CompletedNot Applicable

Low vs Medium Pressure Pneumoperitoneum

Switzerland250 participantsStarted 2021-09-27

Plain-language summary

The purpose of this study is to asses whether the pressure used for the pneumoperitoneum during laparoscopic surgery in children affects their postoperative pain levels.

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Prepped and consented for diagnostic laparoscopy for likely acute appendicitis * 5 years or older * 15 kg or more * Parents/legal custodian give consent, patient shows no signs of unwillingness to participate * Patient is hemodynamically stable Exclusion Criteria: * Clinical signs of four quadrant peritonitis as a clinical sign of perforated appendicitis * Suspected perityphlitic abscess on preoperative ultrasound * Preexisting conditions making postoperative assessment of extent of pain and its localization very difficult or impossible, e.g. conditions that are associated with pronounced developmental delays or with communication difficulties * Parents have inadequate knowledge of German language to understand Informed consent * Child has inadequate knowledge of German language to allow elicitation of Pain Scores

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative pain score on postoperative day one (abdominal pain)

Timeframe: Postoperative day one.

Trial details

NCT IDNCT04949659

SponsorUniversity Children's Hospital, Zurich

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-31

View on ClinicalTrials.gov More Appendicitis Acute trials

Who can participate

Age range

5 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.