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Low vs Medium Pressure Pneumoperitoneum (LoMePneu)

Primary Purpose

Appendicitis Acute

Status
Recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Laparoscopic appendectomy
Sponsored by
University Children's Hospital, Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Appendicitis Acute focused on measuring Pneumoperitoneum, Pressure, Pain

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Children's Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Low pressure pneumoperitoneum

Medium pressure pneumoperitoneum

Arm Description

Use of low pressure pneumoperitoneum during laparoscopic appendectomy

Use of medium pressure pneumoperitoneum during laparoscopic appendectomy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Length of operation
Length of operation in minutes
Length of stay
Length of stay in hospital in hours
Intra- and postoperative complications
Intra- and postoperative complications during hospitalisation
Analgesic use
Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses

Full Information

First Posted
June 21, 2021
Last Updated
September 27, 2021
Sponsor
University Children's Hospital, Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT04949659
Brief Title
Low vs Medium Pressure Pneumoperitoneum
Acronym
LoMePneu
Official Title
Postoperative Pain in Children After Low-Pressure Versus Medium-Pressure Pneumoperitoneum in Laparoscopic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Children's Hospital, Zurich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Appendicitis Acute
Keywords
Pneumoperitoneum, Pressure, Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low pressure pneumoperitoneum
Arm Type
Experimental
Arm Description
Use of low pressure pneumoperitoneum during laparoscopic appendectomy
Arm Title
Medium pressure pneumoperitoneum
Arm Type
Experimental
Arm Description
Use of medium pressure pneumoperitoneum during laparoscopic appendectomy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic appendectomy
Intervention Description
Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum
Primary Outcome Measure Information:
Title
Postoperative pain score on postoperative day one (abdominal pain)
Description
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.
Time Frame
Postoperative day one.
Secondary Outcome Measure Information:
Title
Postoperative pain scores during postoperative phase (abdominal pain)
Description
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.
Time Frame
Through study completion, an average of 3 days
Title
Postoperative pain scores during postoperative phase (shoulder pain)
Description
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.
Time Frame
Through study completion, an average of 3 days
Title
Length of operation
Description
Length of operation in minutes
Time Frame
Intraoperative
Title
Length of stay
Description
Length of stay in hospital in hours
Time Frame
Through study completion, an average of 3 days
Title
Intra- and postoperative complications
Description
Intra- and postoperative complications during hospitalisation
Time Frame
Through study completion, an average of 3 days
Title
Analgesic use
Description
Number and dose (mg/kg) of standard analgesia, as well as so called "rescue" doses
Time Frame
Through study completion, an average of 3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hannah R Neeser, MD
Phone
+41442667045
Email
Hannah.Neeser@kispi.uzh.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Ueli Moehrlen, MD
Phone
+41442667407
Email
Ueli.moehrlen@kispi.uzh.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah R Neeser, MD
Organizational Affiliation
University Children's Hospital of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Children's Hospital Zurich
City
Zürich
State/Province
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannah R Neeser
Phone
+41442667111
Email
hannah.neeser@kispi.uzh.ch

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24639018
Citation
Gurusamy KS, Vaughan J, Davidson BR. Low pressure versus standard pressure pneumoperitoneum in laparoscopic cholecystectomy. Cochrane Database Syst Rev. 2014 Mar 18;(3):CD006930. doi: 10.1002/14651858.CD006930.pub3.
Results Reference
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PubMed Identifier
26275545
Citation
Ozdemir-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.
Results Reference
background
PubMed Identifier
18562251
Citation
McGrath 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.
Results Reference
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Low vs Medium Pressure Pneumoperitoneum

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