Postoperative ComplicationsNCT07007494
Early Outcomes and Nutritional Scores in Bariatric Patients
An observational study of Postoperative Complications and Preoperative Nutritional Markers, run by Istinye University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Complications, Preoperative Nutritional Markers
- What is being tested?
- Nutritional and Inflammatory Marker Evaluation
- Type of treatment
- Pill or oral medicine
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jun 2025to 15 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
ilke dolgun contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istinye Üniversity
Istanbul, Merkez Mahallesi, 34250
ilke dolgun, ilkeser2004@gmail.com
ilke dolgun
About this study
Official title: The Relationship Between Preoperative Nutritional and Inflammatory Markers and Early Postoperative Clinical Outcomes in Patients Undergoing Bariatric Surgery
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.
- Being tested
- Nutritional and Inflammatory Marker Evaluation
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutritional and Inflammatory Marker EvaluationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start2 Jun 2025
- Primary completion2 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- More trials run by Istinye UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlke Dolgun, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007494
- Sponsor's protocol ID
- PNI HALP OBESITY
- Status last verified
- Jul 2025
- First submitted
- 28 May 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 38110235Ishiguro 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 37103068Xu 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 36386497Lee 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 27149460Demirpolat 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 37878772Radkhah 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Preoperative Nutritional and Inflammatory Markers and Early Postoperative Clinical Outcomes in Patients Undergoing Bariatric Surgery
- ClinicalTrials.gov ID
- NCT07007494
- Acronym / sponsor ID
- PNI HALP OBESITY
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 2 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nutritional and Inflammatory Marker EvaluationThis 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. | Other | – |
Primary outcome
Occurrence of Postoperative Complications Within 72 Hours
Time frame: Up to 72 hours after surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Results publication: PubMed 38110235Courcoulas 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.
- Results publication: PubMed 37103068Ishiguro 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.
- Results publication: PubMed 36386497Xu 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.
- Results publication: PubMed 27149460Lee 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.
- Results publication: PubMed 37878772Demirpolat 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.
- Results publication: PubMed 39775392Radkhah 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ilke dolgun contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Preoperative Nutritional Markers, run by Istinye University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ilke dolgun (+905555485632, ilkeser2004@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Postoperative Complications Within 72 Hours (time frame: Up to 72 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07007494, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.