Standard Carbon Dioxide Gas Versus Heated Humidified Gas in Gynaecological Laparoscopy

NCT ID: NCT02319902

Last Updated: 2014-12-18

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-12-31

Brief Summary

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To establish if heated humidified carbon dioxide gas improves pain scores as well as nausea and analgesic requirements in post operative patients compared to standard cold carbon dioxide.

Detailed Description

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Conditions

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Heated Humidified Carbon Dioxide in Gynaecological Laparoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Standard cold carbon dioxide gas

Standard cold carbon dioxide gas

Group Type PLACEBO_COMPARATOR

Standard cold carbon dioxide gas

Intervention Type DEVICE

Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.

Heated humidified carbon dioxide gas

Heated humidified carbon dioxide gas

Group Type ACTIVE_COMPARATOR

Heated humidified carbon dioxide gas

Intervention Type DEVICE

Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.

Interventions

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Standard cold carbon dioxide gas

Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.

Intervention Type DEVICE

Heated humidified carbon dioxide gas

Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age
* Patients planned to undergo laparoscopy for minor procedures such as endometriosis, adhesions, ovarian cystectomies, bilateral salpingoophorectomy, tubal ligation and sterilisation will be invited to participate in the trial.
* Capacity to consent

Exclusion Criteria

* Patients unable to speak English
* Patients unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fevzi Shakir

OTHER

Sponsor Role lead

Responsible Party

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Fevzi Shakir

Senior Clinical Research Fellow in Advanced Gynaecological Laparoscopic Surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Royal Surrey County Hospital NHS Trust

Guildford, Surrey, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Fevzi Shakir, MBBS BSc MRCOG

Role: CONTACT

Email: [email protected]

Andrew Kent, TD MD FRCOG

Role: CONTACT

Email: [email protected]

Facility Contacts

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Fevzi Shakir, MBBS BSc MRCOG

Role: primary

Andrew Kent, TD MD FRCOG

Role: backup

Other Identifiers

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14SURN0015

Identifier Type: -

Identifier Source: org_study_id