NCT01955798

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 8, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

2.8 years

First QC Date

September 20, 2013

Last Update Submit

February 10, 2020

Conditions

Laparoscopic Gynecological Surgery

Keywords

LaparoscopyGyneacologicalEntry techniques

Outcome Measures

Primary Outcomes (1)

  • Complications during entry in laparoscopy

    Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc

    During surgery

Secondary Outcomes (1)

  • Time to enter in the abdominal cavity

    During surgery

Study Arms (2)

Trocar

EXPERIMENTAL

Pyramidal tip reusable 11mm trocar

Procedure: Laparoscopic direct entry TrocarDevice: Trocar

Veress needle

ACTIVE COMPARATOR

Veress needle

Procedure: Laparoscopic entry Veress needleDevice: Veress needle

Interventions

Laparoscopic direct entry TrocarPROCEDURE

Laparoscopic direct entry with trocar

Trocar
Laparoscopic entry Veress needlePROCEDURE

Laparoscopic entry with Veress needle

Veress needle
TrocarDEVICE
Trocar
Veress needleDEVICE
Veress needle

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any woman suitable for laparoscopic gyneacological surgery

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Quiron Dexeus

Barcelona, 08028, Spain

Location

Related 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.

    PMID: 22336819BACKGROUND

  • 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.

    PMID: 21245070BACKGROUND

Related Links

MeSH Terms

Interventions

Surgical Instruments

Intervention Hierarchy (Ancestors)

Surgical EquipmentEquipment and Supplies

Study Officials

  • Alberto Vazquez, MD

    Salut de la Mujer Dexeus

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Epidemilolgy

Study Record Dates

First Submitted

September 20, 2013

First Posted

October 8, 2013

Study Start

January 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

ES(1)