Trial Outcomes & Findings for Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms (NCT NCT01548339)

NCT ID: NCT01548339

Last Updated: 2020-08-06

Results Overview

any adverse event occurring from time of diagnosis until the 30th postoperative day

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 86 participants
• Primary outcome timeframe: 30 postoperative days
• Results posted on: 2020-08-06

Participant Flow

Participant milestones

Measure	Delayed Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Early Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Overall Study STARTED	44	42
Overall Study COMPLETED	38	41
Overall Study NOT COMPLETED	6	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

Baseline characteristics by cohort

Measure	Delayed n=44 Participants Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Early n=42 Participants Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Total n=86 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 16.6 • n=93 Participants	55.8 years STANDARD_DEVIATION 16.8 • n=4 Participants	56.9 years STANDARD_DEVIATION 16.7 • n=27 Participants
Sex: Female, Male Female	19 Participants n=93 Participants	18 Participants n=4 Participants	37 Participants n=27 Participants
Sex: Female, Male Male	25 Participants n=93 Participants	24 Participants n=4 Participants	49 Participants n=27 Participants
Region of Enrollment Switzerland	44 participants n=93 Participants	42 participants n=4 Participants	86 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 postoperative days

any adverse event occurring from time of diagnosis until the 30th postoperative day

Outcome measures

Measure	Delayed n=44 Participants Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Early n=42 Participants Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Number of Participants With Adverse Event ("Global Morbidity").	17 Participants	6 Participants

SECONDARY outcome

Timeframe: 30 postoperative days

postoperative complications graded according to Clavien classification

Outcome measures

Measure	Delayed n=44 Participants Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Early n=42 Participants Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Postoperative Complications	7 Participants	6 Participants

SECONDARY outcome

Timeframe: 30 postoperative days

total in hospital stay

Outcome measures

Measure	Delayed n=44 Participants Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Early n=42 Participants Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Length of Stay	7 days Interval 5.0 to 11.0	4 days Interval 3.0 to 4.0

Adverse Events

Delayed

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Early

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Delayed n=44 participants at risk Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Early n=42 participants at risk Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Hepatobiliary disorders postoperative choledocolithiasis	2.3% 1/44 • Number of events 1	2.4% 1/42 • Number of events 1
Respiratory, thoracic and mediastinal disorders pulmonary acute oedema	0.00% 0/44	2.4% 1/42 • Number of events 1
Hepatobiliary disorders biliary leak	2.3% 1/44 • Number of events 1	0.00% 0/42
Immune system disorders anaphylactic shock	2.3% 1/44 • Number of events 1	0.00% 0/42

Other adverse events

Measure	Delayed n=44 participants at risk Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Early n=42 participants at risk Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Surgical and medical procedures surgical site infection	6.8% 3/44 • Number of events 3	7.1% 3/42 • Number of events 3
Renal and urinary disorders urinary retention	2.3% 1/44 • Number of events 1	2.4% 1/42 • Number of events 1

Additional Information

Prof. N. Demartines

University Hospital Lausanne

Email: demartines@chuv.ch

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place