In patients undergoing inguinal hernia surgery. Bilateral inguinal hernia, with obstruction, without gangrene, recurrent
Conditions
Interventions
Intervention group: In this study, Prolene meshes (BARD brand) are used. For spinal anesthesia in both groups, 15 mg of 0.5% bupivacaine is administered. During laparoscopic procedures, patients under
Sponsors
Arak University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The inclusion criteria were: willingness to participate in the study, primary unilateral non-incarcerated inguinal hernia (non-recurrent), and age 18 years or older.
Exclusion criteria
Exclusion criteria: Failure of the patient to attend scheduled clinical follow-ups according to the study timeline (48 hours and one week after discharge).Withdrawal of consent by the patient or legal guardian to continue participation in the study at any stage of follow-up.Occurrence of serious unexpected intraoperative complications that render the intervention impossible or inappropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary OutcomePostoperative pain intensityPatient pain intensity was assessed using a Visual Analog Scale (VAS) based on information recorded in the clinical record. The VAS score was recorded on a scale of 0 (no pain) to 10 (the most severe pain imaginable) and was extracted and compared at three time points:Immediately after surgery8 hours after surgery24 hours after surgery. Timepoint: Immediately after completion of surgery8 hours after surgery24 hours after surgery. Method of measurement: **Pain Assessment and Data Collection**Patient pain severity is assessed using the **Visual Analog Scale (VAS)**. In addition, data are recorded using a **researcher-designed checklist**.In this study, pain severity is evaluated with the **Visual Analog Scale (VAS)**, which is a valid and standardized instrument widely used in clinical studies.### ValidityThe VAS, as a standard tool for measuring pain intensity, has high **content and construct validity**. Numerous studies have demonstrated a strong correlation between VAS pain scores and other validated pain assessment tools, such as the **Numeric Rating Scale (NRS)** and the **McGill Pain Questionnaire (MPQ)**. Therefore, the VAS is capable of quantitatively measuring the true intensity of pain and allows for reliable comparisons between patients.### ReliabilityStudies have shown that the VAS has **high reliability** and strong **test–retest reliability**. Under stable clinical conditions, repeated pain assessments over short intervals yield similar results. Moreover, the sensitivity of this scale to detect small changes in pain intensity following therapeutic interventions has been well established.The VAS consists of a **10-cm horizontal line** with the following anchors:* **0:** No pain* **10:** Worst pain imaginableThe patient marks a point on the line that best represents the intensity of pain at that moment. The distance from the zero point to the patient’s mark is measured in centimeters and recorded as the pain sco | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary OutcomesSurgery DurationThe duration of surgery was calculated from the time of the first skin incision to the end of suturing based on the report recorded in the patient's file, and was extracted in minutes and compared between the two groups.Length of Hospital StayThe duration of the postoperative hospital stay was recorded as the time interval between the end of surgery and the patient's discharge, according to the information available in the hospital file, and was compared in the two groups.Frequency of Short-term ComplicationsShort-term complications after surgery were extracted and examined based on the medical file documentation and recorded follow-up notes, including the following:Infection of the surgical site: presence of redness, purulent discharge, or antibiotic prescriptionSeroma: accumulation of fluid at the surgical site that was clinically recorded in the fileThese complications were evaluated during follow-up appointments recorded in the patient's file. Timepoint: These complications are assessed and recorded at **two follow-up points: 48 hours and one week after discharge**. Method of measurement: In this study, secondary outcomes include surgery duration, length of hospital stay, and the frequency of short-term complications. Surgery duration is recorded in minutes from the first skin incision to the completion of skin closure and compared between groups. Length of hospital stay is measured in days from the end of surgery to patient discharge and compared across the two groups. Short-term complications include surgical site infection and seroma, which are recorded as binary variables (yes/no) based on clinical criteria; infection is defined by redness, purulent discharge, or the need for antibiotics, and seroma is defined as clinically confirmed fluid accumulation at the surgical site. These complications are assessed and recorded at two follow-up points: 48 hours and one week after discharge. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactYashar Golmoradi Pilehroud
Arak University of Medical Sciences
Outcome results
None listed