Introduction: Clinical trials use inclusion and exclusion criteria to homogenize patient groups. However, how these criteria represent actual patients population is unclear. Our hypothesis is that the inclusion and exclusion criteria of laparoscopic bariatric surgery trial limit the applicability of their to an actual bariatric patient population. Our secondary hypothesis is that there will be a difference in perioperative outcomes between the patients who were and were not represented in the clinical trials.
Methods: With IRB approval, we retrospectively followed 104 patients who underwent bariatric surgery (laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass) at our institution from January 2018 to May 2023. We identified three clinical trials that compared outcomes of laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass. We utilized the inclusion and exclusion criteria of these clinical trials to determine whether our patients would have been represented in the clinical trials. We compared the following perioperative outcomes of the patients who were and were not represented: estimated blood loss (EBL), length of stay (LOS), and rate of intraoperative and post-operative complications. Statistical analyses were performed using Student’s t-test and Chi-square test. Data are presented as median (mean ±SD). Significance was accepted at p-value<0.05.
Results: According to the inclusion and exclusion criteria of the three clinical trials, 63% of the patients who received either a laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass would not have been included in any of the clinical trials and the 37% of the patients would have been included in at least one of three clinical trials. Patients would have been excluded from the clinical trials primarily due to the following reasons: high BMI (>55 kg/m2), prior bariatric or gastrointestinal operations, malignancy, and psychiatric problems. When comparing patients who would have been excluded to patients who would have been included, there was no significant difference in EBL (25(113±237.9) mL vs. 25(87.5±319.9) mL, p-value = 0.65), LOS (2(3±2.6) days vs. 2(2.2±0.9) days, p-value = 0.14), rate of intraoperative complications (4.5% vs 2.6%, p-value = 0.63), and rate of post-operative complications (7.6% vs 13.2%, p-value = 0.56).
Conclusion: Inclusion and exclusion criteria utilized in clinical trials for laparoscopic bariatric surgery was not representative of the population of patients that received bariatric surgery at our institution. However, there was no difference observed in perioperative outcomes between patients who were and were not represented in the clinical trials. Future studies can further explore if the underrepresentation of patients in clinical trials could lead to the reporting of outcomes that are not observed in the patient population.
