Hernia, Inguinal
Conditions
Brief summary
Inguinal hernia can be repaired laparoscopically. In the normal laparoscopy there are only two-dimensional view, which is somewhat challenging when operating in three-dimensional environment. The three-dimensional laparoscopic systems are gradually entering the operating rooms. There are plenty of evidence of the benefits of 3D-system in laboratory conditions. However, no prospective randomized trials have been published in the clinical point of view. Therefore, the purpose of this study is to investigate is there something to gain in changing into 3D laparoscopic system in the transabdominal pre-peritoneal (TAPP) inguinal hernia repair.
Interventions
PROCEDURE2D laparoscopic TAPP inguinal hernia repair
PROCEDURE3D laparoscopic TAPP inguinal hernia repair
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for laparoscopic inguinal hernia repair
Exclusion criteria
* Some other surgical operation planned during TAPP * Expected major risk of conversion (e.g. multiple previous abdominal operation, previous peritonitis) * Operating surgeon experience less than 5 3D laparoscopy operations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of surgery | Expected average time of surgery 1 hour |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total need of opioids in milligrams | Expected range 0-7 day | — |
| Bleeding | During the operation, expected average time of surgery 1 hour | — |
| Operation theatre time | Expected average 1,5 hours | — |
| Postoperative pain, VAS | Expected range 0-7 day | — |
| Complications, Clavien-Dindo classification | 30 days after randomization | — |
| Postoperative stay in hospital | Expected range 0-7 day | — |
| Number of participants with readmission(s) | 30 days after randomization | — |
| Need for conversion into open surgery | During the operation, expected average time of surgery 1 hour | — |
| Intraoperative complications | During the operation, expected average time of surgery 1 hour | Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture |
| Mortality | 30 days after randomization | — |
Other
| Measure | Time frame |
|---|---|
| Inguinal hernia recurrence | after 1, 5 and 10 year |
| Incisional hernias | after 1, 5 and 10 year |
Countries
Finland
Outcome results
None listed