VaricoceleCMMVNCT02092311
Assessing the Rates of Major Complications in Combined Mini-incision Microscopic Varicocelectomy
A study testing Combined Microscopic Varicocelectomy and Inguinal and Subinguinal varicocelectomy in people with Varicocele, run by Omid Fertility Center at 1 site in Iran.
Trial summary
The purpose of this study is to determine the rates of major post-varicocelectomy complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new method named Combined Mini-incision Microscopic Varicocelectomy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Varicocele
- What is being tested?
- Combined Microscopic Varicocelectomy and Inguinal and Subinguinal varicocelectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 1 siteIran
- Study dates
- Jan 2006to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Complexity and tortuosity of the veins at inguinal level so that separating and ligation of the vein could lead to artery injury
- Veins which are contiguous with arteries so that separating and ligation of the vein could lead to artery injury
Who cannot join
- Prior surgery at inguinal level such as Herniorrhaphy, Orchiopexy,etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Post-operative Rates of Recurrence, Hydrocele and Testicular Atrophy in Patients Operated With a New Approach of Varicocelectomy Named Combined Mini-incision Microscopic Varicocelectomy (CMMV)
The purpose of this study is to determine the rates of major post-varicocelectomy complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new method named Combined Mini-incision Microscopic Varicocelectomy. The study hypothesis is that using this method will lead to less major complications of recurrence, hydrocele, and also less incidental injuries to the arteries that will result less testicular atrophy
Read the detailed description
The sample is selected from the patients who were referred to our center for surgical treatment of varicocele. Most of them were diagnosed after being evaluated for infertility.
All of them were operated by a single experienced and expert microscopic surgeon.
Informed consent is received from all of the possible candidates in accordance to national and Declaration of Helsinki guidelines.
Selection of patients for undergoing Combined varicocelectomy was done during the operation due to the nature of including criteria.
In this method after making an incision at inguinal level, veins are evaluated and if the including criteria is existed, only external spermatic vein is ligated at the depth of the inguinal canal and other veins are left alone for prevention of damage to the artery. Then another mini incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach.
The incidence rate of major complications (recurrence, testicular atrophy, hydrocele) of experimental group is compared to the incidence rate of the same complications of the patients in control group that were operated with currently common inguinal and subinguinal microscopic varicocelectomy accompanied by testicular delivery, an approach that is suggested by Goldstein and associates.
The study hypothesis is that using this method will lead to less major complications including recurrence, hydrocele and also less incidental injuries to the arteries that will result to less testicular atrophy.
- Conditions
- Varicocele
- Being tested
- Combined Microscopic Varicocelectomy, Inguinal and Subinguinal varicocelectomy
- Keywords
- varicocele, varicocelectomy, complications of varicocelectomy, Recurrence of varicocele, Post-varicocelectomy testicular atrophy, Post-varicocelectomy hydrocele
- Medical subject headings
- Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Microscopic VaricocelectomyProcedure or surgery
After making a mini-incision at inguinal level, veins are evaluated, and if the including criteria (Complexity and tortuosity of the veins and/or existence of veins that are contiguous with arteries so that separating and ligation of the veins could jeopardize the artery) are existed, only external spermatic vein, if dilated, is ligated at the depth of the inguinal canal, and other veins are left alone for prevention of damage to the artery. Subsequently, another mini-incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach, which is also done microscopically
Inguinal and Subinguinal varicocelectomyProcedure or surgery
Microscopic Inguinal and Sub inguinal varicocelectomy, recommended by Goldstein and associates, are currently popular approaches. In this approach the spermatic cord structures are pulled up and out of the wound so that the testicular artery, lymphatics, and small periarterial veins may be more easily identified. In addition, an inguinal or subinguinal approach allows access to external spermatic and even gubernacular veins.
| Study group | Role | What they receive |
|---|---|---|
| Combined Microscopic Varicocelectomy | Experimental | Patients in this arm were operated with Combined Mini-incision Microscopic approach Receives: Procedure: Combined Microscopic Varicocelectomy |
| Inguinal and Subinguinal Varicocelectomy | Active comparator | Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associates Receives: Procedure: Inguinal and Subinguinal varicocelectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Varicocele
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
Measured: 6 months
Secondary outcomes (1)
Post-varicocelectomy Hydrocele
Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startJan 2006
- Primary completionSep 2013
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omid Fertility Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Sponsor
- Investigators
- Omid Pouyan, MD, Study director, Omid Fertility CenterNavid Pooyan, MD, Principal investigator, Omid Fertility CenterRobabeh Taheri Panah, MD, Study chair, Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciencesAshraf Ale Yasin, MD, Study chair, Omid Fertility CenterMarzieh Agha Hosseini, MD, Study chair, Omid Fertility CenterHojatollah Saeidi Saeid Abadi, P.H.D, Study chair, Omid FC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02092311
- Sponsor's protocol ID
- CMMV
- Acronym
- CMMV
- Status last verified
- Jun 2015
- First submitted
- 18 Mar 2014
- Last updated
- 3 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Post-operative Rates of Recurrence, Hydrocele and Testicular Atrophy in Patients Operated With a New Approach of Varicocelectomy Named Combined Mini-incision Microscopic Varicocelectomy (CMMV)
- ClinicalTrials.gov ID
- NCT02092311
- Acronym / sponsor ID
- CMMV / CMMV
- Conditions
- Varicocele
- Keywords
- varicocele, varicocelectomy, complications of varicocelectomy, Recurrence of varicocele, Post-varicocelectomy testicular atrophy, Post-varicocelectomy hydrocele
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Omid Fertility CenterUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- Jan 2006
- Primary completion
- Sep 2013 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Posted 30 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the rates of major post-varicocelectomy complications (Recurrence, Hydrocele and Testicular Atrophy) in patients operated with a new method named Combined Mini-incision Microscopic Varicocelectomy. The study hypothesis is that using this method will lead to less major complications of recurrence, hydrocele, and also less incidental injuries to the arteries that will result less testicular atrophy
Detailed description
The sample is selected from the patients who were referred to our center for surgical treatment of varicocele. Most of them were diagnosed after being evaluated for infertility.
All of them were operated by a single experienced and expert microscopic surgeon.
Informed consent is received from all of the possible candidates in accordance to national and Declaration of Helsinki guidelines.
Selection of patients for undergoing Combined varicocelectomy was done during the operation due to the nature of including criteria.
In this method after making an incision at inguinal level, veins are evaluated and if the including criteria is existed, only external spermatic vein is ligated at the depth of the inguinal canal and other veins are left alone for prevention of damage to the artery. Then another mini incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach.
The incidence rate of major complications (recurrence, testicular atrophy, hydrocele) of experimental group is compared to the incidence rate of the same complications of the patients in control group that were operated with currently common inguinal and subinguinal microscopic varicocelectomy accompanied by testicular delivery, an approach that is suggested by Goldstein and associates.
The study hypothesis is that using this method will lead to less major complications including recurrence, hydrocele and also less incidental injuries to the arteries that will result to less testicular atrophy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Microscopic Varicocelectomy | Experimental | Procedure: Combined Microscopic VaricocelectomyPatients in this arm were operated with Combined Mini-incision Microscopic approach |
| Inguinal and Subinguinal Varicocelectomy | Active comparator | Procedure: Inguinal and Subinguinal varicocelectomyPatients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associates |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Complexity and tortuosity of the veins at inguinal level so that separating and ligation of the vein could lead to artery injury
- Veins which are contiguous with arteries so that separating and ligation of the vein could lead to artery injury
Key exclusion criteria (1 listed)
- Prior surgery at inguinal level such as Herniorrhaphy, Orchiopexy,etc.
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 |
|---|---|---|
| Combined Microscopic VaricocelectomyAfter making a mini-incision at inguinal level, veins are evaluated, and if the including criteria (Complexity and tortuosity of the veins and/or existence of veins that are contiguous with arteries so that separating and ligation of the veins could jeopardize the artery) are existed, only external spermatic vein, if dilated, is ligated at the depth of the inguinal canal, and other veins are left alone for prevention of damage to the artery. Subsequently, another mini-incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach, which is also done microscopically | Procedure or surgery | Combined Microscopic Varicocelectomy |
| Inguinal and Subinguinal varicocelectomyMicroscopic Inguinal and Sub inguinal varicocelectomy, recommended by Goldstein and associates, are currently popular approaches. In this approach the spermatic cord structures are pulled up and out of the wound so that the testicular artery, lymphatics, and small periarterial veins may be more easily identified. In addition, an inguinal or subinguinal approach allows access to external spermatic and even gubernacular veins. | Procedure or surgery | Inguinal and Subinguinal Varicocelectomy |
Primary outcome
Recurrent Varicocele
Time frame: 6 months
post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery
1 secondary outcome
Post-varicocelectomy Hydrocele
Time frame: 6months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Omid Pouyan, MD study director
Omid Fertility Center
Navid Pooyan, MD principal investigator
Omid Fertility Center
Robabeh Taheri Panah, MD study chair
Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Microscopic Varicocelectomy and Inguinal and Subinguinal varicocelectomy in people with Varicocele, run by Omid Fertility Center at 1 site in Iran.
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: finished, as of the sponsor's last update on 3 Jul 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 Iran. 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?
Yes. Results are posted in the registry (first posted 30 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Recurrent Varicocele (time frame: 6 months). 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 3 Jul 2015.