<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/NCT03757728</url>
  </required_header>
  <id_info>
    <org_study_id>158200-15-792-322</org_study_id>
    <nct_id>NCT03757728</nct_id>
  </id_info>
  <brief_title>Randomized Trial :Hemorrhoidal Pedicle Ligation vs Laser vs Open Hemorrhoidectomy</brief_title>
  <official_title>Hemorrhoidal Pedicle Ligation vs Laser Hemorrhoidectomy vs Open Hemorrhoidectomy: Randomized, Double Blind, Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vilnius University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biolitec Pharma Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Vilnius University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare three different modalities for treatment of symptomatic 2&#xD;
      ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser procedure and&#xD;
      haemorrhoidal pedicle ligation.&#xD;
&#xD;
      To assess early outcomes (after one week and one month) of the procedures: pain, bleeding,&#xD;
      wound healing, return to work and quality of life; To assess late outcomes (after one year)&#xD;
      of the procedures: late functional results (continence) and recurrence of symptoms and&#xD;
      haemorrhoids.&#xD;
&#xD;
      Study design This is a multi-center, double-blind, prospective RCT comparing three different&#xD;
      modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy,&#xD;
      intrahaemorrhoidal laser coagulation and haemorrhoidal artery ligation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Hemorrhoidal pedicle ligation vs laser hemorrhoidectomy vs open hemorrhoidectomy: randomized,&#xD;
      double blind, multicenter trial&#xD;
&#xD;
      AIMS AND OBJECTIVES The aim of this study is to compare three different modalities for&#xD;
      treatment of symptomatic 2 to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal&#xD;
      laser procedure and haemorrhoidal pedicle ligation.&#xD;
&#xD;
      Objectives of the study are:&#xD;
&#xD;
      To assess early outcomes (after one week and one month) of the procedures: pain, bleeding,&#xD;
      wound healing, return to work and quality of life; To assess late outcomes (after one year)&#xD;
      of the procedures: late functional results (continence) and recurrence of symptoms and&#xD;
      haemorrhoids.&#xD;
&#xD;
      MATERIALS AND METHODS Study design This is a randomized, parallel group (1:1:1)&#xD;
      double-blinded single centre prospective study. No changes in methods of the study were&#xD;
      allowed after commen cement. This RCT compares three different modalities for treatment of&#xD;
      symptomatic 2 to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser&#xD;
      coagulation and haemorrhoidal artery ligation.&#xD;
&#xD;
      Patients This prospective randomized study was performed at Vilnius University Hospital&#xD;
      Santara Clinics, Vilnius, Lithuania. It is a large tertiary University hospital with&#xD;
      dedicated outpatient clinic. A period of 3 year starting from April 2015 to November 2018. A&#xD;
      total of 121 patients are included in the study.&#xD;
&#xD;
      Patients with symptomatic 2nd or 3rd ° hemorrhoids, in 1st or 2nd risk group of ASA (American&#xD;
      Society of Anesthesiologists), who consented to participate in this study were included into&#xD;
      the study. Exclusion criteria were 1st or 4th °of hemorrhoids, pregnancy, patients with other&#xD;
      anorectal diseases (fistula, abscess, rectal carcinoma, inflammatory bowel disease, etc.),&#xD;
      patients after previous anal operations (except rubber band ligation, which should have&#xD;
      occurred more than 3 months before the inclusion in the trial) and ≥ 3rd risk group of ASA.&#xD;
&#xD;
      Preoperative evaluation Detailed physical and anorectal examination was performed with&#xD;
      anoscopy and rigid proctoscopy in all cases, as well as colonoscopy if indicated. All&#xD;
      patients filled a dedicated symptom questionnaire, which included questions on intensity and&#xD;
      frequency of hemorrhoidal prolapse, bleeding, itching, pain and other symptoms. Every patient&#xD;
      completed Wexner incontinence score and SF-36 questionnaires.&#xD;
&#xD;
      Preoperative examination, classification, operation technique, postoperative treatment and&#xD;
      follow-up are discussed at the introductory course.&#xD;
&#xD;
      Patients preoperatively fill questionnaires on the quality of life and defecation function&#xD;
      (Patient symptoms scale, Cleveland clinic incontinence scale, Health survey - SF 36, Fecal&#xD;
      incontinence quality of life instrument - FIQol).&#xD;
&#xD;
      Patient symptoms scale (appendix 1) - symptoms of haemorrhoids are assessed (rectal bleeding,&#xD;
      pain, pile prolapse, defecation disturbances, discomfort affecting normal life). Each symptom&#xD;
      gets a number from 1 - very intense to 5 - no complaints.&#xD;
&#xD;
      Cleveland clinic incontinence scale (appendix 2) - the sum of 5 parameters is determined that&#xD;
      are scored on a scale from 0 (=absent) to 4 (daily) frequency of incontinence to gas, liquid,&#xD;
      solid, of need to wear pad, and of lifestyle changes. A score of 0 means perfect control, a&#xD;
      score of 20 - complete incontinence.&#xD;
&#xD;
      Health survey - SF 36 (appendix 3) - it measures eight domains: physical functioning, role&#xD;
      limitations due to physical health, role limitations due to emotional problems,&#xD;
      energy/fatigue, emotional well-being, social functioning, pain, general health. For each of&#xD;
      the eight domains that the SF36 measures an aggregate percentage score is produced. The&#xD;
      percentage scores range from 0% (lowest or worst possible level of functioning) to 100%&#xD;
      (highest or best possible level of functioning).&#xD;
&#xD;
      Fecal incontinence quality of life instrument - FIQol (appendix 4) -scale consists of 29&#xD;
      questions in 4 domains: lifestyle, coping/behavior, depression/self perception,&#xD;
      embarrassment. Category ranges: 1 to 4 for lifestyle, coping/behavior, and embarrassment; 1&#xD;
      to 6 for depression/self perception.&#xD;
&#xD;
      Randomization, blinding and concealment The patients were randomized into three groups.&#xD;
      Randomization sequence was computer-generated before the start of the trial. Every&#xD;
      consecutive case&#xD;
&#xD;
      -history was assigned a randomization number (1, 2 or 3). It was written and sealed within&#xD;
      the envelope and remained unknown neither to the patient, nor to the treating physician, to&#xD;
      avoid selection bias. In the operating room, after induction of anesthesia, operating room&#xD;
      junior staff was asked to unseal the envelope and the intervention was performed according to&#xD;
      the procedure assigned. Pre- and postoperative patient management was identical in all three&#xD;
      operations. The patient remained unaware of the procedure performed until the end of the&#xD;
      study 1 year after the operation. The case-notes and discharge summary of the patient&#xD;
      contained only the note, saying that the patient is included in the study of hemorrhoids with&#xD;
      D.Danys/T.Poskus as Principal Investigators, patient's number is X. This number was within&#xD;
      the locked and coded database and the staff, evaluating the result of the patients' treatment&#xD;
      remained unaware of the procedure allocated. The patients were followed-up by different&#xD;
      surgeons (E.P. and V.J.) than the ones, performing the operation. They had the access to the&#xD;
      patient notes but not to the coded database, and were not able to know, which procedure was&#xD;
      performed. In emergency situations, un-blinding of the patient and treating physicians was&#xD;
      possible but was not required in any of the patients.&#xD;
&#xD;
      Operative procedure Patients were started on lactulose the day before the operation, which&#xD;
      was continued after the operation to have regular bowel movements. Preoperative intravenous&#xD;
      antibiotic prophylaxis was given according to the hospital protocol, which was 1g of&#xD;
      Cephazolin (2g if patient was over 80 kg of weight), 240 mg of gentamycin and 500 mg of&#xD;
      metronidazole (Ciprofloxacin can be used if patient is allergic to cephalosporins). Each&#xD;
      surgeon performing operative procedures (T.P., D.D. and S.M.) had personal experience of at&#xD;
      least 50 operations of each modality. 1 hour seminar was conducted between all surgeons&#xD;
      before the start of the trial to unify the technique of operative procedures.All patients&#xD;
      were photographed after induction of anesthesia before the start of the procedure and&#xD;
      immediately after the procedure.LHP was performed using Ceralas diode laser of 1420 nm&#xD;
      wavelength (Biolitec). Disposable LHP kit (Biolitec) was used, which contains sharp-tipped&#xD;
      laser fiber and anoscope. Perianal skin immediately aboral to hemorrhoid was penetrated using&#xD;
      needle-tip cautery (Figure 2). Laser fiber was introduced into the opening until the level of&#xD;
      hemorrhoidal pedicle and coagulation was activated. 8 Watt 3 second pulses with 1 second&#xD;
      pulse-pauses were used to coagulate the area of hemorrhoids. 5 mm of hemorrhoidal tissue is&#xD;
      coagulated with one such pulse (experimental data). 250 Joules was the upper limit of energy&#xD;
      delivered per 1 hemorrhoidal quadrant. Smaller hemorrhoids were treated with less energy,&#xD;
      larger ones - with more energy. The procedure was repeated in three other quadrants, thus&#xD;
      treating all anal circumference. RAR was performed as described by Schurmann JP et al. For&#xD;
      these patients, the ligations were placed in the area of visible pathologic hemorrhoidal&#xD;
      tissue, and in patients with large prolapse mucopexy - lifting of prolapsing hemorrhoidal&#xD;
      tissue with sutures was performed. Standard EH was performed up to the level of hemorrhoidal&#xD;
      pedicle, with ligation or suture-ligation of the pedicle and meticulous hemostasis. Follow-up&#xD;
      was performed by different surgeons to those, performing the operations (E.P., V.J.). Each of&#xD;
      them has more than 25 years of experience of colorectal and hemorrhoidal surgery. 1 hour&#xD;
      seminar was conducted with them to unify the evaluation of the patients within the study.&#xD;
      Each patient was followed up at 1 and 6 weeks and after 1 year after the operation (Figure&#xD;
      1). Perianal examination with photographic documentation was performed during all the visits.&#xD;
      Anoscopy was performed during visits at 6 weeks and 1 year. Each patient was asked to fill in&#xD;
      the diary during each day of the first post-operative week and present it at the first visit&#xD;
      after 1 week. Symptom questionnaires were filled in during visits at 1 and 6 weeks and 1&#xD;
      year. Wexner incontinence score was filled during the visit at 6 weeks and 1 year. SF-36 QOL&#xD;
      questionnaire was filled during the final visit at 1 year.&#xD;
&#xD;
      Statistical analysis Sample size calculation was performed using R statistical software&#xD;
      package(©The R Foundation).Presuming the effect size of 0.3, power of 0.8 and alpha=0.05 the&#xD;
      sample size was calculated to be 108 patients. To compensate for possible follow-up losses&#xD;
      sample size was increased to 120 patients. Chi-square test and Anova tests were used to&#xD;
      compare differences between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">April 2016</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recurrence rate of rectal prolapse</measure>
    <time_frame>one years</time_frame>
    <description>Visual rectal prolapse during postoperative anoscopy requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrence rate of rectal bleeding</measure>
    <time_frame>one years</time_frame>
    <description>Intensity and frequency of postoperative bleeding requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Continence</measure>
    <time_frame>after one year</time_frame>
    <description>Using Wexner fecal incontinence score (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993; 36:77-97)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence of any perianal symptoms</measure>
    <time_frame>One years</time_frame>
    <description>Evalluation by abdominal surgeon: pain, bleeding, external haemorrhoids, etc</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to return to work</measure>
    <time_frame>One years</time_frame>
    <description>Time to return to work or regular activity, in days, reported by the patient</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensity and duration of postoperative perianal pain</measure>
    <time_frame>7 postoperative days</time_frame>
    <description>Intensity and duration of perianal pain after the operation (in days) based on visual analogue scale during after first 7 days of the operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>One years</time_frame>
    <description>Quality of life based on Short-form (SF)-36 questionnaire (https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fecal incontinence quality of life (FIQOL) score</measure>
    <time_frame>One years</time_frame>
    <description>Fecal incontinence quality of life (FIQOL) score at 1 year (Rockwood TH, Church JM, Fleshman JW. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000; 43:9-17)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the operation by the patient</measure>
    <time_frame>One years</time_frame>
    <description>Evaluation of the operation by the patient on visual analogue scale from 1 to 10 at 1-year visit.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">121</enrollment>
  <condition>Hemorrhoids Second Degree</condition>
  <condition>Hemorrhoids Third Degree</condition>
  <arm_group>
    <arm_group_label>open haemorrhoidectomy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Open haemorrhoidectomy is performed using an anal retractor, exposed haemorrhoids at 3 - 7- 11 hours are excised using cautery. The arteries are ligated or cauterized. Open or closed technique is used (the choice of the surgeon). The Spongostan plug is then introduced</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Haemorrhodal pedicle ligation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Haemorrhodal pedicle ligation is performed using operating proctoscope. The pedicle of symptomatic haemorrhoid is suture ligated with absorbable Vycril 2/0. Mucopexy is performed simultaneously if the prolapse is noticed. No tissue removal is performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intrahaemoroidal laser coagulation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Intrahaemoroidal laser coagulation is performed using disposable THD kit [Biolitec Co]. The haemorrhoidal pedicle is sutured. 1mm opening is created at the external haemorrhoid (skin level). Laser is then introduced up to pedicle and coagulation performed. This is repeated to all the piles. The procedure is finished with placing Spongostan plug into anal canal</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Haemorrhoidectomy operations</intervention_name>
    <description>for treatment of symptomatic 2 to 3 degree haemorrhoids</description>
    <arm_group_label>Haemorrhodal pedicle ligation</arm_group_label>
    <arm_group_label>Intrahaemoroidal laser coagulation</arm_group_label>
    <arm_group_label>open haemorrhoidectomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consented &gt;18 year old male and female patients with 2 to 3 degree&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with 1st and 4th degree haemorrhoids.&#xD;
&#xD;
          2. Patients with associated anorectal pathology (anorectal fistula, abscess, fissure,&#xD;
             tumor or inflammatory bowel disease).&#xD;
&#xD;
          3. Patients who had undergone previous anorectal surgery.&#xD;
&#xD;
          4. ASA &gt; 3.&#xD;
&#xD;
          5. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Center of Abdominal Surgery, Vilnius University Hospital Santariskiu Clinics, Lithuania, 2 Santariskiu Street,</name>
      <address>
        <city>Vilnius</city>
        <zip>LT-08661</zip>
        <country>Lithuania</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Lithuania</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vilnius University</investigator_affiliation>
    <investigator_full_name>Tomas Poskus</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhoids</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>2017</ipd_description>
  </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/NCT03757728
org study id: 158200-15-792-322
nct id: NCT03757728
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to compare three different modalities for treatment of symptomatic 2
      ° to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser procedure and
      haemorrhoidal pedicle ligation.

      To assess early outcomes (after one week and one month) of the procedures: pain, bleeding,
      wound healing, return to work and quality of life; To assess late outcomes (after one year)
      of the procedures: late functional results (continence) and recurrence of symptoms and
      haemorrhoids.

      Study design This is a multi-center, double-blind, prospective RCT comparing three different
      modalities for treatment of symptomatic 2 ° to 3 ° haemorrhoids: open haemorrhoidectomy,
      intrahaemorrhoidal laser coagulation and haemorrhoidal artery ligation.
Hemorrhoidal pedicle ligation vs laser hemorrhoidectomy vs open hemorrhoidectomy: randomized,
      double blind, multicenter trial

      AIMS AND OBJECTIVES The aim of this study is to compare three different modalities for
      treatment of symptomatic 2 to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal
      laser procedure and haemorrhoidal pedicle ligation.

      Objectives of the study are:

      To assess early outcomes (after one week and one month) of the procedures: pain, bleeding,
      wound healing, return to work and quality of life; To assess late outcomes (after one year)
      of the procedures: late functional results (continence) and recurrence of symptoms and
      haemorrhoids.

      MATERIALS AND METHODS Study design This is a randomized, parallel group (1:1:1)
      double-blinded single centre prospective study. No changes in methods of the study were
      allowed after commen cement. This RCT compares three different modalities for treatment of
      symptomatic 2 to 3 ° haemorrhoids: open haemorrhoidectomy, intrahaemorrhoidal laser
      coagulation and haemorrhoidal artery ligation.

      Patients This prospective randomized study was performed at Vilnius University Hospital
      Santara Clinics, Vilnius, Lithuania. It is a large tertiary University hospital with
      dedicated outpatient clinic. A period of 3 year starting from April 2015 to November 2018. A
      total of 121 patients are included in the study.

      Patients with symptomatic 2nd or 3rd ° hemorrhoids, in 1st or 2nd risk group of ASA (American
      Society of Anesthesiologists), who consented to participate in this study were included into
      the study. Exclusion criteria were 1st or 4th °of hemorrhoids, pregnancy, patients with other
      anorectal diseases (fistula, abscess, rectal carcinoma, inflammatory bowel disease, etc.),
      patients after previous anal operations (except rubber band ligation, which should have
      occurred more than 3 months before the inclusion in the trial) and ≥ 3rd risk group of ASA.

      Preoperative evaluation Detailed physical and anorectal examination was performed with
      anoscopy and rigid proctoscopy in all cases, as well as colonoscopy if indicated. All
      patients filled a dedicated symptom questionnaire, which included questions on intensity and
      frequency of hemorrhoidal prolapse, bleeding, itching, pain and other symptoms. Every patient
      completed Wexner incontinence score and SF-36 questionnaires.

      Preoperative examination, classification, operation technique, postoperative treatment and
      follow-up are discussed at the introductory course.

      Patients preoperatively fill questionnaires on the quality of life and defecation function
      (Patient symptoms scale, Cleveland clinic incontinence scale, Health survey - SF 36, Fecal
      incontinence quality of life instrument - FIQol).

      Patient symptoms scale (appendix 1) - symptoms of haemorrhoids are assessed (rectal bleeding,
      pain, pile prolapse, defecation disturbances, discomfort affecting normal life). Each symptom
      gets a number from 1 - very intense to 5 - no complaints.

      Cleveland clinic incontinence scale (appendix 2) - the sum of 5 parameters is determined that
      are scored on a scale from 0 (=absent) to 4 (daily) frequency of incontinence to gas, liquid,
      solid, of need to wear pad, and of lifestyle changes. A score of 0 means perfect control, a
      score of 20 - complete incontinence.

      Health survey - SF 36 (appendix 3) - it measures eight domains: physical functioning, role
      limitations due to physical health, role limitations due to emotional problems,
      energy/fatigue, emotional well-being, social functioning, pain, general health. For each of
      the eight domains that the SF36 measures an aggregate percentage score is produced. The
      percentage scores range from 0% (lowest or worst possible level of functioning) to 100%
      (highest or best possible level of functioning).

      Fecal incontinence quality of life instrument - FIQol (appendix 4) -scale consists of 29
      questions in 4 domains: lifestyle, coping/behavior, depression/self perception,
      embarrassment. Category ranges: 1 to 4 for lifestyle, coping/behavior, and embarrassment; 1
      to 6 for depression/self perception.

      Randomization, blinding and concealment The patients were randomized into three groups.
      Randomization sequence was computer-generated before the start of the trial. Every
      consecutive case

      -history was assigned a randomization number (1, 2 or 3). It was written and sealed within
      the envelope and remained unknown neither to the patient, nor to the treating physician, to
      avoid selection bias. In the operating room, after induction of anesthesia, operating room
      junior staff was asked to unseal the envelope and the intervention was performed according to
      the procedure assigned. Pre- and postoperative patient management was identical in all three
      operations. The patient remained unaware of the procedure performed until the end of the
      study 1 year after the operation. The case-notes and discharge summary of the patient
      contained only the note, saying that the patient is included in the study of hemorrhoids with
      D.Danys/T.Poskus as Principal Investigators, patient's number is X. This number was within
      the locked and coded database and the staff, evaluating the result of the patients' treatment
      remained unaware of the procedure allocated. The patients were followed-up by different
      surgeons (E.P. and V.J.) than the ones, performing the operation. They had the access to the
      patient notes but not to the coded database, and were not able to know, which procedure was
      performed. In emergency situations, un-blinding of the patient and treating physicians was
      possible but was not required in any of the patients.

      Operative procedure Patients were started on lactulose the day before the operation, which
      was continued after the operation to have regular bowel movements. Preoperative intravenous
      antibiotic prophylaxis was given according to the hospital protocol, which was 1g of
      Cephazolin (2g if patient was over 80 kg of weight), 240 mg of gentamycin and 500 mg of
      metronidazole (Ciprofloxacin can be used if patient is allergic to cephalosporins). Each
      surgeon performing operative procedures (T.P., D.D. and S.M.) had personal experience of at
      least 50 operations of each modality. 1 hour seminar was conducted between all surgeons
      before the start of the trial to unify the technique of operative procedures.All patients
      were photographed after induction of anesthesia before the start of the procedure and
      immediately after the procedure.LHP was performed using Ceralas diode laser of 1420 nm
      wavelength (Biolitec). Disposable LHP kit (Biolitec) was used, which contains sharp-tipped
      laser fiber and anoscope. Perianal skin immediately aboral to hemorrhoid was penetrated using
      needle-tip cautery (Figure 2). Laser fiber was introduced into the opening until the level of
      hemorrhoidal pedicle and coagulation was activated. 8 Watt 3 second pulses with 1 second
      pulse-pauses were used to coagulate the area of hemorrhoids. 5 mm of hemorrhoidal tissue is
      coagulated with one such pulse (experimental data). 250 Joules was the upper limit of energy
      delivered per 1 hemorrhoidal quadrant. Smaller hemorrhoids were treated with less energy,
      larger ones - with more energy. The procedure was repeated in three other quadrants, thus
      treating all anal circumference. RAR was performed as described by Schurmann JP et al. For
      these patients, the ligations were placed in the area of visible pathologic hemorrhoidal
      tissue, and in patients with large prolapse mucopexy - lifting of prolapsing hemorrhoidal
      tissue with sutures was performed. Standard EH was performed up to the level of hemorrhoidal
      pedicle, with ligation or suture-ligation of the pedicle and meticulous hemostasis. Follow-up
      was performed by different surgeons to those, performing the operations (E.P., V.J.). Each of
      them has more than 25 years of experience of colorectal and hemorrhoidal surgery. 1 hour
      seminar was conducted with them to unify the evaluation of the patients within the study.
      Each patient was followed up at 1 and 6 weeks and after 1 year after the operation (Figure
      1). Perianal examination with photographic documentation was performed during all the visits.
      Anoscopy was performed during visits at 6 weeks and 1 year. Each patient was asked to fill in
      the diary during each day of the first post-operative week and present it at the first visit
      after 1 week. Symptom questionnaires were filled in during visits at 1 and 6 weeks and 1
      year. Wexner incontinence score was filled during the visit at 6 weeks and 1 year. SF-36 QOL
      questionnaire was filled during the final visit at 1 year.

      Statistical analysis Sample size calculation was performed using R statistical software
      package(©The R Foundation).Presuming the effect size of 0.3, power of 0.8 and alpha=0.05 the
      sample size was calculated to be 108 patients. To compensate for possible follow-up losses
      sample size was increased to 120 patients. Chi-square test and Anova tests were used to
      compare differences between the groups.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Recurrence rate of rectal prolapse
time frame: one years
description: Visual rectal prolapse during postoperative anoscopy requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).
measure: Recurrence rate of rectal bleeding
time frame: one years
description: Intensity and frequency of postoperative bleeding requiring any kind of medical attention or treatment (visit to the doctor or pharmacy, medical, invasive or surgical treatment).
measure: Continence
time frame: after one year
description: Using Wexner fecal incontinence score (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum 1993; 36:77-97)
measure: Recurrence of any perianal symptoms
time frame: One years
description: Evalluation by abdominal surgeon: pain, bleeding, external haemorrhoids, etc
measure: Time to return to work
time frame: One years
description: Time to return to work or regular activity, in days, reported by the patient
measure: Intensity and duration of postoperative perianal pain
time frame: 7 postoperative days
description: Intensity and duration of perianal pain after the operation (in days) based on visual analogue scale during after first 7 days of the operation
measure: Quality of life
time frame: One years
description: Quality of life based on Short-form (SF)-36 questionnaire (https://www.rand.org/health/surveys_tools/mos/36-item-short-form.html )
measure: Fecal incontinence quality of life (FIQOL) score
time frame: One years
description: Fecal incontinence quality of life (FIQOL) score at 1 year (Rockwood TH, Church JM, Fleshman JW. Fecal incontinence quality of life scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum 2000; 43:9-17)
measure: Evaluation of the operation by the patient
time frame: One years
description: Evaluation of the operation by the patient on visual analogue scale from 1 to 10 at 1-year visit.
arm group label: open haemorrhoidectomy
arm group type: Other
description: Open haemorrhoidectomy is performed using an anal retractor, exposed haemorrhoids at 3 - 7- 11 hours are excised using cautery. The arteries are ligated or cauterized. Open or closed technique is used (the choice of the surgeon). The Spongostan plug is then introduced
arm group label: Haemorrhodal pedicle ligation
arm group type: Other
description: Haemorrhodal pedicle ligation is performed using operating proctoscope. The pedicle of symptomatic haemorrhoid is suture ligated with absorbable Vycril 2/0. Mucopexy is performed simultaneously if the prolapse is noticed. No tissue removal is performed
arm group label: Intrahaemoroidal laser coagulation
arm group type: Other
description: Intrahaemoroidal laser coagulation is performed using disposable THD kit [Biolitec Co]. The haemorrhoidal pedicle is sutured. 1mm opening is created at the external haemorrhoid (skin level). Laser is then introduced up to pedicle and coagulation performed. This is repeated to all the piles. The procedure is finished with placing Spongostan plug into anal canal
intervention type: Procedure
intervention name: Haemorrhoidectomy operations
description: for treatment of symptomatic 2 to 3 degree haemorrhoids
arm group label: Haemorrhodal pedicle ligation
arm group label: Intrahaemoroidal laser coagulation
arm group label: open haemorrhoidectomy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Lithuania
responsible party type: Principal Investigator
investigator affiliation: Vilnius University
investigator full name: Tomas Poskus
investigator title: Professor
mesh term: Hemorrhoids
sharing ipd: Yes
ipd description: 2017