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临床试验/NCT06828185
NCT06828185招募中不适用

Patient Reported Experiences With Sparing ExteRnal Oblique Fascia Vs Standard Inguinal OrchiEctomy

Loma Linda University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年12月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
80
试验地点
1
主要终点
Postoperative Pain Level

研究概览

简要总结

The purpose of this study is to evaluate the difference in patient-reported postoperative outcomes between two standard-of-care surgical techniques for radical orchiectomy (inguinal orchiectomy versus external oblique fascia sparing orchiectomy) for treatment of patients with suspected testicular malignancy. The main questions it aims to answer are:

  1. Does sparing the external oblique fascia during orchiectomy reduce pain after surgery?
  2. Is there a difference in narcotic consumption after surgery?
  3. Is there a difference in neuropathic pain after surgery?
  4. Is there a difference in complications after surgery?

详细描述

Radical inguinal orchiectomy is the standard of care surgical approach for removing a testicle when clinically there is concern for testicular cancer. The procedure is generally minor and performed in the outpatient setting. Recent data demonstrates a trend towards high opioid prescription following this procedure in an attempt to minimize postoperative pain, which is associated with persistent new opioid use in the future. Numerous efforts have been put in place to minimize postoperative pain following scrotal procedures, with success noted when opioid sparing pathways have been adopted. However, there has been sparse data on modifications within surgical technique that could improve patient pain following this procedure.

There have been various descriptions of technique to performing a radical orchiectomy which involves removal of the diseased testicle and spermatic cord. Classically, performing a radical inguinal orchiectomy involves incision of the external oblique fascia to expose and ligate the spermatic cord. During this step, the ilioinguinal nerve is exposed and can be injured by either traction injury or inadvertent transection. Modifications to this technique have been described which involve sparing of the external oblique fascia. Both approaches are performed via a similar incision and both the testicle and spermatic cord are removed. In fascia sparing modification, the spermatic cord is controlled, dissected, and subsequently ligated at the level of the superficial inguinal ring without incising the external oblique fascia. Proponents of this approach suggest the potential for less convalescence and faster recovery due to less tissue manipulation and avoidance of disturbances to the ilioinguinal nerve. Despite this potential benefit, there is no evidence to demonstrate superiority of either approach as it relates to patient recovery.

Therefore, we propose a randomized single-blinded clinical trial investigating postoperative pain outcomes of inguinal radical orchiectomy compared to external oblique fascia sparing radical orchiectomy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Participants undergoing radical orchiectomy for suspected testicular malignancy
  • Testicular malignancy can be germ cell tumor or non germ cell tumors, including paratesticular tumors as long as a radical orchiectomy is planned
  • Participants over 18 years of age who can provide informed consent
  • Participants not currently using opiates for another reason
  • Regional and metastatic patients are allowed, as long as participant does not require opiates for pain related to metastatic disease
  • No contraindication for participant to receive standardized medication pathway in the peri-operative period.

排除标准

  • Clinical T4 disease
  • History of illicit substance abuse (including prior opioid abuse) except for marijuana
  • Participants who underwent chemotherapy or radiotherapy prior to orchiectomy
  • Opioid use within 1 month of study enrollment
  • Participants with large testis masses requiring skin incision larger than 8 cm in size.
  • Participants with large testis masses requiring orchiectomy through an incision other than the standard transverse inguinal incision (i.e. hockey stick incision, vertical incision)

研究组 & 干预措施

Radical inguinal orchiectomy

Active Comparator

干预措施: Radical inguinal orchiectomy (Procedure)

Radical external oblique fascia sparing orchiectomy

Active Comparator

干预措施: Radical external oblique fascia sparing orchiectomy (Procedure)

结局指标

主要结局

Postoperative Pain Level

时间窗: Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7

Post-operative pain levels will be measured by the Short Form Inguinal Pain Score (sf-IPQ) The score range is between 0 and 12, with zero points indicating no pain and 12 points indicating the most intense pain. Scores for subjects undergoing inguinal orchiectomy will be compared to subjects undergoing external oblique fascia sparing radical orchiectomy.

次要结局

  • Opioid consumption(Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7)
  • Neuropathic Pain Level(Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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