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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01955798
Enrollment
0
Registered
2013-10-08
Start date
2015-01-31
Completion date
2017-10-31
Last updated
2020-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Gynecological Surgery

Keywords

Laparoscopy, Gyneacological, Entry techniques

Brief 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

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.

Interventions

PROCEDURELaparoscopic direct entry Trocar

Laparoscopic direct entry with trocar

PROCEDURELaparoscopic entry Veress needle

Laparoscopic entry with Veress needle

DEVICETrocar

Sponsors

Fundacion Dexeus
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Any woman suitable for laparoscopic gyneacological surgery

Exclusion criteria

* Previus supra-infra umbilical laparotomy * three or more previous abdominal surgeries

Design outcomes

Primary

MeasureTime frameDescription
Complications during entry in laparoscopyDuring surgeryComplications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc

Secondary

MeasureTime frameDescription
Time to enter in the abdominal cavityDuring surgeryTime in seconds from the impact of the trocar or the veress needle to enter in the abdominal cavity

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026