<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/NCT04437043</url>
  </required_header>
  <id_info>
    <org_study_id>RB-UNITE-01</org_study_id>
    <nct_id>NCT04437043</nct_id>
  </id_info>
  <brief_title>A Multicenter Belgian Trial of Ventral Hernia Repair</brief_title>
  <acronym>UNITE</acronym>
  <official_title>A Multicenter Belgian Trial on Ventral Hernia Repair. UNITE Study Protocol Number: RB-UNITE-01</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Ghent</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Royal Belgian Society for Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Archer Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Ghent</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>
      Patients with incisional midline ventral hernias with a minimal width of 3 cm and a maximal&#xD;
      width of 8 cm, treated according to the standard practice of the participating investigators.&#xD;
&#xD;
      Patients can be treated with the following ventral hernia repair approaches:&#xD;
&#xD;
        -  Laparoscopic ventral hernia repair with closure of the defect (IPOM+)&#xD;
&#xD;
        -  Open ventral hernia repair with closure of the defect (retromuscular repair)&#xD;
&#xD;
        -  Robotic ventral hernia repair with closure of the defect (retromuscular repair)&#xD;
&#xD;
      To evaluate the total number of days spent in the hospital within a period of 90 days&#xD;
      post-operative. This will be calculated by adding the hospital length of stay for initial&#xD;
      surgery or index-procedure, length of stay for any additional readmission resulting from the&#xD;
      surgery or re-interventions, and emergency room visits resulting from the surgery or Serious&#xD;
      Adverse Event (SAE) related to the index-procedure.&#xD;
&#xD;
      Secondary objectives: To assess the safety, performance and efficacy of laparoscopic, open&#xD;
      and robotic ventral hernia repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ventral hernia repair&#xD;
&#xD;
        1. Laparoscopic: In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is&#xD;
           inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general&#xD;
           steps include safe entry into the peritoneum, insufflation and placement of the trocars&#xD;
           to gain access and visibility (via laparoscope) of the defect. Careful adhesiolysis is&#xD;
           performed, which is the removal of scar tissue connecting tissues and organs. The&#xD;
           content of the hernia, which may include intestine and fatty tissue, is returned into&#xD;
           the abdominal cavity. After closure of the hernia defect, a wide intraperitoneal mesh is&#xD;
           fixed over the defect. Desufflation releases the gas from the abdomen. The trocars will&#xD;
           be removed and the incisions are closed.&#xD;
&#xD;
        2. Open: An open retromuscular ventral hernia repair involves an incision through the&#xD;
           abdominal wall. Adhesiolysis is performed and the content of the hernia is returned into&#xD;
           the abdominal cavity. The posterior rectus sheath is separated from the rectus muscle&#xD;
           and closed, which closes the abdominal cavity. The mesh is then placed behind the muscle&#xD;
           and anterior to the re-approximated posterior rectus sheath. Preperitoneal mesh&#xD;
           extension is allowed via transversus abdominis release (TAR). The anterior rectus sheath&#xD;
           is closed over the mesh, which closes the hernia.&#xD;
&#xD;
        3. Robotic: A robotic retromuscular ventral hernia repair involves a similar separation of&#xD;
           the layers of the abdominal wall, similar closure of the hernia defect and similar&#xD;
           retromuscular mesh placement as for the open approach. Preperitoneal mesh extension is&#xD;
           allowed via TAR. The da Vinci System is a robotic-assisted surgical device that allows&#xD;
           the surgeon to place long, narrow instruments through small incisions in order to&#xD;
           perform surgery from the inside of the abdominal cavity. Rather than one long incision&#xD;
           with open repair, four to six small incisions are made along the outer part of the&#xD;
           abdomen between the rib cage and the hip.&#xD;
&#xD;
      Classifications and questionnaires&#xD;
&#xD;
        1. European Hernia Society (EHS) classification: The EHS classification is a simple and&#xD;
           reproducible system, developed to allow comparison of publications and future studies on&#xD;
           primary and incisional abdominal wall hernias. The classification includes the&#xD;
           localization of the hernia as well as the size of the hernia defect as decisive for the&#xD;
           outcome. The EHS classification is to be filled in by the participating investigator&#xD;
           following the patients CT scan.&#xD;
&#xD;
        2. Post-Anaesthetic Discharge Scoring System (PADSS): The Modified PADSS has proven to be&#xD;
           an efficient system that guarantees safe discharge. PADSS is based on the assessment of&#xD;
           6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory&#xD;
           rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output.&#xD;
           Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for&#xD;
           discharge, provided that the score for vital signs is not lower than 2 and that none of&#xD;
           the other five criteria is 0, even if the total score reaches 9. PADSS scoring will be&#xD;
           performed twice a day, in the morning and in the afternoon with minimally 9 hours in&#xD;
           between. Same day discharge (on the day of hernia repair) is allowed as long as the&#xD;
           required PADSS score is reached.&#xD;
&#xD;
        3. American Society of Anesthesiologists (ASA) Classification: The ASA physical status&#xD;
           classification system was developed to offer clinicians a simple categorization of a&#xD;
           patient's physiological status that can be helpful in predicting operative risk.&#xD;
&#xD;
        4. Visual Analog Scale (VAS): The VAS scoring system is frequently used as a reliable and&#xD;
           valid measure of pain. It contains a 0 - 100 grading scale with 0 equaling no pain and&#xD;
           100 equaling the worst conceivable pain. The patient is asked to select the number on&#xD;
           the scale that corresponds to the worst level of pain he / she experiences in rest and&#xD;
           activity. The patient will be asked to bend over to score pain during activity. Pain is&#xD;
           classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm).&#xD;
           Absence of pain is defined as VAS = 0.&#xD;
&#xD;
        5. Carolinas Comfort Scale (CSS): The CCS is a disease-specific, quality of life&#xD;
           questionnaire developed for patients undergoing hernia repair with mesh. It is a 23-item&#xD;
           questionnaire that measures the severity of pain, sensation and movement limitations&#xD;
           from the mesh in eight categories. The CCS score is derived by adding the scores from&#xD;
           each of the 23 items. The best possible score is 0 and the worst possible score is 115.&#xD;
&#xD;
        6. Body Image Questionnaire (BIQ): The BIQ is an ten-item questionnaire incorporating body&#xD;
           image and cosmetic subscales. The body image scale measures patients' perception and&#xD;
           satisfaction with their bodies after surgery, and it is calculated by reverse scoring&#xD;
           and summing the responses to questions 1 through 5. It ranges from 5 to 20 with a higher&#xD;
           number representing greater body image perception. The cosmetic scale assesses&#xD;
           satisfaction with surgical scars and is calculated by simply summing responses to&#xD;
           questions 6 through 8, for a score range of 3 to 24, with a higher score indicating&#xD;
           greater cosmetic satisfaction. The last two items (9, 10) score self-confidence before&#xD;
           and after surgery. The Baseline BIQ was generated to score body image perception and&#xD;
           satisfaction at baseline and consists of 9 questions.&#xD;
&#xD;
        7. Seroma classification: Seroma is one of the most common complications after hernia&#xD;
           repair. The seroma classification is used to describe the incidence of seroma after&#xD;
           ventral hernia repair and was developed in order to unify criteria among surgeons when&#xD;
           describing their experience. Originally developed for seroma classification after&#xD;
           laparoscopic ventral hernia repair, it can also be used to describe the incidence of&#xD;
           seroma after open ventral hernia repair.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 16, 2020</start_date>
  <completion_date type="Anticipated">April 30, 2024</completion_date>
  <primary_completion_date type="Actual">July 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Investigator-initiated, academic, prospective, interventional, multicenter study</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Total number of days in the hospital</measure>
    <time_frame>90 days post-operative</time_frame>
    <description>This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery. The hospital length of stay for the initial surgery will be assessed using a Modified Post Anaesthetic Discharge Scoring System (PADSS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-operative adverse events</measure>
    <time_frame>index procedure, 30 days post-operative, and 90 days post-operative</time_frame>
    <description>Definitions according to ICH-GCP E6 (R2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Surgical Site Infection (SSI)</measure>
    <time_frame>post-operative at 30 days, 1 year, and 2 years</time_frame>
    <description>CDC definition</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Surgical Site Occurence (SSO)</measure>
    <time_frame>post-operative at 30 days, 1 year, and 2 years</time_frame>
    <description>Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operating time</measure>
    <time_frame>index procedure</time_frame>
    <description>Total operating time from incision to last stitch (in minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effective day of discharge</measure>
    <time_frame>index procedure, and post-operative at 30 days</time_frame>
    <description>Number of effective hospital stay after the index procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Conversion rate</measure>
    <time_frame>index procedure</time_frame>
    <description>Conversion rate for the laparoscopic and robot-assisted groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative and post-operative pain</measure>
    <time_frame>enrollment, post-operative at 30 days, 1 year, and 2 years</time_frame>
    <description>Pain scoring using the Visual Analog Scale (VAS) The VAS scoring system is frequently used as a reliable and valid measure of pain. It contains a 0 - 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he / she experiences in rest and activity. The patient will be asked to bend over to score pain during activity. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesic intake</measure>
    <time_frame>post-operative at 30 days, 1 year, and 2 years</time_frame>
    <description>Amount and type of analgesic intake</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life improvement: Carolina's Comfort Scale (CCS)</measure>
    <time_frame>enrollment, post-operative at 30 days, 1 year, and 2 years</time_frame>
    <description>Carolina's Comfort Scale (CCS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body image</measure>
    <time_frame>enrollment, post-operative at 30 days, 1 year, and 2 years</time_frame>
    <description>Body Image Questionnaire (BIQ) The BIQ is a ten-item questionnaire incorporating body image and cosmetic subscales. The body image scale measures patients' perception and satisfaction with their bodies after surgery, and it is calculated by reverse scoring and summing the responses to questions 1 through 5. It ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars and is calculated by simply summing responses to questions 6 through 8, for a score range of 3 to 24, with a higher score indicating greater cosmetic satisfaction. The last two items (9, 10) score self-confidence before and after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence</measure>
    <time_frame>post-operative at 30 days, 1 year, and 2 years</time_frame>
    <description>Recurrent hernia</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Ventral Hernia</condition>
  <arm_group>
    <arm_group_label>Laparoscopic ventral hernia repair with closure of the defect</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general steps include safe entry into the peritoneum, insufflation and placement of the trocars to gain access and visibility (via laparoscope) of the defect. Careful adhesiolysis is performed, which is the removal of scar tissue connecting tissues and organs. The content of the hernia, which may include intestine and fatty tissue, is returned into the abdominal cavity. After closure of the hernia defect, a wide intraperitoneal mesh is fixed over the defect. Desufflation releases the gas from the abdomen. The trocars will be removed and the incisions are closed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Open ventral hernia repair with closure of the defect</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>An open retromuscular ventral hernia repair involves an incision through the abdominal wall. Adhesiolysis is performed and the content of the hernia is returned into the abdominal cavity. The posterior rectus sheath is separated from the rectus muscle and closed, which closes the abdominal cavity. The mesh is then placed behind the muscle and anterior to the re-approximated posterior rectus sheath. Preperitoneal mesh extension is allowed via transversus abdominis release (TAR). The anterior rectus sheath is closed over the mesh, which closes the hernia.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic ventral hernia repair with closure of the defect</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar closure of the hernia defect and similar retromuscular mesh placement as for the open approach. Preperitoneal mesh extension is allowed via TAR. The da Vinci System is a robotic-assisted surgical device that allows the surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of the abdominal cavity. Rather than one long incision with open repair, four to six small incisions are made along the outer part of the abdomen between the rib cage and the hip.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>quality of life questionnaires</intervention_name>
    <description>pain will be recorded in rest and activity (VAS) and patients will complete the quality of life questionnaires (CCS, BIQ). Also, the intake of analgesic medication will be registered. A clinical examination is conducted to evaluate the occurrence of seroma and to evaluate recurrence, defined as a protrusion of the contents of the abdominal cavity or preperitoneal fat through the defect, which is no longer covered by the mesh.</description>
    <arm_group_label>Laparoscopic ventral hernia repair with closure of the defect</arm_group_label>
    <arm_group_label>Open ventral hernia repair with closure of the defect</arm_group_label>
    <arm_group_label>Robotic ventral hernia repair with closure of the defect</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient with incisional midline ventral hernia (M2: epigastric, M3: umbilical, M4:&#xD;
             infra-umbilical) with a minimal width of 3 cm and a maximum width of 8 cm. Multiple&#xD;
             hernia defects (Swiss cheese) are allowed according to European Hernia Society (EHS)&#xD;
             classification (Appendix 1).&#xD;
&#xD;
          2. Recurrences are only allowed to be included after former primary repair (suture repair&#xD;
             without mesh).&#xD;
&#xD;
          3. Patients with ASA grade I to III.&#xD;
&#xD;
          4. Patient is at least 18 years old.&#xD;
&#xD;
          5. Patient must sign and date the informed consent form prior to treatment.&#xD;
&#xD;
          6. Patient is able to tolerate general anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient with a life expectancy of less than 2 years.&#xD;
&#xD;
          2. Patient is suspected of being unable to comply with the study protocol.&#xD;
&#xD;
          3. Patient is pregnant.&#xD;
&#xD;
          4. Patient needs acute surgery.&#xD;
&#xD;
          5. Patient is enrolled in another study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ghent University Hospital</name>
      <address>
        <city>Ghent</city>
        <state>East Flanders</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>March 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ventral hernia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hernia</mesh_term>
    <mesh_term>Hernia, Ventral</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04437043
org study id: RB-UNITE-01
nct id: NCT04437043
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients with incisional midline ventral hernias with a minimal width of 3 cm and a maximal
      width of 8 cm, treated according to the standard practice of the participating investigators.

      Patients can be treated with the following ventral hernia repair approaches:

        -  Laparoscopic ventral hernia repair with closure of the defect (IPOM+)

        -  Open ventral hernia repair with closure of the defect (retromuscular repair)

        -  Robotic ventral hernia repair with closure of the defect (retromuscular repair)

      To evaluate the total number of days spent in the hospital within a period of 90 days
      post-operative. This will be calculated by adding the hospital length of stay for initial
      surgery or index-procedure, length of stay for any additional readmission resulting from the
      surgery or re-interventions, and emergency room visits resulting from the surgery or Serious
      Adverse Event (SAE) related to the index-procedure.

      Secondary objectives: To assess the safety, performance and efficacy of laparoscopic, open
      and robotic ventral hernia repair.
Ventral hernia repair

        1. Laparoscopic: In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is
           inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general
           steps include safe entry into the peritoneum, insufflation and placement of the trocars
           to gain access and visibility (via laparoscope) of the defect. Careful adhesiolysis is
           performed, which is the removal of scar tissue connecting tissues and organs. The
           content of the hernia, which may include intestine and fatty tissue, is returned into
           the abdominal cavity. After closure of the hernia defect, a wide intraperitoneal mesh is
           fixed over the defect. Desufflation releases the gas from the abdomen. The trocars will
           be removed and the incisions are closed.

        2. Open: An open retromuscular ventral hernia repair involves an incision through the
           abdominal wall. Adhesiolysis is performed and the content of the hernia is returned into
           the abdominal cavity. The posterior rectus sheath is separated from the rectus muscle
           and closed, which closes the abdominal cavity. The mesh is then placed behind the muscle
           and anterior to the re-approximated posterior rectus sheath. Preperitoneal mesh
           extension is allowed via transversus abdominis release (TAR). The anterior rectus sheath
           is closed over the mesh, which closes the hernia.

        3. Robotic: A robotic retromuscular ventral hernia repair involves a similar separation of
           the layers of the abdominal wall, similar closure of the hernia defect and similar
           retromuscular mesh placement as for the open approach. Preperitoneal mesh extension is
           allowed via TAR. The da Vinci System is a robotic-assisted surgical device that allows
           the surgeon to place long, narrow instruments through small incisions in order to
           perform surgery from the inside of the abdominal cavity. Rather than one long incision
           with open repair, four to six small incisions are made along the outer part of the
           abdomen between the rib cage and the hip.

      Classifications and questionnaires

        1. European Hernia Society (EHS) classification: The EHS classification is a simple and
           reproducible system, developed to allow comparison of publications and future studies on
           primary and incisional abdominal wall hernias. The classification includes the
           localization of the hernia as well as the size of the hernia defect as decisive for the
           outcome. The EHS classification is to be filled in by the participating investigator
           following the patients CT scan.

        2. Post-Anaesthetic Discharge Scoring System (PADSS): The Modified PADSS has proven to be
           an efficient system that guarantees safe discharge. PADSS is based on the assessment of
           6 criteria: vital signs (including blood pressure, pulse, temperature and respiratory
           rate), ambulation, nausea / vomiting, pain, surgical bleeding and fluid intake / output.
           Each criterion is given a score from 0 to 2. Patients scoring ≥ 9 are considered fit for
           discharge, provided that the score for vital signs is not lower than 2 and that none of
           the other five criteria is 0, even if the total score reaches 9. PADSS scoring will be
           performed twice a day, in the morning and in the afternoon with minimally 9 hours in
           between. Same day discharge (on the day of hernia repair) is allowed as long as the
           required PADSS score is reached.

        3. American Society of Anesthesiologists (ASA) Classification: The ASA physical status
           classification system was developed to offer clinicians a simple categorization of a
           patient's physiological status that can be helpful in predicting operative risk.

        4. Visual Analog Scale (VAS): The VAS scoring system is frequently used as a reliable and
           valid measure of pain. It contains a 0 - 100 grading scale with 0 equaling no pain and
           100 equaling the worst conceivable pain. The patient is asked to select the number on
           the scale that corresponds to the worst level of pain he / she experiences in rest and
           activity. The patient will be asked to bend over to score pain during activity. Pain is
           classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm).
           Absence of pain is defined as VAS = 0.

        5. Carolinas Comfort Scale (CSS): The CCS is a disease-specific, quality of life
           questionnaire developed for patients undergoing hernia repair with mesh. It is a 23-item
           questionnaire that measures the severity of pain, sensation and movement limitations
           from the mesh in eight categories. The CCS score is derived by adding the scores from
           each of the 23 items. The best possible score is 0 and the worst possible score is 115.

        6. Body Image Questionnaire (BIQ): The BIQ is an ten-item questionnaire incorporating body
           image and cosmetic subscales. The body image scale measures patients' perception and
           satisfaction with their bodies after surgery, and it is calculated by reverse scoring
           and summing the responses to questions 1 through 5. It ranges from 5 to 20 with a higher
           number representing greater body image perception. The cosmetic scale assesses
           satisfaction with surgical scars and is calculated by simply summing responses to
           questions 6 through 8, for a score range of 3 to 24, with a higher score indicating
           greater cosmetic satisfaction. The last two items (9, 10) score self-confidence before
           and after surgery. The Baseline BIQ was generated to score body image perception and
           satisfaction at baseline and consists of 9 questions.

        7. Seroma classification: Seroma is one of the most common complications after hernia
           repair. The seroma classification is used to describe the incidence of seroma after
           ventral hernia repair and was developed in order to unify criteria among surgeons when
           describing their experience. Originally developed for seroma classification after
           laparoscopic ventral hernia repair, it can also be used to describe the incidence of
           seroma after open ventral hernia repair.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Investigator-initiated, academic, prospective, interventional, multicenter study
primary purpose: Other
masking: None (Open Label)
measure: Total number of days in the hospital
time frame: 90 days post-operative
description: This will be calculated by adding the hospital length of stay for initial surgery, length of stay for any additional readmission resulting from the surgery, and emergency room visits resulting from the surgery. This information will be collected up to 90 days after the surgery. The hospital length of stay for the initial surgery will be assessed using a Modified Post Anaesthetic Discharge Scoring System (PADSS)
measure: Intra-operative adverse events
time frame: index procedure, 30 days post-operative, and 90 days post-operative
description: Definitions according to ICH-GCP E6 (R2)
measure: Number of participants with Surgical Site Infection (SSI)
time frame: post-operative at 30 days, 1 year, and 2 years
description: CDC definition
measure: Number of participants with Surgical Site Occurence (SSO)
time frame: post-operative at 30 days, 1 year, and 2 years
description: Hematoma, seroma, dehiscence, necrosis, non-healing wound found on abdominal exam
measure: Operating time
time frame: index procedure
description: Total operating time from incision to last stitch (in minutes)
measure: Effective day of discharge
time frame: index procedure, and post-operative at 30 days
description: Number of effective hospital stay after the index procedure
measure: Conversion rate
time frame: index procedure
description: Conversion rate for the laparoscopic and robot-assisted groups
measure: Preoperative and post-operative pain
time frame: enrollment, post-operative at 30 days, 1 year, and 2 years
description: Pain scoring using the Visual Analog Scale (VAS) The VAS scoring system is frequently used as a reliable and valid measure of pain. It contains a 0 - 100 grading scale with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he / she experiences in rest and activity. The patient will be asked to bend over to score pain during activity. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
measure: Analgesic intake
time frame: post-operative at 30 days, 1 year, and 2 years
description: Amount and type of analgesic intake
measure: Quality of life improvement: Carolina's Comfort Scale (CCS)
time frame: enrollment, post-operative at 30 days, 1 year, and 2 years
description: Carolina's Comfort Scale (CCS)
measure: Body image
time frame: enrollment, post-operative at 30 days, 1 year, and 2 years
description: Body Image Questionnaire (BIQ) The BIQ is a ten-item questionnaire incorporating body image and cosmetic subscales. The body image scale measures patients' perception and satisfaction with their bodies after surgery, and it is calculated by reverse scoring and summing the responses to questions 1 through 5. It ranges from 5 to 20 with a higher number representing greater body image perception. The cosmetic scale assesses satisfaction with surgical scars and is calculated by simply summing responses to questions 6 through 8, for a score range of 3 to 24, with a higher score indicating greater cosmetic satisfaction. The last two items (9, 10) score self-confidence before and after surgery.
measure: Recurrence
time frame: post-operative at 30 days, 1 year, and 2 years
description: Recurrent hernia
arm group label: Laparoscopic ventral hernia repair with closure of the defect
arm group type: Other
description: In laparoscopic intraperitoneal onlay mesh or IPOM repair, the mesh is inserted intra-abdominally and fixed to the peritoneum / abdominal wall. The general steps include safe entry into the peritoneum, insufflation and placement of the trocars to gain access and visibility (via laparoscope) of the defect. Careful adhesiolysis is performed, which is the removal of scar tissue connecting tissues and organs. The content of the hernia, which may include intestine and fatty tissue, is returned into the abdominal cavity. After closure of the hernia defect, a wide intraperitoneal mesh is fixed over the defect. Desufflation releases the gas from the abdomen. The trocars will be removed and the incisions are closed.
arm group label: Open ventral hernia repair with closure of the defect
arm group type: Other
description: An open retromuscular ventral hernia repair involves an incision through the abdominal wall. Adhesiolysis is performed and the content of the hernia is returned into the abdominal cavity. The posterior rectus sheath is separated from the rectus muscle and closed, which closes the abdominal cavity. The mesh is then placed behind the muscle and anterior to the re-approximated posterior rectus sheath. Preperitoneal mesh extension is allowed via transversus abdominis release (TAR). The anterior rectus sheath is closed over the mesh, which closes the hernia.
arm group label: Robotic ventral hernia repair with closure of the defect
arm group type: Other
description: A robotic retromuscular ventral hernia repair involves a similar separation of the layers of the abdominal wall, similar closure of the hernia defect and similar retromuscular mesh placement as for the open approach. Preperitoneal mesh extension is allowed via TAR. The da Vinci System is a robotic-assisted surgical device that allows the surgeon to place long, narrow instruments through small incisions in order to perform surgery from the inside of the abdominal cavity. Rather than one long incision with open repair, four to six small incisions are made along the outer part of the abdomen between the rib cage and the hip.
intervention type: Other
intervention name: quality of life questionnaires
description: pain will be recorded in rest and activity (VAS) and patients will complete the quality of life questionnaires (CCS, BIQ). Also, the intake of analgesic medication will be registered. A clinical examination is conducted to evaluate the occurrence of seroma and to evaluate recurrence, defined as a protrusion of the contents of the abdominal cavity or preperitoneal fat through the defect, which is no longer covered by the mesh.
arm group label: Laparoscopic ventral hernia repair with closure of the defect
arm group label: Open ventral hernia repair with closure of the defect
arm group label: Robotic ventral hernia repair with closure of the defect
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Hernia
mesh term: Hernia, Ventral
sharing ipd: No