Acute Cholecystitis, Cholecystectomy
Conditions
Brief summary
The purpose of this study is to compare the clinical outcomes of early versus delayed laparoscopic cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
Detailed description
In acute biliary cholecystitis, there was a dogma that patients should be operated within 72 hours of evolution. However, retrospective studies suggested that laparoscopic cholecystectomy even after 72 hours was safe. Moreover, some randomized controlled-trials did not found any differences in term of complications between early and delayed cholecystectomy, however none of these studies did separate patients according to the onset of symptoms. The aim of our present study was to compare the clinical outcomes of immediate versus delayed cholecystectomies for acute cholecystitis with more than 72 hours of symptoms.
Interventions
PROCEDURELaparoscopic cholecystectomy
3 trocars laparoscopic cholecystectomy
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* proven echographic cholecystitis
Exclusion criteria
* pregnancy * immunosuppression * severe sepsis * perforated cholecystitis * peritonitis * cholangitis * acute pancreatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Event (Global Morbidity). | 30 postoperative days | any adverse event occurring from time of diagnosis until the 30th postoperative day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | 30 postoperative days | postoperative complications graded according to Clavien classification |
| Length of Stay | 30 postoperative days | total in hospital stay |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Delayed Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment
Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy | 44 |
| Early Laparoscopic cholecystectomy performed directly after the initial diagnosis
Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy | 42 |
| Total | 86 |
Baseline characteristics
| Characteristic | Delayed | Early | Total |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 16.6 | 55.8 years STANDARD_DEVIATION 16.8 | 56.9 years STANDARD_DEVIATION 16.7 |
| Region of Enrollment Switzerland | 44 participants | 42 participants | 86 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 25 Participants | 24 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 42 |
| other Total, other adverse events | 4 / 44 | 4 / 42 |
| serious Total, serious adverse events | 3 / 44 | 2 / 42 |
Outcome results
Primary
Number of Participants With Adverse Event (Global Morbidity).
any adverse event occurring from time of diagnosis until the 30th postoperative day
Time frame: 30 postoperative days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delayed | Number of Participants With Adverse Event (Global Morbidity). | 17 Participants |
| Early | Number of Participants With Adverse Event (Global Morbidity). | 6 Participants |
Secondary
Length of Stay
total in hospital stay
Time frame: 30 postoperative days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Delayed | Length of Stay | 7 days |
| Early | Length of Stay | 4 days |
Secondary
Postoperative Complications
postoperative complications graded according to Clavien classification
Time frame: 30 postoperative days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delayed | Postoperative Complications | 7 Participants |
| Early | Postoperative Complications | 6 Participants |