3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

Not Applicable

Completed

• Conditions: Hernia, Inguinal
• Interventions: Procedure: 2D laparoscopic TAPP inguinal hernia repair; Procedure: 3D laparoscopic TAPP inguinal hernia repair

• Registration Number: NCT02367573
• Lead Sponsor: Helsinki University Central Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-09
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-20
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-13
• Last Update Posted: 2018-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2D TAPP	2D laparoscopic TAPP inguinal hernia repair	Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view
3D TAPP	3D laparoscopic TAPP inguinal hernia repair	Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view

Primary Outcome Measures

Name	Time	Method
Duration of surgery	Expected average time of surgery 1 hour

Secondary Outcome Measures

Name	Time	Method
Number of participants with readmission(s)	30 days after randomization
Intraoperative complications	During the operation, expected average time of surgery 1 hour	Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture
Total need of opioids in milligrams	Expected range 0-7 day
Complications, Clavien-Dindo classification	30 days after randomization
Operation theatre time	Expected average 1,5 hours
Postoperative pain, VAS	Expected range 0-7 day
Mortality	30 days after randomization
Need for conversion into open surgery	During the operation, expected average time of surgery 1 hour
Bleeding	During the operation, expected average time of surgery 1 hour
Postoperative stay in hospital	Expected range 0-7 day

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland