CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,617 enrolled
Drug / intervention
Laparascopic Sleeve Gastrectomy +3 moreprocedure
Likely dose
Not stated in record
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Search/NCT04427644
NCT04427644N/ACompleted

Is Body Mass Index and Obesity Surgery Mortality Risk Score Important in Perioperative Complications of Laparoscopic Sleeve Gastrectomy Before Discharge? A Retrospective Cohort Study

Kahramanmaras Sutcu Imam University·observational·Posted Jun 11, 2020·Updated Jun 16, 2020

In Brief

An observational study evaluating Laparascopic Sleeve Gastrectomy, İnterventional radiologic drainage, and 2 other interventions for Perioperative Complication and 5 related conditions. Completed, enrolled 1,617 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 11, 2020
Enrollment StartJan 1, 2016
Primary CompletionOct 1, 2018
Study CompletionJan 1, 2019
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 6.1 years ago

Interventions

Laparascopic Sleeve Gastrectomyprocedure

Operations performed for complciation of laparascopic sleeve gastrectomy

İnterventional radiologic drainageprocedure

İnterventional radiologic drainage of gastric leakage

Complte Blood Count and Biochemical evaluationother

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

Computed tomographyother

Admitted to observe leakage