Composition of the Exhaust Gas of Pneumoperitoneum During... | NCT03585816

Studies
Composition of the Exhaust Gas of Pneumoperitoneum During Laparoscopic Surgery

NCT03585816

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Feb 19, 2019Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Pneumoperitoneum

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2015Actual

Primary Completion Date

Dec 2018Actual

Completion Date

Dec 2018Actual

First Submitted Date

Jun 20, 2018

First Submission Date that Met QC Criteria

Jul 2, 2018

First Posted Date

Jul 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 18, 2019

Last Update Posted Date

Feb 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research aims to study the composition of the peritoneal exhaust gas during laparoscopic surgery to detect and possibly quantify the presence of air and / or N2O. This purely descriptive work is part of other experimental work that the investigators have already published.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to quantify the composition of the exhaust gas of pneumoperitoneum during laparoscopic surgery by gas chromatography		1 day after laparoscopic surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patient
Patient who will benefit from a laparoscopic surgery at Strasbourg University Hospitals
Patient who has consented to the use of her medical data for research purposes.

Exclusion Criteria:

- Refusal of the patient to participate in the study

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient who will benefit from a laparoscopic surgery at Strasbourg University Hospitals

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d' Anesthésie Réanimation Chirurgicale		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D011027	Pneumoperitoneum

Ancestor Terms

ID	Term
D010532	Peritoneal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided