Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-25 @ 4:17 AM
NCT ID:
NCT04615520
Eligibility Criteria:
Inclusion Criteria:
* Age \>18yrs
* Emergency laparotomy (operation simultaneously with resuscitation usually within one hour) or urgent (operation as soon as possible after resuscitation, within 24hrs)
* Operation in the gastrointestinal tract:
* Open or laparoscopic, or laparoscopically assisted procedures.
* Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction
* Wash out/evacuation of intraperitoneal abscess or haematoma
* Bowel resection/repair due to incarcerated/incisional hernias
* Bowel resection or repair due to incarcerated umbilical, inguinal or femoral hernias
* Open or laparoscopic adhesiolysis
* Laparotomy/laparoscopy with inoperable pathology
* Return to theatre for repair of a substantial dehiscence of major abdominal wound (i.e. "burst abdomen")
* Return to theatre after any operation (including vascular, gynecology, urology, cardiac) meeting the criteria above
* In the case of multiple procedures in the abdominopelvic cavity the patient is included if the main procedure is a general surgical one (i.e. if bowel resection happens during an open aneurysm repair it should not be included)
* Any intra-abdominal procedure not identifiable within exclusion criteria should be included.
Exclusion Criteria:
* Patients under 18
* Elective operation
* Diagnostic laparoscopy or laparotomy where no other procedure is performed (NB, if no procedure is performed due to inoperable pathology, then include)
* Appendicectomy with or without drainage of localized abscess
* Cholecystectomy with or without drainage of localized abscess
* Hernia repair without bowel resection
* Minor abdominal wound revision
* Vascular surgery
* Gynecological surgery - c-section - ruptured ectopic pregnancy
* Surgery relating to organ transplantation
* Removal of dialysis catheters
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04615520
Study Brief:
Protocol Section:
NCT04615520