Perioperative Pulmonary Monitoring in Major Emergency Surgery

NCT ID: NCT03977337

Last Updated: 2019-06-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 350 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-29
• Study Completion Date: 2019-11-30

Brief Summary

1. Describe the incidence of postoperative hypoxemia after major emergency abdominal surgery as well as correlate this to clinical outcomes.

2. Investigate the association between postoperative pulmonary complications and respiratory muscle dysfunction.

3. Investigate the association between the length and type of incision as well as the distance to the xiphoid process and respiratory muscle dysfunction.

4. Investigate the association between postoperative hypoxemia, myocardial ischemia and ischemic electrocardiographic (ECG) changes within three days of major emergency abdominal surgery

5. Describe the incidence of postoperative cardiac arrhythmias within three days of major emergency abdominal surgery and the association with postoperative cardiovascular complications within 30 days, 90 days and 1 year of surgery.

6. Describe the association between HRV and postoperative cardiovascular and non-cardiovascular complications within 30 days, 90 days and 1 year of surgery

Conditions

Pulmonary Complication; Cardiovascular Complication; Postoperative Complications

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Major emergency abdominal surgery

Major emergency gastrointestinal surgery performed within 72 hours of an acute admission or an acute reoperation.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Surgery within 72 hours of an acute admission to the Department of Surgery or an acute reoperation.
• Major gastrointestinal surgery on the gastrointestinal tract.

This will include:

• Open, laparoscopic, or laparoscopically-assisted procedures
• Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding or obstruction
• Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
• Washout/evacuation of intra-peritoneal hematoma
• Bowel resection/repair due to incarcerated umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair)
• Bowel resection/repair due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute
• Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases)
• Laparoscopic/Open adhesiolysis
• Return to theatre for repair of fascial dehiscence
• Any reoperation/return to theatre meeting the criteria above is included

If multiple procedures (primary surgery or reoperation) are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical.

Exclusion Criteria

• Not capable of giving informed consent after oral and written information
• Previously included in the trial
• Elective laparoscopy
• Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
• Appendectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract
• Cholecystectomy +/- drainage of localized collection unless the procedure is incidental to a non-elective procedure on the GI tract (All surgery involving the appendix or gallbladder, including any surgery relating to complications such as abscess or bile leak is excluded)
• Non-elective hernia repair without bowel resection.
• Minor abdominal wound dehiscence unless this causes bowel complications requiring resection
• Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
• Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
• Laparotomy/laparoscopy for esophageal pathology
• Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ismail Gögenur, MD

Role: STUDY_CHAIR

Zealand University Hospital

Jakob Burcharth, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

Department of Surgery, Zealand University Hospital, Denmark.

Køge, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Ismail Gögenur, MD

Role: CONTACT

igo@regionsjaelland.dk

+45 26336426

Jakob Burcharth, MD

Role: CONTACT

jbur@regionsjaelland.dk

Facility Contacts

Ismail Gögenur, MD

Role: primary

igo@regionsjaelland.dk

+45 26336426

Jakob Burcharth, MD

Role: backup

jbur@regionsjaelland.dk

Other Identifiers

PROMIES

Identifier Type: -

Identifier Source: org_study_id