Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Background and study aims
Surgery for cholelithiasis (hard deposits or gallstones in the gallbladder) has traditionally been an inpatient procedure. The introduction of laparoscopic cholecystectomy (surgical removal of the gallbladder with keyhole surgery) radically changed the treatment of cholelithiasis and is now regarded as the best treatment for benign gallbladder disease. According to the results of the first published study of outpatient laparoscopic cholecystectomy in 1990, 45% of the patients could be treated as outpatients with minimum complications, especially in young patients with no history of abdominal surgery. Several studies have shown that outpatient laparoscopic cholecystectomy is reliable and effective and has a high degree of patient satisfaction and perceived quality. However, a high proportion of admissions have been attributed to the appearance of postoperative nausea and pain in some cases. Early research on the benefits of preoperative education of patients were reported in 1958, showing that preoperative information about the various aspects of the operation and expectations reduces patients’ stress. Other studies since then have shown that patients who had received preoperative information required less analgesia (pain relief) and recovered faster than did those who had not received such information. When patients are scheduled for laparoscopic cholecystectomy for cholelithiasis, they only receive information about the surgical technique and the type of hospitalisation. The aim in this study is to increase the information that is offered to patients by an educational nurse before the surgery and assess the effect on nausea, pain and unwanted readmissions, illness, quality of life, and patient satisfaction after surgery.

Who can participate?
Patients aged 18–75 years old needing surgery for cholelithiasis.

What does the study involve?
Patients will be randomly allocated to one of two groups. Patients in the study group will receive preoperative information about all the proceedings and after-surgery treatments by the education nurse. The control group will receive conventional information about laparoscopic cholecystectomy.

What are the possible benefits and risks of participating?
The possible benefits are faster recovery after surgery and the need for less pain relief. Risks were not provided at the time of registration.

Where is the study run from?
University Hospital Joan XXIII (Spain)

When is the study starting and how long is it expected to run for?
From May 2014 to June 2015

Who is funding the study?
University Hospital Joan XXIII (Spain)

Who is the main contact?
Dr Aleidis Caro

Trial website

Contact information



Primary contact

Dr Aleidis Caro


Contact details

Merce Rodoreda Street
B 2º1ª

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

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


Study hypothesis

Patients who have received preoperative education will have reduced anxiety related to surgery because they will have been better informed of the symptoms that can occur after surgery; these informed patients could control the postoperative symptoms better and could be operated on an ambulatory regimen with higher levels of satisfaction.

Ethics approval

Ethics Committee of Clinical Research of the University Hospital Joan XXIII (Spain), 09/04/2014, ref: CEIC 26/2014

Study design

Randomised controlled double-blind single-centre trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Postoperative pain and quality of life


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 conventional information about laparoscopic cholecystectomy.

Intervention type



Drug names

Primary outcome measure

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

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

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant 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

Participant type


Age group




Target number of participants

62 patients, two clusters with 31 patients each

Participant 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

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

University Hospital Joan XXIII
4th Doctor Mallafre Guasch Street

Sponsor information


University Hospital Joan XXIII

Sponsor details

General and Digestive Surgery Department
4th Doctor Mallafre Guasch Street

Sponsor type

Hospital/treatment centre



Funder type

Hospital/treatment centre

Funder name

Fundació Hospital Joan XXIII (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

The study results will be presented in conference papers and publications in scientific journals

Intention to publish date

Participant level data

Available on request

Basic results (scientific)

Publication list

2017 results in:

Publication citations

Additional files

Editorial Notes

15/02/2018: Publication reference added.