NCT02367573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 9, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 20, 2015

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

June 14, 2018

Status Verified

June 1, 2018

Enrollment Period

2.8 years

First QC Date

February 9, 2015

Last Update Submit

June 13, 2018

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

  • Duration of surgery

    Expected average time of surgery 1 hour

Secondary Outcomes (10)

  • 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

  • Complications, Clavien-Dindo classification

    30 days after randomization

  • Postoperative stay in hospital

    Expected range 0-7 day

  • Bleeding

    During the operation, expected average time of surgery 1 hour

  • +5 more secondary outcomes

Other Outcomes (2)

  • Incisional hernias

    after 1, 5 and 10 year

  • Inguinal hernia recurrence

    after 1, 5 and 10 year

Study Arms (2)

2D TAPP

ACTIVE COMPARATOR

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

Procedure: 2D laparoscopic TAPP inguinal hernia repair

3D TAPP

EXPERIMENTAL

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

Procedure: 3D laparoscopic TAPP inguinal hernia repair

Interventions

2D laparoscopic TAPP inguinal hernia repairPROCEDURE
2D TAPP
3D laparoscopic TAPP inguinal hernia repairPROCEDURE
3D TAPP

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients scheduled for laparoscopic inguinal hernia repair

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

Related Publications (1)

  • 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.

    PMID: 31754852DERIVED

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Ville Sallinen, MD,PhD

    Helsinki University Central Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 9, 2015

First Posted

February 20, 2015

Study Start

January 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

June 14, 2018

Record last verified: 2018-06

Locations

FI(1)