Frailty and Sarcopenia Outcomes in Emergency General Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 294
- 试验地点
- 9
- 主要终点
- 30-day mortality
研究概览
简要总结
- 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.
- 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.
详细描述
Frailty has a significant impact on surgical outcomes. It is an independent risk factor for adverse outcomes following surgery including complications, length of stay, inability to return home and mortality. Frailty is a physiological decline across multiple body systems accumulating in loss of reserves and increased vulnerability to stressors.
Sarcopenia, loss of muscle mass or progressive reduction in muscle mass, is one of the central physiological manifestations of frailty resulting in weight loss, weakness and exhaustion. Frailty has both a strong correlation with age as well as significant overlap with disability and co-morbidity. Further factors strongly influencing outcome, 30 day and mortality have been described including polypharmacy, Charlson co-morbidity index, age, not independently mobile, emergency admission and falls. It has been recognised that poor outcomes are multimodal relating to the interplay of co-morbidities, physical functioning and nutrition.
Assessing frailty can be completed using simple questionnaire tools, as well as more complex assessment of co-morbidity, functional status, and disability. There is good evidence the simple tools can be as accurate as formal geriatric assessments.
As sarcopenia relates directly to many manifestations of frailty it can be used as a surrogate marker. One of the favoured ways for diagnosing sarcopenia is using CT morphometric biological markers. This uses an axial image at the level of the 3rd lumbar vertebra (L3) to assess the total or cross-sectional volume of the psoas muscle, giving rise to indices measuring muscle mass, visceral adipose tissue and subcutaneous adipose tissue.
Major abdominal emergency surgery is a high-risk procedure with ongoing audit and outcome monitoring. Currently data collection for UK National Emergency Laparotomy Audit (NELA) is in its fourth year with annual reports into the management and outcomes of emergency laparotomies. Observation and audit of these outcomes remain central to improving service and healthcare both regionally and nationally. Furthermore, this group of patients is not well represented in research and is one of the most understudied surgical cohorts that exist. This is especially the case for patients presenting with an acute surgical diagnosis and are deemed unable to withstand the stress of surgery, and hence pursue a conservative or radiological treatment option. With our ageing, co-morbid population this is becoming increasing common. The diagnosis of frailty and sarcopenia are a significant measurable and modifiable risk factor that impacts on perioperative surgical care, healthcare provider and patient decision-making and most importantly long and short term outcomes. This urgently requires further audit and study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
30-day mortality
时间窗: 30 days post surgery
Deaths (all cause) within 30 days of surgical procedure
次要结局
- 1 year mortality(1 year post surgery)
- Post-operative morbidity(30 days post surgery)
- Hospital readmission(30 days after discharge)
- Length of stay(Reported at 30 days after surgical procedure)
- Destination of discharge from hospital(End of initial hospital inpatient care episode. Closes at time of discharge within 30 days of surgical procedure))
- Participant care needs at time of hospital discharge(End of initial hospital inpatient care episode. Closes at time of discharge within 30 days of surgical procedure))
研究者
Nathan Curtis
Clinical Research Fellow
Yeovil District Hospital NHS Foundation Trust