Laparoscopic Surgerynew techniqueNCT05475470
Blade Finger Technique for Safe Laparoscopic Entery
A study testing finger-blade technique, Hasson's technique and veress needle technique in people with Laparoscopic Surgery and Operative Surgical Procedure, run by Zagazig University at 1 site in Egypt.
Trial summary
blade-finger technique is a new technique for laparoscopic access which is safe Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery, Operative Surgical Procedure, Insufflation
- What is being tested?
- finger-blade technique, Hasson's technique and veress needle technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,005 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Mar 2020to 31 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients more than 18 year-old.
- underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to May, 2022.
Who cannot join
- Patients with one or more previous abdominal surgery (upper, lower or upper and lower midline scars).
- Patients with distended abdomen due to bowel obstruction.
- Patients with uncorrected coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Controlled Trial on Safe Laparoscopic Access and Ports Insertion Using the Blade-Finger Technique
blade-finger technique is a new technique for laparoscopic access which is safe
Read the detailed description
after optaining irb approval and patients consented, they were divided into 3 groups to whom one of the techniques of laparoscopic entery was applied and there was a comparison between these groups
- Being tested
- finger-blade technique, Hasson's technique, veress needle technique
- Keywords
- veress needle, Hasson's technique, laparoscopic access, blade-finger technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
finger-blade techniqueProcedure or surgery
Also called laparoscopic access technique
laparoscopic access technique for group a
Hasson's techniqueProcedure or surgery
Also called laparoscopic access technique
laparoscopic access technique for group b
veress needle techniqueProcedure or surgery
Also called laparoscopic access technique for group c
laparoscopic access technique for group c
| Study group | Role | What they receive |
|---|---|---|
| group a | Experimental | the group we used our new blade-finger technique Receives: Procedure: finger-blade technique |
| group b | Experimental | the group we used Hasson's technique Receives: Procedure: Hasson's technique |
| group c | Experimental | the group we used veress needle technique Receives: Procedure: veress needle technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
time needed to access the peritoneal cavity
the time of the procedure of access
Measured: the first 15 minutes of operation
numbers of trials till the good peritoneal access achieved
number of trials till succeeded peritoneal access
Measured: the first 15 minutes of operation
Secondary outcomes (1)
rate of complications
bleeding, bowel injury
Measured: the first 15 minutes of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start20 Mar 2020
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,005 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohamed lotfy, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05475470
- Sponsor's protocol ID
- zuh 247
- Acronym
- new technique
- Status last verified
- Jul 2022
- First submitted
- 24 Jul 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial on Safe Laparoscopic Access and Ports Insertion Using the Blade-Finger Technique
- ClinicalTrials.gov ID
- NCT05475470
- Acronym / sponsor ID
- new technique / zuh 247
- Keywords
- veress needle, Hasson's technique, laparoscopic access, blade-finger technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,005 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 27 Jul 2022 (actual)
- 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.
blade-finger technique is a new technique for laparoscopic access which is safe
Detailed description
after optaining irb approval and patients consented, they were divided into 3 groups to whom one of the techniques of laparoscopic entery was applied and there was a comparison between these groups
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| group a | Experimental | Procedure: finger-blade techniquethe group we used our new blade-finger technique |
| group b | Experimental | Procedure: Hasson's techniquethe group we used Hasson's technique |
| group c | Experimental | Procedure: veress needle techniquethe group we used veress needle technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients more than 18 year-old.
- underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to May, 2022.
Key exclusion criteria (3 listed)
- Patients with one or more previous abdominal surgery (upper, lower or upper and lower midline scars).
- Patients with distended abdomen due to bowel obstruction.
- Patients with uncorrected coagulopathy.
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 |
|---|---|---|
| finger-blade techniqueAlso: laparoscopic access techniquelaparoscopic access technique for group a | Procedure or surgery | group a |
| Hasson's techniqueAlso: laparoscopic access techniquelaparoscopic access technique for group b | Procedure or surgery | group b |
| veress needle techniqueAlso: laparoscopic access technique for group claparoscopic access technique for group c | Procedure or surgery | group c |
Primary outcome
time needed to access the peritoneal cavity
Time frame: the first 15 minutes of operation
the time of the procedure of access
numbers of trials till the good peritoneal access achieved
Time frame: the first 15 minutes of operation
number of trials till succeeded peritoneal access
1 secondary outcome
rate of complications
Time frame: the first 15 minutes of operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing finger-blade technique, Hasson's technique and veress needle technique in people with Laparoscopic Surgery and Operative Surgical Procedure, run by Zagazig University at 1 site in Egypt.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jul 2022. 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 Egypt. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time needed to access the peritoneal cavity (time frame: the first 15 minutes of operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jul 2022.