The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function

NCT ID: NCT02543853

Last Updated: 2015-09-07

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

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2015-10-31

Brief Summary

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The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.

Detailed Description

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Women planned to have laparoscopic surgery will be randomized into two groups, in first group pneumoperitoneum will be provided by veres needle, in other group direct trocar entry will be used to provide pneumoperitoneum. After surgery gastrointesitinal functions, shoulder pain, blood loss will be compared between groups.

Conditions

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Gastrointestinal Disorder Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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veres needle entry arm

Vere needle will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared

Group Type ACTIVE_COMPARATOR

veres needle entry

Intervention Type OTHER

veres needle entry to provide pneumoperitoneum

direct trocar entry arm

Direct trocar entry will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared

Group Type ACTIVE_COMPARATOR

direct trocar entry

Intervention Type OTHER

direct trocar entry to provide pneumoperitoneum

Interventions

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direct trocar entry

direct trocar entry to provide pneumoperitoneum

Intervention Type OTHER

veres needle entry

veres needle entry to provide pneumoperitoneum

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Laparoscopic surgery for benign or malignant disease

Exclusion Criteria

* Patients with gastrointestinal intervention
* Patients who had undergone previous operations
* Patients with gastrointestinal intervention dysfunction
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zeynep Kamil Maternity and Pediatric Research and Training Hospital

OTHER

Sponsor Role lead

Responsible Party

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enis ozkaya

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zeynep Kamil

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Enis Ozkaya, md

Role: CONTACT

905054742459

Facility Contacts

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enis ozkaya, md

Role: primary

References

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Compeau C, McLeod NT, Ternamian A. Laparoscopic entry: a review of Canadian general surgical practice. Can J Surg. 2011 Oct;54(5):315-20. doi: 10.1503/cjs.011210.

Reference Type BACKGROUND
PMID: 21774882 (View on PubMed)

Daskalakis M, Scheffel O, Weiner RA. High flow insufflation for the maintenance of the pneumoperitoneum during bariatric surgery. Obes Facts. 2009;2 Suppl 1(Suppl 1):37-40. doi: 10.1159/000198252. Epub 2009 Mar 18.

Reference Type BACKGROUND
PMID: 20124777 (View on PubMed)

Ahmad G, O'Flynn H, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD006583. doi: 10.1002/14651858.CD006583.pub3.

Reference Type RESULT
PMID: 22336819 (View on PubMed)

Other Identifiers

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990902

Identifier Type: -

Identifier Source: org_study_id

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