Surgery Clinical Trial
— FrOGSOfficial title:
Frailty and Sarcopenia Outcomes in Emergency General Surgery
NCT number | NCT03534765 |
Other study ID # | 224891 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2018 |
Est. completion date | August 1, 2020 |
1. A retrospective scoping cohort review of adult patients undergoing emergency
laparotomy/laparoscopy for acute gastrointestinal (GI) pathology who have had a CT scan
of the abdomen(+/- pelvis). CT measured sarcopenia would be compared with clinical
outcomes, 30-day and 1-year mortality.
2. A prospective observational cohort study and bio-banking exercise of routinely collected
clinical data, in a cohort of patient undergoing emergency laparotomy/laparoscopy or
conservative treatment for an otherwise operable pathology. An interrogation of CT
measured sarcopenia and a validated clinical frailty score would be analysed against
clinical outcomes, 30-day and 1-year mortality.
The investigators aim to research the association and predictive advantage of combining
subjectively measured frailty, objectively measured CT sarcopenia and other risk predicting
tools used in every day surgical practice and surgical outcomes (mortality and morbidity) in
a cohort of acute surgical patients undergoing surgery or conservative treatment.
Status | Recruiting |
Enrollment | 294 |
Est. completion date | August 1, 2020 |
Est. primary completion date | March 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Adults age over 18 - Route of admission should include all general surgical admission or referrals via emergency department, interdepartmental transfers, direct referrals and GP referrals to an acute general surgical team. - All patients are required to have had a CT scan abdomen or abdomen and pelvis, supine or prone, with or without contrast. - All patients are required to have a completed REFS. - Those treated with operative measure (NCEPOD criteria) or those that would be treated operatively as an emergency, expedited, or urgently on the GI tract including: - Laparoscopic, open, converted or laparoscopic assisted - Surgical or radiological procedure or conservative treatments for pathology involving the stomach, small bowel, large bowel as a result of perforation, obstruction, ischaemia, bleeding or abscess. - Washout or evacuation of intrabdominal haematoma or abscess - Laparotomy or laparoscopy with no intervention due to inoperable pathology where the intention was to perform definition intervention. - Bowel resection or repair or conservative treatment due to obstructed or incarcerated incisional umbilical femoral or inguinal hernia. - Bowel resection/repair or conservative treatment due to obstructing/incarcerated incisional hernias provided the presentation and findings were acute. This will include large incisional hernia repair with division of adhesions. - Laparoscopic/Open Adhesiolysis or conservative treatment for bowel obstruction - Return to theatre for repair of substantial dehiscence of major abdominal wound (i.e. "burst abdomen") - Any reoperation/return to theatre or conservative treatment for complications of elective general/upper GI surgery meeting the criteria above is included. Returns to theatre for complications following non-GI surgery are excluded (see exclusion criteria below). - If multiple procedures are performed on different anatomical sites within the abdominal/pelvic cavity, the patient would be included if the major procedure is general surgical. - Non-elective colonic resection with hysterectomy for a fistulating colonic cancer would be included as the bowel resection is the major procedure - Bowel resection at the same time as emergency abdominal aortic aneurysm repair would not be included as the aneurysm repair is the major procedure - The subjects are required to have had an acute admission, inpatient stay, formal ward admission, review and diagnosis of acute GIT surgical pathology under an acute surgical team. Exclusion Criteria: - Do not meet inclusion criteria for specific work package - Patients less than 18 years old - Ambulant or day case admission or outpatient admission only - No review from an acute surgical team. - Prisoners or patients under arrest or on remand. - Isolated gynaecology pathology: pathology of the ovaries, uterus or tubal systems not involving the gastrointestinal tract(GIT) i.e ectopic pregnancy. - Isolated urology acute abdomen: pathology of the kidneys, ureters or bladder not involving the GIT i.e pyelonephritis, lower urinary tract infections, renal or ureteric stones, bladder malignancy - Isolated vascular pathology I.e Ruptured aortic aneurysm with no GIT ischaemia, iliac aneurysmal disease. - Excluded uncomplicated appendicectomy, cholecystectomy and ventral wall, or inguinal hernia. - Elective laparotomy / laparoscopy - Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed (NB, if no procedure is performed because of inoperable pathology, the case is included). - 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. We acknowledge that 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 excluded. i.e returns to theatre following renal, urological, gynaecological, vascular, hepatic, pancreatic, splenic surgery are excluded. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hampshire Hospitals NHS Foundation Trust | Basingstoke | |
United Kingdom | Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust | Bournemouth | |
United Kingdom | Dorset County Hospital NHS Foundation Trust | Dorchester | |
United Kingdom | Isle of Wight NHS Trust | Newport | |
United Kingdom | Poole Hospital NHS Foundation Trust | Poole | |
United Kingdom | Portsmouth Hospitals NHS Trust | Portsmouth | |
United Kingdom | Salisbury NHS Foundation Trust | Salisbury | |
United Kingdom | University Hospital Southampton NHS Foundation Trust | Southampton | |
United Kingdom | Hampshire Hospitals NHS Foundation Trust | Winchester | |
United Kingdom | Yeovil District Hospital NHS Foundation Trust | Yeovil |
Lead Sponsor | Collaborator |
---|---|
Yeovil District Hospital NHS Foundation Trust | Basingstoke and North Hampshire Hospital, Dorset County Hospital NHS Foundation Trust, Hampshire Hospitals NHS Foundation Trust, Isle of Wight NHS Trust, National Institute for Health Research, United Kingdom, Poole Hospital NHS Foundation Trust, Portsmouth Hospitals NHS Trust, Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust, Salisbury NHS Foundation Trust, University Hospital Southampton NHS Foundation Trust, University of Southampton |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 30-day mortality | Deaths (all cause) within 30 days of surgical procedure | 30 days post surgery | |
Secondary | 1 year mortality | Deaths (all cause) within one year of surgery | 1 year post surgery | |
Secondary | Length of stay | Index hospital admission length of stay (measured as number of nights as inpatient) | Reported at 30 days after surgical procedure | |
Secondary | Post-operative morbidity | Complications following surgery assessed using the Clavien Dindo classification | 30 days post surgery | |
Secondary | Destination of discharge from hospital | Place of discharge after hospital care (Home, rehabilitation facility, nursing or care home) | End of initial hospital inpatient care episode. Closes at time of discharge within 30 days of surgical procedure) | |
Secondary | Hospital readmission | Unplanned readmission to hospital | 30 days after discharge | |
Secondary | Participant care needs at time of hospital discharge | Frequency, length and nature of care needs and formal support required to allow safe discharge | End of initial hospital inpatient care episode. Closes at time of discharge within 30 days of surgical procedure) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05583916 -
Same Day Discharge for Video-Assisted Thoracoscopic Surgery (VATS) Lung Surgery
|
N/A | |
Completed |
NCT04448041 -
CRANE Feasibility Study: Nutritional Intervention for Patients Undergoing Cancer Surgery in Low- and Middle-Income Countries
|
||
Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
Enrolling by invitation |
NCT05534490 -
Surgery and Functionality in Older Adults
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Recruiting |
NCT06397287 -
PROM Project Urology
|
||
Recruiting |
NCT04444544 -
Quality of Life and High-Risk Abdominal Cancer Surgery
|
||
Completed |
NCT04204785 -
Noise in the OR at Induction: Patient and Anesthesiologists Perceptions
|
N/A | |
Completed |
NCT03432429 -
Real Time Tissue Characterisation Using Mass Spectrometry REI-EXCISE iKnife Study
|
||
Completed |
NCT04176822 -
Designing Animated Movie for Preoperative Period
|
N/A | |
Recruiting |
NCT05370404 -
Prescribing vs. Recommending Over-The-Counter (PROTECT) Analgesics for Patients With Postoperative Pain:
|
N/A | |
Not yet recruiting |
NCT05467319 -
Ferric Derisomaltose/Iron Isomaltoside and Outcomes in the Recovery of Gynecologic Oncology ERAS
|
Phase 3 | |
Recruiting |
NCT04602429 -
Children's Acute Surgical Abdomen Programme
|
||
Completed |
NCT03124901 -
Accuracy of Noninvasive Pulse Oximeter Measurement of Hemoglobin for Rainbow DCI Sensor
|
N/A | |
Completed |
NCT04595695 -
The Effect of Clear Masks in Improving Patient Relationships
|
N/A | |
Recruiting |
NCT06103136 -
Maestro 1.0 Post-Market Registry
|
||
Completed |
NCT05346588 -
THRIVE Feasibility Trial
|
Phase 3 | |
Completed |
NCT04059328 -
Novel Surgical Checklists for Gynecologic Laparoscopy in Haiti
|
||
Recruiting |
NCT03697278 -
Monitoring Postoperative Patient-controlled Analgesia (PCA)
|
N/A |