Laparoscopic Cholecystectomy for Acute Cholecystitis After 72 Hours of Symptoms

• Sponsor: University of Lausanne Hospitals (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01548339
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Duration (Months): 79.9
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Cholecystitis; Cholecystectomy	Procedure: Laparoscopic cholecystectomy	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Laparoscopic Cholecystectomy for Acute Cholecystitis: is the Rule of 72 Hours Still Actual?
• Study Start Date: Feb 1, 2009
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Oct 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Delayed Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment	Procedure: Laparoscopic cholecystectomy; 3 trocars laparoscopic cholecystectomy
Experimental: Early Laparoscopic cholecystectomy performed directly after the initial diagnosis	Procedure: Laparoscopic cholecystectomy; 3 trocars laparoscopic cholecystectomy

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Postoperative Complications [30 postoperative days]

   postoperative complications graded according to Clavien classification

2. Length of Stay [30 postoperative days]

   total in hospital stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• proven echographic cholecystitis

Exclusion Criteria:

• pregnancy

• immunosuppression

• severe sepsis

• perforated cholecystitis

• peritonitis

• cholangitis

• acute pancreatitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Lausanne Hospitals	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• University of Lausanne Hospitals

Investigators

• Study Chair: Nicolas Demartines, MD, University of Lausanne Hospitals
• Study Director: Nermin Halkic, MD, University of Lausanne Hospitals
• Principal Investigator: Luca Di Mare, MD, University of Lausanne Hospitals

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nicolas DEMARTINES, Chairman of the Department of Surgery, Professor of Surgery, University of Lausanne Hospitals
• ClinicalTrials.gov Identifier: NCT01548339
• Other Study ID Numbers: 252/08 CHV
• First Posted: Mar 8, 2012
• Last Update Posted: Aug 6, 2020
• Last Verified: Jul 1, 2020

• Additional relevant MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Delayed	Early	Total
Arm/Group Description	Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Total of all reporting groups
Overall Participants	44	42	86
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57.9 (16.6)	55.8 (16.8)	56.9 (16.7)
Sex: Female, Male (Count of Participants)
Female	19 43.2%	18 42.9%	37 43%
Male	25 56.8%	24 57.1%	49 57%
Region of Enrollment (participants) [Number]
Switzerland	44 100%	42 100%	86 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Event ("Global Morbidity").
Description	any adverse event occurring from time of diagnosis until the 30th postoperative day
Time Frame	30 postoperative days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delayed	Early
Arm/Group Description	Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Measure Participants	44	42
Count of Participants [Participants]	17 38.6%	6 14.3%

2. Secondary Outcome

Title	Postoperative Complications
Description	postoperative complications graded according to Clavien classification
Time Frame	30 postoperative days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delayed	Early
Arm/Group Description	Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Measure Participants	44	42
Count of Participants [Participants]	7 15.9%	6 14.3%

3. Secondary Outcome

Title	Length of Stay
Description	total in hospital stay
Time Frame	30 postoperative days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Delayed	Early
Arm/Group Description	Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy	Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
Measure Participants	44	42
Median (Inter-Quartile Range) [days]	7	4

Adverse Events

Arm/Group Title	Delayed		Early
Arm/Group Description	Laparoscopic cholecystectomy performed secondarily after an initial conservative treatment Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy		Laparoscopic cholecystectomy performed directly after the initial diagnosis Laparoscopic cholecystectomy: 3 trocars laparoscopic cholecystectomy
All Cause Mortality
	Delayed		Early
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/42 (0%)
Serious Adverse Events
	Delayed		Early
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/44 (6.8%)		2/42 (4.8%)
Hepatobiliary disorders
postoperative choledocolithiasis	1/44 (2.3%)	1	1/42 (2.4%)	1
biliary leak	1/44 (2.3%)	1	0/42 (0%)	0
Immune system disorders
anaphylactic shock	1/44 (2.3%)	1	0/42 (0%)	0
Respiratory, thoracic and mediastinal disorders
pulmonary acute oedema	0/44 (0%)	0	1/42 (2.4%)	1
Other (Not Including Serious) Adverse Events
	Delayed		Early
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/44 (9.1%)		4/42 (9.5%)
Renal and urinary disorders
urinary retention	1/44 (2.3%)	1	1/42 (2.4%)	1
Surgical and medical procedures
surgical site infection	3/44 (6.8%)	3	3/42 (7.1%)	3

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.