Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Conditions
Keywords
Inguinal Hernia, lichtenstein technique, desarda technique
Brief summary
This study aims to evaluate whether a surgical technique (Desarda) is superior to the commonly used surgical technique (Lichtenstein) in inguinal hernia repair concerning the occurrence of postoperative complications. The Lichtenstein technique involves the use of a mesh, while the Desarda technique does not.
Interventions
PROCEDUREDesarda
This technique prevent from using a mesh to surgical repair of a inguinal hernia
PROCEDURELichtenstein
This technique implies using a mesh to surgical repair of a inguinal hernia
Sponsors
Consorci Sanitari de l'Alt Penedès i Garraf
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with primary inguinal hernia. * Body mass index below 31 * Indication for inguinal hernia repair via anterior approach, either as outpatient surgery (CMA) or elective admission. * Legal capacity to provide informed consent.
Exclusion criteria
* Patients with a weak, thin, or divided external oblique aponeurosis. * Participants diagnosed with any of the following conditions: * Ongoing oncological disease * Cirrhotic patients classified as Child B or higher * Women who have previously undergone a cesarean section * Cognitive or affective conditions that limit the ability to cooperate with the study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Participants with Post-surgery Complications | 3 months | Any of the following complications: ● Sensation of a foreign body that persists beyond 3 months after surgery, self-reported by the participant ● Seroma within the first 30 days after surgery, verified through physical examination by a surgeon ● Hematoma within the first 30 days after surgery, verified through physical examination by a surgeon ● Infection at the surgical site within the first 30 days after surgery, verified by a surgeon ● Severe postoperative pain (7 or higher on the visual analog scale \[VAS\]) within the first 30 days after surgery, self-reported by the participant ● Chronic postoperative pain (persisting more than three months after surgery), self-reported by the participant ● Persistent loss of skin sensitivity beyond 30 days after surgery, self-reported by the participant ● Limitation of normal activities at home, outside the home, or at work beyond 3 months after surgery, self-reported by the participant |
Countries
Spain
Contacts
Primary ContactJavier Errando, MD
Backup ContactNoemi Casaponsa
Outcome results
None listed