NCT03069586

Brief Summary

The investigators want to test the hypothesis that the addition of a recruitment manoeuvre to a low pressure pneumoperitoneum will lead to an additional reduction in postoperative pain. Therefore the investigators will conduct a prospective randomized controlled, single blind trial.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

February 10, 2016

Last Update Submit

February 27, 2017

Conditions

PneumoperitoneumRecruitmentPostoperative Pain

Outcome Measures

Primary Outcomes (1)

  • pain relief during the first 24 hours

    VAS (0-10)

    24hours

Secondary Outcomes (3)

  • Total analgesic use during the first 24 hours

    24hours

  • Length of hospital stay

    2 days

  • Recovery after 48 hours

    48 hours

Study Arms (2)

Low pressure pneumoperitoneum

OTHER

Surgery on low pressure pneumoperitoneum (8 - 10 mmHg).

Procedure: No pulmonary recruitment

low pressure peritoneum and pulmonary recruitment

ACTIVE COMPARATOR

Surgery on low pressure pneumoperitoneum (8 - 10 mmHg) and at the end of surgery a manual pulmonary recruitment manoeuver (2 x 5sec max 40cmH2O) will be done

Procedure: Pulmonary recruitment

Interventions

Pulmonary recruitmentPROCEDURE

At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt

low pressure peritoneum and pulmonary recruitment
No pulmonary recruitmentPROCEDURE

At the end of surgery no intervention was completed

Low pressure pneumoperitoneum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ASA I and II

You may not qualify if:

  • refusal to give consent
  • cholecystitis
  • BMI above 35
  • intolerance to one of the pain medication
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AZ groeninge

Kortrijk, 8500, Belgium

RECRUITING

MeSH Terms

Conditions

PneumoperitoneumPain, Postoperative

Condition Hierarchy (Ancestors)

Peritoneal DiseasesDigestive System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

February 10, 2016

First Posted

March 3, 2017

Study Start

May 1, 2015

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

March 3, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)