Ignite Creation Date:
2024-05-06 @ 1:29 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04033822
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2019-02-04
Brief Title:
Fast Track Pathway to Accelerated Cholecystectomy
Sponsor:
PJ Devereaux
Organization:
Population Health Research Institute
Study Overview
Official Title:
Fast Track Pathway to Accelerated Cholecystectomy Versus Standard of Care for Acute Cholecystitis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST
Brief Summary:
More than 10 of Canadians have gallstones and approximately 10 of these individuals will develop gallbladder inflammation related to gallstones which is referred to as acute cholecystitis AC Patients with AC who do not have their gallbladder surgically removed have a 30 risk of serious complications that can lead to death Surgery is the only definitive treatment for AC however there is controversy regarding the ideal timing of surgery The two main approaches are early surgery typically within 7 days of diagnosis or delayed surgery 7 days to 6 weeks after diagnosis Although preliminary evidence suggests that early surgery is associated with shorter hospital length of stay lower risk for complications and lower costs practice varies widely regarding the timing of surgery The limitations of the existing studies include small sample sizes varied definitions of early versus delayed surgery and an imbalance of risk between study groups The proposed pilot study aims to inform the design of a large clinical trial that will compare the outcomes of patients with AC who receive accelerated surgery ie as soon as possible with a goal of surgery within 6 hours of diagnosis with those who receive standard care
Detailed Description:
The prevalence of gallstones is 10 and approximately 10 of patients develop acute cholecystitis AC AC prevalence increases with age and complications are as high as 30 in patients who do not undergo surgery the only definitive treatment There is controversy regarding ideal surgical timing Previously delayed surgery was thought to decrease bile duct injuries resulting from active inflammation However the state of persistent inflammation hypercoagulability and stress can cause medical complications such as myocardial injury Chronic inflammation can lead to fibrosis adhesions and higher chance of bile duct injuries during delayed surgery There is also concern for recurrent AC episodes recurrent pain biliary pancreatitis cholangitis or sepsis
Recent studies suggest that early surgery may be associated with better outcomes but practice remains variable ranging anywhere from early surgery 7 days to delayed surgery 7 days Among 24000 Ontarians with AC admitted to 106 hospitals timing of cholecystectomy varied widely across sites Only 58 of patients underwent surgery within 7 days High volume hospitals were more likely to perform early surgery17
Among 14200 Ontarians with AC a propensity score analysis demonstrated that early surgery was associated with less bile duct injury relative risk RR053 95 confidence interval CI 031-090 and shorter length of hospital stay LOS mean 19 days 95 CI 17-21 Early surgery was less costly and more effective than delayed cholecystectomy
Trials of surgical timing in patients with AC are limited The largest randomized controlled trial RCT compared early and delayed surgery for AC only included 618 patients9 Cholecystectomy was performed a median of 1 day after randomization in the early group compared to a median of 25 days in the delayed group Duration of surgery and conversion rate to open surgery were similar in both groups Early surgery was associated with less morbidity 118 vs 344 p0001 shorter LOS 54 vs 100 days p0001 and lower cost 2919 vs 4262 p0001
Multiple meta-analyses have suggested that early surgery for AC is associated with fewer wound infections RR 057 95 CI 035-093 and have suggested a trend to fewer complications RR 066 95 CI 042-103 Limitations of these meta-analyses include studies with small sample sizes few events wide confidence intervals and variation in the definition of early surgery Finally there is a lack of strong evidence to make definitive conclusions regarding impact of early surgery in AC which has led to substantial variation in clinical practice
AC initiates inflammatory hypercoagulable and stress states that can cause medical complications Early surgical treatment will reduce the time patients are exposed to these harmful states and therefore may reduce the risk of complications Furthermore rapid surgery results in a shorter period of AC which may impact hospital costs The goal is to undertake a large multicentre RCT of the impact of accelerated surgery goal within 6 hours of diagnosis vs usual timing of surgery in patients with AC on a composite outcome of major clinical and surgical complications at 90 days Standard of care as described is highly variable and depends on the surgeon and hospital practice patterns
The main objective of this pilot study is to assess the feasibility of a large trial The team hypothesizes that accelerated surgery for AC will improve clinical and surgical outcomes A large RCT on this topic is needed for the following reasons 1 time to surgery is a modifiable factor 2 available data are encouraging but not definitive 3 there is variation in clinical practice across Ontario and internationally 4 the definition of early surgery has varied substantially across studies 5 available data may be substantially underestimating the effect of timing of surgery because no trial has evaluated surgery within 6 hours of diagnosis 6 high-quality evidence will modify clinical practice and 7 implementation of accelerated surgery could save millions of healthcare dollars annually
Recent studies suggest that early surgery may be associated with better outcomes but practice remains variable ranging anywhere from early surgery 7 days to delayed surgery 7 days Among 24000 Ontarians with AC admitted to 106 hospitals timing of cholecystectomy varied widely across sites Only 58 of patients underwent surgery within 7 days High volume hospitals were more likely to perform early surgery17
Among 14200 Ontarians with AC a propensity score analysis demonstrated that early surgery was associated with less bile duct injury relative risk RR053 95 confidence interval CI 031-090 and shorter length of hospital stay LOS mean 19 days 95 CI 17-21 Early surgery was less costly and more effective than delayed cholecystectomy
Trials of surgical timing in patients with AC are limited The largest randomized controlled trial RCT compared early and delayed surgery for AC only included 618 patients9 Cholecystectomy was performed a median of 1 day after randomization in the early group compared to a median of 25 days in the delayed group Duration of surgery and conversion rate to open surgery were similar in both groups Early surgery was associated with less morbidity 118 vs 344 p0001 shorter LOS 54 vs 100 days p0001 and lower cost 2919 vs 4262 p0001
Multiple meta-analyses have suggested that early surgery for AC is associated with fewer wound infections RR 057 95 CI 035-093 and have suggested a trend to fewer complications RR 066 95 CI 042-103 Limitations of these meta-analyses include studies with small sample sizes few events wide confidence intervals and variation in the definition of early surgery Finally there is a lack of strong evidence to make definitive conclusions regarding impact of early surgery in AC which has led to substantial variation in clinical practice
AC initiates inflammatory hypercoagulable and stress states that can cause medical complications Early surgical treatment will reduce the time patients are exposed to these harmful states and therefore may reduce the risk of complications Furthermore rapid surgery results in a shorter period of AC which may impact hospital costs The goal is to undertake a large multicentre RCT of the impact of accelerated surgery goal within 6 hours of diagnosis vs usual timing of surgery in patients with AC on a composite outcome of major clinical and surgical complications at 90 days Standard of care as described is highly variable and depends on the surgeon and hospital practice patterns
The main objective of this pilot study is to assess the feasibility of a large trial The team hypothesizes that accelerated surgery for AC will improve clinical and surgical outcomes A large RCT on this topic is needed for the following reasons 1 time to surgery is a modifiable factor 2 available data are encouraging but not definitive 3 there is variation in clinical practice across Ontario and internationally 4 the definition of early surgery has varied substantially across studies 5 available data may be substantially underestimating the effect of timing of surgery because no trial has evaluated surgery within 6 hours of diagnosis 6 high-quality evidence will modify clinical practice and 7 implementation of accelerated surgery could save millions of healthcare dollars annually
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None