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

July 19, 2022 updated by: IRCCS Azienda Ospedaliero-Universitaria di Bologna

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Alessandro Dazzi, MD
  • Phone Number: 0039 0516363721
  • Email: alled78@yahoo.it

Study Locations

  • Italy
      • Bologna, Italy, 40100
        • St Orsola-Malpighi Hospital - University of Bologna
        • Contact:
        • Principal Investigator:
          • Luca Ansaloni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: overnight stay group
Group of patients who rests at least one night in Hospital
Procedure: Laparoscopic Cholecystectomy
Other: day-care Group
Group of patients who is discharged tha same day of operation
Procedure: Laparoscopic Cholecystectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of better quality of life revealed by SF-36 test
Time Frame: before surgery, 7 days after surgery, 30 days after surgery
before surgery, 7 days after surgery, 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
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
prior to surgery, 7 days after surgery and 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

January 19, 2010

First Submitted That Met QC Criteria

January 19, 2010

First Posted (Estimate)

January 20, 2010

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-DOLCE-01-2010-BO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholelithiasis

Clinical Trials on Laparoscopic Cholecystectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe