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

Primary Purpose

Gastrointestinal Disorder Postoperative

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
direct trocar entry
veres needle entry
Sponsored by
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrointestinal Disorder Postoperative

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zeynep KamilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

veres needle entry arm

direct trocar entry arm

Arm Description

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

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

Outcomes

Primary Outcome Measures

Bowel sound (first bowel sound)
time from surgery to first bowel sound as hours

Secondary Outcome Measures

Gas discharge
time from surgery to first bowel sound as hours

Full Information

First Posted
May 24, 2015
Last Updated
September 4, 2015
Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02543853
Brief Title
The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function
Official Title
The Effect of Two Different Endoscopic Entry Techniques on Postoperative Gastrointestinal Function
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Disorder Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
veres needle entry arm
Arm Type
Active Comparator
Arm Description
Vere needle will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared
Arm Title
direct trocar entry arm
Arm Type
Active Comparator
Arm Description
Direct trocar entry will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared
Intervention Type
Other
Intervention Name(s)
direct trocar entry
Intervention Description
direct trocar entry to provide pneumoperitoneum
Intervention Type
Other
Intervention Name(s)
veres needle entry
Intervention Description
veres needle entry to provide pneumoperitoneum
Primary Outcome Measure Information:
Title
Bowel sound (first bowel sound)
Description
time from surgery to first bowel sound as hours
Time Frame
Postoperative first 72 hours
Secondary Outcome Measure Information:
Title
Gas discharge
Description
time from surgery to first bowel sound as hours
Time Frame
Postoperative first 72 hours

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enis Ozkaya, md
Phone
905054742459
Email
enozkaya1979@gmail.com
Facility Information:
Facility Name
Zeynep Kamil
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
enis ozkaya, md
Email
enokaya1979@gmail.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
21774882
Citation
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.
Results Reference
background
PubMed Identifier
20124777
Citation
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.
Results Reference
background
PubMed Identifier
22336819
Citation
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.
Results Reference
result

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

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