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RecruitingNCT07007494Updated Jul 16, 2025

Early Outcomes and Nutritional Scores in Bariatric Patients

An observational study in Postoperative Complications and Preoperative Nutritional Markers, sponsored by Istinye University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-07-16.

Sponsored by Istinye University · Observational

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Jun 2025; still recruiting 1 year 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
86
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This prospective observational study aims to evaluate whether preoperative immune-nutritional markers-specifically the Prognostic Nutritional Index (PNI), HALP score, Neutrophil-to-Lymphocyte Ratio (NLR), and C-Reactive Protein (CRP)-can predict early postoperative clinical outcomes such as time to oral intake, mobilization, complications, and length of hospital stay in patients undergoing elective laparoscopic sleeve gastrectomy.

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Conditions studied

  • Postoperative Complications
  • Preoperative Nutritional Markers
03

In context

Postoperative Complications

1,233 studies on the registry are indexed under Postoperative Complications; 292 are open to participants now.

This study's planned enrollment of 86 is below the median of 254 across 519 observational studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Istinye University is the lead sponsor of 207 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients aged 18-65 years with morbid obesity (BMI ≥ 35 kg/m²) who are scheduled to undergo elective laparoscopic sleeve gastrectomy at a tertiary care center.

Inclusion criteria

  • Age between 18 and 65 years
  • Body mass index (BMI) ≥ 35 kg/m²
  • Scheduled for elective laparoscopic sleeve gastrectomy
  • Availability of complete preoperative laboratory test results
  • Signed informed consent

Exclusion criteria

Exclusion Criteria:

  • Severe hepatic or renal dysfunction
  • Presence of active infection
  • History of immunosuppressive therapy or hematologic malignancy
  • Need for intensive care unit (ICU) admission within the first 72 hours postoperatively
  • Preoperative administration of albumin or blood products
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
86 participants (estimated)
Patient registry
No

Interventions

  • OtherNutritional and Inflammatory Marker Evaluation

    This is a prospective observational cohort study evaluating whether preoperative immune-nutritional markers-including Prognostic Nutritional Index (PNI), HALP score, Neutrophil-to-Lymphocyte Ratio (NLR), and C-Reactive Protein (CRP)-can predict early postoperative clinical outcomes (complication development, time to oral intake, mobilization, and length of hospital stay) in patients undergoing elective laparoscopic sleeve gastrectomy. No intervention or treatment is administered as part of this study. All data are collected from routine preoperative laboratory tests and standard postoperative clinical follow-up.

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What researchers measure

Primary outcomes

  1. Occurrence of Postoperative Complications Within 72 Hours

    Complications such as fever, surgical site infection, nausea/vomiting, hypotension, or need for reintervention will be recorded during the first 72 hours after laparoscopic sleeve gastrectomy. The association between preoperative nutritional and inflammatory scores (PNI, HALP, NLR, CRP) and complication occurrence will be evaluated.

    Time frame: Up to 72 hours after surgery

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Study locations

1 of 1 sites recruiting
  • Istinye Üniversity
    Istanbul, Merkez Mahallesi 34250, Turkey (Türkiye)
    Recruiting
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References and documents

Publications

  • Courcoulas AP, Daigle CR, Arterburn DE. Long term outcomes of metabolic/bariatric surgery in adults. BMJ. 2023 Dec 18;383:e071027. doi: 10.1136/bmj-2022-071027. PubMed 38110235 ↗
  • Ishiguro T, Aoyama T, Ju M, Kazama K, Fukuda M, Kanai H, Sawazaki S, Tamagawa H, Tamagawa A, Cho H, Hara K, Numata M, Hashimoto I, Maezawa Y, Segami K, Oshima T, Saito A, Yukawa N, Rino Y. Prognostic Nutritional Index as a Predictor of Prognosis in Postoperative Patients With Gastric Cancer. In Vivo. 2023 May-Jun;37(3):1290-1296. doi: 10.21873/invivo.13207. PubMed 37103068 ↗
  • Xu F, Meng C, Yang Z, Li H, Gao J, Sun L, Zhang X, Wei Q, Wu G, Yao H, Zhang Z. Prognostic nutrition index predicts short-term surgical complications in patients with rectal cancer after laparoscopic surgery. Front Surg. 2022 Oct 25;9:1000108. doi: 10.3389/fsurg.2022.1000108. eCollection 2022. PubMed 36386497 ↗
  • Lee JY, Kim HI, Kim YN, Hong JH, Alshomimi S, An JY, Cheong JH, Hyung WJ, Noh SH, Kim CB. Clinical Significance of the Prognostic Nutritional Index for Predicting Short- and Long-Term Surgical Outcomes After Gastrectomy: A Retrospective Analysis of 7781 Gastric Cancer Patients. Medicine (Baltimore). 2016 May;95(18):e3539. doi: 10.1097/MD.0000000000003539. PubMed 27149460 ↗
  • Demirpolat MT, Sisik A. Effectiveness of the Modified Hemoglobin, Albumin, Lymphocyte, and Platelet Score in Predicting Weight Loss After Laparoscopic Sleeve Gastrectomy. J Laparoendosc Adv Surg Tech A. 2024 Jan;34(1):61-66. doi: 10.1089/lap.2023.0333. Epub 2023 Oct 25. PubMed 37878772 ↗
  • Radkhah H, Zooravar D, Shateri-Amiri B, Saffar H, Najjari K, Hazaveh MM. Predictive Value of Complete Blood Count (CBC)-Derived Indices-C-Reactive-Protein-Albumin-Lymphocyte index (CALLY), Glucose-to-Lymphocyte Ratio (GLR), Prognostic Nutritional Index (PNI), Hemoglobin, Albumin, Lymphocyte, Platelet (HALP), and Controlling Nutritional Status (COUNT)-on Body Composition Changes After Bariatric Surgery. Obes Surg. 2025 Feb;35(2):544-555. doi: 10.1007/s11695-024-07643-1. Epub 2025 Jan 8. PubMed 39775392 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07007494
Lead sponsor
Istinye University
Responsible party
İlke Dolgun (Assoc. prof, Istinye University) — Principal investigator
First posted
Jun 5, 2025
Start date
Jun 2, 2025
Primary completion
Aug 2, 2025 (estimated)
Completion
Aug 15, 2025 (estimated)
Last update
Jul 16, 2025

Study contacts

ilke dolgun
Contact
ilkeser2004@gmail.com
+905555485632
ilke dolgun
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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