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

Cholelithiasis Clinical Trial

— DOLCE  

Official title:

DOLCE Study: Day-care Versus Overnight-stay Laparoscopic Cholecystectomy Randomized, Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01052727
• Other study ID #: CHU-DOLCE-01-2010-BO
• Status: Not yet recruiting
• Phase: Phase 4

Study information

• Verified date: July 2022
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Luca Ansaloni, MD
• Phone: 0039 0516363235
• Email: luca.ansaloni[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Laparoscopic Cholecystectomy

Locations

Country	Name	City	State
Italy	St Orsola-Malpighi Hospital - University of Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of better quality of life revealed by SF-36 test		before surgery, 7 days after surgery, 30 days after surgery
Secondary	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.		prior to surgery, 7 days after surgery and 30 days after surgery