NCT01597362

Brief Summary

The study compares the Veress needle technique, the Direct trocar insertion and the Open technique with each other, in terms of minor complications, in elective laparoscopic procedures for benign pathologies.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
608

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Status
completed

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

Study Start

First participant enrolled

February 1, 2006

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2012

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

4.2 years

First QC Date

May 9, 2012

Last Update Submit

May 11, 2012

Conditions

Benign Gynecological Pathology

Keywords

laparoscopytrocarsveressopendirect

Outcome Measures

Primary Outcomes (1)

  • minor complications

    feasibility of the techniques and the incidence of Veress needle, Direct technique insertion and Open technique related minor complications

    1 year

Study Arms (3)

Veress needle technique

OTHER
Procedure: Laparoscopy

Direct trocar technique

OTHER
Procedure: Laparoscopy

Open technique

OTHER
Procedure: laparoscopy

Interventions

LaparoscopyPROCEDURE

Trocar access in laparoscopy

Open technique

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • not-obese adult patients referred for scheduled laparoscopic and gynecologic procedures,
  • benign pathology
  • no previous abdominal surgery
  • Age range was 18-70 years

You may not qualify if:

  • obesity, defined as a body mass index (BMI) \> 30 kg/m2
  • previous abdominal surgery by laparoscopy or laparotomy
  • history of PID
  • irritable Bowel Syndrome
  • suspicion of malignancy or malignancy at the histological examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Angioli R, Terranova C, De Cicco Nardone C, Cafa EV, Damiani P, Portuesi R, Muzii L, Plotti F, Zullo MA, Panici PB. A comparison of three different entry techniques in gynecological laparoscopic surgery: a randomized prospective trial. Eur J Obstet Gynecol Reprod Biol. 2013 Dec;171(2):339-42. doi: 10.1016/j.ejogrb.2013.09.012. Epub 2013 Sep 23.

    PMID: 24103531DERIVED

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 9, 2012

First Posted

May 14, 2012

Study Start

February 1, 2006

Primary Completion

May 1, 2010

Study Completion

September 1, 2010

Last Updated

May 14, 2012

Record last verified: 2012-05