VaricoceleNCT02335385
Single Incision Laparoscopic Varicocelectomy
A study testing single incision laparoscopic varicocelectomy and conventional transperitoneal laparoscopic varicocelectomy in people with Varicocele, run by Mansoura University.
Trial summary
Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- single incision laparoscopic varicocelectomy and conventional transperitoneal laparoscopic varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2009to Jun 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with palpable varicoceles
Who cannot join
- unfit for anesthesia or laparoscopy
About this study
Official title: Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.
Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds.
Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.
- Conditions
- Varicocele
- Being tested
- single incision laparoscopic varicocelectomy, conventional transperitoneal laparoscopic varicocelectomy
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single incision laparoscopic varicocelectomyProcedure or surgery
bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.
conventional transperitoneal laparoscopic varicocelectomyProcedure or surgery
bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy
| Study group | Role | What they receive |
|---|---|---|
| SIL-V | Active comparator | single incision laparoscopic varicocelectomy Receives: Procedure: single incision laparoscopic varicocelectomy |
| CTL-V | Active comparator | conventional transperitoneal laparoscopic varicocelectomy Receives: Procedure: conventional transperitoneal laparoscopic varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with improvement in semen parameters and resolution of testicular pain
Measured: 2 years
Secondary outcomes (1)
number of patients developing postoperative complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2015 (estimated)
- Study startJun 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tamer Youssef Mohamed, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335385
- Sponsor's protocol ID
- MFM200912
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2015
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Youssef T, Abdalla E. Single incision transumbilical laparoscopic varicocelectomy versus the conventional laparoscopic technique: A randomized clinical study. Int J Surg. 2015 Jun;18:178-83. doi: 10.1016/j.ijsu.2015.04.048. Epub 2015 May 1.
PubMed 25937155
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Incision Transumbilical Laparoscopic Varicocelectomy: Comparison With the Conventional Laparoscopic Approach.
- ClinicalTrials.gov ID
- NCT02335385
- Acronym / sponsor ID
- MFM200912
- Conditions
- Varicocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Jan 2015 (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.
Conventional laparoscopic varicocelectomy using 3 ports has been used for treatment of varicocele in our department since the nineties. However, the relatively several trocar wounds represent a big challenge against its acceptance by many of our patients who prefer the open approach with one or at least two wounds.
Single incision laparoscopic surgery (SILS), since its introduction in 2007, has been proven to be feasible and effective, with high patient satisfaction rates regarding improved cosmotic outcomes, reduced postoperative pain, and rapid return to normal activities. (10, 11) SILS for varicocelectomy has been reported to be safe and effective alternative to conventional laparoscopic varicocelectomy in a few studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIL-V | Active comparator | Procedure: single incision laparoscopic varicocelectomysingle incision laparoscopic varicocelectomy |
| CTL-V | Active comparator | Procedure: conventional transperitoneal laparoscopic varicocelectomyconventional transperitoneal laparoscopic varicocelectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with palpable varicoceles
Key exclusion criteria (1 listed)
- unfit for anesthesia or 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 |
|---|---|---|
| single incision laparoscopic varicocelectomybilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port. | Procedure or surgery | SIL-V |
| conventional transperitoneal laparoscopic varicocelectomybilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy | Procedure or surgery | CTL-V |
Primary outcome
number of patients with improvement in semen parameters and resolution of testicular pain
Time frame: 2 years
1 secondary outcome
number of patients developing postoperative complications
Time frame: 2 years
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 9 Jan 2015.
- Derived from this study: PubMed 25937155Youssef T, Abdalla E. Single incision transumbilical laparoscopic varicocelectomy versus the conventional laparoscopic technique: A randomized clinical study. Int J Surg. 2015 Jun;18:178-83. doi: 10.1016/j.ijsu.2015.04.048. Epub 2015 May 1.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing single incision laparoscopic varicocelectomy and conventional transperitoneal laparoscopic varicocelectomy in people with Varicocele, run by Mansoura University.
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 9 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
number of patients with improvement in semen parameters and resolution of testicular pain (time frame: 2 years). 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 NCT02335385, which also lists 1 linked publication.
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 9 Jan 2015.