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Trial · NCT07891845

Registered outcomes17

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryProportion of Participants With Seroma at Postoperative Day 30Postoperative Day 30
Percentage of participants with a seroma in the operated inguinal or scrotal region at postoperative day 30. Seroma is defined as a fluctuant fluid collection detected on physical examination and/or a fluid collection demonstrated by ultrasonography. Ultrasonography will be performed when examination findings are uncertain or a seroma is clinically suspected. Seroma rates will be compared between groups to assess non-inferiority of PAS using an absolute margin of 15 percentage points.
OtherOperative TimeIntraoperative period, from skin incision to skin closureDuration of surgery in minutes, measured from the first skin incision to final skin closure.
OtherPostoperative Pain ScorePostoperative Days 1 and 7, and Months 1, 6, and 12Pain intensity measured on a 0-10 visual analog scale or numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
OtherHernia-Related Quality of LifeBaseline and Postoperative Months 1, 6, and 12
Hernia-related quality of life assessed using the EuraHS-QoL questionnaire, covering pain, activity restriction, and cosmetic discomfort. Higher scores indicate worse quality of life. Postoperative scores will be compared between groups and with baseline values.
OtherLength of Hospital StayFrom surgery to hospital discharge, an average of 1 dayDuration of hospitalization in days following hernia repair, measured from surgery to discharge.
OtherTime to Return to Normal Daily ActivitiesFrom surgery through postoperative Month 12Number of days from surgery until the participant can independently perform basic daily activities without a marked increase in analgesic requirements.
OtherPostoperative ComplicationsThrough postoperative Month 12Percentage of participants experiencing postoperative complications. Complications will be graded according to the Clavien-Dindo classification.
OtherPostoperative HematomaThrough postoperative Month 12Percentage of participants with a hematoma in the operated inguinal or scrotal region.
OtherPostoperative HydroceleThrough postoperative Month 12Percentage of participants with a postoperative hydrocele on the operated side.
OtherPostoperative Scrotal EdemaThrough postoperative Month 12Percentage of participants with postoperative scrotal edema.
OtherSurgical Site InfectionThrough postoperative Month 12Percentage of participants with a surgical site infection following hernia repair.
OtherPostoperative Testicular PainPostoperative Days 1 and 7, and Months 1, 6, and 12Percentage of participants reporting testicular pain on the operated side.
OtherPostoperative Urinary RetentionThrough postoperative Month 12Percentage of participants experiencing urinary retention following surgery.
OtherChronic Inguinal PainPostoperative Months 6 and 12Percentage of participants reporting persistent pain in the operated inguinal region at the 6-month and 12-month follow-up assessments.
OtherHernia RecurrenceThrough postoperative Month 12Percentage of participants with a recurrent hernia on the operated side, confirmed by clinical examination and/or ultrasonography.
OtherIntraoperative ComplicationsIntraoperative period, from skin incision to skin closure
Percentage of participants experiencing intraoperative complications, including injury to the spermatic cord, vas deferens, testicular vessels, inferior epigastric vessels, bladder, or bowel, and peritoneal tears.
OtherConversion to Open SurgeryIntraoperative period, from skin incision to skin closurePercentage of participants whose planned laparoscopic repair is converted to open surgery.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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