<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/NCT04427644</url>
  </required_header>
  <id_info>
    <org_study_id>13281952-929</org_study_id>
    <nct_id>NCT04427644</nct_id>
  </id_info>
  <brief_title>Body Mass Index and Obesity Surgery Mortality Risk Score in Perioperative Complications of Laparoscopic Sleeve Gastrectomy</brief_title>
  <official_title>Is Body Mass Index and Obesity Surgery Mortality Risk Score Important in Perioperative Complications of Laparoscopic Sleeve Gastrectomy Before Discharge? A Retrospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kahramanmaras Sutcu Imam University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kahramanmaras Sutcu Imam University</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>
      The term obesity is defined as body mass index (BMI) 30 and over, and morbid obesity is&#xD;
      considered as BMI greater than 40 (1).Its incidence in the general population is&#xD;
      approximately 20% according to Organisation for data of Economic Co-operation and Development&#xD;
      (OECD) countries and unfortunately, it is increasing worldwide (2). Obesity should not be&#xD;
      thought ofas a single disorderasit is related tomany disorders like hypertension, diabetes,&#xD;
      obstructive sleep apnea, cardiovascular diseases, and increased risk of malignancies (1).For&#xD;
      years people have struggled with obesitywithboth metabolic and physical problems. Surgical&#xD;
      treatment is the most effective long-term therapeutic treatment in current and modern&#xD;
      medicine of obesity and obesity-related diseases as the last resort.(3-5). Roux-en-y&#xD;
      gastrojejunostomy is the method that has been applied for many years and there isconsensus on&#xD;
      its effect.However, in recent years, laparoscopic sleeve gastrectomy (LSG) has an increasing&#xD;
      number of procedures with a short learning curve and it is the most performed surgical&#xD;
      technique all over the world and also in Turkey (2,6).&#xD;
&#xD;
      Unfortunately, like any surgical procedure, this surgery has its own complications.Although&#xD;
      being performed frequently increases the experience of surgeons, this situation cannot reduce&#xD;
      the risk of complications of surgery to zero. In morbid obesity patients, the risk of any&#xD;
      complications in all surgical procedures is higher than withother patients who were not&#xD;
      morbidly obese. Due to these complications, prolonged hospital stays, increased&#xD;
      reapplications to the hospital, reoperations and deaths can result(5,7). Despite both an&#xD;
      increased risk of complications according to obesity and the risk of specific complications&#xD;
      due to sleeve gastrectomy, laparoscopic sleeve gastrectomy is associated with acceptable&#xD;
      postoperative morbidity and mortality rates (8).&#xD;
&#xD;
      Various classifications have been described in the literature for complications after&#xD;
      surgery.In one of these classifications, according to Clavien-Dindo (CD) Classification,&#xD;
      complications are divided into two groups as major and minor. (1, 9)(Table 1). This&#xD;
      classification can be applied to bariatric and metabolic surgeries as withall surgery types.&#xD;
      Especially major complications in this classification are life-threatening situations and&#xD;
      their early detection is important (8).&#xD;
&#xD;
      In fact, surgeons do not want to encounter mortality in any of their patients. In this&#xD;
      respect, DeMaria et al. developed an easily applicable mortality risk scoring system, which&#xD;
      is consisted of five items (age ≥45 years, male sex, body mass index (BMI) ≥ 50 kg / m2,&#xD;
      arterial hypertension, and risk factors for pulmonary thromboembolism) and can be used for&#xD;
      the pre-operative determination of risky patients in obesity surgery(Obesity Surgery&#xD;
      Mortality Risk Score; OR-MRS) (8,10,11).&#xD;
&#xD;
      In this study, it is aimed to determine the perioperative complications seen in the&#xD;
      laparoscopic sleeve gastrectomy patients that we performed in our clinic without being&#xD;
      discharged from the hospital and to evaluate the treatment processes of the complications&#xD;
      under literature. In addition, whether the OS-MRS risk assessment scale and BMI had a role&#xD;
      indetermining perioperative complications before discharge was investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Material - Method Our study was carried out with the approval numbered 13281952-929 from&#xD;
      Elazig Training and Research Hospital. All procedures performed in studies involving human&#xD;
      participants were in accordance with the ethical standards of the institutional and/or&#xD;
      national research committee and with the 1964 Helsinki declaration and its later amendments&#xD;
      or comparable ethical standards. 1752 patients who met the criteria of patient selection in&#xD;
      terms of obesity and metabolic disease surgery, operated in the Elazığ Training and Research&#xD;
      Hospital General Surgery Clinic between January 2016 and October 2018 were evaluated&#xD;
      retrospectively. Patients' data were obtained from epicrisis forms in the hospital computer&#xD;
      system, patient follow-up charts and patient files. Data for OS-MRS and Clavien Dindo&#xD;
      complication classification were obtained from patient follow-up charts, patient files and&#xD;
      hospital computer records. Patients' demographic data (age, sex), presence of comorbidities,&#xD;
      complications (wound complications, thromboembolic events, leakage from anastomosis, splenic&#xD;
      infarction proven by imaging methods, bleeding detected due to low hemoglobin and hematocite&#xD;
      values during follow-up, acute renal failure due to deterioration in biochemical parameters)&#xD;
      seen in follow up period before discharge (postoperative first 72 hours), complication type&#xD;
      (major and minor), whether emergency surgery was performed, BMI values, postoperative&#xD;
      hospitalization and OS-MRS. Additionally, while grouping according to BMI values, patients&#xD;
      with BMI values below 40 were excluded and three groups with BMI values of 40 - 45 kg / m^2,&#xD;
      45 - 50 kg / m^2 and 50 kg / m^2 and above were created. It was investigated whether there&#xD;
      were any complications among these groups and the presence of major or minor complications by&#xD;
      CD classification. 1617 patients who met the inclusion criteria were evaluated.&#xD;
&#xD;
      IBM Statistical Package for Social Sciences (SPSS) 20.0 was used for statistical evaluation.&#xD;
      Kolmogorow-Smirnov test results were examined in terms of the suitability of the groups for&#xD;
      normal distribution. In comparisons between groups, independent sample t-test or Mann Whitney&#xD;
      U test was used to evaluate numerical data according to normality test. In the evaluation of&#xD;
      categorical data, chi-square analysis and Fischer's exact test were performed. In terms of&#xD;
      the relation between complication formation and BMI, univariate analysis and multivariate&#xD;
      analysis were performed. Numerical data were given as mean ± standard deviation (ss) (minimum&#xD;
      - maximum values) or median (minimum - maximum values) according to normality test.&#xD;
      Categorical data are given as count (n) and percentage (%).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2018</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>Relation between preoperative BMI levels and perioperative complication positivity before discharge</measure>
    <time_frame>postoperative 72 hour period before discharge</time_frame>
    <description>Relation between preoperative BMI levels and perioperative complication positivity before discharge</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Relation between preoperative OS-MRS and perioperative complication positivity before discharge</measure>
    <time_frame>postoperative 72 hour period before discharge</time_frame>
    <description>Relation between preoperative OS-MRS and perioperative complication positivity before discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Perioperative complication rates after laparascopic sleeve gastrectomy before discharge</measure>
    <time_frame>postoperative 72 hour period before discharge</time_frame>
    <description>Perioperative complication rates after laparascopic sleeve gastrectomy before discharge</description>
  </secondary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Actual">1617</enrollment>
  <condition>Perioperative Complication</condition>
  <condition>Laparascopic Sleeve Gastrectomy</condition>
  <condition>BMD</condition>
  <condition>Obesity, Morbid</condition>
  <condition>Obesity Surgery Mortality Score</condition>
  <condition>Clavien Dindo Surgical Complication Scale</condition>
  <arm_group>
    <arm_group_label>Complication positive</arm_group_label>
    <description>Patients with perioeprative complications after laparascopic sleeve gastrectomy before discharge (wound complications, thromboembolic events, staple line leakage, splenic infarction proven by imaging modalities, bleeding detected due to low hemoglobin and hematocrit values during follow-up, acute renal failure due to deterioration in biochemical parameters)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Complication negative</arm_group_label>
    <description>Patients without perioeprative complications after laparascopic sleeve gastrectomy before discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI 40 - 45 kg/m2</arm_group_label>
    <description>Operated patients preoperative BMI values between 40 - 45 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI 45 - 50 kg/m2</arm_group_label>
    <description>Operated patients preoperative BMI values between 45 - 50 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BMI over 50 kg/m2</arm_group_label>
    <description>Operated patients preoperative BMI values 45 - 50 kg/m2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clavien Dindo Major Complications</arm_group_label>
    <description>Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Acceptable therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes and physiotherapy This grade also includes wound infections opened at the bedside&#xD;
Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions, antibiotics and total parenteral nutrition are also included</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clavien Dindo Minor Complciations</arm_group_label>
    <description>3. Requiring surgical, endoscopic or radiological intervention 3a Intervention under regional/local anaesthesia 3b Intervention under general anaesthesia 4. Life-threatening complication requiring intensive care/intensive care unit management 4a Single-organ dysfunction 4b Multi-organ dysfunction 5. Patient demise</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparascopic Sleeve Gastrectomy</intervention_name>
    <description>Operations performed for complciation of laparascopic sleeve gastrectomy</description>
    <arm_group_label>Clavien Dindo Major Complications</arm_group_label>
    <arm_group_label>Complication positive</arm_group_label>
    <other_name>Reoperation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>İnterventional radiologic drainage</intervention_name>
    <description>İnterventional radiologic drainage of gastric leakage</description>
    <arm_group_label>Clavien Dindo Major Complications</arm_group_label>
    <arm_group_label>Clavien Dindo Minor Complciations</arm_group_label>
    <arm_group_label>Complication positive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Complte Blood Count and Biochemical evaluation</intervention_name>
    <description>blood samples obtained from patients to determine the hgb and htc levels of patients and biochemical changes of patients after surgery</description>
    <arm_group_label>BMI 40 - 45 kg/m2</arm_group_label>
    <arm_group_label>BMI 45 - 50 kg/m2</arm_group_label>
    <arm_group_label>BMI over 50 kg/m2</arm_group_label>
    <arm_group_label>Clavien Dindo Major Complications</arm_group_label>
    <arm_group_label>Clavien Dindo Minor Complciations</arm_group_label>
    <arm_group_label>Complication negative</arm_group_label>
    <arm_group_label>Complication positive</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Computed tomography</intervention_name>
    <description>Admitted to observe leakage</description>
    <arm_group_label>Clavien Dindo Major Complications</arm_group_label>
    <arm_group_label>Clavien Dindo Minor Complciations</arm_group_label>
    <arm_group_label>Complication positive</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient selection in terms of obesity and metabolic disease surgery(12);&#xD;
&#xD;
          1. Patients with a body mass index (BMI) of 40 and above, without the additional comorbid&#xD;
             disease,&#xD;
&#xD;
          2. Patients with a BMI of 35 and above, withtheadditional comorbid disease (such as&#xD;
             hypertension, diabetes mellitus)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients whose data was available&#xD;
&#xD;
          -  Morbid obesity patients who were operated with surgical technique laparoscopic sleeve&#xD;
             gastrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients whose data was not available&#xD;
&#xD;
          -  Patients who were operated with other types of bariatric metabolic surgery&#xD;
&#xD;
          -  Patients who left the hospital due to referral&#xD;
&#xD;
          -  Patients whose OS-MRS scale wasn't calculated&#xD;
&#xD;
          -  Patients whose American Society of Anesthesiologists (ASA) score was 4 or greater&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <link>
    <url>https://www.oecd.org/health/health-systems/Obesity-Update-2017.pdf</url>
    <description>OECD Update 2017</description>
  </link>
  <reference>
    <citation>Falk V, Twells L, Gregory D, Murphy R, Smith C, Boone D, Pace D. Laparoscopic sleeve gastrectomy at a new bariatric surgery centre in Canada: 30-day complication rates using the Clavien-Dindo classification. Can J Surg. 2016 Apr;59(2):93-7. doi: 10.1503/cjs.016815.</citation>
    <PMID>27007089</PMID>
  </reference>
  <reference>
    <citation>Kirkil C, Aygen E, Korkmaz MF, Bozan MB. QUALITY OF LIFE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY USING BAROS SYSTEM. Arq Bras Cir Dig. 2018 Aug 16;31(3):e1385. doi: 10.1590/0102-672020180001e1385.</citation>
    <PMID>30133677</PMID>
  </reference>
  <reference>
    <citation>Angrisani L, Santonicola A, Iovino P, Formisano G, Buchwald H, Scopinaro N. Bariatric Surgery Worldwide 2013. Obes Surg. 2015 Oct;25(10):1822-32. doi: 10.1007/s11695-015-1657-z.</citation>
    <PMID>25835983</PMID>
  </reference>
  <reference>
    <citation>van Mil SR, Duinhouwer LE, Mannaerts GHH, Biter LU, Dunkelgrun M, Apers JA. The Standardized Postoperative Checklist for Bariatric Surgery; a Tool for Safe Early Discharge? Obes Surg. 2017 Dec;27(12):3102-3109. doi: 10.1007/s11695-017-2746-y.</citation>
    <PMID>28620895</PMID>
  </reference>
  <reference>
    <citation>Welbourn R, Hollyman M, Kinsman R, Dixon J, Liem R, Ottosson J, Ramos A, Vage V, Al-Sabah S, Brown W, Cohen R, Walton P, Himpens J. Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Fourth IFSO Global Registry Report 2018. Obes Surg. 2019 Mar;29(3):782-795. doi: 10.1007/s11695-018-3593-1. Epub 2018 Nov 12.</citation>
    <PMID>30421326</PMID>
  </reference>
  <reference>
    <citation>Chang SH, Freeman NLB, Lee JA, Stoll CRT, Calhoun AJ, Eagon JC, Colditz GA. Early major complications after bariatric surgery in the USA, 2003-2014: a systematic review and meta-analysis. Obes Rev. 2018 Apr;19(4):529-537. doi: 10.1111/obr.12647. Epub 2017 Dec 20.</citation>
    <PMID>29266740</PMID>
  </reference>
  <reference>
    <citation>Major P, Wysocki M, Pedziwiatr M, Malczak P, Pisarska M, Migaczewski M, Winiarski M, Budzynski A. Can the Obesity Surgery Mortality Risk Score predict postoperative complications other than mortality? Wideochir Inne Tech Maloinwazyjne. 2016;11(4):247-252. doi: 10.5114/wiitm.2016.64448. Epub 2016 Dec 6.</citation>
    <PMID>28194244</PMID>
  </reference>
  <reference>
    <citation>Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.</citation>
    <PMID>15273542</PMID>
  </reference>
  <reference>
    <citation>DeMaria EJ, Portenier D, Wolfe L. Obesity surgery mortality risk score: proposal for a clinically useful score to predict mortality risk in patients undergoing gastric bypass. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):134-40. doi: 10.1016/j.soard.2007.01.005.</citation>
    <PMID>17386394</PMID>
  </reference>
  <reference>
    <citation>Garcia-Garcia ML, Martin-Lorenzo JG, Liron-Ruiz R, Torralba-Martinez JA, Garcia-Lopez JA, Aguayo-Albasini JL. Failure of the Obesity Surgery Mortality Risk Score (OS-MRS) to Predict Postoperative Complications After Bariatric Surgery. A Single-Center Series and Systematic Review. Obes Surg. 2017 Jun;27(6):1423-1429. doi: 10.1007/s11695-016-2506-4.</citation>
    <PMID>27975153</PMID>
  </reference>
  <reference>
    <citation>Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres A, Weiner R, Yashkov Y, Fruhbeck G; International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC); European Association for the Study of Obesity (EASO); European Association for the Study of Obesity Obesity Management Task Force (EASO OMTF). Interdisciplinary European guidelines on metabolic and bariatric surgery. Obes Surg. 2014 Jan;24(1):42-55. doi: 10.1007/s11695-013-1079-8.</citation>
    <PMID>24081459</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kahramanmaras Sutcu Imam University</investigator_affiliation>
    <investigator_full_name>Mehmet Buğra Bozan</investigator_full_name>
    <investigator_title>Professor, Assistant</investigator_title>
  </responsible_party>
  <keyword>Morbid Obesity</keyword>
  <keyword>Laparoscopic Sleeve Gastrectomy</keyword>
  <keyword>Perioperative Complication</keyword>
  <keyword>Obesity Surgery Mortality Score</keyword>
  <keyword>Body Mass Index</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04427644
org study id: 13281952-929
nct id: NCT04427644
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The term obesity is defined as body mass index (BMI) 30 and over, and morbid obesity is
      considered as BMI greater than 40 (1).Its incidence in the general population is
      approximately 20% according to Organisation for data of Economic Co-operation and Development
      (OECD) countries and unfortunately, it is increasing worldwide (2). Obesity should not be
      thought ofas a single disorderasit is related tomany disorders like hypertension, diabetes,
      obstructive sleep apnea, cardiovascular diseases, and increased risk of malignancies (1).For
      years people have struggled with obesitywithboth metabolic and physical problems. Surgical
      treatment is the most effective long-term therapeutic treatment in current and modern
      medicine of obesity and obesity-related diseases as the last resort.(3-5). Roux-en-y
      gastrojejunostomy is the method that has been applied for many years and there isconsensus on
      its effect.However, in recent years, laparoscopic sleeve gastrectomy (LSG) has an increasing
      number of procedures with a short learning curve and it is the most performed surgical
      technique all over the world and also in Turkey (2,6).

      Unfortunately, like any surgical procedure, this surgery has its own complications.Although
      being performed frequently increases the experience of surgeons, this situation cannot reduce
      the risk of complications of surgery to zero. In morbid obesity patients, the risk of any
      complications in all surgical procedures is higher than withother patients who were not
      morbidly obese. Due to these complications, prolonged hospital stays, increased
      reapplications to the hospital, reoperations and deaths can result(5,7). Despite both an
      increased risk of complications according to obesity and the risk of specific complications
      due to sleeve gastrectomy, laparoscopic sleeve gastrectomy is associated with acceptable
      postoperative morbidity and mortality rates (8).

      Various classifications have been described in the literature for complications after
      surgery.In one of these classifications, according to Clavien-Dindo (CD) Classification,
      complications are divided into two groups as major and minor. (1, 9)(Table 1). This
      classification can be applied to bariatric and metabolic surgeries as withall surgery types.
      Especially major complications in this classification are life-threatening situations and
      their early detection is important (8).

      In fact, surgeons do not want to encounter mortality in any of their patients. In this
      respect, DeMaria et al. developed an easily applicable mortality risk scoring system, which
      is consisted of five items (age ≥45 years, male sex, body mass index (BMI) ≥ 50 kg / m2,
      arterial hypertension, and risk factors for pulmonary thromboembolism) and can be used for
      the pre-operative determination of risky patients in obesity surgery(Obesity Surgery
      Mortality Risk Score; OR-MRS) (8,10,11).

      In this study, it is aimed to determine the perioperative complications seen in the
      laparoscopic sleeve gastrectomy patients that we performed in our clinic without being
      discharged from the hospital and to evaluate the treatment processes of the complications
      under literature. In addition, whether the OS-MRS risk assessment scale and BMI had a role
      indetermining perioperative complications before discharge was investigated.
Material - Method Our study was carried out with the approval numbered 13281952-929 from
      Elazig Training and Research Hospital. All procedures performed in studies involving human
      participants were in accordance with the ethical standards of the institutional and/or
      national research committee and with the 1964 Helsinki declaration and its later amendments
      or comparable ethical standards. 1752 patients who met the criteria of patient selection in
      terms of obesity and metabolic disease surgery, operated in the Elazığ Training and Research
      Hospital General Surgery Clinic between January 2016 and October 2018 were evaluated
      retrospectively. Patients' data were obtained from epicrisis forms in the hospital computer
      system, patient follow-up charts and patient files. Data for OS-MRS and Clavien Dindo
      complication classification were obtained from patient follow-up charts, patient files and
      hospital computer records. Patients' demographic data (age, sex), presence of comorbidities,
      complications (wound complications, thromboembolic events, leakage from anastomosis, splenic
      infarction proven by imaging methods, bleeding detected due to low hemoglobin and hematocite
      values during follow-up, acute renal failure due to deterioration in biochemical parameters)
      seen in follow up period before discharge (postoperative first 72 hours), complication type
      (major and minor), whether emergency surgery was performed, BMI values, postoperative
      hospitalization and OS-MRS. Additionally, while grouping according to BMI values, patients
      with BMI values below 40 were excluded and three groups with BMI values of 40 - 45 kg / m^2,
      45 - 50 kg / m^2 and 50 kg / m^2 and above were created. It was investigated whether there
      were any complications among these groups and the presence of major or minor complications by
      CD classification. 1617 patients who met the inclusion criteria were evaluated.

      IBM Statistical Package for Social Sciences (SPSS) 20.0 was used for statistical evaluation.
      Kolmogorow-Smirnov test results were examined in terms of the suitability of the groups for
      normal distribution. In comparisons between groups, independent sample t-test or Mann Whitney
      U test was used to evaluate numerical data according to normality test. In the evaluation of
      categorical data, chi-square analysis and Fischer's exact test were performed. In terms of
      the relation between complication formation and BMI, univariate analysis and multivariate
      analysis were performed. Numerical data were given as mean ± standard deviation (ss) (minimum
      - maximum values) or median (minimum - maximum values) according to normality test.
      Categorical data are given as count (n) and percentage (%).
observational model: Cohort
time perspective: Retrospective
measure: Relation between preoperative BMI levels and perioperative complication positivity before discharge
time frame: postoperative 72 hour period before discharge
description: Relation between preoperative BMI levels and perioperative complication positivity before discharge
measure: Relation between preoperative OS-MRS and perioperative complication positivity before discharge
time frame: postoperative 72 hour period before discharge
description: Relation between preoperative OS-MRS and perioperative complication positivity before discharge
measure: Perioperative complication rates after laparascopic sleeve gastrectomy before discharge
time frame: postoperative 72 hour period before discharge
description: Perioperative complication rates after laparascopic sleeve gastrectomy before discharge
arm group label: Complication positive
description: Patients with perioeprative complications after laparascopic sleeve gastrectomy before discharge (wound complications, thromboembolic events, staple line leakage, splenic infarction proven by imaging modalities, bleeding detected due to low hemoglobin and hematocrit values during follow-up, acute renal failure due to deterioration in biochemical parameters)
arm group label: Complication negative
description: Patients without perioeprative complications after laparascopic sleeve gastrectomy before discharge
arm group label: BMI 40 - 45 kg/m2
description: Operated patients preoperative BMI values between 40 - 45 kg/m2
arm group label: BMI 45 - 50 kg/m2
description: Operated patients preoperative BMI values between 45 - 50 kg/m2
arm group label: BMI over 50 kg/m2
description: Operated patients preoperative BMI values 45 - 50 kg/m2
arm group label: Clavien Dindo Major Complications
description: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions Acceptable therapeutic regimens are: drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes and physiotherapy This grade also includes wound infections opened at the bedside
Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions, antibiotics and total parenteral nutrition are also included
arm group label: Clavien Dindo Minor Complciations
description: 3. Requiring surgical, endoscopic or radiological intervention 3a Intervention under regional/local anaesthesia 3b Intervention under general anaesthesia 4. Life-threatening complication requiring intensive care/intensive care unit management 4a Single-organ dysfunction 4b Multi-organ dysfunction 5. Patient demise
intervention type: Procedure
intervention name: Laparascopic Sleeve Gastrectomy
description: Operations performed for complciation of laparascopic sleeve gastrectomy
arm group label: Clavien Dindo Major Complications
arm group label: Complication positive
other name: Reoperation
intervention type: Procedure
intervention name: İnterventional radiologic drainage
description: İnterventional radiologic drainage of gastric leakage
arm group label: Clavien Dindo Major Complications
arm group label: Clavien Dindo Minor Complciations
arm group label: Complication positive
intervention type: Diagnostic Test
intervention name: Complte Blood Count and Biochemical evaluation
description: blood samples obtained from patients to determine the hgb and htc levels of patients and biochemical changes of patients after surgery
arm group label: BMI 40 - 45 kg/m2
arm group label: BMI 45 - 50 kg/m2
arm group label: BMI over 50 kg/m2
arm group label: Clavien Dindo Major Complications
arm group label: Clavien Dindo Minor Complciations
arm group label: Complication negative
arm group label: Complication positive
intervention type: Diagnostic Test
intervention name: Computed tomography
description: Admitted to observe leakage
arm group label: Clavien Dindo Major Complications
arm group label: Clavien Dindo Minor Complciations
arm group label: Complication positive
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
url: https://www.oecd.org/health/health-systems/Obesity-Update-2017.pdf
description: OECD Update 2017
citation: Falk V, Twells L, Gregory D, Murphy R, Smith C, Boone D, Pace D. Laparoscopic sleeve gastrectomy at a new bariatric surgery centre in Canada: 30-day complication rates using the Clavien-Dindo classification. Can J Surg. 2016 Apr;59(2):93-7. doi: 10.1503/cjs.016815.
PMID: 27007089
citation: Kirkil C, Aygen E, Korkmaz MF, Bozan MB. QUALITY OF LIFE AFTER LAPAROSCOPIC SLEEVE GASTRECTOMY USING BAROS SYSTEM. Arq Bras Cir Dig. 2018 Aug 16;31(3):e1385. doi: 10.1590/0102-672020180001e1385.
PMID: 30133677
citation: Angrisani L, Santonicola A, Iovino P, Formisano G, Buchwald H, Scopinaro N. Bariatric Surgery Worldwide 2013. Obes Surg. 2015 Oct;25(10):1822-32. doi: 10.1007/s11695-015-1657-z.
PMID: 25835983
citation: van Mil SR, Duinhouwer LE, Mannaerts GHH, Biter LU, Dunkelgrun M, Apers JA. The Standardized Postoperative Checklist for Bariatric Surgery; a Tool for Safe Early Discharge? Obes Surg. 2017 Dec;27(12):3102-3109. doi: 10.1007/s11695-017-2746-y.
PMID: 28620895
citation: Welbourn R, Hollyman M, Kinsman R, Dixon J, Liem R, Ottosson J, Ramos A, Vage V, Al-Sabah S, Brown W, Cohen R, Walton P, Himpens J. Bariatric Surgery Worldwide: Baseline Demographic Description and One-Year Outcomes from the Fourth IFSO Global Registry Report 2018. Obes Surg. 2019 Mar;29(3):782-795. doi: 10.1007/s11695-018-3593-1. Epub 2018 Nov 12.
PMID: 30421326
citation: Chang SH, Freeman NLB, Lee JA, Stoll CRT, Calhoun AJ, Eagon JC, Colditz GA. Early major complications after bariatric surgery in the USA, 2003-2014: a systematic review and meta-analysis. Obes Rev. 2018 Apr;19(4):529-537. doi: 10.1111/obr.12647. Epub 2017 Dec 20.
PMID: 29266740
citation: Major P, Wysocki M, Pedziwiatr M, Malczak P, Pisarska M, Migaczewski M, Winiarski M, Budzynski A. Can the Obesity Surgery Mortality Risk Score predict postoperative complications other than mortality? Wideochir Inne Tech Maloinwazyjne. 2016;11(4):247-252. doi: 10.5114/wiitm.2016.64448. Epub 2016 Dec 6.
PMID: 28194244
citation: Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.
PMID: 15273542
citation: DeMaria EJ, Portenier D, Wolfe L. Obesity surgery mortality risk score: proposal for a clinically useful score to predict mortality risk in patients undergoing gastric bypass. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):134-40. doi: 10.1016/j.soard.2007.01.005.
PMID: 17386394
citation: Garcia-Garcia ML, Martin-Lorenzo JG, Liron-Ruiz R, Torralba-Martinez JA, Garcia-Lopez JA, Aguayo-Albasini JL. Failure of the Obesity Surgery Mortality Risk Score (OS-MRS) to Predict Postoperative Complications After Bariatric Surgery. A Single-Center Series and Systematic Review. Obes Surg. 2017 Jun;27(6):1423-1429. doi: 10.1007/s11695-016-2506-4.
PMID: 27975153
citation: Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres A, Weiner R, Yashkov Y, Fruhbeck G; International Federation for Surgery of Obesity and Metabolic Disorders-European Chapter (IFSO-EC); European Association for the Study of Obesity (EASO); European Association for the Study of Obesity Obesity Management Task Force (EASO OMTF). Interdisciplinary European guidelines on metabolic and bariatric surgery. Obes Surg. 2014 Jan;24(1):42-55. doi: 10.1007/s11695-013-1079-8.
PMID: 24081459
responsible party type: Principal Investigator
investigator affiliation: Kahramanmaras Sutcu Imam University
investigator full name: Mehmet Buğra Bozan
investigator title: Professor, Assistant
mesh term: Obesity
mesh term: Obesity, Morbid
sharing ipd: Undecided