CholelithiasisPhase 4DOLCENCT01052727
Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized Controlled Trial.
A Phase 4 study testing Laparoscopic Cholecystectomy in people with Cholelithiasis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cholelithiasis
- What is being tested?
- Laparoscopic Cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
St Orsola-Malpighi Hospital - University of Bologna
Bologna, 40100
Luca Ansaloni, MD, 0039 0516363235, luca.ansaloni@aosp.bo.it
Luca Ansaloni, MD
About this study
Official title: DOLCE Study: Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized, Controlled Trial
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.
Read the 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:
- 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.
- Conditions
- Cholelithiasis
- Being tested
- Laparoscopic Cholecystectomy
- Keywords
- Laparoscopic Cholecystectomy, quality of life
- Medical subject headings
- Cholelithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic CholecystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| overnight stay group | Other | Group of patients who rests at least one night in Hospital Receives: Procedure: Laparoscopic Cholecystectomy |
| day-care Group | Other | Group of patients who is discharged tha same day of operation Receives: Procedure: Laparoscopic Cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of better quality of life revealed by SF-36 test
Measured: before surgery, 7 days after surgery, 30 days after surgery
Secondary outcomes (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.
Measured: prior to surgery, 7 days after surgery and 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CholelithiasisStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01052727
- Sponsor's protocol ID
- CHU-DOLCE-01-2010-BO
- Acronym
- DOLCE
- Status last verified
- Jul 2022
- First submitted
- 19 Jan 2010
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18398648Gurusamy 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.
PubMed 18196561
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DOLCE Study: Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01052727
- Acronym / sponsor ID
- DOLCE / CHU-DOLCE-01-2010-BO
- Conditions
- Cholelithiasis
- Keywords
- Laparoscopic Cholecystectomy, quality of life
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- First posted
- 20 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| overnight stay group | Other | Procedure: Laparoscopic CholecystectomyGroup of patients who rests at least one night in Hospital |
| day-care Group | Other | Procedure: Laparoscopic CholecystectomyGroup of patients who is discharged tha same day of operation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Cholecystectomy | Procedure or surgery | day-care Group, overnight stay group |
Primary outcome
Evidence of better quality of life revealed by SF-36 test
Time frame: before surgery, 7 days after surgery, 30 days after surgery
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Background: PubMed 18398648Ahmad 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.
- Background: PubMed 18196561Gurusamy 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.
Related trials for Cholelithiasis
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Effect of Prophylactic Dexamethasone vs Placebo on Airway Dimensions Assessed by Ultrasonography in Patients Undergoing Laparoscopic Cholecystectomy
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Two Bupivacaine Concentrations for Recto-Intercostal Fascial Plane Block After Laparoscopic Cholecystectomy
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Comparison of the Efficacy of Different Analgesic Strategies for Pain Control After Laparoscopic Cholecystectomy (LC)
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Electrosurgical Patterns and Learning Curve in Elective Laparoscopic Cholecystectomy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Laparoscopic Cholecystectomy in people with Cholelithiasis, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luca Ansaloni, MD (0039 0516363235, luca.ansaloni@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of better quality of life revealed by SF-36 test (time frame: before surgery, 7 days after surgery, 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01052727, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.