Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery

Laparoscopic Gynecological Surgery Clinical Trial

Official title:

Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery , a Randomized Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01955798
• Other study ID #: DEX2013001
• Status: Withdrawn
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: February 2020
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Any woman suitable for laparoscopic gyneacological surgery

Exclusion Criteria:

• Previus supra-infra umbilical laparotomy

• three or more previous abdominal surgeries

Related Conditions & MeSH terms

• Laparoscopic Gynecological Surgery

Intervention

Procedure:
• Laparoscopic direct entry Trocar
Laparoscopic direct entry with trocar
• Laparoscopic entry Veress needle
Laparoscopic entry with Veress needle

Device:
• Trocar

• Veress needle

Locations

Country	Name	City	State
Spain	Hospital Quiron Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. Review. Update in: Cochrane Database Syst Rev. 2015;8:CD006583. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications during entry in laparoscopy	Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc	During surgery
Secondary	Time to enter in the abdominal cavity	Time in seconds from the impact of the trocar or the veress needle to enter in the abdominal cavity	During surgery

External Links

•   Related Info