Evaluation of One Day Discharge After Laparoscopic Appendectomy for Uncomplicated Appendicitis in Children.
Phase: NA
Conditions: Appendicitis Acute
Sponsor: Miro Jukić

 
 
 
Evaluation of One Day Discharge After 
Laparoscopic Appendectomy for Uncomplicated 
Appendicitis in Children. 
 
 
 
NCT05095987 
 
 
 
12.07.2022 
 
 
 
 
 

Study Protocol and Statistical Analysis Plan 
 
Objectives: Laparoscopic appendectomy is one of the most common emergency interventions 
in pediatric surgery. Over the last decade a protocol for one day discharge after laparoscopic 
appendectomy was established. The aim of this study is to determine the safety, which is 
evaluated using rates of compilation, readmissions and return into operating room. Additionally, 
parental satisfaction is investigated for discharge to home within 24 hours after laparoscopic 
appendectomy for uncomplicated AA.  
Primary outcome measures are the safety of laparoscopic appendectomy due to uncomplicated 
AA and discharge within 24 hours and parental satisfaction. 
 
Secondary outcome measures include the rate of readmission and return to operating room, the 
complication rate and cost reduction. 
 
 
Inclusion Criteria: Patients of both genders, between 6 to 17 years of age, who undergoe 
laparoscopic appendectomy and are discharged within 24 hours after surgery. 
Exclusion Criteria: Patients younger than 6 and older than 17 years of age, operated due to 
complicated AA; patients with prolonged hospital stay, more than 24 hours after surgical 
treatment for any reason – surgeon choice, intraoperative complications, additional pathology; 
patients undergoing conventional open operating technique for AA. 
 
Type of study: Single-center prospective non-randomized cohort study. 
 
Place of study: All patients included are operated by three surgeons at the Department of 
Pediatric surgery, University Hospital of Split in Croatia. 
 
Description: In this prospective cohort single center study, patients presenting with the clinical 
picture of AA to the surgical emergency admission of the University Hospital of Split go 
through the diagnostical algorithm and are evaluated using the AIR score. Intraoperative 
decision of inclusion is made by the surgeon and parents are informed about possibility of 
participation in this study postoperatively. Before discharge the parents are counselled about 
pain management and home childcare. The two-page questionnaire is handed to the parents 
with instruction of use. The questionnaire is designed to investigate on possible changes in 
behavior and the pain level of the child by using visual analogue scale (VAS) measuring from 
0 to 10. With this questionnaire, homebased pain management is recorded. Parents return to the 
outpatient check-up on 7th postoperative day and hand in the filled-out questionnaires. 
Complication is defined as any postsurgical condition requiring emergency visit, readmission, 
or return to operating room. Patients are evaluated for surgical related complications using the 
Clavien-Dindo classification. 
 
Methods: The data is collected from the study protocol which is completed from the medical 
history data and operative list. Additionally, a two-page questionnaire is handed out to the 
parents which they fill out immediately after discharge, every postoperative day until the first 
outpatient control appointment and directly before the appointment. The corresponding data is 
obtained by revising the study protocols and medical records. The data is analyzed using the 
Microsoft Excel for Windows Version 11.0 (Microsoft Corporation) and SPSS 24.0 (IBM Corp, 
Armonk, NY) software programs. Statistical methods used are median with IQR, and 
percentage of total.  
 

Ethical approval: All procedures performed in studies involving human participants are in 
accordance with ethical standards of the institution and/or national research committee and with 
the 1964 Helsinki declaration and its later amendments or comparable ethical standards. 
Authors declare that the research is conducted according to the principles of the World Medical 
Association Declaration of Helsinki “Ethical Principles for Medical Research Involving Human 
Subjects”. Patients are informed in detail and informed consent is obtained from the parents or 
legal guardians of the patients to use the data. The study protocol is approved by the Ethics 
Review Board of University Hospital of Split with reference Number 2181-147/01/06/M.S.-21-
02. 
 
 

 
Evaluation of the discharge of children from hospital treatment to home care operated on for acute 
appendicitis Protocol number____ 
CLINICAL AND DEMOGRAPHIC DATA 
Datum __________________ 
 
 
MB _______________________ 
Name and Surname _________________________; Age _______; Sex   M  /  F; 
Height ______ cm; Weight _____kg; Duration of Symptoms ______h;  
Body Temperature _____ °C; Duration of surgery _________min; 
Operation Starting Time ______ h; Exact discharge time (date and hour) ______________ 
LABORATORY AND RADIOLOGIC REPORTS 
Leukocytes ________x109/L   CRP ______mg/L   Neutrophils ______ % 
ULTRASOUND:  
INTRAOPERATIVE REPORT 
Medical report: a) catarrhal  b) phlegmonous  c) gangrenous   
d) perforated – local peritonitis  e) perforated – diffuse peritonitis   
f) without pathological findings  g) other _________________________ 
Appendiceal Base Management: 
a) polymeric clip  b) endoscopic loop  c) harmonic scalpel (Gupta) ULTRACISION  /  LOTUS 
INTRAOPERATIVE COMPLICATIONS: 
 
EARLY POSTOPERATIVE COMPLICATIONS: 
 
PATHOLOGICAL REPORT 
a) catarrhal  b) phlegmonous  c) gangrenous  d) without pathological findings   
AIR SCORE 
Vomiting 
1 
  
Pain in the RLQ 
1 
  
Rebound tenderness1 – light; 2 – medium; 3 – strong  
0 - 3 
  
Elevated Body Temperature > 38.5 °C 
1 
  
Neutrophils: 0  ≤70%;  1  70 – 84%;  2  ≥85%  
0 - 2 
  
Leukocytes: 0 ≤10;  110 –14.9;  2≥15 
0 - 2 
  
CRP: 0 ≤10;  1  10 – 49;  2  ≥50 
0 - 2 
  
AIR SCORE 
12 
  
KOMPLICATION: 
SATISFACTION ON DISCHARGE:   
 
 
 
 
1   /   2   /   3 
SATISFACTION AT FIRST POSTOPERATIVE APPOINTMENT: 1   /   2   /   3 
SURGEON ________________________________ 
 
 
 
 

CHILD'S NAME:                     DATE & HOUR OF SURGERY:                        PROTOCOL NUMBER: 
PARENTS' NAME:                 DATE & HOUR OF DISCHARGE:             ORDERING PEDIATRIC SURGEON:  
SATISFACTION OF PARENTS ABOUT DISMISSAL WITHIN 24 HOURS 
FROM SURGICAL TREATMENT OF CHILD DUE TO ACUTE 
INFLAMMATION OF APPENDIX 
(TO BE COMPLETED ON DAY OF DISCHARGE) 
Immediately after the surgery and getting detailed information about the past procedure from the 
pediatric surgeon, how did you feel about being discharged to home care within 24 hours? 
1. Angry about the child's short hospital stay, unhappy, very nervous and scared, 
completely unprepared. 
2. Moderately nervous and unprepared and averagely satisfied. 
3. Good, lucky, prepared, maximally satisfied. 
Comment: 
_____________________________________________________________________________
_____________________________________________________________________________
__________________________________________________________________________ 
PARENTAL MEASUREMENT OF POSTOPERATIVE PAIN AT HOME 
(To be completed at home until the first outpatient check-up) 
Children sometimes have behavioural changes when recovering from surgical treatment. The 
attached questionnaire consists of a list of behavioural changes that your child may or may not 
show during recovery in home care. Please answer yes or no for each symptom: 
 
1. Complains and ask for more than usual 
 
 
 
YES / NO 
2. Cries more than usual  
 
 
 
 
 
YES / NO 
3. Plays less than usual  
 
 
 
 
 
YES / NO 
4. Does not do things he/she usually does 
 
 
 
 
YES / NO 
5. Seems more worried than usual 
 
 
 
 
YES / NO 
6. Quieter than usual 
 
 
 
 
 
 
YES / NO 
7. Has less energy than usual 
 
 
 
 
 
YES / NO 
8. Refuses to eat (more than usual) 
 
 
 
 
YES / NO 
9. Eats less than usual 
 
 
 
 
 
 
YES / NO 
10. Holds on to the painful part of the body 
 
 
 
YES / NO 
11. Is careful not to hit the painful part of the body 
 
 
 
YES / NO 
12. Moans, sighs, and painfully whines more than usual  
 
YES / NO 
13. Redder in the face than usual  
 
 
 
 
YES / NO 
14. Wants to be close to you more than usual without separating  
YES / NO 
15. Agrees to take medication without discussion or refusal 
 
YES / NO 
Additional comments on the child's condition and behaviour: 
____________________________________________________________________________ 
 
 
 
 
 

POSTOPERATIVE PAIN I (CHILD INFROMATION) 
Weight:______kg; Height:______ cm; Sex: M / F; Allergies to medication: ____________ 
What does your child normally take for pain or fever? _____________________________ 
POSTOPERATIVE PAIN II (HOME CARE AND THERAPY) 
Please indicate by postoperative day how you alleviated pain and lowered your child's 
temperature and how often per day (indicate the name of the drug, the amount of one dose and 
how many times a day she/he received the drug) and the child's pain rating on the same days. up 
to 10; (0-without pain; 10-unbearable intense pain) 
 
I. P.O. day: ____________________Child's rating: 
II. P.O. day: ____________________Child's rating: 
III. P.O. day: ____________________Child's rating: 
IV. P.O. day: ____________________Child's rating: 
V. P.O. day: ____________________Child's rating: 
VI. P.O. day: ____________________Child's rating: 
VII. P.O. day: ____________________Child's rating: 
Comment: 
____________________________________________________________________________ 
PARENTAL ASSESSMENT AND SATISFACTION ONE WEEK AFTER 
SURGICAL TREATMENT AND RELEASE WITHIN 24 HOURS OF 
SURGERY 
(Fill in just before coming to the outpatient check-up and take the above with 
you and hand it over to the attending physician) 
Looking back at it how do you feel and what do you think now about the child being discharged 
from hospital within 24 hours of surgery? 
1. I think it was a good choice and the best thing that could be done. 
2. I am not sure if it was a good choice and the best thing that could be done. 
3. I think it was a bad decision releasing the child from hospital this early and that he has 
this condition/disease again. I would like her/him to be discharged to home care later 
and to stay in the hospital longer. 
Parents' comments on this type of discharge: 
____________________________________________________________________