- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07747168
Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications After Bariatric Surgery (BARI-NUTRI)
The Predictive Value of Nutritional and Inflammatory Indices for Postoperative Complications in Bariatric Surgery Patients: A Single-Centre Retrospective Cohort Study
Bariatric surgery is an effective treatment for severe obesity, but postoperative complications remain an important cause of morbidity. Several nutritional and inflammatory biomarkers derived from routine preoperative blood tests have been proposed as predictors of postoperative outcomes; however, their comparative value in bariatric surgery has not been fully established.
This single-center retrospective cohort study will evaluate the ability of preoperative nutritional and inflammatory indices, including the Prognostic Nutritional Index (PNI), Neutrophil-to-Lymphocyte Ratio (NLR), Platelet-to-Lymphocyte Ratio (PLR), Systemic Immune-Inflammation Index (SII), Systemic Inflammation Response Index (SIRI), and C-reactive Protein-to-Albumin Ratio (CAR), to predict 30-day postoperative complications following bariatric surgery. The study aims to identify the most clinically useful biomarker for preoperative risk stratification and optimization of perioperative care.
연구 개요
상세 설명
Bariatric surgery is the most effective treatment for severe obesity and obesity-related comorbidities. Despite advances in perioperative care, early postoperative complications continue to contribute to patient morbidity and healthcare utilization. Reliable preoperative risk stratification tools are therefore essential for identifying patients at increased risk and optimizing perioperative management.
Nutritional status and systemic inflammation have emerged as important determinants of surgical outcomes. Several composite indices calculated from routinely available laboratory parameters, including albumin, C-reactive protein, leukocyte subsets, and platelet counts, have demonstrated prognostic value in different surgical populations. However, evidence regarding their comparative predictive performance in bariatric surgery remains limited.
This single-center retrospective cohort study will include consecutive adult patients who underwent sleeve gastrectomy or gastric bypass procedures between 2023 and 2026. Preoperative nutritional and inflammatory indices (PNI, NLR, PLR, SII, SIRI, and CAR) will be calculated from the most recent preoperative laboratory values.
The primary outcome is the occurrence of any Clavien-Dindo grade II or higher postoperative complication within 30 days after surgery. Secondary outcomes include the Comprehensive Complication Index (CCI), length of hospital stay, intensive care unit admission, and 30-day mortality. Multivariable regression analyses will be performed to determine the independent predictive value of each index after adjustment for relevant demographic and clinical variables.
The findings of this study are expected to improve preoperative risk assessment and facilitate identification of patients who may benefit from targeted perioperative optimization strategies.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Athens, 그리스, 11526
- General Hospital of Athens G Gennimatas
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Adults aged 18 years or older.
- Patients who underwent bariatric surgery (sleeve gastrectomy, Roux-en-Y gastric bypass, SADI, or SASI).
- Availability of complete preoperative laboratory data required for calculation of nutritional and inflammatory indices.
- Availability of postoperative follow-up data for assessment of 30-day complications.
Exclusion Criteria:
Patients younger than 18 years.
- Missing key preoperative laboratory values required to calculate study indices.
- Incomplete medical records or unavailable 30-day postoperative outcome data.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Bariatric Surgery Cohort
Adult patients who underwent bariatric surgery (sleeve gastrectomy or gastric bypass procedures including Roux-en-Y gastric bypass, SADI, and SASI) between 2023 and 2026.
Preoperative nutritional and inflammatory indices were evaluated for their association with 30-day postoperative complications.
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Standard bariatric surgical procedures performed as part of routine clinical care, including sleeve gastrectomy and gastric bypass procedures (Roux-en-Y gastric bypass, SADI, and SASI).
No study-specific intervention was assigned.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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30-Day Postoperative Complications (Clavien-Dindo Grade II or Higher)
기간: 30 days after surgery
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Occurrence of any postoperative complication classified as Clavien-Dindo grade II or higher within 30 days after bariatric surgery.
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30 days after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Comprehensive Complication Index (CCI)
기간: 30 days after surgery
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Comprehensive Complication Index calculated from all postoperative complications occurring within 30 days after surgery.
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30 days after surgery
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Length of Hospital Stay
기간: From surgery until hospital discharge (up to 30 days)
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Total duration of hospitalization following bariatric surgery.
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From surgery until hospital discharge (up to 30 days)
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From surgery until hospital discharge (up to 30 days)
기간: 30 days after surgery
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All-cause mortality occurring within 30 days after bariatric surgery.
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30 days after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Amalia Douma, MD PHD, G.Gennimatas General Hospital
- 수석 연구원: Panagiotis Chatzistavridis, MD, G.Gennimatas General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 24050/28-07-2026 (레지스트리 식별자: Scientific Council Approval, General Hospital G. Gennimatas, Athens, Greece)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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