Comparison of Hybrid and Laparoscopic Incisional Hernia Repair
NCT ID: NCT02542085
Last Updated: 2015-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2012-11-30
2016-08-31
Brief Summary
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Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka, Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).
Patients are randomized to operative groups (lap. vs hybrid).
Follow-up visits are scheduled at 1- and 12-month after surgery. Patients are evaluated for their clinical status and an ultrasound scan is performed. QoL-questionnaire and pain score (VAS) are reported.
The primary end-points:
* clinically and/or radiologically detected seroma in 1 month control
* clinically and/or radiologically detected recurrent hernia in 1 year control
The secondary end-points:
* peri-and postoperative outcomes/ complications, morbidity, mortality
* duration of hospital stay
* pain scale (VAS)
* Quality of Life (SF/Rand36)
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Detailed Description
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Patient exclusion criteria:
Age\< 18 y or \> 80 y ASA \>4 (the American Society of Anaesthesiologists' classification of Physical Health) BMI\> 40 A previous mesh repair of the hernia Hernia defect size \<2 or \>7 cm Emergency operation
Eligible patients are randomized into two operative groups (lap/hybrid). In the laparoscopic group the hernia defect is covered with a Parietex composite mesh (using minimum of 5 cm marginals, Securestrap fixation instrument and four lifting strings. In hybrid group the hernia sack is resected and fascial defect is sutured through a minilaparotomy incision. After this, a mesh repair is performed laparoscopically.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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laparoscopic repair
patients who are randomized to have a laparoscopic mesh repair
Laparoscopic repair
operative method
hybrid repair
patients who are randomized to have a laparoscopic mesh repair and fascial closure
Hybrid repair
operative method
Interventions
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Laparoscopic repair
operative method
Hybrid repair
operative method
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* ASA IV
* a Prior mesh repair
* Hernia defect size \<2 or \>7 cm
* Emergency operation
18 Years
80 Years
ALL
No
Sponsors
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Helsinki University Central Hospital
OTHER
Kymenlaakso Central Hospital Kotka Finland
OTHER
Päijät Häme Central Hospital
OTHER
Seinajoki Central Hospital
OTHER
Kuopio University Hospital
OTHER
Oulu University Hospital
OTHER
Responsible Party
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Mirella Ahonen-Siirtola
MD
Principal Investigators
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Tero Rautio, MD, PhD
Role: STUDY_DIRECTOR
Oulu University Hospital
Mirella Ahonen-Siirtola, MD
Role: PRINCIPAL_INVESTIGATOR
Oulu University Hospital
References
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Ahonen-Siirtola M, Nevala T, Vironen J, Kossi J, Pinta T, Niemelainen S, Keranen U, Ward J, Vento P, Karvonen J, Ohtonen P, Makela J, Rautio T. Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomised multicentre study, 1-year results. Surg Endosc. 2020 Jan;34(1):88-95. doi: 10.1007/s00464-019-06735-9. Epub 2019 Apr 2.
Ahonen-Siirtola M, Nevala T, Vironen J, Kossi J, Pinta T, Niemelainen S, Keranen U, Ward J, Vento P, Karvonen J, Ohtonen P, Makela J, Rautio T. Laparoscopic versus hybrid approach for treatment of incisional ventral hernia: a prospective randomized multicenter study of 1-month follow-up results. Hernia. 2018 Dec;22(6):1015-1022. doi: 10.1007/s10029-018-1784-2. Epub 2018 Jun 7.
Other Identifiers
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OuluUH
Identifier Type: -
Identifier Source: org_study_id
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