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

Study Description

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Brief Summary:

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

Detailed 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.

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
overnight stay group; Group of patients who rests at least one night in Hospital	Procedure: Laparoscopic Cholecystectomy
day-care Group; Group of patients who is discharged tha same day of operation	Procedure: Laparoscopic Cholecystectomy

Outcome Measures

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Primary Outcome Measures :

1. Evidence of better quality of life revealed by SF-36 test [ Time Frame: before surgery, 7 days after surgery, 30 days after surgery ]

Secondary Outcome Measures :

1. 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 ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Luca Ansaloni, MD	0039 0516363235	luca.ansaloni@aosp.bo.it
Contact: Alessandro Dazzi, MD	0039 0516363721	alled78@yahoo.it

Locations

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

Sponsors and Collaborators

St. Orsola Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Ahmad NZ, Byrnes G, Naqvi SA. A meta-analysis of ambulatory versus inpatient laparoscopic cholecystectomy. Surg Endosc. 2008 Sep;22(9):1928-34. doi: 10.1007/s00464-008-9867-2. Epub 2008 Apr 9. Review.

Gurusamy K, Junnarkar S, Farouk M, Davidson BR. Meta-analysis of randomized controlled trials on the safety and effectiveness of day-case laparoscopic cholecystectomy. Br J Surg. 2008 Feb;95(2):161-8. doi: 10.1002/bjs.6105. Review.

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
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