NCT01052727

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
Last Updated

July 20, 2022

Status Verified

July 1, 2022

First QC Date

January 19, 2010

Last Update Submit

July 19, 2022

Conditions

Cholelithiasis

Keywords

Laparoscopic Cholecystectomyquality of life

Outcome Measures

Primary Outcomes (1)

  • Evidence of better quality of life revealed by SF-36 test

    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.

    prior to surgery, 7 days after surgery and 30 days after surgery

Study Arms (2)

overnight stay group

OTHER

Group of patients who rests at least one night in Hospital

Procedure: Laparoscopic Cholecystectomy

day-care Group

OTHER

Group of patients who is discharged tha same day of operation

Procedure: Laparoscopic Cholecystectomy

Interventions

Laparoscopic CholecystectomyPROCEDURE
day-care Groupovernight stay group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Orsola-Malpighi Hospital - University of Bologna

Bologna, 40100, Italy

Location

Related 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.

    PMID: 18398648BACKGROUND

  • 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.

    PMID: 18196561BACKGROUND

MeSH Terms

Conditions

Cholelithiasis

Interventions

Cholecystectomy, Laparoscopic

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical Procedures

Central Study Contacts

Luca Ansaloni, MD

CONTACT

0039 0516363235luca.ansaloni@aosp.bo.it

Alessandro Dazzi, MD

CONTACT

0039 0516363721alled78@yahoo.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2010

First Posted

January 20, 2010

Last Updated

July 20, 2022

Record last verified: 2022-07

Locations

IT(1)