Assessment of the preoperative education on pain after outpatient surgery to remove the gallbladder

Completed

• Conditions: Postoperative pain and quality of life; Surgery; Postoperative pain

• Registration Number: ISRCTN83787412
• Lead Sponsor: niversity Hospital Joan XXIII

Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29224843

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-03-23
• Study Completion: 2015-06-30
• Last Update Posted: 19 March 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

1. Age 18–75 years old
2. American Society of Anesthesiology (ASA) scores I and II
3. Ambulatory surgery criteria: 30 minutes proximity to the hospital, living with family and telephone at home
4. Patient acceptance for ambulatory surgery
5. Symptomatic cholelithiasis or chronic cholecystitis
6. Liver enzymes and bilirubin within normal ranges
7. No previous supramesocolic surgery

Exclusion Criteria

1. ASA score III or IV
2. No ambulatory surgery criteria
3. No patient acceptance for ambulatory surgery
4. Difficulty of instruction comprehension
5. Difficulty for airway intubation
6. Co-morbidity
7. Haemodialysis
8. Congestive heart failure
9. Coagulopathy
10. Body-mass index >35 kg/m2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative pain related, measured using the visual analogue scale (VAS), at the immediate postoperative time, at 6 postoperative hours, at 24 hours, 7 days and 30 days

Secondary Outcome Measures

Name	Time	Method
1. Postoperative nausea, measured by questioning the patient at the immediate postoperative time, at 6 postoperative hours, at 24 hours, 7 days and 30 days<br>2. Intraoperative morbidity, measured by Clavien-Dindo classification at 30 days<br>3. Postoperative morbidity, measured by Clavien-Dindo classification at 30 days<br>4. Unexpected admissions<br>5. Time to return to normal work activity, measured by questioning the patient at 30 days<br>6. Patient satisfaction, measured by Satisfaction Test especifically designed at preoperative and 30 days postoperative<br>7. Quality of life, measured by SF-12 Quality of Life Test at preoperative and 30 days postoperative