum. 2010 Jun;53(6):932-5. doi: 10.1007/DCR.0b013e3181d8283b.</citation>
    <PMID>20485008</PMID>
  </results_reference>
  <results_reference>
    <citation>Emiroglu M, Karaali C, Esin H, Akpinar G, Aydin C. Treatment of pilonidal disease by phenol application. Turk J Surg. 2017 Mar 1;33(1):5-9. doi: 10.5152/UCD.2016.3532. eCollection 2017.</citation>
    <PMID>28589180</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Konya Meram State Hospital</investigator_affiliation>
    <investigator_full_name>Osman DOĞRU</investigator_full_name>
    <investigator_title>Professor, MD</investigator_title>
  </responsible_party>
  <keyword>recurrent pilonidal disease</keyword>
  <keyword>nonoperative treatment</keyword>
  <keyword>crystallized phenol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pilonidal Sinus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Phenol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We are planned to share that all of individual participant data.</ipd_description>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The data will become available starting 6 months after publication.</ipd_time_frame>
    <ipd_access_criteria>The data will share as SPSS dataset.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04423510
org study id: KonyaTRH01
nct id: NCT04423510
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Postoperative recurrent pilonidal sinus disease is troublesome and its treatment is
      challenge. Many treatment modalities have been advocated in the treatment of recurrent
      pilonidal sinus disease; however, there is still no consensus in the literature. Some
      minimally invasive techniques are used alone or as an adjunct to surgery. Crystallized phenol
      is the most popular method in the nonoperative treatment of primer pilonidal sinus disease.
      But its long term effect in the postoperative recurrent cases is unclear. Investigators aimed
      to present the long-term efficacy of crystallized phenol treatment on postoperative recurrent
      pilonidal sinus disease through our results collected within the last 20 years.
Study data were collected prospectively and analyzed retrospectively. The demographic data of
      the patients, other parameters such as smoking, whether they sit a lot due to occupation
      (sitting at work for at least 6 hours a day), skin tone (whiter, darker), presence of
      positive family history, BMI (kg/m2, patients were divided into BMI <30 and BMI> 30),
      pilosity levels (mild,moderate, severe) were also recorded. In addition, the time from the
      recurrence to admission, the number and type of previous operations, and the status of the
      sinus at presentation (acute, chronic) were recorded. The presence of purulent discharge from
      the sinus opening and the presence of signs of inflammation or abscess formation in this
      region were evaluated as acute pilonidal sinus disease (PSD). The presence of serous
      discharge from the sinus opening and absence of abscess formation were evaluated as chronic
      PSD. Investigators investigated whether the factors mentioned above affect the number of
      applications and recurrence after crystallized phenol treatment (CPT).

      The treatment procedure was applied to all patients by one surgical team. One day before the
      procedure, patients were asked to clean the hair from the waist to the middle of the thighs
      with depilatory creams or epilation. After local anesthesia was performed around the holes, a
      thin mosquito clamp was inserted into the sinus and the hairs were removed and the skin
      around the hole was covered by nitrofurantoin pomade to prevent chemical irritation. Then
      crystallized phenol was introduced into the sinus with the same clamp. Patients were allowed
      to return to their daily activities after the procedure. This procedure was performed every 3
      weeks. If there was discharge from the wound during the follow-up examination, the procedure
      was repeated. The closure of the sinus hole and the complete disappearance of the discharge
      were accepted as healing. After the treatment, follow-up was started. Follow up was done
      first yearly than five years intervals. All of our patients' contact information was recorded
      by us and we tried to reach the patients every 5 years by any means (phone or e-mail).
      Investigators tried to follow them up by contacting them periodically, whether they contact
      us or not. According to this follow-up, patients were analyzed by divided into 3 groups(1-5
      years, 5-10 years, 10-20 years). Patients who could not be reached by any means of
      communication were included in the unreachable group. Patients were recommended to have hair
      removal at the wound site once a month for 6 years.

      Number of crystallized phenol application, presence of recurrence and number of recurrence
      after CPT and follow-up data were evaluated. Recurrence of the sinus hole which was found to
      occur again at least 6 months after being determined to be closed was considered as
      recurrence. If no recurrence was observed during the follow-up or if post-CPT recurrence was
      healed after treatment, CPT was considered successful.
observational model: Cohort
time perspective: Retrospective
measure: Long term effect of crystallized phenol treatment in recurrent pilonidal sinus
time frame: January 1995-February 2015
description: All participants we applied to crystallized phenol treatment (CPT) were contacted via e-mail, telephone or face-to-face interview and questioned whether there was a recurrence. The number of CPT applications and sinus characteristics (primer openings, seconder openings, sinus presentation etc.) were compared between recurrent participants and non-recurrent participants. The number of CPT application and sinus characteristic features was obtained patients files that were recorded in first consult.
measure: The effects of factors playing a role in the etiology of pilonidal sinus on treatment results
time frame: January 1995-February 2016
description: All participants we applied to crystallized phenol treatment were contacted via e-mail, telephone or face-to-face interview and questioned whether there was a recurrence. The relationship between relapsed participants and non-relapsed participants was investigated between the factors accused in etiology (gender, BMI, family history, pilosity levels, skin tone etc.). Factors accused in etiology were obtained patients files that were recorded in first consult.
arm group label: Recurrent pilonidal sinus
description: Postoperative recurrent pilonidal sinus disease
intervention type: Procedure
intervention name: Crystallized phenol treatment
arm group label: Recurrent pilonidal sinus
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ersin TURAN, 3
role: Study Chair
affiliation: Konya Education and Research Hospital
last name: Ramazan Saygın KERİMOĞLU, 4
role: Study Chair
affiliation: Konya Education and Research Hospital
last name: Emet Ebru NAZİK, 5
role: Study Chair
affiliation: Konya Education and Research Hospital
last name: Ebru Esen, 6
role: Study Chair
affiliation: Konya Education and Research Hospital
citation: Lund JN, Leveson SH. Fibrin glue in the treatment of pilonidal sinus: results of a pilot study. Dis Colon Rectum. 2005 May;48(5):1094-6. doi: 10.1007/s10350-004-0905-4.
PMID: 15868239
citation: Dessily M, Charara F, Ralea S, Alle JL. Pilonidal sinus destruction with a radial laser probe: technique and first Belgian experience. Acta Chir Belg. 2017 Jun;117(3):164-168. doi: 10.1080/00015458.2016.1272285. Epub 2017 Jan 6.
PMID: 28056720
citation: Othman I. Skin glue improves outcome after excision and primary closure of sacrococcygeal pilonidal disease. Indian J Surg. 2010 Dec;72(6):470-4. doi: 10.1007/s12262-010-0170-9. Epub 2010 Nov 16.
PMID: 22131657
citation: Stauffer VK, Luedi MM, Kauf P, Schmid M, Diekmann M, Wieferich K, Schnuriger B, Doll D. Common surgical procedures in pilonidal sinus disease: A meta-analysis, merged data analysis, and comprehensive study on recurrence. Sci Rep. 2018 Feb 15;8(1):3058. doi: 10.1038/s41598-018-20143-4.
PMID: 29449548
citation: Doll D, Luedi MM, Wysocki AP. Pilonidal sinus disease guidelines: a minefield? Tech Coloproctol. 2016 Apr;20(4):263-4. doi: 10.1007/s10151-015-1398-y. Epub 2015 Dec 17. No abstract available.
PMID: 26681445
citation: Dag A, Colak T, Turkmenoglu O, Sozutek A, Gundogdu R. Phenol procedure for pilonidal sinus disease and risk factors for treatment failure. Surgery. 2012 Jan;151(1):113-7. doi: 10.1016/j.surg.2011.07.015. Epub 2011 Oct 6.
PMID: 21982072
citation: Kaymakcioglu N, Yagci G, Simsek A, Unlu A, Tekin OF, Cetiner S, Tufan T. Treatment of pilonidal sinus by phenol application and factors affecting the recurrence. Tech Coloproctol. 2005 Apr;9(1):21-4. doi: 10.1007/s10151-005-0187-4.
PMID: 15868494
citation: Dogru O, Camci C, Aygen E, Girgin M, Topuz O. Pilonidal sinus treated with crystallized phenol: an eight-year experience. Dis Colon Rectum. 2004 Nov;47(11):1934-8. doi: 10.1007/s10350-004-0720-y.
PMID: 15622588
citation: Aygen E, Arslan K, Dogru O, Basbug M, Camci C. Crystallized phenol in nonoperative treatment of previously operated, recurrent pilonidal disease. Dis Colon Rectum. 2010 Jun;53(6):932-5. doi: 10.1007/DCR.0b013e3181d8283b.
PMID: 20485008
citation: Emiroglu M, Karaali C, Esin H, Akpinar G, Aydin C. Treatment of pilonidal disease by phenol application. Turk J Surg. 2017 Mar 1;33(1):5-9. doi: 10.5152/UCD.2016.3532. eCollection 2017.
PMID: 28589180
responsible party type: Sponsor-Investigator
investigator affiliation: Konya Meram State Hospital
investigator full name: Osman DOĞRU
investigator title: Professor, MD
mesh term: Pilonidal Sinus
mesh term: Phenol
sharing ipd: Yes
ipd description: We are planned to share that all of individual participant data.
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: The data will become available starting 6 months after publication.
ipd access criteria: The data will share as SPSS dataset.