Gallbladder DiseasesNCT01413633
A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy
A study testing cholecystectomy in people with Gallbladder Diseases, run by Mansoura University at 1 site in Egypt.
Trial summary
The investigators describe a novel technique for GB fundus retraction. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gallbladder Diseases
- What is being tested?
- cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2012to Dec 2012
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all cases underwent single incision cholecystectomy
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
The investigators describe a novel technique for GB fundus retraction.
Read the detailed description
few methods are available for gall bladder (GB) retraction in SILC to replace the usage of ancillary ports imitating retraction from conventional technique, e.g. trans-parietal stitches mini-loop retractor , a Kirschner wire . This technical note describes a novel way to retract the gall bladder fundus.
- Conditions
- Gallbladder Diseases
- Being tested
- cholecystectomy
- Medical subject headings
- Gallbladder Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecystectomyProcedure or surgery
Also called SILC
single incision laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| cholecystectomy | Experimental | single incision laparoscopic cholecystectomy Receives: Procedure: cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
the time from starting the procedure till the skin closure
Measured: about 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MOHAMED ABDELLATIF, Mansoura University
- Investigators
- DRAMADAN ELLITHY, M, Study chair, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413633
- Sponsor's protocol ID
- how to do it
- Status last verified
- Apr 2015
- First submitted
- 8 Aug 2011
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Technique For Gall Bladder Fundus Retraction In Single Incision Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT01413633
- Acronym / sponsor ID
- how to do it
- Conditions
- Gallbladder Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 10 Aug 2011 (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 investigators describe a novel technique for GB fundus retraction.
Detailed description
few methods are available for gall bladder (GB) retraction in SILC to replace the usage of ancillary ports imitating retraction from conventional technique, e.g. trans-parietal stitches mini-loop retractor , a Kirschner wire . This technical note describes a novel way to retract the gall bladder fundus.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cholecystectomy | Experimental | Procedure: cholecystectomysingle incision laparoscopic cholecystectomy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all cases underwent single incision cholecystectomy
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| cholecystectomyAlso: SILCsingle incision laparoscopic cholecystectomy | Procedure or surgery | cholecystectomy |
Primary outcome
operative time
Time frame: about 3 hours
the time from starting the procedure till the skin closure
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 8 Apr 2015.
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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.
DRAMADAN ELLITHY, M study chair
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cholecystectomy in people with Gallbladder Diseases, run by Mansoura 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 1 inclusion and 1 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 8 Apr 2015. 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?
operative time (time frame: about 3 hours). 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 8 Apr 2015.