Gallbladde StonesSILSNCT01272505
Conventional SILS vs Harmonic Scalpel SILS
A study testing converntional SILC and Harmonic scalpel Single incision laparoscopic cholecystectomy in people with Gallbladde Stones, run by Mansoura University at 1 site in Egypt.
Trial summary
Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Gallbladde Stones
- What is being tested?
- converntional SILC and Harmonic scalpel Single incision laparoscopic cholecystectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 137 participants
- Where
- 1 siteEgypt
- Study dates
- Start not givento not given
- 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 14 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients with symptomatic gallbladder stones
Who cannot join
- acute cholecystitis cbd stones contraindications for laparoscopy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Gastroenterology Surgical Center
Al Mansurah, Dakahlia Governorate, 35516
ahmed a elgeidie, md, 0020105290111 ext. 0, ahmedraoaf@mans.edu.eg
ahmed a elgeidie, md
About this study
Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. The investigators will compare the ordinary method of single incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic cholecystectomy.
- Conditions
- Gallbladde Stones
- Being tested
- converntional SILC, Harmonic scalpel Single incision laparoscopic cholecystectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
converntional SILCProcedure or surgery
Harmonic scalpel Single incision laparoscopic cholecystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| conventional SILC | Placebo comparator | Conventional method of single incision laparoscopic cholecystectomy Receives: Procedure: converntional SILC; Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy |
| HS-SILC | Active comparator | Not described Receives: Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time
Secondary outcomes (1)
complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladde StonesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 137 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01272505
- Sponsor's protocol ID
- HSSILSVSCSILS
- Acronym
- SILS
- Status last verified
- Apr 2010
- First submitted
- 6 Jan 2011
- Last updated
- 7 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional SILS vs Harmonic Scalpel SILS
- ClinicalTrials.gov ID
- NCT01272505
- Acronym / sponsor ID
- SILS / HSSILSVSCSILS
- Conditions
- Gallbladde Stones
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 137 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- First posted
- 7 Jan 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.
Single incision laparoscopic cholecystectomy is gaining widespread acceptance. there are some obstacles making this procedure more complex than conventional laparoscopic cholecystectomy. The use of harmonic scalpel may aid in solving some of these issues that may allow simplification of the technique. The investigators will compare the ordinary method of single incision laparoscopic cholecystectomy versus harmonic scalpel single incision laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional SILC | Placebo comparator | Procedure: converntional SILC, Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomyConventional method of single incision laparoscopic cholecystectomy |
| HS-SILC | Active comparator | Procedure: Harmonic scalpel Single incision laparoscopic cholecystectomy |
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients with symptomatic gallbladder stones
Key exclusion criteria (1 listed)
- acute cholecystitis cbd stones contraindications for laparoscopy
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 |
|---|---|---|
| converntional SILC | Procedure or surgery | conventional SILC |
| Harmonic scalpel Single incision laparoscopic cholecystectomy | Procedure or surgery | HS-SILC, conventional SILC |
Primary outcome
operative time
1 secondary outcome
complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2011.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing converntional SILC and Harmonic scalpel Single incision laparoscopic cholecystectomy in people with Gallbladde Stones, 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: status not confirmed, as of the sponsor's last update on 7 Jan 2011. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed a elgeidie, md (0020105290111 ext. 0, ahmedraoaf@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time. 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 7 Jan 2011.