Status:
UNKNOWN
An Investigation of Frailty Markers and Outcomes in Patients Requiring Emergency Laparotomy
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
University of Strathclyde
Conditions:
Frailty
Surgery
Eligibility:
All Genders
40+ years
Brief Summary
Over 30,000 emergency abdominal operations (laparotomy, EmLAP) are performed in the UK annually and they are usually performed in adults over the age of 65. As such, it can be a risky operation with h...
Detailed Description
Over 30,000 emergency laparotomies (EmLAP) are performed in the UK annually yet research in EmLAP is sparse. The largest UK national observational cohort study (Emergency Laparotomy and frailty study,...
Eligibility Criteria
Inclusion
- Over 40 years of age
- NELA/ ELLSA inclusion criteria:
- Open, 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
- Washout/evacuation of intra-peritoneal abscess (unless due to appendicitis or cholecystitis - excluded, see below)
- Washout/evacuation of intra-peritoneal haematoma
- Bowel resection/repair due to incarcerated incisional, umbilical, inguinal and femoral hernias (but not hernia repair without bowel resection/repair). E.g. Large incisional hernia repair with bowel resection Bowel resection/repair due to obstructing/ incarcerated incisional hernias provided the presentation and findings were acute. This will include large incisional hernia repair with division of adhesions.
- Laparotomy/laparoscopy with inoperable pathology (e.g. peritoneal/hepatic metastases) where the intention was to perform a definitive procedure. This does not include purely diagnostic procedures.
- Laparoscopic/Open Adhesiolysis
- Return to theatre for repair of substantial dehiscence of major abdominal wound (i.e. "burst abdomen")
- Any reoperation/return to theatre for complications of elective general/upper GI surgery meeting the criteria above is included. Returns to theatre for complications following non-GI surgery are now excluded (see exclusion criteria below).
Exclusion
- Under 40 years of age
- CT scan or postoperative finding of inoperable disseminated peritoneal disease
- Open and close laparotomy (postoperative palliation, non-survivable global ischemia where there are \<90cm from duodenojejunal junction to stoma)
- Complication from colonic stenting requiring laparotomy
- NELA exclusion criteria:
- Elective laparotomy / laparoscopy
- Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, then include)
- Appendicectomy +/- drainage of localised collection unless the procedure is incidental to a non-elective procedure on the GI tract
- Cholecystectomy +/- drainage of localised 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. The only exception to this is if carried out as an incidental procedure to a more major procedure. There might be extreme cases of peritoneal contamination, but total exclusion avoids subjective judgement calls about severity of contamination.)
- Non-elective hernia repair without bowel resection or division of adhesions
- Minor abdominal wound dehiscence unless this causes bowel complications requiring resection.
- Non-elective formation of a colostomy or ileostomy as either a trephine or a laparoscopic procedure (NB: if a midline laparotomy is performed, with the primary procedure being formation of a stoma then this should be included)
- Vascular surgery, including abdominal aortic aneurysm repair
- Caesarean section or obstetric laparotomies
- Gynaecological laparotomy
- Ruptured ectopic pregnancy, or pelvic abscesses due to pelvic inflammatory disease
- Laparotomy/laparoscopy for pathology caused by blunt or penetrating trauma
- All surgery relating to organ transplantation (including returns to theatre for any reason following transplant surgery)
- Surgery relating to sclerosing peritonitis
- Surgery for removal of dialysis catheters
- Laparotomy/laparoscopy for oesophageal pathology
- Laparotomy/laparoscopy for pathology of the spleen, renal tract, kidneys, liver, gall bladder and biliary tree, pancreas or urinary tract
- Returns to theatre for complications (eg bowel injury, haematoma, collection) following non-GI surgery are now excluded. i.e returns to theatre following renal, urological, gynaecological, vascular, hepatic, pancreatic, splenic surgery are excluded
Key Trial Info
Start Date :
May 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05416047
Start Date
May 30 2022
End Date
August 1 2024
Last Update
April 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Royal Alexandra Hospital
Paisley, Renfrewshire, United Kingdom, PA2 9PN