Body Mass Index and Obesity Surgery Mortality Risk Score in Perioperative Complications of Laparoscopic Sleeve Gastrectomy

Obesity, Morbid Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04427644
• Other study ID #: 13281952-929
• Status: Completed
• Start date: January 1, 2016
• Est. completion date: January 1, 2019

Study information

• Verified date: June 2020
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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 (%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1617
• Est. completion date: January 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients whose data was available

• Morbid obesity patients who were operated with surgical technique laparoscopic sleeve gastrectomy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• BMD
• Clavien Dindo Surgical Complication Scale
• Laparascopic Sleeve Gastrectomy
• Obesity
• Obesity Surgery Mortality Score
• Obesity, Morbid
• Perioperative Complication

Intervention

Procedure:
• Laparascopic Sleeve Gastrectomy
Operations performed for complciation of laparascopic sleeve gastrectomy
• Interventional radiologic drainage
Interventional radiologic drainage of gastric leakage

Diagnostic Test:
• Complte Blood Count and Biochemical evaluation
blood samples obtained from patients to determine the hgb and htc levels of patients and biochemical changes of patients after surgery
• Computed tomography
Admitted to observe leakage

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Fried M, Yumuk V, Oppert JM, Scopinaro N, Torres A, Weiner R, Yashkov Y, Frühbeck 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. — View Citation

García-García ML, Martín-Lorenzo JG, Lirón-Ruiz R, Torralba-Martínez JA, García-López 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. Review. — View 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. English, Portuguese. — View 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. — View 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. — View Citation

Welbourn R, Hollyman M, Kinsman R, Dixon J, Liem R, Ottosson J, Ramos A, Våge 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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relation between preoperative BMI levels and perioperative complication positivity before discharge	Relation between preoperative BMI levels and perioperative complication positivity before discharge	postoperative 72 hour period before discharge
Primary	Relation between preoperative OS-MRS and perioperative complication positivity before discharge	Relation between preoperative OS-MRS and perioperative complication positivity before discharge	postoperative 72 hour period before discharge
Secondary	Perioperative complication rates after laparascopic sleeve gastrectomy before discharge	Perioperative complication rates after laparascopic sleeve gastrectomy before discharge	postoperative 72 hour period before discharge

External Links

•   OECD Update 2017