Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized Controlled Trial.

Study Overview
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Brief Summary
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DOLCE Study: Day-care versus Overnight-stay Laparoscopic Cholecystectomy randomized, controlled trial. The aim of this study was to evaluate the feasibility, safety and patient acceptance of outpatient LC in Italy. In particular this randomized clinical trial will use the SF-36 as powerful instrument to compare quality of life and global health status after LC performed as a day-care procedure or with an overnight stay. Particular attention is taken to answer to the following methodological issues: concealed randomization, ITT analysis, number of eligible, excluded and refusing patients clearly stated.

Detailed Description
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The DOLCE study project is a prospective, randomised, open label, comparison of LC performed either as a day-care procedure or with overnight stay with symptomatic gallstones. The aim of this study was to evaluate the feasibility, safety and patient acceptance of outpatient LC in Italy. In particular this randomized clinical trial will use the SF-36 as powerful instrument to compare quality of life and global health status after LC performed as a day-care procedure or with an overnight stay. The outcome measured are the following: quality of life and health status admissions and readmissions; postoperative pain (SVS, number of analgesic doses); wound infections (rate); intraoperative and postoperative complications duration of operation (minutes), defined as operating time, anesthesia time, or operating room time; return to normal activity (days), subdivided in: time until return to full activity, work, or sport; The instrument used to assess quality of life and heath status will be SF-36. The study will be performed in a Day-Surgery Unit where an over-night stay is possible in case of complications. INCLUSION AND EXCLUSION CRITERIA Inclusion criteria are: • Adult (from 18 to 70 years old) patients presenting for gallstone disease surgery (symptomatic cholelithiasis, according to the Rome criteria ) confirmed by ultrasound living less than 50 km from the hospital (the day-care protocol specifies that an adult must be available to accompany the patient home and stay there overnight) were considered for entry into the trial. Exclusion criteria Refusing of informed consent Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient) Patients with contraindication to be operated with LC Patients with an American Society of Anesthesiologists (ASA) score of III or more. BMI >35 kg/m2 Asthma extensive previous abdominal surgery patients with a clinical suspicion of common bile duct stones or a history of acute cholecystitis or pancreatitis, calcified gallbladder.

Official Title
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DOLCE Study: Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized, Controlled Trial

Conditions
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Cholelithiasis

Intervention / Treatment
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* Procedure: Laparoscopic Cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (from 18 to 70 years old) patients presenting for gallstone disease surgery (symptomatic cholelithiasis, according to the Rome criteria ) confirmed by ultrasound living less than 50 km from the hospital (the day-care protocol specifies that an adult must be available to accompany the patient home and stay there overnight) were considered for entry into the trial. Exclusion Criteria: Refusing of informed consent Any condition preventing a correct evaluation of pain (non-cooperative patient, blind patient) Patients with contraindication to be operated with LC Patients with an American Society of Anesthesiologists (ASA) score of III or more. BMI >35 kg/m2 Asthma extensive previous abdominal surgery patients with a clinical suspicion of common bile duct stones or a history of acute cholecystitis or pancreatitis, calcified gallbladder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: overnight stay group<br>Group of patients who rests at least one night in Hospital | Procedure: Laparoscopic Cholecystectomy<br> <br> |
| Other: day-care Group<br>Group of patients who is discharged tha same day of operation | Procedure: Laparoscopic Cholecystectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of better quality of life revealed by SF-36 test |  | before surgery, 7 days after surgery, 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmissions, Postoperative pain, Wound infections, Intraoperative and postoperative complications, Duration of operation(minutes), Return to normal activity (days) defined as time until return to full activity, work, school or sport. |  | prior to surgery, 7 days after surgery and 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Cholecystectomy, quality of life