NCT07325656

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2021

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

November 30, 2025

Last Update Submit

January 16, 2026

Conditions

Keywords

mortalitymorbidity

Outcome Measures

Primary Outcomes (1)

  • 30- and 60-day All-Cause Postoperative Mortality

    All-cause mortality within 30 and 60 days after gastrointestinal malignancy surgery performed under general anesthesia. Mortality data will be obtained from hospital records and verified through national health databases.

    60 days after surgery

Secondary Outcomes (1)

  • Postoperative Pulmonary Complications

    Within 30 days after surgery

Other Outcomes (1)

  • Postoperative Non-Pulmonary Complications

    Within 30 days after surgery

Study Arms (1)

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.

Eligibility Criteria

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

The study population includes adult patients (≥18 years) scheduled for elective gastrointestinal malignancy surgery performed under general anesthesia at a tertiary referral hospital. Participants are followed prospectively from the preoperative assessment through the postoperative period. Demographic characteristics, baseline clinical data, and operative variables are collected. Postoperative clinical outcomes are assessed to evaluate the predictive performance of perioperative risk scoring systems for postoperative morbidity and mortality.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kartal Dr. Lutfi Kirdar City Hospital

Istanbul, Kartal, 34899, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

Study Officials

  • MEHMET E GECICI, MD

    Kartal Dr. Lutfi Kirdar City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
60 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Physician

Study Record Dates

First Submitted

November 30, 2025

First Posted

January 8, 2026

Study Start

February 1, 2021

Primary Completion

August 28, 2021

Study Completion

August 31, 2021

Last Updated

January 20, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations