Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic SurgeryNCT01940042

the Effect of Simple Clinical Maneuver on Shoulder and Abdominal Pain a Laparascopic Gynecological Surgery:a Prospective Randomised Trial

A study testing CO2 was removed by means of trandelenburg positions in people with Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic Surgery, run by Istanbul Bakirkoy Maternity and Children Diseases Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain. Read more about this study

Who is it for?: Ages 15 to 65 years, women only
Conditions the study is for: Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic Surgery
What is being tested?: CO2 was removed by means of trandelenburg positions
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 110 participants
Where: 1 siteTurkey (Türkiye)
Study dates: Oct 2013to Dec 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 65 years
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

females aged 15-65 years,
American Society of Anesthesiologists (ASA) physical status classification I-III
no previous laparotomy(major abdominal surgery).
need a laparascopic surgery

Who cannot join

required hospitalization after the laparoscopic surgery,
the procedure required conversion to laparotomy
if a 48-hour follow-up was not feasible

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Tepecik Education and Research Hospital
Izmir, 35120

Other trials in Turkey (Türkiye)

About this study

The investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain.

Conditions: Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic Surgery
Being tested: CO2 was removed by means of trandelenburg positions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CO2 was removed by means of trandelenburg positionsBehavioural

Study groups in NCT01940042
Study group	Role	What they receive
maneuver group	Experimental	In the intervention group, CO2 was removed by means of Trendelenburg position (30 degrees) and a pulmonary recruitment maneuver consisting of five manual inflations of the lung. Receives: Behavioral: CO2 was removed by means of trandelenburg positions
clasical group	No intervention	no additional action will be taken after the operation

What is being measured

The primary outcome is the main question the study is designed to answer.

postoperative 12. hour VAS pain score
Measured: 12 hour

Secondary outcomes (1)

postoperative analgesic requırements
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2013Dec 2017

First posted11 Sep 2013 (estimated)
Study startOct 2013
Primary completionDec 2017
Study completionDec 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Participant
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01940042
Sponsor's protocol ID: aşıcıoğlu07
Status last verified: Sep 2018
First submitted: 7 Sep 2013
Last updated: 5 Sep 2018
Results posted: No

Publications

Esin S, Culha ZK, Kara OF, Yildirim H. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 Aug;112(2 Pt 1):380; author reply 380. doi: 10.1097/AOG.0b013e318182cb6e. No abstract available.
PubMed 18669740
Gungorduk K, Asicioglu O, Ozdemir IA. Effect of the pulmonary recruitment maneuver on pain after laparoscopic gynecological oncologic surgery: a prospective randomized trial. J Gynecol Oncol. 2018 Nov;29(6):e92. doi: 10.3802/jgo.2018.29.e92.
PubMed 30207100

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: the Effect of Simple Clinical Maneuver on Shoulder and Abdominal Pain a Laparascopic Gynecological Surgery:a Prospective Randomised Trial
ClinicalTrials.gov ID: NCT01940042
Acronym / sponsor ID: aşıcıoğlu07
Conditions: Effect of CO2 Was Removed by Means Trandelenburg Position at Laparascopic Surgery
Study type: Interventional
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases HospitalOther government
Study start: Oct 2013
Primary completion: Dec 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 11 Sep 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The investigators think that a simple maneuver at laparascopic surgery to reduce the postoperative pain.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
maneuver group	Experimental	Behavioral: CO2 was removed by means of trandelenburg positionsIn the intervention group, CO2 was removed by means of Trendelenburg position (30 degrees) and a pulmonary recruitment maneuver consisting of five manual inflations of the lung.
clasical group	No intervention	–no additional action will be taken after the operation

Who may qualify

Ages: 15 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

females aged 15-65 years,
American Society of Anesthesiologists (ASA) physical status classification I-III
no previous laparotomy(major abdominal surgery).
need a laparascopic surgery

Key exclusion criteria (3 listed)

required hospitalization after the laparoscopic surgery,
the procedure required conversion to laparotomy
if a 48-hour follow-up was not feasible

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CO2 was removed by means of trandelenburg positions	Behavioural	maneuver group

Primary outcome

postoperative 12. hour VAS pain score
Time frame: 12 hour

1 secondary outcome

postoperative analgesic requırements
Time frame: 48 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
Results publication: PubMed 18669740Esin S, Culha ZK, Kara OF, Yildirim H. A simple clinical maneuver to reduce laparoscopy-induced shoulder pain: a randomized controlled trial. Obstet Gynecol. 2008 Aug;112(2 Pt 1):380; author reply 380. doi: 10.1097/AOG.0b013e318182cb6e. No abstract available.
Derived from this study: PubMed 30207100Gungorduk K, Asicioglu O, Ozdemir IA. Effect of the pulmonary recruitment maneuver on pain after laparoscopic gynecological oncologic surgery: a prospective randomized trial. J Gynecol Oncol. 2018 Nov;29(6):e92. doi: 10.3802/jgo.2018.29.e92.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

isa aykut özdemir, m.d. principal investigator

tepecik education and research hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative 12. hour VAS pain score (time frame: 12 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01940042, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.