Perioperative ComplicationNCT04427644
Body Mass Index and Obesity Surgery Mortality Risk Score in Perioperative Complications of Laparoscopic Sleeve Gastrectomy
An observational study of Perioperative Complication and Laparascopic Sleeve Gastrectomy, run by Kahramanmaras Sutcu Imam University.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perioperative Complication, Laparascopic Sleeve Gastrectomy, BMD
- What is being tested?
- Laparascopic Sleeve Gastrectomy, İnterventional radiologic drainage and Complte Blood Count and Biochemical evaluation
- Type of treatment
- Surgery or procedure
- How many people
- 1,617 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 1 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient selection in terms of obesity and metabolic disease surgery(12); 1. Patients with a body mass index (BMI) of 40 and above, without the additional comorbid disease, 2. Patients with a BMI of 35 and above, withtheadditional comorbid disease (such as hypertension, diabetes mellitus)
Who may be able to join
- Patients whose data was available
- Morbid obesity patients who were operated with surgical technique laparoscopic sleeve gastrectomy
Who cannot join
- Patients whose data was not available
- Patients who were operated with other types of bariatric metabolic surgery
- Patients who left the hospital due to referral
- Patients whose OS-MRS scale wasn't calculated
- Patients whose American Society of Anesthesiologists (ASA) score was 4 or greater
About this study
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
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).
Read more
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.
Read the detailed description
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 (%).
- Conditions
- Perioperative Complication, Laparascopic Sleeve Gastrectomy, BMD, Obesity, Morbid, Obesity Surgery Mortality Score, Clavien Dindo Surgical Complication Scale
- Being tested
- Laparascopic Sleeve Gastrectomy, İnterventional radiologic drainage, Complte Blood Count and Biochemical evaluation, Computed tomography
- Keywords
- Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Perioperative Complication, Obesity Surgery Mortality Score, Body Mass Index
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparascopic Sleeve GastrectomyProcedure or surgery
Also called Reoperation
Operations performed for complciation of laparascopic sleeve gastrectomy
İnterventional radiologic drainageProcedure or surgery
İnterventional radiologic drainage of gastric leakage
Complte Blood Count and Biochemical evaluationDiagnostic test
blood samples obtained from patients to determine the hgb and htc levels of patients and biochemical changes of patients after surgery
Computed tomographyDiagnostic test
Admitted to observe leakage
| Study group | Role | What they receive |
|---|---|---|
| Complication positive | 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) Receives: Procedure: Laparascopic Sleeve Gastrectomy; Procedure: İnterventional radiologic drainage; Diagnostic Test: Complte Blood Count and Biochemical evaluation; Diagnostic Test: Computed tomography | |
| Complication negative | Patients without perioeprative complications after laparascopic sleeve gastrectomy before discharge Receives: Diagnostic Test: Complte Blood Count and Biochemical evaluation | |
| BMI 40 - 45 kg/m2 | Operated patients preoperative BMI values between 40 - 45 kg/m2 Receives: Diagnostic Test: Complte Blood Count and Biochemical evaluation | |
| BMI 45 - 50 kg/m2 | Operated patients preoperative BMI values between 45 - 50 kg/m2 Receives: Diagnostic Test: Complte Blood Count and Biochemical evaluation | |
| BMI over 50 kg/m2 | Operated patients preoperative BMI values 45 - 50 kg/m2 Receives: Diagnostic Test: Complte Blood Count and Biochemical evaluation | |
| Clavien Dindo Major Complications | 1. 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
2. Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions, antibiotics and total parenteral nutrition are also included Receives: Procedure: Laparascopic Sleeve Gastrectomy; Procedure: İnterventional radiologic drainage; Diagnostic Test: Complte Blood Count and Biochemical evaluation; Diagnostic Test: Computed tomography | |
| Clavien Dindo Minor Complciations | 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 Receives: Procedure: İnterventional radiologic drainage; Diagnostic Test: Complte Blood Count and Biochemical evaluation; Diagnostic Test: Computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between preoperative BMI levels and perioperative complication positivity before discharge
Relation between preoperative BMI levels and perioperative complication positivity before discharge
Measured: postoperative 72 hour period before discharge
Relation between preoperative OS-MRS and perioperative complication positivity before discharge
Relation between preoperative OS-MRS and perioperative complication positivity before discharge
Measured: postoperative 72 hour period before discharge
Secondary outcomes (1)
Perioperative complication rates after laparascopic sleeve gastrectomy before discharge
Perioperative complication rates after laparascopic sleeve gastrectomy before discharge
Measured: postoperative 72 hour period before discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jan 2016
- Primary completion1 Oct 2018
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Perioperative ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Buğra Bozan, Kahramanmaras Sutcu Imam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427644
- Sponsor's protocol ID
- 13281952-929
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27007089Kirkil 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.
PubMed 30133677Angrisani 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.
PubMed 25835983van 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.
PubMed 28620895Welbourn 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.
PubMed 30421326Chang 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.
PubMed 29266740Major 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.
PubMed 28194244Dindo 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.
PubMed 15273542DeMaria 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.
PubMed 17386394Garcia-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.
PubMed 27975153Fried 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.
PubMed 24081459
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04427644
- Acronym / sponsor ID
- 13281952-929
- Conditions
- Perioperative Complication, Laparascopic Sleeve Gastrectomy, BMD, Obesity, Morbid, Obesity Surgery Mortality Score, Clavien Dindo Surgical Complication Scale
- Keywords
- Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Perioperative Complication, Obesity Surgery Mortality Score, Body Mass Index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,617 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (%).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Complication positive | – | Procedure: Laparascopic Sleeve Gastrectomy, Procedure: İnterventional radiologic drainage, Diagnostic Test: Complte Blood Count and Biochemical evaluation, Diagnostic Test: Computed tomographyPatients 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) |
| Complication negative | – | Diagnostic Test: Complte Blood Count and Biochemical evaluationPatients without perioeprative complications after laparascopic sleeve gastrectomy before discharge |
| BMI 40 - 45 kg/m2 | – | Diagnostic Test: Complte Blood Count and Biochemical evaluationOperated patients preoperative BMI values between 40 - 45 kg/m2 |
| BMI 45 - 50 kg/m2 | – | Diagnostic Test: Complte Blood Count and Biochemical evaluationOperated patients preoperative BMI values between 45 - 50 kg/m2 |
| BMI over 50 kg/m2 | – | Diagnostic Test: Complte Blood Count and Biochemical evaluationOperated patients preoperative BMI values 45 - 50 kg/m2 |
| Clavien Dindo Major Complications | – | Procedure: Laparascopic Sleeve Gastrectomy, Procedure: İnterventional radiologic drainage, Diagnostic Test: Complte Blood Count and Biochemical evaluation, Diagnostic Test: Computed tomography1. 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 2. Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions, antibiotics and total parenteral nutrition are also included |
| Clavien Dindo Minor Complciations | – | Procedure: İnterventional radiologic drainage, Diagnostic Test: Complte Blood Count and Biochemical evaluation, Diagnostic Test: Computed tomography3. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient selection in terms of obesity and metabolic disease surgery(12); 1. Patients with a body mass index (BMI) of 40 and above, without the additional comorbid disease, 2. Patients with a BMI of 35 and above, withtheadditional comorbid disease (such as hypertension, diabetes mellitus)
Key inclusion criteria (2 listed)
- Patients whose data was available
- Morbid obesity patients who were operated with surgical technique laparoscopic sleeve gastrectomy
Key exclusion criteria (5 listed)
- Patients whose data was not available
- Patients who were operated with other types of bariatric metabolic surgery
- Patients who left the hospital due to referral
- Patients whose OS-MRS scale wasn't calculated
- Patients whose American Society of Anesthesiologists (ASA) score was 4 or greater
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparascopic Sleeve GastrectomyAlso: ReoperationOperations performed for complciation of laparascopic sleeve gastrectomy | Procedure or surgery | Clavien Dindo Major Complications, Complication positive |
| İnterventional radiologic drainageİnterventional radiologic drainage of gastric leakage | Procedure or surgery | Clavien Dindo Major Complications, Clavien Dindo Minor Complciations, Complication positive |
| Complte Blood Count and Biochemical evaluationblood samples obtained from patients to determine the hgb and htc levels of patients and biochemical changes of patients after surgery | Diagnostic test | BMI 40 - 45 kg/m2, BMI 45 - 50 kg/m2, BMI over 50 kg/m2, Clavien Dindo Major Complications, Clavien Dindo Minor Complciations, Complication negative, Complication positive |
| Computed tomographyAdmitted to observe leakage | Diagnostic test | Clavien Dindo Major Complications, Clavien Dindo Minor Complciations, Complication positive |
Primary outcome
Relation between preoperative BMI levels and perioperative complication positivity before discharge
Time frame: postoperative 72 hour period before discharge
Relation between preoperative BMI levels and perioperative complication positivity before discharge
Relation between preoperative OS-MRS and perioperative complication positivity before discharge
Time frame: postoperative 72 hour period before discharge
Relation between preoperative OS-MRS and perioperative complication positivity before discharge
1 secondary outcome
Perioperative complication rates after laparascopic sleeve gastrectomy before discharge
Time frame: postoperative 72 hour period before discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2020.
- Background: PubMed 27007089Falk 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.
- Background: PubMed 30133677Kirkil 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.
- Background: PubMed 25835983Angrisani 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.
- Background: PubMed 28620895van 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.
- Background: PubMed 30421326Welbourn 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.
- Background: PubMed 29266740Chang 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.
- Background: PubMed 28194244Major 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.
- Background: PubMed 15273542Dindo 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.
- Background: PubMed 17386394DeMaria 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.
- Background: PubMed 27975153Garcia-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.
- Background: PubMed 24081459Fried 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Perioperative Complication and Laparascopic Sleeve Gastrectomy, run by Kahramanmaras Sutcu Imam University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between preoperative BMI levels and perioperative complication positivity before discharge (time frame: postoperative 72 hour period before discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04427644, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2020.