Single Infrapubic Versus Bilateral Subinguinal Microsurgical Varicocelectomy
2026년 6월 11일 업데이트: Hany Fathy Badawy, MD, Beni-Suef University
Single Infrapubic Versus Bilateral Subinguinal Approaches for Bilateral Microsurgical Varicocelectomy: A Prospective Randomized Controlled Trial
Bilateral varicocele is commonly treated by microsurgical varicocelectomy. The conventional bilateral subinguinal approach usually requires two separate skin incisions, one on each side. A single midline infrapubic approach may allow bilateral microsurgical repair through one incision and may reduce access-related morbidity.
This prospective randomized controlled trial will compare single infrapubic microsurgical bilateral varicocelectomy with conventional bilateral subinguinal microsurgical varicocelectomy in adult men with clinically palpable bilateral varicocele. The study will evaluate postoperative pain, analgesic requirement, time to return to normal daily activity, operative time, scar satisfaction, wound complications, recurrence, and other safety outcomes during follow-up.
연구 개요
상태
모병
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Hany F Badawy, MD
- 전화번호: +201149525028
- 이메일: HANYFATHY86@GMAIL.COM
연구 장소
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Beni Suweif Governorate
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Banī Suwayf, Beni Suweif Governorate, 이집트, 02456
- 모병
- Department of Urology- Beni-Suef University Hospitals
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연락하다:
- Hany F Badawy, MD
- 전화번호: +201149525028
- 이메일: HANYFATHY86@GMAIL.COM
-
수석 연구원:
- Hany F Badawy, MD
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연락하다:
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Male patients aged 18 to 45 years.
- Clinically palpable bilateral varicocele, grade II or grade III.
- Diagnosis confirmed by color Doppler ultrasound.
- Infertility for at least 12 months and/or abnormal semen analysis.
- Female partner evaluation performed or planned to exclude major uncorrected female-factor infertility.
- Patient fit for surgery and anesthesia.
- Written informed consent provided by the participant.
Exclusion Criteria:
- Subclinical varicocele detected only by Doppler ultrasound.
- Unilateral varicocele.
- Recurrent varicocele after previous surgery, embolization, or sclerotherapy.
- Previous inguinal, scrotal, pelvic, or penile surgery likely to distort surgical anatomy.
- Associated inguinal hernia, hydrocele, spermatocele, epididymal cyst, or other scrotal condition requiring simultaneous surgery.
- Azoospermia, especially suspected non-obstructive azoospermia.
- Active urinary tract or genital infection.
- Coagulopathy or anticoagulant therapy that cannot be safely interrupted.
- Severe obesity, defined as body mass index greater than 40 kg/m², or any anatomical condition preventing safe exposure by either surgical approach.
- Refusal to participate or inability to complete follow-up.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Single Infrapubic Microsurgical Bilateral Varicocelectomy
Participants allocated to this arm will undergo bilateral microsurgical varicocelectomy through a single midline infrapubic skin incision.
The right and left spermatic cords will be approached sequentially through the same incision under microscopic or high-magnification surgical loupes with microsurgical capability.
Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
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Bilateral microsurgical varicocelectomy performed through a single midline infrapubic skin incision.
The right and left spermatic cords will be approached sequentially through the same incision under microscopic or high-magnification surgical loupes with microsurgical capability.
Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
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활성 비교기: Bilateral Subinguinal Microsurgical Varicocelectomy
Participants allocated to this arm will undergo conventional bilateral subinguinal microsurgical varicocelectomy through two separate standard subinguinal incisions, one on each side.
Each spermatic cord will be isolated at the subinguinal level under microscopic or high-magnification surgical loupes with microsurgical capability.
Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
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Conventional bilateral microsurgical varicocelectomy performed through two separate standard subinguinal incisions, one on each side.
Each spermatic cord will be isolated at the subinguinal level under microscopic or high-magnification surgical loupes with microsurgical capability.
Dilated spermatic veins will be ligated while preserving the testicular artery or arteries, lymphatic vessels, vas deferens, and vasal vessels.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Postoperative Pain Score
기간: 6 hours, 24 hours, and 7 days after surgery
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Postoperative pain will be assessed using the Visual Analog Scale.
The scale ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate worse postoperative pain.
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6 hours, 24 hours, and 7 days after surgery
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Analgesic Requirement
기간: During the first 7 postoperative days
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Analgesic requirement will be assessed by recording the total number and dose of analgesic tablets and/or injections consumed by the participant during the first 7 postoperative days.
Higher analgesic use indicates greater postoperative analgesic requirement.
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During the first 7 postoperative days
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Time to Return to Normal Daily Activity
기간: From surgery until return to normal daily activity, assessed up to 30 days after surgery
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Time to return to normal daily activity will be defined as the number of days from surgery until the participant resumes usual non-strenuous daily activities.
A shorter time indicates faster postoperative recovery.
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From surgery until return to normal daily activity, assessed up to 30 days after surgery
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Total Operative Time
기간: During surgery
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Total operative time will be defined as the time from skin incision to completion of skin closure, measured in minutes.
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During surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Scar Satisfaction and Cosmetic Outcome
기간: 6 months after surgery
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Scar satisfaction and cosmetic outcome will be assessed using the Patient and Observer Scar Assessment Scale version 2.0.
The scale includes two components: the Patient Scale and the Observer Scale.
The Patient Scale assesses pain, itching, color, stiffness, thickness, and irregularity.
The Observer Scale assesses vascularity, pigmentation, thickness, relief, pliability, and surface area.
Each item is scored from 1 to 10, where 1 indicates normal skin or no symptoms and 10 indicates the worst imaginable scar or the greatest difference from normal skin.
The total score for each component ranges from 6 to 60. Higher scores indicate worse scar quality and lower scar satisfaction.
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6 months after surgery
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Varicocele Recurrence
기간: 6 months after surgery
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Varicocele recurrence will be assessed by clinical examination and/or color Doppler ultrasound.
Recurrence will be reported as the number and percentage of participants with recurrent varicocele.
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6 months after surgery
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Conversion or Access Failure
기간: During surgery
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Conversion or access failure will be recorded when the allocated surgical approach cannot be completed as planned and an additional or alternative incision or approach is required to safely complete the procedure.
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During surgery
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Wound Complications
기간: Up to 30 days after surgery
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Wound complications will be assessed by recording the occurrence of surgical site infection, hematoma, seroma, wound dehiscence, or delayed wound healing.
The outcome will be reported as the number and percentage of participants with any wound complication.
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Up to 30 days after surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Hany F Badawy, MD, Faculty of medicine Beni-Suef University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 6월 8일
기본 완료 (추정된)
2027년 4월 1일
연구 완료 (추정된)
2027년 5월 1일
연구 등록 날짜
최초 제출
2026년 6월 11일
QC 기준을 충족하는 최초 제출
2026년 6월 11일
처음 게시됨 (실제)
2026년 6월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 16일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 11일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- BSU-INFRAP-VARICO-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
Individual participant data will not be shared because the study includes sensitive reproductive health data, semen analysis results, infertility-related information, and treatment-related clinical information.
Only aggregated, de-identified results will be reported in publications or presentations.
Any future sharing of de-identified participant-level data would require additional approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .