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3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
2D laparoscopic TAPP inguinal hernia repair
3D laparoscopic TAPP inguinal hernia repair
Sponsored by
Helsinki University Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Helsinki University Central Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

2D TAPP

3D TAPP

Arm Description

Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view

Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view

Outcomes

Primary Outcome Measures

Duration of surgery

Secondary Outcome Measures

Need for conversion into open surgery
Intraoperative complications
Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture
Complications, Clavien-Dindo classification
Postoperative stay in hospital
Bleeding
Number of participants with readmission(s)
Total need of opioids in milligrams
Mortality
Operation theatre time
Postoperative pain, VAS

Full Information

First Posted
February 9, 2015
Last Updated
June 13, 2018
Sponsor
Helsinki University Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02367573
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Helsinki University Central Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
278 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2D TAPP
Arm Type
Active Comparator
Arm Description
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with two dimensional view
Arm Title
3D TAPP
Arm Type
Experimental
Arm Description
Trans-abdominal pre-peritoneal laparoscopic inguinal hernia repair operated with three dimensional view
Intervention Type
Procedure
Intervention Name(s)
2D laparoscopic TAPP inguinal hernia repair
Intervention Type
Procedure
Intervention Name(s)
3D laparoscopic TAPP inguinal hernia repair
Primary Outcome Measure Information:
Title
Duration of surgery
Time Frame
Expected average time of surgery 1 hour
Secondary Outcome Measure Information:
Title
Need for conversion into open surgery
Time Frame
During the operation, expected average time of surgery 1 hour
Title
Intraoperative complications
Description
Any complication during the operation e.g. hemorrhagic, intestine or bladder rupture
Time Frame
During the operation, expected average time of surgery 1 hour
Title
Complications, Clavien-Dindo classification
Time Frame
30 days after randomization
Title
Postoperative stay in hospital
Time Frame
Expected range 0-7 day
Title
Bleeding
Time Frame
During the operation, expected average time of surgery 1 hour
Title
Number of participants with readmission(s)
Time Frame
30 days after randomization
Title
Total need of opioids in milligrams
Time Frame
Expected range 0-7 day
Title
Mortality
Time Frame
30 days after randomization
Title
Operation theatre time
Time Frame
Expected average 1,5 hours
Title
Postoperative pain, VAS
Time Frame
Expected range 0-7 day
Other Pre-specified Outcome Measures:
Title
Incisional hernias
Time Frame
after 1, 5 and 10 year
Title
Inguinal hernia recurrence
Time Frame
after 1, 5 and 10 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ville Sallinen, MD,PhD
Organizational Affiliation
Helsinki University Central Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31754852
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.
Results Reference
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3D vs 2D HD Laparoscopy in Inguinal Hernia Repair

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