Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized Controlled Trial. (DOLCE)
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ClinicalTrials.gov Identifier: NCT01052727 |
Recruitment Status : Unknown
Verified December 2009 by St. Orsola Hospital.
Recruitment status was: Not yet recruiting
First Posted : January 20, 2010
Last Update Posted : January 20, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cholelithiasis | Procedure: Laparoscopic Cholecystectomy | Phase 4 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | DOLCE Study: Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized, Controlled Trial |
Arm | Intervention/treatment |
---|---|
overnight stay group
Group of patients who rests at least one night in Hospital
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Procedure: Laparoscopic Cholecystectomy |
day-care Group
Group of patients who is discharged tha same day of operation
|
Procedure: Laparoscopic Cholecystectomy |
- Evidence of better quality of life revealed by SF-36 test [ Time Frame: before surgery, 7 days after surgery, 30 days after surgery ]
- 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. [ Time Frame: prior to surgery, 7 days after surgery and 30 days after surgery ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT01052727
Contact: Luca Ansaloni, MD | 0039 0516363235 | luca.ansaloni@aosp.bo.it | |
Contact: Alessandro Dazzi, MD | 0039 0516363721 | alled78@yahoo.it |
Italy | |
St Orsola-Malpighi Hospital - University of Bologna | Not yet recruiting |
Bologna, Italy, 40100 | |
Contact: Luca Ansaloni, MD 0039 0516363235 luca.ansaloni@aosp.bo.it | |
Principal Investigator: Luca Ansaloni, MD |
Publications:
Responsible Party: | Principal investigator: Dott. Luca Ansaloni, St. Orsola Hospital |
ClinicalTrials.gov Identifier: | NCT01052727 History of Changes |
Other Study ID Numbers: |
CHU-DOLCE-01-2010-BO |
First Posted: | January 20, 2010 Key Record Dates |
Last Update Posted: | January 20, 2010 |
Last Verified: | December 2009 |
Keywords provided by St. Orsola Hospital:
Laparoscopic Cholecystectomy quality of life |
Additional relevant MeSH terms:
Cholelithiasis Cholecystolithiasis Gallstones Biliary Tract Diseases |
Digestive System Diseases Gallbladder Diseases Calculi Pathological Conditions, Anatomical |