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| Name | Class |
|---|---|
| Shahid Beheshti University of Medical Sciences | OTHER |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Microscopic Varicocelectomy | Experimental | Patients in this arm were operated with Combined Mini-incision Microscopic approach |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Microscopic Varicocelectomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Varicocele | post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-varicocelectomy Hydrocele | Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery | 6months |
| Measure | Description | Time Frame |
|---|---|---|
| Post-varicocelectomy Testicular Atrophy | development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery | 6months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Omid Pouyan, MD | Omid Fertility Center | Study Director |
| Navid Pooyan, MD | Omid Fertility Center | Principal Investigator |
| Robabeh Taheri Panah, MD | Infertility and Reproductive Health research center of Shahid Beheshti university of medical sciences | Study Chair |
| Ashraf Ale Yasin, MD | Omid Fertility Center | Study Chair |
| Marzieh Agha Hosseini, MD | Omid Fertility Center | Study Chair |
| Hojatollah Saeidi Saeid Abadi, P.H.D | Omid FC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Omid fertility center | Tehran | Tehran Province | Iran |
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| ID | Title | Description |
|---|---|---|
| FG000 | Combined Microscopic Varicocelectomy | Combined Mini-Incision Microscopic Varicocelectomy |
| FG001 | Inguinal and Subinguinal Varicocelectomy | 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 associate |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Combined Microscopic Varicocelectomy | Patients underwent Combined Mini-incision Microscopic Varicocelectomy |
| BG001 | Inguinal and Subinguinal Varicocelectomy | 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 associate |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent Varicocele | post-varicocelectomy recurrence is measured by physical exam at intervals of 10 days,3months and 6months after surgery | Posted | Number | participants | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Combined Microscopic Varicocelectomy | Patients underwent Combined Mini-incision Microscopic Varicocelectomy |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Testicular Atrophy | Reproductive system and breast disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Recurrent Varicocele | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Navid Pooyan | OMID FERTILITY CENTER | 00989124474032 | navidpooyan@yahoo.com |
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| ID | Term |
|---|---|
| D014646 | Varicocele |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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|
| Inguinal and Subinguinal varicocelectomy | Procedure | 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. |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Post-varicocelectomy Hydrocele | Development of hydrocele is assessed by physical exam at intervals of 10 days,3months and 6months after surgery | Posted | Number | Participants | 6months |
|
|
|
| Other Pre-specified | Post-varicocelectomy Testicular Atrophy | development of testicular atrophy is assessed by physical exam at intervals of 3 and 6 months after surgery | Posted | Number | Participants | 6months |
|
|
|
| 0 |
| 285 |
| 2 |
| 285 |
| EG001 | Inguinal and Subinguinal Varicocelectomy | 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 associate | 0 | 285 | 16 | 285 |
| Hydrocele | Reproductive system and breast disorders | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |