Appendicitis AcuteLoMePneuNCT04949659
Low vs Medium Pressure Pneumoperitoneum
A study testing Laparoscopic appendectomy in people with Appendicitis Acute, run by University Children's Hospital, Zurich at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Appendicitis Acute
- What is being tested?
- Laparoscopic appendectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSwitzerland
- Study dates
- 27 Sep 2021to 25 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital Zurich
Zurich, Canton of Zurich, 8032
About this study
Official title: Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
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.
- Conditions
- Appendicitis Acute
- Being tested
- Laparoscopic appendectomy
- Keywords
- Pneumoperitoneum, Pressure, Pain
- Medical subject headings
- Appendicitis, Pneumoperitoneum, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic appendectomyProcedure or surgery
Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum
| Study group | Role | What they receive |
|---|---|---|
| Low pressure pneumoperitoneum | Experimental | Use of low pressure pneumoperitoneum during laparoscopic appendectomy Receives: Procedure: Laparoscopic appendectomy |
| Medium pressure pneumoperitoneum | Experimental | Use of medium pressure pneumoperitoneum during laparoscopic appendectomy Receives: Procedure: Laparoscopic appendectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score on postoperative day one (abdominal pain)
Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
Measured: Postoperative day one.
Secondary outcomes (6)
Postoperative pain scores during postoperative phase (abdominal pain)
Postoperative pain score for abdominal pain on further postoperative days (excluding day one, which is primary outcome) after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
Measured: Through study completion, an average of 3 days
Postoperative pain scores during postoperative phase (shoulder pain)
Postoperative pain score for shoulder pain during hospitalisation after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
Measured: Through study completion, an average of 3 days
Length of operation
Length of operation in minutes
Measured: Intraoperative
Length of stay
Length of stay in hospital in hours
Measured: Through study completion, an average of 3 days
Intra- and postoperative complications
Intra- and postoperative complications during hospitalisation
Measured: Through study completion, an average of 3 days
Analgesic use
Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses
Measured: Through study completion, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start27 Sep 2021
- Primary completion23 Jul 2026
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Appendicitis AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital, Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hannah R Neeser, MD, Principal investigator, University Children's Hospital of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949659
- Sponsor's protocol ID
- 1001
- Acronym
- LoMePneu
- Status last verified
- Jul 2026
- First submitted
- 21 Jun 2021
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
PubMed 24639018Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
PubMed 26275545McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.
PubMed 18562251
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04949659
- Acronym / sponsor ID
- LoMePneu / 1001
- Conditions
- Appendicitis Acute
- Keywords
- Pneumoperitoneum, Pressure, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Children's Hospital, ZurichUniversity, hospital or other
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low pressure pneumoperitoneum | Experimental | Procedure: Laparoscopic appendectomyUse of low pressure pneumoperitoneum during laparoscopic appendectomy |
| Medium pressure pneumoperitoneum | Experimental | Procedure: Laparoscopic appendectomyUse of medium pressure pneumoperitoneum during laparoscopic appendectomy |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic appendectomyLaparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum | Procedure or surgery | Low pressure pneumoperitoneum, Medium pressure pneumoperitoneum |
Primary outcome
Postoperative pain score on postoperative day one (abdominal pain)
Time frame: Postoperative day one.
Postoperative pain score for abdominal pain on postoperative day one after laparoscopic appendectomy using the Faces Pain Score Revised (FPS-R score), a self-reported pain score using drawn faces with values from 0 (no pain) to 10 (most pain). It is validated for use in studies with children.
6 secondary outcomes
Postoperative pain scores during postoperative phase (abdominal pain)
Time frame: Through study completion, an average of 3 days
Postoperative pain scores during postoperative phase (shoulder pain)
Time frame: Through study completion, an average of 3 days
Length of operation
Time frame: Intraoperative
Length of stay
Time frame: Through study completion, an average of 3 days
Intra- and postoperative complications
Time frame: Through study completion, an average of 3 days
Analgesic use
Time frame: Through study completion, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 24639018Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;2014(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
- Background: PubMed 26275545Ozdemir-van Brunschot DM, van Laarhoven KC, Scheffer GJ, Pouwels S, Wever KE, Warle MC. What is the evidence for the use of low-pressure pneumoperitoneum? A systematic review. Surg Endosc. 2016 May;30(5):2049-65. doi: 10.1007/s00464-015-4454-9. Epub 2015 Aug 15.
- Background: PubMed 18562251McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannah R Neeser, MD principal investigator
University Children's Hospital of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic appendectomy in people with Appendicitis Acute, run by University Children's Hospital, Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain score on postoperative day one (abdominal pain) (time frame: Postoperative day one.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04949659, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.