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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by St. Orsola Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
St. Orsola Hospital
ClinicalTrials.gov Identifier:
NCT01052727
First received: January 19, 2010
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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 Intervention Phase
Cholelithiasis
Procedure: Laparoscopic Cholecystectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DOLCE Study: Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by St. Orsola Hospital:

Primary Outcome Measures:
  • Evidence of better quality of life revealed by SF-36 test [ Time Frame: before surgery, 7 days after surgery, 30 days after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01052727

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

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
Study First Received: January 19, 2010
Last Updated: January 19, 2010
Health Authority: Italy: Ethics Committee

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

ClinicalTrials.gov processed this record on September 29, 2014