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

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Cholecystitis
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Brief Title

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

Official Title

Acute Cholecystitis in the Elderly: Comparative Randomized and Cohort Study of Laparoscopic Cholecystectomy vs. Conservative Treatment With Antibiotics Alone

Brief Summary

      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 with additional cohort of all elderly patients with acute cholecystitis in the
      study hospitals during study period.

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. 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) and additional cohort of all
      elderly patients (>75 years old) with acute cholecystitis.

      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 control group will be managed conservatively with
      intravenous antibiotics and elective cholecystectomy will not be scheduled later.

      Primary outcome: Assessment of morbidities related to acute cholecystitis 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.

      In addition of RCT, we decided to record and analyze all acute cholecystitis of elderly
      patients in study hospitals during the study period. We will present these results in the
      connection of RCT analysis.

Study Type

Interventional

Primary Outcome

Specific Morbidity Index Scores

Secondary Outcome

 Quality of life RAND-36 scores

Condition

Cholecystitis, Acute

Intervention

Laparoscopic cholecystectomy

Study Arms / Comparison Groups

 Cholecystectomy group
Description:  Cholecystectomy group will undergo laparoscopic cholecystectomy within 48 hrs after randomization.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

200

Start Date

October 2016

Completion Date

December 2021

Primary Completion Date

December 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Radiologically confirmed acute cholecystitis

          -  Age over 75 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 75 yrs

          -  Peritonitis

          -  Sepsis or septic shock

          -  Duration of symptoms over 6 days

          -  Cholestasis or diagnosed stone at common biliary duct.

          -  Acute Pancreatitis

Gender

All

Ages

75 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, 17 173 311, [email protected]

Location Countries

Finland

Location Countries

Finland

Administrative Informations

NCT ID

NCT02972944

Organization ID

326/2016

Responsible Party

Principal Investigator

Study Sponsor

Kuopio University Hospital

Collaborators

 Turku University Hospital

Study Sponsor

, ,

Verification Date

February 2021