Health Condition 1: K402- Bilateral inguinal hernia, withoutobstruction or gangrene
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Adults greater than 18 years old Patients diagnosed with unilateral or bilateral uncomplicated inguinal hernia less than 3 cm Patients requiring laparoscopic or robotic inguinal hernia repair with mesh fixation using glue or tackers Patients who consent to participate in the study and adhere to the follow up schedule
Exclusion criteria
Exclusion criteria: Patients with recurrent hernias Patients with irreducible hernia Patients with contraindications to laparoscopic/robotic procedures Patients with a history of glue or tacker hypersensitivity Patients with other significant comorbidities (example uncontrolled diabetes active infection) that may affect surgical outcomes Patients unwilling or unable to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-operative pain as measured by the Visual Analogue Scale (VAS) at 1 day, 1 week, 1 month and 3 months post-surgeryTimepoint: Post-operative pain as measured by the Visual Analogue Scale (VAS) at 1 day, 1 week, 1 month and 3 months post-surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Recurrence of Hernia To evaluate the recurrence rates of inguinal hernia in patients treated with n-butyl 2 cyanoacrylate glueversus mechanical tackers over a 3 month period 2 Post-operative Complications To assess the occurrence of complications at 1 day 1 week 1 month & 3 months post-surgery 3 Quality of Life (QoL) To evaluate the quality of life using the EuraHS QoL questionnaire at 1 week 1 month & 3 months post-surgery 4 Other Measures o Mean time of operation To assess the duration of the surgical procedure for both fixation methods o Requirement of analgesics To compare the amount of analgesic medication required by patients in the two groups o Time to return to work To measure the number of days it takes for patients to return to work after surgeryTimepoint: Secondary Outcome should be access after end of study | — |
Countries
India
Contacts
Max Super Speciality Hospital Vaishali (A unit of Crosslay Remedies Limited)