Laparoscopic Gynecological SurgeryNCT01955798
Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery
A study testing Laparoscopic direct entry Trocar, Laparoscopic entry Veress needle and Trocar in people with Laparoscopic Gynecological Surgery, run by Fundacion Dexeus at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Laparoscopic Gynecological Surgery
- What is being tested?
- Laparoscopic direct entry Trocar, Laparoscopic entry Veress needle and Trocar
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any woman suitable for laparoscopic gyneacological surgery
Who cannot join
- Previus supra-infra umbilical laparotomy
- three or more previous abdominal surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Laparoscopic Gynecological Surgery
- Being tested
- Laparoscopic direct entry Trocar, Laparoscopic entry Veress needle, Trocar, Veress needle
- Keywords
- Laparoscopy, Gyneacological, Entry techniques
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic direct entry TrocarProcedure or surgery
Laparoscopic direct entry with trocar
Laparoscopic entry Veress needleProcedure or surgery
Laparoscopic entry with Veress needle
TrocarDevice
Veress needleDevice
| Study group | Role | What they receive |
|---|---|---|
| Trocar | Experimental | Pyramidal tip reusable 11mm trocar Receives: Procedure: Laparoscopic direct entry Trocar; Device: Trocar |
| Veress needle | Active comparator | Veress needle Receives: Procedure: Laparoscopic entry Veress needle; Device: Veress needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications during entry in laparoscopy
Complications during entry in laparoscopy like vascular injury, bowel injury,conversion to laparotomy, omental injury, etc
Measured: During surgery
Secondary outcomes (1)
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
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startJan 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: IP Change Hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Gynecological SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Rodriguez MSc, Fundacion Dexeus
- Investigators
- Alberto Vazquez, MD, Principal investigator, Salut de la Mujer Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955798
- Sponsor's protocol ID
- DEX2013001
- Status last verified
- Feb 2020
- First submitted
- 20 Sep 2013
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 22336819Tinelli 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.
PubMed 21245070
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Trocar Entry Versus Veress Needle Entry in Laparoscopic Gynecological Surgery , a Randomized Study
- ClinicalTrials.gov ID
- NCT01955798
- Acronym / sponsor ID
- DEX2013001
- Conditions
- Laparoscopic Gynecological Surgery
- Keywords
- Laparoscopy, Gyneacological, Entry techniques
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: IP Change Hospital
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trocar | Experimental | Procedure: Laparoscopic direct entry Trocar, Device: TrocarPyramidal tip reusable 11mm trocar |
| Veress needle | Active comparator | Procedure: Laparoscopic entry Veress needle, Device: Veress needleVeress needle |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any woman suitable for laparoscopic gyneacological surgery
Key exclusion criteria (2 listed)
- Previus supra-infra umbilical laparotomy
- three or more previous abdominal surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic direct entry TrocarLaparoscopic direct entry with trocar | Procedure or surgery | Trocar |
| Laparoscopic entry Veress needleLaparoscopic entry with Veress needle | Procedure or surgery | Veress needle |
| Trocar | Device | Trocar |
| Veress needle | Device | Veress needle |
Primary outcome
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
1 secondary outcome
Time to enter in the abdominal cavity
Time frame: During surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Background: PubMed 22336819Ahmad 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.
- Background: PubMed 21245070Tinelli 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Vazquez, MD principal investigator
Salut de la Mujer Dexeus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic direct entry Trocar, Laparoscopic entry Veress needle and Trocar in people with Laparoscopic Gynecological Surgery, run by Fundacion Dexeus at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications during entry in laparoscopy (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01955798, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.