To demonstrate that primary LC as compared to PC is preferable with respect to morbidity and mortality in high risk surgical patients (APACHE-II score 7-14) with acute calculous cholecystitis.
ID
Source
Brief title
Condition
- Gallbladder disorders
- Hepatobiliary therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Combined endpoint including all major complications, need for re-intervention
and mortality.
Secondary outcome
Individual components of composite endpoint, Minor complications, Difficulty of
cholecystectomy, total length of hospital stay, emergency room visits, cost
efficiency
Background summary
Acute calculous cholecystitis is a frequently encountered problem in the
surgical practice and laparoscopic cholecystectomy (LC) is still the standard
treatment for patients without significant comorbidity and therefore
low-moderate risks on intervention. Acute cholecystitis is not a disease
confined to this population, and in elderly patients or patients with
significant comorbidity, surgery in general is associated with higher
complication rates and even mortality, and there is no consensus in the general
surgical practice if LC actually is the treatment of choice in this patient
category. In addition, LC for acute cholecystitis can be a more difficult
procedure than elective LC for cholelithiasis and is associated with increased
operating time, higher conversion rate and more post-operative complications in
any patient category, especially in elderly patients or patients with
comorbidity. Percutaneous cholecystostomy (PC) may be a more preferable method,
and in the current surgical practice many surgeons prefer this method over LC
in acute calculous cholecystitis in patients with increased risks. Because the
gallbladder remains in situ, the infection can worsen mandating an emergency LC
which can be even more difficult, and there is always the risk of recurrence.
There is some evidence in the current literature regarding the safety, success
rate and procedure specific technique of this procedure, but the question
whether there is a place for PC in the treatment of acute calculous
cholecystitis, remains unanswered.
Study objective
To demonstrate that primary LC as compared to PC is preferable with respect to
morbidity and mortality in high risk surgical patients (APACHE-II score 7-14)
with acute calculous cholecystitis.
Study design
Multi center randomized controlled trial
Intervention
The study has two treatment arms; arm one will be treated with laparoscopic
cholecystectomy, arm two with percutaneous cholecystostomy.
Study burden and risks
Risks of participation are no greater or different from the general treatment
of acute calculous cholecystitis.
Burden of participation is a total of 12 follow up phone calls that would
normally not take place.
Benefit of participation is treatment within 24 hours, and, when assigned to
the LC-arm, surgery by a specialised GI-surgeon.
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Koekoekslaan 1
Nieuwegein 3435 CM
NL
Listed location countries
Age
Inclusion criteria
APACHE-II score >= 7 AND <= 14
Acute calculous cholecystitis
Written informed consent
Exclusion criteria
Onset of symptoms >=7 days before first presentation
Already admitted to ICU
Pregnancy
<18 Years of age
Acalculous cholecystitis
Decompensated liver cirrhosis
Mental illness prohibiting informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL33662.100.10 |