Clinical trial NCT02367573: 3D vs 2D HD Laparoscopy in Inguinal Hernia Repair
Official title: 3D Versus 2D HD Laparoscopy in Inguinal Hernia Repair: a Prospective, Single Blinded, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2015-02-20
Enrollment: 278
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Duration of surgery
timeFrame: Expected average time of surgery 1 hour
Secondary outcomes:
measure: Need for conversion into open surgery
timeFrame: During the operation, expected average time of surgery 1 hour
measure: Intraoperative complications
timeFrame: During the operation, expected average time of surgery 1 hour
measure: Complications, Clavien-Dindo classification
timeFrame: 30 days after randomization
measure: Postoperative stay in hospital
timeFrame: Expected range 0-7 day
measure: Bleeding
timeFrame: During the operation, expected average time of surgery 1 hour
measure: Number of participants with readmission(s)
timeFrame: 30 days after randomization
measure: Total need of opioids in milligrams
timeFrame: Expected range 0-7 day
measure: Mortality
timeFrame: 30 days after randomization
measure: Operation theatre time
timeFrame: Expected average 1,5 hours
measure: Postoperative pain, VAS
timeFrame: Expected range 0-7 day
Other outcomes:
measure: Incisional hernias
timeFrame: after 1, 5 and 10 year
measure: Inguinal hernia recurrence
timeFrame: after 1, 5 and 10 year
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Sallinen, MD,PhD
role: STUDY_CHAIR
References:
citation: Koppatz HE, Harju JI, Siren JE, Mentula PJ, Scheinin TM, Sallinen VJ. Three-dimensional versus two-dimensional high-definition laparoscopy in transabdominal preperitoneal inguinal hernia repair: a prospective randomized controlled study. Surg Endosc. 2020 Nov;34(11):4857-4865. doi: 10.1007/s00464-019-07266-z. Epub 2019 Nov 21.