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

NCT ID: NCT01052727

Last Updated: 2022-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

Cholelithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

overnight stay group

Group of patients who rests at least one night in Hospital

Group Type: OTHER

Laparoscopic Cholecystectomy

Intervention Type: PROCEDURE

day-care Group

Group of patients who is discharged tha same day of operation

Group Type: OTHER

Laparoscopic Cholecystectomy

Intervention Type: PROCEDURE

Interventions

Laparoscopic Cholecystectomy

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

St. Orsola Hospital

Locations

St Orsola-Malpighi Hospital - University of Bologna

Bologna, , Italy

Countries

Italy

Central Contacts

Luca Ansaloni, MD

Role: CONTACT

luca.ansaloni@aosp.bo.it

0039 0516363235

Alessandro Dazzi, MD

Role: CONTACT

alled78@yahoo.it

0039 0516363721

Facility Contacts

Luca Ansaloni, MD

Role: primary

luca.ansaloni@aosp.bo.it

0039 0516363235

References

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.

Reference Type: BACKGROUND

PMID: 18398648 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 18196561 (View on PubMed)

Other Identifiers

CHU-DOLCE-01-2010-BO

Identifier Type: -

Identifier Source: org_study_id