An interventional study of Video telescopic operating microscope and Loupe with magnification 4x in Video Telescopic Operating Microscope and Loupe- Assisted Varicocelectomy, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
This study aims to compare the efficacy, outcome and surgeon satisfaction in Video Telescopic Operating Microscope (VITOM) microsurgical subinguinal varicocelectomy with Loupe- assisted subinguinal varicocelectomy.
Varicocele is a common medical condition characterized by abnormal dilation and enlargement of the scrotal venous pampiniform plexus, which drains blood from the testicles resulting in complex network of swollen regurging veins.
There are different approaches in varicocelectomy; open surgical inguinal , subinguinal or intrascrotal ,which can be conventional open surgery or by using surgical microscope or Video Telescopic Operating Microscope (VITOM) or Loupeassisted. Also varicocelectomy can be done by laparoscopic retroperitoneal abdominal ligation of gonadal veins or endovascular approach using antegrade sclerotherapy. Improved semen parameters and fewer complications are noticed, when magnification has been used. Magnification can be done using surgical microscope or VITOM or Loupe-assisted.
Cairo University is the lead sponsor of 4,929 studies on the registry; 1,450 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Patients will be managed using video telescopic operating microscope (VITOM).
Device: Video telescopic operating microscope
Patients will be managed using Loupe with magnification 4x.
Device: Loupe with magnification 4x
Patients will be managed using video telescopic operating microscope (VITOM).
Patients will be managed using Loupe with magnification 4x.
Total Motile Sperm Count
Total motile sperm count (TMSC), expressed as millions of motile sperm per ejaculate, will be assessed by semen analysis. TMSC will be calculated by multiplying semen volume (mL) by sperm concentration (million/mL) and the proportion of motile sperm.
Time frame: 3 months after surgery
Scrotal Pain Intensity
Scrotal pain will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity.
Time frame: 3 months after surgery
Scrotal Swelling
Number of participants with scrotal swelling will be assessed by clinical examination.
Time frame: 3 months after surgery
Surgeon Satisfaction With the Visualization Device
Surgeon-reported assessment using the protocol's 13-item questionnaire covering image quality, equipment handling, ergonomics, and educational usefulness. Each item is rated on a five-point scale.
Time frame: Immediately after surgery (with in one hour)
Erectile Function
Erectile function will be assessed using the five-item International Index of Erectile Function (IIEF-5). As presented in the protocol, total scores range from 5 to 25, with higher scores indicating better erectile function.
Time frame: 3 months after surgery
Serum Total Testosterone
Serum total testosterone concentration will be measured by laboratory testing and compared between treatment groups.
Time frame: 3 months after surgery
Varicocele Recurrence
Number of participants with recurrent varicocele will be assessed clinically at follow-up, with scrotal duplex ultrasonography performed at 3 months.
Time frame: 3 months after surgery
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
Time frame: After the end of study for one year.
Access criteria: The data will be available upon a reasonable request from the corresponding author.
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for Nov 2026, 12 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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