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

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status and phase: Not yet enrolling; Phase 4

Conditions: Cholelithiasis

Treatments: Procedure: Laparoscopic Cholecystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01052727

CHU-DOLCE-01-2010-BO

Details and patient eligibility

About

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.

Full description

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:

1. quality of life and health status
2. admissions and readmissions;
3. postoperative pain (SVS, number of analgesic doses);
4. wound infections (rate);
5. intraoperative and postoperative complications
6. duration of operation (minutes), defined as operating time, anesthesia time, or operating room time;
7. 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

overnight stay group

Other group

Description:

Group of patients who rests at least one night in Hospital

Treatment:

Procedure: Laparoscopic Cholecystectomy

day-care Group

Other group

Description:

Group of patients who is discharged tha same day of operation

Treatment:

Procedure: Laparoscopic Cholecystectomy