Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06559449
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-14
Brief Title:
Cholecystectomy During Weekends
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Cholecystectomy for Acute Cholecystitis During Weekend Compared to Delayed Weekday Surgery- a Nationwide Population Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Acute cholecystitis is the most common acute complication of gallstone disease Although there are diverging opinions about optimal timing for surgery the general recommendation is that surgery is performed as soon as possible after admission when the diagnosis is established The study will compare acute cholecystectomies for acute cholecystitis performed during weekends with procedures where patient have been waiting during weekend and surgery performed during a subsequent weekday
Hypothesis Performing acute cholecystectomies for acute cholecystitis during weekends are associated with higher risk for complications
Hypothesis Performing acute cholecystectomies for acute cholecystitis during weekends are associated with higher risk for complications
Detailed Description:
Acute cholecystitis is the most common acute complication of gallstone disease About 15-20 of all cholecystectomies is performed because of acute cholecystitis Laparoscopic cholecystectomy is one of the most common acute surgical procedure and several studies have tried to identify the optimal time between debut of symptoms and surgery
Although there are diverging opinions about optimal timing for surgery the general recommendation is that surgery is performed as soon as possible after admission when the diagnosis is established According to the latest Tokyo Guidelines early laparoscopic cholecystectomy is the recommended treatment for all severity grades of acute cholecystitis and delayed surgery is only recommended for selected high-risk patients An English study based on data from a national register have shown that surgery within three days after admission is recommended for patients with acute cholecystitis A randomised controlled trail RCT with the same formulation of question would need a large number of patients to reach sufficient power which makes it impossible to perform a study of that kind during a reasonable time An alternative to RCT studies is studies based on national register data which provides a large number of patients to achieve sufficient statistical power
In daily clinical practice there are often other acute surgical procedures with higher priority leading to down prioritizing of acute cholecystectomies causing the surgery to be delayed This is common despite that early cholecystectomy generally is accepted as golden standard for acute cholecystitis Although there are sufficient evidence that risk for complication days admitted at hospital and risk for conversion to open surgery are increased for every day that surgery is postponed the phenomenon of delay is usual To avoid delay of surgery many clinics perform cholecystectomies during weekends and out-of-hours Results from studies that compare complication rate between cholecystectomies performed during out-of-hours and office-hours are contradictive This difference seems to be even larger for cholecystectomies that are performed during weekends when there are often surgeons during internship and surgeons not specialized in upper GI-surgery on call To this day there are no published studies that investigates acute cholecystectomies following acute cholecystitis performed during weekend compared to operations that are delayed until the next following weekday
The study will be a population-based cohort studie Data will be extracted from the Swedish gallstone surgery and Retrograde Cholangiopancreatography register GallRiks The register is established and have collected data about patients undergoing cholecystectomies and ERCPs since 2005 More than 90 of all cholecystectomies and endoscopic retrograde cholangiopancreaticographies ERCPs performed in Sweden are registered About 20 000 procedures 12 000 cholecystectomies and 8000 ERCPs are annually registered and data about indication for surgery surgical technique duration of surgery and complications
Although there are diverging opinions about optimal timing for surgery the general recommendation is that surgery is performed as soon as possible after admission when the diagnosis is established According to the latest Tokyo Guidelines early laparoscopic cholecystectomy is the recommended treatment for all severity grades of acute cholecystitis and delayed surgery is only recommended for selected high-risk patients An English study based on data from a national register have shown that surgery within three days after admission is recommended for patients with acute cholecystitis A randomised controlled trail RCT with the same formulation of question would need a large number of patients to reach sufficient power which makes it impossible to perform a study of that kind during a reasonable time An alternative to RCT studies is studies based on national register data which provides a large number of patients to achieve sufficient statistical power
In daily clinical practice there are often other acute surgical procedures with higher priority leading to down prioritizing of acute cholecystectomies causing the surgery to be delayed This is common despite that early cholecystectomy generally is accepted as golden standard for acute cholecystitis Although there are sufficient evidence that risk for complication days admitted at hospital and risk for conversion to open surgery are increased for every day that surgery is postponed the phenomenon of delay is usual To avoid delay of surgery many clinics perform cholecystectomies during weekends and out-of-hours Results from studies that compare complication rate between cholecystectomies performed during out-of-hours and office-hours are contradictive This difference seems to be even larger for cholecystectomies that are performed during weekends when there are often surgeons during internship and surgeons not specialized in upper GI-surgery on call To this day there are no published studies that investigates acute cholecystectomies following acute cholecystitis performed during weekend compared to operations that are delayed until the next following weekday
The study will be a population-based cohort studie Data will be extracted from the Swedish gallstone surgery and Retrograde Cholangiopancreatography register GallRiks The register is established and have collected data about patients undergoing cholecystectomies and ERCPs since 2005 More than 90 of all cholecystectomies and endoscopic retrograde cholangiopancreaticographies ERCPs performed in Sweden are registered About 20 000 procedures 12 000 cholecystectomies and 8000 ERCPs are annually registered and data about indication for surgery surgical technique duration of surgery and complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None