Inguinal Hernia Repair (Not Urgent)
Conditions
Keywords
total extraperitoneal repair, inguinal hernia, laparoscopic, extended
Brief summary
The enhanced-view totally extraperitoneal (eTEP) technique provides a wider operative field than the conventional totally extraperitoneal (TEP) technique and may facilitate dissection, instrument manipulation, and mesh placement. This study evaluates the potential advantages of eTEP compared with TEP in laparoscopic inguinal hernia repair.
Detailed description
The aim of this study was to compare the laparoscopic totally extraperitoneal (TEP) and enhanced-view totally extraperitoneal (eTEP) techniques for inguinal hernia repair. The two techniques were compared in terms of perioperative parameters, postoperative complications, early recurrence, length of hospital stay, postoperative pain, and quality of postoperative recovery. Quality of recovery was assessed using the Turkish version of the 15-item Quality of Recovery questionnaire (QoR-15T), and the outcomes were statistically compared between the TEP and eTEP groups.
Interventions
PROCEDURETEP Repair
Total extraperitoneal repair (TEP)
PROCEDUREeTEP Repair
extended view total extraperitoneal (eTEP)
Sponsors
Fatih Sultan Mehmet Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Randomised Prospective Clinical Trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Over 18 years of age and patients who agreed to a laparoscopic hernia repair, * Unilateral inguinal hernia with fascia defect larger than 0.5 cm, * EHS (European Hernia Society) ( Classification (Primary, lateral or medial, 1, 2 and 3) * ASA (American Society of Anesthesiologists) 1-3 (not in need of intensive care)
Exclusion criteria
* Strangulated hernias * Patients in whom laparoscopic operation is contraindicated, * Patients who developed recurrence after TEP or eTEP, * Patients with a history of previous open lower abdominal operation * Patients who should not receive general anesthesia. * ASA 3 patients in need of intensive care and ASA 4 patients * Bilateral hernias.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Ages | 1 week | Age in years |
| Patients' Gender | 1 week | Male or Female |
| Patients' Weight | 1 week | Weight in kilograms (kg) |
| Patients' Height | 1 week | Height in meters (m) |
| Patients' BMI | 1 week | BMI in kg/m² |
| the number of people with Diabetes Mellitus | 1 week | determined by numbers of people with Diabetes Mellitus |
| the number of people with Hypertension | 1 week | determined by numbers of people with Hypertension |
| the number of smoker people | 1 week | determined by numbers of smoker people |
| Side of operation | 1 week | Right or Left |
| the number of people with Direct hernia | 1 week | determined by numbers of people with Direct hernia |
| the number of people with Indirect hernia | 1 week | determined by numbers of people with Indirect hernia |
| the number of people with Direct+ Indirect hernia | 1 week | determined by numbers of people with Direct+ Indirect hernia |
| Defect size | 1 week | Defect in centimeters (cm) |
| Diameter of swelling | 1 week | Diameter of swelling in centimeters2 (cm2) |
| Number of Tacks | 1 week | determined by the numbers of tacks used on the patients. |
| Operation time (min) | 1 week | Operation time in minutes (min) |
| Bleeding | 1 week | Bleeding in milliliters (ml) |
| Analgesic requirement | 1 week | 1 time or 2 times or 3 times |
| Duration of hospitalisation | 1 week | Duration of hospitalisation in days |
| Return to work time | 1 week | Return to work time in days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Complications | 3 months | Determined by medical examinations: Whether there is seroma, haematoma or ecchymosis at 1st- and 3rd-month controls (in terms of number) |
| Postoperative pain | 1 week | Postoperative pain was assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst possible pain. VAS scores were assessed on postoperative day 1 and at postoperative week 1. (in terms of number) |
| postoperative recovery | 1 day | Postoperative recovery was assessed using the 15-item Quality of Recovery questionnaire (QoR-15), with a total score ranging from 0 to 150. Higher scores indicate better postoperative recovery, whereas lower scores indicate poorer recovery. The QoR-15 score was assessed at 24 hours postoperatively. (in terms of number) |
Countries
Turkey (Türkiye)
Contacts
STUDY_CHAIRBirol Agca, Assoc. Prof. MD
Fatih Sultan Mehmet Training and Research Hospital
Outcome results
None listed