Low vs Medium Pressure Pneumoperitoneum

NCT ID: NCT04949659

Last Updated: 2024-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-27

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Appendicitis Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Low pressure pneumoperitoneum

Use of low pressure pneumoperitoneum during laparoscopic appendectomy

Group Type EXPERIMENTAL

Laparoscopic appendectomy

Intervention Type PROCEDURE

Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum

Medium pressure pneumoperitoneum

Use of medium pressure pneumoperitoneum during laparoscopic appendectomy

Group Type EXPERIMENTAL

Laparoscopic appendectomy

Intervention Type PROCEDURE

Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum

Interventions

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Laparoscopic appendectomy

Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Children's Hospital, Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hannah R Neeser, MD

Role: PRINCIPAL_INVESTIGATOR

University Children's Hospital of Zurich

Locations

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University Children's Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Hannah R Neeser, MD

Role: CONTACT

+41442667045

Ueli Moehrlen, MD

Role: CONTACT

+41442667407

Facility Contacts

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Hannah R Neeser

Role: primary

+41442667111

References

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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.

Reference Type BACKGROUND
PMID: 24639018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26275545 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18562251 (View on PubMed)

Other Identifiers

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1001

Identifier Type: -

Identifier Source: org_study_id

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