3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

Hernia, Inguinal Clinical Trial

Official title:

3D Versus 2D HD Laparoscopy in Inguinal Hernia Repair: a Prospective, Single Blinded, Randomized, Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02367573
• Other study ID #: HUCH-328-150128
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 2017

Study information

• Verified date: June 2018
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• 2D laparoscopic TAPP inguinal hernia repair

• 3D laparoscopic TAPP inguinal hernia repair

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incisional hernias		after 1, 5 and 10 year
Other	Inguinal hernia recurrence		after 1, 5 and 10 year
Primary	Duration of surgery		Expected average time of surgery 1 hour
Secondary	Need for conversion into open surgery		During the operation, expected average time of surgery 1 hour
Secondary	Intraoperative complications	Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture	During the operation, expected average time of surgery 1 hour
Secondary	Complications, Clavien-Dindo classification		30 days after randomization
Secondary	Postoperative stay in hospital		Expected range 0-7 day
Secondary	Bleeding		During the operation, expected average time of surgery 1 hour
Secondary	Number of participants with readmission(s)		30 days after randomization
Secondary	Total need of opioids in milligrams		Expected range 0-7 day
Secondary	Mortality		30 days after randomization
Secondary	Operation theatre time		Expected average 1,5 hours
Secondary	Postoperative pain, VAS		Expected range 0-7 day