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

NCT04427644 | Completed

• 1 other identifier: 13281952-929
• Study Type: observational
• Target: 1,617
• Locations: 0 countries
• Sites: N/A

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Perioperative complication rates after laparascopic sleeve gastrectomy before discharge

  postoperative 72 hour period before discharge

Study Arms (7)

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)

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

Diagnostic Test: Complte Blood Count and Biochemical evaluation

BMI 40 - 45 kg/m2

Operated patients preoperative BMI values between 40 - 45 kg/m2

Diagnostic Test: Complte Blood Count and Biochemical evaluation

BMI 45 - 50 kg/m2

Operated patients preoperative BMI values between 45 - 50 kg/m2

Diagnostic Test: Complte Blood Count and Biochemical evaluation

BMI over 50 kg/m2

Operated patients preoperative BMI values 45 - 50 kg/m2

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

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

Procedure: İnterventional radiologic drainage; Diagnostic Test: Complte Blood Count and Biochemical evaluation; Diagnostic Test: Computed tomography

Interventions

Laparascopic Sleeve Gastrectomy PROCEDURE

Operations performed for complciation of laparascopic sleeve gastrectomy

Also known as: Reoperation

Clavien Dindo Major Complications; Complication positive

İnterventional radiologic drainage PROCEDURE

İnterventional radiologic drainage of gastric leakage

Clavien Dindo Major Complications; Clavien Dindo Minor Complciations; Complication positive

Complte Blood Count and Biochemical evaluation DIAGNOSTIC_TEST

blood samples obtained from patients to determine the hgb and htc levels of patients and biochemical changes of patients after surgery

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 tomography DIAGNOSTIC_TEST

Admitted to observe leakage

Clavien Dindo Major Complications; Clavien Dindo Minor Complciations; Complication positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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)

You may qualify if:

• Patients whose data was available
• Morbid obesity patients who were operated with surgical technique laparoscopic sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Kahramanmaras Sutcu Imam University: lead

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• OECD Update 2017

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Reoperation; Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Assistant

Study Record Dates

• First Submitted: June 6, 2020
• First Posted: June 11, 2020
• Study Start: January 1, 2016
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06