NCT04539028

Brief Summary

This study will observe the postoperative morbidity and mortality trends in patients with non- traumatic abdominal pathology who will undergo emergency general surgery. This prospective study will help us in establishing a prospective de-identified registry that may be used to further research this cohort in the future.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

September 4, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2022

Completed
Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

3 years

First QC Date

July 31, 2019

Last Update Submit

August 31, 2020

Conditions

Keywords

Emergency Abdominal surgery, Acute abdomen

Outcome Measures

Primary Outcomes (1)

  • morbidity and mortality

    The objective of this study is to analyze postoperative outcomes as well as morbidity and mortality trends for this sick cohort of patients with non- traumatic abdominal pathology who will undergo emergency general surgery.

    1 year

Interventions

Emergency Abdominal surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult patients ages 18-99, regardless of sex, racial or ethnic background who will undergo or underwent emergency abdominal surgery

You may qualify if:

  • All adult patients ages 18-99, regardless of sex, racial or ethnic background who will undergo or underwent emergency abdominal surgery for acute abdomen due to perforated viscus, acute bowel obstruction, bowel ischemia, acute or gangrenous gall bladder, post-operative complications such as anastomotic leaks after bowel anastomosis,abdominal compartment syndrome,enterocutaneous/enteroatmospheric fistula or bleeding.
  • Investigators will also include patients after organ transplant that will undergo emergent surgery for post-operative bleeding, anastomotic leak or organ ischemia.
  • As well as any patients undergoing bariatric surgery or colorectal procedures that develop any complication that might need return to the operating room emergently will also be included in the study from 2019 at Westchester Medical Center.

You may not qualify if:

  • Elective delayed repair for surgery done after clinic follow-up.
  • Age \< 18 years or greater than 89 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Westchester Medical Center

Valhalla, New York, 10595, United States

RECRUITING

MeSH Terms

Conditions

Intestinal ObstructionAbdomen, Acute

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesAbdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Study Officials

  • Rifat Latifi, MD

    Chairman, Department of Surgery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman, Department of Surgery

Study Record Dates

First Submitted

July 31, 2019

First Posted

September 4, 2020

Study Start

June 1, 2019

Primary Completion

May 30, 2022

Study Completion

May 30, 2022

Last Updated

September 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations