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

Effect of the preoperative education on pain after ambulatory laparoscopic cholecystectomy: a randomised controlled double-blind trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN83787412
Enrollment
62
Registered
2015-03-23
Start date
2014-04-09
Completion date
Unknown
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative pain and quality of life Surgery Postoperative pain

Interventions

1. Patients in the study group will receive preoperative information about all the proceedings and post operative treatments by the education nurse. 2. Patients in the control group will receive conve

Sponsors

University Hospital Joan XXIII
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 2. Intraoperative morbidity, measured by Clavien-Dindo classification at 30 days 3. Postoperative morbidity, measured by Clavien-Dindo classification at 30 days 4. Unexpected admissions 5. Time to return to normal work activity, measured by questioning the patient at 30 days 6. Patient satisfaction, measured by Satisfaction Test especifically designed at preoperative and 30 days postoperative 7. Quality of life, measured by SF-12 Quality of Life Test at preoperative and 30 days postoperative

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026