Assessment of the preoperative education on pain after outpatient surgery to remove the gallbladder
| ISRCTN | ISRCTN83787412 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83787412 |
| Secondary identifying numbers | COLE_HJ23 |
- Submission date
- 21/01/2015
- Registration date
- 23/03/2015
- Last edited
- 15/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Merce Rodoreda Street
11, B 2º1ª
Tarragona
43007
Spain
 ORCID ID |
0000-0001-6151-3879 |
|---|
Study information
| Study design | Randomised controlled double-blind single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effect of the preoperative education on pain after ambulatory laparoscopic cholecystectomy: a randomised controlled double-blind trial |
| Study objectives | 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(s) | Ethics Committee of Clinical Research of the University Hospital Joan XXIII (Spain), 09/04/2014, ref: CEIC 26/2014 |
| Health condition(s) or problem(s) studied | Postoperative pain and quality of life |
| Intervention | 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 | Other |
| 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 study start date | 01/02/2014 |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 62 patients, two clusters with 31 patients each |
| Key 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 |
| Key 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 |
| Date of first enrolment | 09/04/2014 |
| Date of final enrolment | 28/02/2015 |
Locations
Countries of recruitment
- Spain
Study participating centre
Tarragona
43007
Spain
Sponsor information
Hospital/treatment centre
General and Digestive Surgery Department
4th Doctor Mallafre Guasch Street
Tarragona
43007
Spain
"ROR" |
https://ror.org/05s4b1t72 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The study results will be presented in conference papers and publications in scientific journals |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2018 | Yes | No |
Editorial Notes
15/02/2018: Publication reference added.
