Comparison of Scoring Systems in Gastrointestinal Cancer Surgery

NCT ID: NCT07325656

Last Updated: 2026-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2021-08-31

Brief Summary

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Accurate prediction of postoperative morbidity and mortality is essential for optimizing perioperative management in patients undergoing gastrointestinal cancer surgery. This study evaluates the predictive performance of commonly used perioperative risk scoring systems in patients undergoing gastrointestinal surgery for malignancy under general anesthesia.

Detailed Description

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This prospective observational study is designed to assess the predictive accuracy of multiple perioperative risk assessment tools in adult patients undergoing gastrointestinal (GI) surgery for malignancy under general anesthesia. Preoperative risk stratification is a key component of perioperative care, as it supports identification of patients at increased risk for postoperative complications and mortality and facilitates appropriate perioperative planning and resource utilization.

Perioperative risk scores are calculated using routinely collected clinical data obtained during the preoperative evaluation and intraoperative period, in accordance with established definitions for each scoring system. The scoring systems evaluated include the American Society of Anesthesiologists Physical Status classification (ASA-PS), Surgical Apgar Score (SAS), Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM), American College of Surgeons National Surgical Quality Improvement Program Surgical Risk Calculator (ACS-NSQIP-SRC), and the ARISCAT risk score for postoperative pulmonary complications.

Postoperative outcomes are assessed during the index hospitalization and early postoperative follow-up period, focusing on the occurrence of pulmonary and non-pulmonary complications, short-term mortality, requirement for intensive care unit admission, and length of hospital and intensive care unit stay.

The primary objective of the study is to determine which perioperative risk assessment tools demonstrate the highest predictive accuracy for postoperative complications and mortality following gastrointestinal malignancy surgery. Secondary objectives include comparison of score performance for pulmonary versus non-pulmonary complications and evaluation of associations between risk scores and postoperative length of stay.

The results of this study are expected to provide clinically relevant evidence regarding the utility of commonly used perioperative risk scoring systems in gastrointestinal cancer surgery and to support improved perioperative risk stratification.

Conditions

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Gastro Intestinal Cancer Scoring Systems

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Gastrointestinal Cancer Surgery Cohort

Prospective observational group including adult patients undergoing elective surgery for gastrointestinal malignancy. Risk prediction scores will be recorded pre- and peri-operatively.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: Age ≥ 18 years, Scheduled to undergo elective gastrointestinal surgery for malignancy via laparotomy, Planned general anesthesia, Provision of written informed consent

Exclusion Criteria: Emergency surgery, Surgery performed using laparoscopic or robotic approaches, Previous gastrointestinal surgery for malignancy within the past 6 months, Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lütfi Kırdar City Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mehmet Emre Gecici

Specialist Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MEHMET E GECICI, MD

Role: PRINCIPAL_INVESTIGATOR

Kartal Dr. Lutfi Kirdar City Hospital

Locations

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Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Vashistha N, Singhal S, Budhiraja S, Singhal D. Evaluation of ACS-NSQIP and CR-POSSUM risk calculators for the prediction of mortality after colorectal surgery: A retrospective cohort study. J Minim Access Surg. 2024 Apr 1;20(2):142-147. doi: 10.4103/jmas.jmas_187_22. Epub 2022 Sep 12.

Reference Type RESULT
PMID: 36124474 (View on PubMed)

Nag DS, Dembla A, Mahanty PR, Kant S, Chatterjee A, Samaddar DP, Chugh P. Comparative analysis of APACHE-II and P-POSSUM scoring systems in predicting postoperative mortality in patients undergoing emergency laparotomy. World J Clin Cases. 2019 Aug 26;7(16):2227-2237. doi: 10.12998/wjcc.v7.i16.2227.

Reference Type RESULT
PMID: 31531317 (View on PubMed)

Crea N, Di Fabio F, Pata G, Nascimbeni R. APACHE II, POSSUM, and ASA scores and the risk of perioperative complications in patients with colorectal disease. Ann Ital Chir. 2009 May-Jun;80(3):177-81.

Reference Type RESULT
PMID: 20131533 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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LutfiKırdarCityHospital

Identifier Type: -

Identifier Source: org_study_id

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