Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Laparoscopic Cholecystectomy or Conservative Treatment in the Acute Cholecystitis of Elderly Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02972944
Recruitment Status : Recruiting
First Posted : November 25, 2016
Last Update Posted : August 14, 2018
Sponsor:
Collaborators:
Turku University Hospital
Tampere University Hospital
Oulu University Hospital
Mikkeli Central Hospital
North Karelia Central Hospital
Jyväskylä Central Hospital
Päijänne Tavastia Central Hospital
Central Hospital of Hämeenlinna
Central Hospital of Jorvi
Information provided by (Responsible Party):
Hannu Paajanen, Kuopio University Hospital

Brief Summary:
Laparoscopic cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.The purpose of this study is to find the most effective treatment (laparoscopic cholecystectomy vs. conservative) for elderly patients with acute cholecystitis. Therefore a randomized multi-centre study of 200 elderly patients suffering from acute cholecystitis is performed.

Condition or disease Intervention/treatment Phase
Cholecystitis, Acute Procedure: Laparoscopic cholecystectomy Procedure: Non-operative treatment Not Applicable

Detailed Description:

The increasing age is one of the main risk factors for developing complicated gallstone disease. Currently, there is lack of good quality studies comparing risks and benefits of early laparoscopic cholecystectomy in the elderly patients. Laparoscopic cholecystectomy is the only curative treatment for gallstone disease of acute calculous cholecystitis.

Aim: The purpose is to find out the most effective treatment (laparoscopic cholecystectomy vs. conservative) with the least morbidity for elderly patients with acute cholecystitis.

Study design: multicenter randomized controlled trial (RCT).

Patient allocation: Elderly patients with diagnosis of acute cholecystitis will be randomly allocated to either early laparoscopic cholecystectomy or treatment with antibiotics. Reasonably healthy elderly patients (ASA 2-3) are included in this study, excluding the patients with ASA-class above 4.

Interventions: The study group of patients will undergo early laparoscopic cholecystectomy within 48 hours after hospitalization. The other group will be managed conservatively with intravenous antibiotics and elective cholecystectomy will not be scheduled later.

Primary outcome: Assessment of morbidities and individual quality of life. Secondary outcomes include number of hospital admissions, length of hospitalization, pain, complications, mortality and cost analysis.

Sample size and data-analysis: Based on data of previous studies the recruitment of 200 patients in total is expected. Follow-up will be for 12 months.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Multi-center Study of Acute Cholecystitis in the Elderly: Comparison of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics
Study Start Date : October 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cholecystectomy group
Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.
Procedure: Laparoscopic cholecystectomy
Active Comparator: Non-operative group
Patients of non-operative group will be treated conservatively with intravenous antibiotics (cefuroxime) at surgical ward. Elective cholecystectomy will not be arranged.
Procedure: Non-operative treatment



Primary Outcome Measures :
  1. Specific Morbidity Index Scores [ Time Frame: 1 year postoperatively ]
    The primary outcome is morbidity, all complications will be scored (according to "morbidity-index" -chart) (ref: Gutt et al: Ann Surg 2013;258:385-393)


Secondary Outcome Measures :
  1. Quality of life RAND-36 scores [ Time Frame: pre-operatively and 1 year postoperatively ]
    Quality of life according to RAND-36

  2. Pain scores (0-100) [ Time Frame: pre-operatively, 1 week, 1 month and 1 year postoperatively ]
    Pain (VAS, range 0-100)

  3. Number of patients with failure of antibiotic therapy [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    Recurrent cholecystitis after antibiotic therapy

  4. Time of hospitalization (days) [ Time Frame: 1 month ]
    Length of time at hospital

  5. Mortality (number of patients) [ Time Frame: 1 month ]
    Death within 30 d

  6. Number of patients with complications [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    Bile duct injury, re-operations, bile leakage, hemorragia, wound infections, pneumonia etc.

  7. Cost analysis in euros [ Time Frame: 1 week, 1 month and 1 year postoperatively ]
    cost analysis comparison between groups



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Radiologically confirmed acute cholecystitis
  • Age over 80 yrs
  • American Association of Anesthesiologists Classification class 2-3
  • Duration of symptoms < 5 days

Exclusion Criteria:

  • American Association of Anesthesiologists Classification class 4-5
  • Age under 80 yrs
  • Peritonitis
  • Sepsis or septic shock
  • Duration of symptoms over 6 days
  • Cholestasis or diagnosed stone at common biliary duct.
  • Acute Pancreatitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02972944


Contacts
Layout table for location contacts
Contact: Hannu Paajanen, Professor 17 173 311 ext +358 Hannu.Paajanen@kuh.fi
Contact: Antti Kivivuori, MD 443516698 ext +358 Antti.Kivivuori@esshp.fi

Locations
Layout table for location information
Finland
Kuopio University Hospital Recruiting
Kuopio, Pohjois-Savo, Finland, 70200
Contact: Tuomo Rantanen, Professor    17 173 311 ext +358    Tuomo.Rantanen@kuh.fi   
Sponsors and Collaborators
Kuopio University Hospital
Turku University Hospital
Tampere University Hospital
Oulu University Hospital
Mikkeli Central Hospital
North Karelia Central Hospital
Jyväskylä Central Hospital
Päijänne Tavastia Central Hospital
Central Hospital of Hämeenlinna
Central Hospital of Jorvi

Layout table for additonal information
Responsible Party: Hannu Paajanen, Professor, Kuopio University Hospital
ClinicalTrials.gov Identifier: NCT02972944     History of Changes
Other Study ID Numbers: 326/2016
First Posted: November 25, 2016    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases