[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06828185":3,"trial-entities:NCT06828185":107,"trial-summary:NCT06828185":111},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":14,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":46,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":15,"eligibility_criteria":57,"std_ages":73,"locations":76,"central_contacts":94,"overall_officials":100,"references":101,"see_also_links":106},"NCT06828185","5250002","Patient Reported Experiences With Sparing External Oblique Fascia Vs Standard Inguinal Orchiectomy","Patient Reported Experiences With Sparing ExteRnal Oblique Fascia Vs Standard Inguinal OrchiEctomy","RECRUITING","2029-09","2026-07","2026-07-10","2026-12","Loma Linda University","OTHER",false,"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:\n\n1. Does sparing the external oblique fascia during orchiectomy reduce pain after surgery?\n2. Is there a difference in narcotic consumption after surgery?\n3. Is there a difference in neuropathic pain after surgery?\n4. Is there a difference in complications after surgery?","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.\n\nThere 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.\n\nTherefore, we propose a randomized single-blinded clinical trial investigating postoperative pain outcomes of inguinal radical orchiectomy compared to external oblique fascia sparing radical orchiectomy.",[19],"Testicular Cancer",[21,22,23,24],"orchiectomy","postoperative pain","testis cancer","germ cell tumors","INTERVENTIONAL",[27],"NA",{"count":29,"type":30},80,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"PROCEDURE","Radical inguinal orchiectomy","External oblique fascia will be incised during orchiectomy",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Radical external oblique fascia sparing orchiectomy","External oblique fascia will be spared during orchiectomy",[38],[42],{"measure":43,"description":44,"timeFrame":45},"Postoperative Pain Level","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.","Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7",[47,50],{"measure":48,"description":49,"timeFrame":45},"Opioid consumption","Subjects will self-report the total number of Oxycodone 5 mg tablets consumed for breakthrough pain during the first post-op week. There is no pre-defined range for this self-report but the higher the number of tablets consumed may be an indication of great pain intensity.",{"measure":51,"description":52,"timeFrame":53},"Neuropathic Pain Level","Post-Operative Neuropathic pain levels will be measured by the modified Barrow Neurological Institute hypesthesia scale. A total score ranging between 1 and 4, with 1 representing minimal neuropathic pain and 4 representing intense neuropathic pain.","Change between Postoperative day 0 [the day surgery was completed] through postoperative day 7)","MALE","18 Years",null,{"inclusion":58,"exclusion":65,"raw_text":72},[59,60,61,62,63,64],"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.",[66,67,68,69,70,71],"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)","Inclusion Criteria:\n\n* Participants undergoing radical orchiectomy for suspected testicular malignancy\n* Testicular malignancy can be germ cell tumor or non germ cell tumors, including paratesticular tumors as long as a radical orchiectomy is planned\n* Participants over 18 years of age who can provide informed consent\n* Participants not currently using opiates for another reason\n* Regional and metastatic patients are allowed, as long as participant does not require opiates for pain related to metastatic disease\n* No contraindication for participant to receive standardized medication pathway in the peri-operative period.\n\nExclusion Criteria:\n\n* Clinical T4 disease\n* History of illicit substance abuse (including prior opioid abuse) except for marijuana\n* Participants who underwent chemotherapy or radiotherapy prior to orchiectomy\n* Opioid use within 1 month of study enrollment\n* Participants with large testis masses requiring skin incision larger than 8 cm in size.\n* Participants with large testis masses requiring orchiectomy through an incision other than the standard transverse inguinal incision (i.e. hockey stick incision, vertical incision)",[74,75],"ADULT","OLDER_ADULT",[77],{"facility":13,"status":8,"city":78,"state":79,"zip":80,"country":81,"contacts":82,"geoPoint":91},"Loma Linda","California","92354","United States",[83,89],{"name":84,"role":85,"phone":86,"phoneExt":87,"email":88},"Muhannad Alsyouf, MD","CONTACT","909-558-4000","44196","Malsyouf@llu.edu",{"name":84,"role":90},"PRINCIPAL_INVESTIGATOR",{"lat":92,"lon":93},34.04835,-117.26115,[95,97],{"name":84,"role":85,"phone":96,"phoneExt":87,"email":88},"9095584000",{"name":98,"role":85,"phone":96,"phoneExt":87,"email":99},"Brian Hu, MD","Bhu@llu.edu",[],[102],{"pmid":103,"type":104,"citation":105},"25661018","BACKGROUND","Shei A, Rice JB, Kirson NY, Bodnar K, Birnbaum HG, Holly P, Ben-Joseph R. Sources of prescription opioids among diagnosed opioid abusers. Curr Med Res Opin. 2015 Apr;31(4):779-84. doi: 10.1185\u002F03007995.2015.1016607. Epub 2015 Feb 24.",[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Malignant Testicular Neoplasm",[],{"nct_id":4,"found":112,"summary":113,"prompt_version":123},true,{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This interventional study compares two surgical techniques in 80 men. It is not specified if participants will be randomly assigned to a technique.","completed","Comparing Surgical Techniques for Testicular Cancer","This study is looking at two ways to perform surgery for suspected testicular cancer, called radical orchiectomy (removal of the testicle). One method involves cutting a tissue layer called the external oblique fascia, which is the standard approach. The other method tries to avoid cutting this fascia. Researchers want to see if sparing the external oblique fascia can reduce your pain after surgery, how much pain medication you might need, if you experience nerve pain, and if there are differences in complications. You may be able to join if you are a man over 18, are having surgery for suspected testicular cancer, and are not currently taking opioid pain medication for another reason. The study aims to enroll 80 participants.","Your pain level will be measured daily from the day of surgery through seven days after surgery.",120,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]