NCT07747168

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
17mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Jan 2023Dec 2027

Study Start

First participant enrolled

January 1, 2023

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2026

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2027

Expected
Last Updated

August 6, 2026

Status Verified

July 1, 2026

Enrollment Period

3.4 years

First QC Date

July 31, 2026

Last Update Submit

August 4, 2026

Conditions

Obesity (BMI > 35)Morbid Obesity

Keywords

Bariatric SurgerySleeve GastrectomyGastric BypassPrognostic Nutritional IndexPNINeutrophil-to-Lymphocyte RatioNLRPlatelet-to-Lymphocyte RatioPLRSystemic Immune-Inflammation IndexSIISystemic Inflammation Response IndexClavien-Dindo ClassificationRisk StratificationC-Reactive Protein-to-Albumin RatioCAR

Outcome Measures

Primary Outcomes (1)

  • 30-Day Postoperative Complications (Clavien-Dindo Grade II or Higher)

    Occurrence of any postoperative complication classified as Clavien-Dindo grade II or higher within 30 days after bariatric surgery.

    30 days after surgery

Secondary Outcomes (3)

  • Comprehensive Complication Index (CCI)

    30 days after surgery

  • Length of Hospital Stay

    From surgery until hospital discharge (up to 30 days)

  • From surgery until hospital discharge (up to 30 days)

    30 days after surgery

Study Arms (1)

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.

Procedure: Bariatric Surgery

Interventions

Bariatric SurgeryPROCEDURE

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.

Bariatric Surgery Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who underwent bariatric surgery at a single tertiary referral center between 2023 and 2026 and met the study eligibility criteria.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Athens G Gennimatas

Athens, 11526, Greece

Location

MeSH Terms

Conditions

ObesityObesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Amalia Douma, MD PHD

    G.Gennimatas General Hospital

    PRINCIPAL INVESTIGATOR

  • Panagiotis Chatzistavridis, MD

    G.Gennimatas General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Anesthesiologist MD PHDc , Clinical Pharmacologist

Study Record Dates

First Submitted

July 31, 2026

First Posted

August 5, 2026

Study Start

January 1, 2023

Primary Completion

May 31, 2026

Study Completion (Estimated)

December 30, 2027

Last Updated

August 6, 2026

Record last verified: 2026-07

Locations

GR(1)