NCT03719508

Brief Summary

Predictive Value of Various Nutritional Screening and Assesment Tools and a Surgery Scoring System (POSSUM Score) for Predicting Postoperative Complications in Patients Scheduled for Abdominal Surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 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

January 5, 2013

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 22, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
Last Updated

July 23, 2020

Status Verified

July 1, 2020

Enrollment Period

4.8 years

First QC Date

October 22, 2018

Last Update Submit

July 21, 2020

Conditions

Abdominal Surgery

Keywords

Nutritional assesmentNutritional screening toolsAbdominal SurgeryStomach NeoplasmsColorectal Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative clinical complications.

    Number of respiratory, cardiovascular, renal, neurological, infectious and surgical after surgery. Complication will be defined by the Clavien-Dindo classification and our primary outcome will be long-term complications higher than grade III.

    3 months

Secondary Outcomes (4)

  • Length of stay in hospital

    3 months

  • All-cause mortality

    3 months

  • Readmission

    6 months

  • Accuracy of the POSSUM Scoring Systems to predict clinical complications and mortality.

    1 month

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients aged at least 18 years who presented with diseases of the digestive tract (oesophageal, gastric or intestinal), or with other abdominal diseases requiring elective surgery.

You may qualify if:

  • years at least
  • Diseases of the digestive tract (oesophageal, gastric or intestinal), or other abdominal diseases requiring elective surgery,

You may not qualify if:

  • Age \< 18
  • Pregnancy
  • Major coagulopathy
  • Permanent pacemaker
  • Specific preoperative nutritional support before admission to hospital
  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nutrition and Dietetics, Evaggelismos Hospital

Athens, Kolonaki, 10676, Greece

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • George Stylianides, MD, PhD

    2nd Department of Surgery

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Dietitian, Department of Clinical Nutrition and Metabolism

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 25, 2018

Study Start

January 5, 2013

Primary Completion

October 10, 2017

Study Completion

December 20, 2017

Last Updated

July 23, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)