Not provided
Not provided
Not provided
Not provided
Not provided
Intermediary analysis showing increased morbidity in the delayed group
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Delayed | Active Comparator | Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment |
|
| Early | Experimental | Laparoscopic cholecystectomy performed directly after the initial diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy | Procedure | 3 trocars laparoscopic cholecystectomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Event ("Global Morbidity"). | any adverse event occurring from time of diagnosis until the 30th postoperative day | 30 postoperative days |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Complications | postoperative complications graded according to Clavien classification | 30 postoperative days |
| Length of Stay | total in hospital stay |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicolas Demartines, MD | University of Lausanne Hospitals | Study Chair |
| Nermin Halkic, MD | University of Lausanne Hospitals | Study Director |
| Luca Di Mare, MD | University of Lausanne Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lausanne Hospitals | Lausanne | Canton of Vaud | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27741006 | Derived | Roulin D, Saadi A, Di Mare L, Demartines N, Halkic N. Early Versus Delayed Cholecystectomy for Acute Cholecystitis, Are the 72 hours Still the Rule?: A Randomized Trial. Ann Surg. 2016 Nov;264(5):717-722. doi: 10.1097/SLA.0000000000001886. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Delayed | Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy |
| FG001 | Early | Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Delayed | Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy |
| BG001 | Early |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Event ("Global Morbidity"). | any adverse event occurring from time of diagnosis until the 30th postoperative day | Posted | Count of Participants | Participants | 30 postoperative days |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Delayed | Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| postoperative choledocolithiasis | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| surgical site infection | Surgical and medical procedures | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. N. Demartines | University Hospital Lausanne | demartines@chuv.ch |
Not provided
| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| ID | Term |
|---|---|
| D002764 | Cholecystitis |
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 postoperative days |
Laparoscopic cholecystectomy performed directly after the initial diagnosis
Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Postoperative Complications | postoperative complications graded according to Clavien classification | Posted | Count of Participants | Participants | 30 postoperative days |
|
|
|
| Secondary | Length of Stay | total in hospital stay | Posted | Median | Inter-Quartile Range | days | 30 postoperative days |
|
|
|
| 0 |
| 44 |
| 3 |
| 44 |
| 4 |
| 44 |
| EG001 | Early | Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy | 0 | 42 | 2 | 42 | 4 | 42 |
| pulmonary acute oedema | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| biliary leak | Hepatobiliary disorders | Systematic Assessment |
|
| anaphylactic shock | Immune system disorders | Systematic Assessment |
|
| urinary retention | Renal and urinary disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |