Viewing Study NCT04774354



Ignite Creation Date: 2024-05-06 @ 3:50 PM
Last Modification Date: 2024-10-26 @ 1:58 PM
Study NCT ID: NCT04774354
Status: RECRUITING
Last Update Posted: 2024-02-21
First Post: 2021-02-24

Brief Title: POSSUM P-POSSUM and Charlsons Comorbidity Index in Abdominal Surgery
Sponsor: Ángel Becerra
Organization: Dr Negrin University Hospital

Study Overview

Official Title: Prospective Assessment of Surgical Risk Using the POSSUM System P-POSSUM and Charlsons Comorbidity Index in Abdominal Surgery
Status: RECRUITING
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Abdominal surgery represents the most frequent activity in the surgical block Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales

A prospective observational study will be carried out during 2021 All patients undergoing abdominal surgery will be included Demographic variables personal and surgical history preoperative and intraoperative data and variables related to surgery will be collected At 30 days postoperatively the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred With these data the POSSUM the P-POSSUM and the Charlson comorbidity index will be calculated
Detailed Description: Abdominal surgery represents the most frequent activity in the surgical block Advances in surgical techniques and improvements in postoperative care imply the need for greater control of the surgical outcomes obtained and the comparison of results between services with the same characteristics with the help of assessment scales

A prospective observational study will be carried out during 2021 All patients undergoing abdominal surgery will be included Demographic variables personal and surgical history preoperative and intraoperative data and variables related to surgery will be collected At 30 days postoperatively the clinical history of the patients will be reviewed and postoperative complications will be collected as well as the mortality that occurred With these data the POSSUM the P-POSSUM and the Charlson comorbidity index will be calculated

Once this data are collected the following objectives will be met

Validate the POSSUM and P-POSSUM systems in patients undergoing gastrointestinal surgery in our hospital comparing the estimated morbidity and mortality with that observed 30 days after surgery
Analyze the correlation of estimated morbidity and mortality of the POSSUM and P-POSSUM with respect to that observed in scheduled surgery vs emergencies
Analyze the correlation of estimated morbidity and mortality of POSSUM and P-POSSUM with respect to that observed in laparoscopic surgery vs laparotomy
Establish the relationship and predictive ability of CHF with respect to morbidity and mortality at 30

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None