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

NCT ID: NCT01940042

Last Updated: 2018-09-05

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

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-12-31

Brief Summary

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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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maneuver group

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.

Group Type EXPERIMENTAL

CO2 was removed by means of trandelenburg positions

Intervention Type BEHAVIORAL

clasical group

no additional action will be taken after the operation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CO2 was removed by means of trandelenburg positions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. required hospitalization after the laparoscopic surgery,
2. the procedure required conversion to laparotomy
3. if a 48-hour follow-up was not feasible
Minimum Eligible Age

15 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Bakirkoy Maternity and Children Diseases Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Osman Aşıcıoğlu

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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isa aykut özdemir, m.d.

Role: PRINCIPAL_INVESTIGATOR

tepecik education and research hospital

Locations

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Tepecik Education and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 18669740 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30207100 (View on PubMed)

Other Identifiers

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aşıcıoğlu07

Identifier Type: -

Identifier Source: org_study_id

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