- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01955798
Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery
Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery , a Randomized Study
The Veress needle is the laparoscopic entry technique most commonly used among gynecologists. Direct trocar entry is another method to gain entry to the abdomen that is uncommon to gynecologists.
This prospective and randomized study will compare the two entry techniques with regard to:
- Complications related to the entry technique and previous surgeries
- Time taken to enter the abdomen
- The number of attempts taken to enter the abdomen
Study Overview
Status
Conditions
Detailed Description
Patients of Dexeus Universitary Institute that are having a laparoscopic surgery for gynecological purposes will participate in the study. Patients with previous middle laparotomies or 3 or more abdominal suregeries will be excluded from the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will be randomized into the two arms of the trial. All patient information will be confidential and only be available to researches involved in the study.
Only three expert surgeons of the Gynecological Department of Dexeus Universitary Institute will participate in the study.
300 women will be recruited over a two year period and the data will be analysed by a statistician.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Barcelona, Spain, 08028
- Hospital Quiron Dexeus
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any woman suitable for laparoscopic gyneacological surgery
Exclusion Criteria:
- Previus supra-infra umbilical laparotomy
- three or more previous abdominal surgeries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Trocar
Pyramidal tip reusable 11mm trocar
|
Laparoscopic direct entry with trocar
|
ACTIVE_COMPARATOR: Veress needle
|
Laparoscopic entry with Veress needle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complications during entry in laparoscopy
Time Frame: During surgery
|
Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc
|
During surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to enter in the abdominal cavity
Time Frame: During surgery
|
Time in seconds from the impact of the trocar or the veress needle to enter in the abdominal cavity
|
During surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Alberto Vazquez, MD, Salut de la Mujer Dexeus
Publications and helpful links
General Publications
- 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.
- Tinelli A, Malvasi A, Guido M, Tsin DA, Hudelist G, Stark M, Mettler L. Laparoscopy entry in patients with previous abdominal and pelvic surgery. Surg Innov. 2011 Sep;18(3):201-5. doi: 10.1177/1553350610393989. Epub 2011 Jan 18.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DEX2013001
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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