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

September 4, 2015 updated by: enis ozkaya, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
The purpose of this study is to determine effect of veres needle entry and direct trocar entry on postoperative gastrointestinal functions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: veres needle entry arm
Vere needle will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared
Other: veres needle entry
veres needle entry to provide pneumoperitoneum
Active Comparator: direct trocar entry arm
Direct trocar entry will be used to provide penumoperiteum than postoperative gastrointestinal functions will be compared
Other: direct trocar entry
direct trocar entry to provide pneumoperitoneum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bowel sound (first bowel sound)
Time Frame: Postoperative first 72 hours
time from surgery to first bowel sound as hours
Postoperative first 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gas discharge
Time Frame: Postoperative first 72 hours
time from surgery to first bowel sound as hours
Postoperative first 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

May 24, 2015

First Submitted That Met QC Criteria

September 4, 2015

First Posted (Estimate)

September 7, 2015

Study Record Updates

Last Update Posted (Estimate)

September 7, 2015

Last Update Submitted That Met QC Criteria

September 4, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 990902

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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