Cholecystitis; GallstoneNCT06045546
A (5-5-5-8) Technique for Laparoscopic Cholecystectomy
A study testing 5-5-5-8 technique and 10-10-5-5 technique in people with Cholecystitis; Gallstone and Cholecystolithiasis, run by ClinAmygate at 1 site in Egypt.
Trial summary
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis; Gallstone, Cholecystolithiasis, Cholecystitis, Chronic
- What is being tested?
- 5-5-5-8 technique and 10-10-5-5 technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2023to 20 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged > 18 years
- Patients eligible for LC during the study period
Who cannot join
- refused to participate
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.
Read the detailed description
More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances.
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.
The study has two analyses:
- at 6 month follow up
- at 24 months follow up
- Being tested
- 5-5-5-8 technique, 10-10-5-5 technique
- Medical subject headings
- Cholecystitis, Gallstones, Cholecystolithiasis, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-5-5-8 techniqueProcedure or surgery
the new technique of 5-5-5-8 for laparoscopic cholecystectomy
10-10-5-5 techniqueProcedure or surgery
the standard technique of 10-10-5-5 for laparoscopic cholecystectomy
| Study group | Role | What they receive |
|---|---|---|
| 5-5-5-8 group | Experimental | In this group, the new 5-5-5-8 technique of laparoscopic cholecystectomy will be done. Receives: Procedure: 5-5-5-8 technique |
| Control | Active comparator | In this group, the 10-10-5-5 technique of laparoscopic cholecystectomy will be done. Receives: Procedure: 10-10-5-5 technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the operation
Duration of the operation in minutes
Measured: 1 hour
Number of participants with Conversion to open surgery
Number of participants with Failure of the technique and conversion to open surgery
Measured: 1 hour
Incidence of intra operative visceral injury
Incidence of intra operative visceral injury
Measured: 2 hours
intra operative amount of blood loss
intra operative amount of blood loss in ml
Measured: 2 hours
incidence of intra operative complications
incidence of intra operative complications
Measured: 2 hours
Secondary outcomes (5)
post operative stay
post operative stay in days
Measured: 1 week
incidence of port site infection
incidence of infection of the port site
Measured: 1 month
Incidence of port site hernia
Incidence of hernia of the port site
Measured: 6 months
Incidence of port site hernia
Incidence of hernia of the port site
Measured: 12 months
Incidence of port site hernia
Incidence of hernia of the port site
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start20 Sep 2023
- Primary completion20 Sep 2024
- Study completion20 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis; GallstoneStudies 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, Outcomes assessor
- Enrolment
- 524 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinAmygate
- Sponsor type
- University, hospital or other
- Collaborators
- Aswan University Hospital
- Responsible party
- Sponsor
- Investigators
- Mohie El-Din M Madani, MD, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045546
- Sponsor's protocol ID
- PR00C1947
- Status last verified
- Apr 2025
- First submitted
- 11 Sep 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared after approval of the IRB
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A (5-5-5-8) Technique for Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT06045546
- Acronym / sponsor ID
- PR00C1947
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 524 participants (actual)
- Lead sponsor
- ClinAmygateUniversity, hospital or other
- Collaborators
- Aswan University Hospital
- Study start
- 20 Sep 2023 (actual)
- Primary completion
- 20 Sep 2024 (actual)
- Study completion
- 20 Sep 2026 (estimated)
- First posted
- 21 Sep 2023 (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.
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.
Detailed description
More than 50 different LC procedures are described in the literature, mostly as a result of changes made by surgeons to enhance cosmetic and postoperative results. Some adjustments include port size and/or number reductions relative to conventional LC usage. Each of these methods has benefits and drawbacks, and each one is appropriate for usage in particular circumstances.
The aim of this current study is to investigate the effectiveness and safety of a novel technique which is the 5-5-5-8 where the camera port is 5 mm.
The study has two analyses:
- at 6 month follow up
- at 24 months follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5-5-5-8 group | Experimental | Procedure: 5-5-5-8 techniqueIn this group, the new 5-5-5-8 technique of laparoscopic cholecystectomy will be done. |
| Control | Active comparator | Procedure: 10-10-5-5 techniqueIn this group, the 10-10-5-5 technique of laparoscopic cholecystectomy will be done. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged > 18 years
- Patients eligible for LC during the study period
Key exclusion criteria (1 listed)
- refused to participate
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 |
|---|---|---|
| 5-5-5-8 techniquethe new technique of 5-5-5-8 for laparoscopic cholecystectomy | Procedure or surgery | 5-5-5-8 group |
| 10-10-5-5 techniquethe standard technique of 10-10-5-5 for laparoscopic cholecystectomy | Procedure or surgery | Control |
Primary outcome
Duration of the operation
Time frame: 1 hour
Duration of the operation in minutes
Number of participants with Conversion to open surgery
Time frame: 1 hour
Number of participants with Failure of the technique and conversion to open surgery
Incidence of intra operative visceral injury
Time frame: 2 hours
Incidence of intra operative visceral injury
intra operative amount of blood loss
Time frame: 2 hours
intra operative amount of blood loss in ml
incidence of intra operative complications
Time frame: 2 hours
incidence of intra operative complications
5 secondary outcomes
post operative stay
Time frame: 1 week
incidence of port site infection
Time frame: 1 month
Incidence of port site hernia
Time frame: 6 months
Incidence of port site hernia
Time frame: 12 months
Incidence of port site hernia
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: No. IPD will be shared after approval of the IRB
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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.
Mohie El-Din M Madani, MD principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-5-5-8 technique and 10-10-5-5 technique in people with Cholecystitis; Gallstone and Cholecystolithiasis, run by ClinAmygate 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 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: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Duration of the operation (time frame: 1 hour). The study lists 5 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 16 Apr 2025; AzTrials last refreshed its copy on 31 Oct 2026.