Incisional HerniaNCT02542085
Comparison of Hybrid and Laparoscopic Incisional Hernia Repair
A study testing Laparoscopic repair and Hybrid repair in people with Incisional Hernia, run by Oulu University Hospital.
Trial summary
Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Laparoscopic repair and Hybrid repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients with incisional hernia
Who cannot join
- BMI >40
- ASA IV
- a Prior mesh repair
- Hernia defect size <2 or >7 cm
- Emergency operation
About this study
Official title: Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study
Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation).
Patients are recruited prospectively from 10 Finnish Hospitals (Oulu, Jorvi, Hyvinkää, Kotka, Seinäjoki, Valkeakoski, Lahti, Kuopio, Kokkola, Loimaa).
Read more
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)
Read the detailed description
Hypothesis: Using a hybrid method seroma formation and hernia recurrence can be diminished.
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
- Incisional Hernia
- Being tested
- Laparoscopic repair, Hybrid repair
- Keywords
- incisional hernia, laparoscopic repair, hybrid repair, seroma, recurrent hernia
- Medical subject headings
- Incisional Hernia, Seroma, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic repairProcedure or surgery
operative method
Hybrid repairProcedure or surgery
operative method
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic repair | Active comparator | patients who are randomized to have a laparoscopic mesh repair Receives: Procedure: Laparoscopic repair |
| hybrid repair | Active comparator | patients who are randomized to have a laparoscopic mesh repair and fascial closure Receives: Procedure: Hybrid repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with seroma formation
Measured: 1 month
number of patients with hernia recurrence
Measured: 1 year
Secondary outcomes (3)
number of patients with peri/postoperative complications
complications are reported perioperatively, during hospital stay, in 1 month control and in 1 year control
Measured: up to 1 year
VAS pain scale
Pain scores (VAS) are measured during hospital day (average 3 days), in 1 month control and in 1 year control
Measured: 1 year
Quality of Life
patients are asked to fill SF/rand36-questionnaire preoperatively, in 1 month control and in 1 year control
Measured: preoperative-1month-1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startNov 2012
- Primary completionAug 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Päijät Häme Central Hospital, Seinajoki Central Hospital, Kuopio University Hospital
- Responsible party
- Principal investigator, Mirella Ahonen-Siirtola, Oulu University Hospital
- Investigators
- Tero Rautio, MD, PhD, Study director, Oulu University HospitalMirella Ahonen-Siirtola, MD, Principal investigator, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542085
- Sponsor's protocol ID
- OuluUH
- Status last verified
- Sep 2015
- First submitted
- 31 Aug 2015
- Last updated
- 7 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30941550Ahonen-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.
PubMed 29882170
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Hybrid and Laparoscopic Incisional Hernia Repair: A Prospective Randomized Multicentre Study
- ClinicalTrials.gov ID
- NCT02542085
- Acronym / sponsor ID
- OuluUH
- Conditions
- Incisional Hernia
- Keywords
- incisional hernia, laparoscopic repair, hybrid repair, seroma, recurrent hernia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, Kymenlaakso Central Hospital Kotka Finland, Päijät Häme Central Hospital, Seinajoki Central Hospital, Kuopio University Hospital
- Study start
- Nov 2012
- Primary completion
- Aug 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study is a prospective, multicenter, randomized trial evaluating two laparoscopic incisional hernia repair methods: basic laparoscopic mesh repair (lap.) and a hybrid repair (laparoscopic mesh and fascial suturation).
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)
Detailed description
Hypothesis: Using a hybrid method seroma formation and hernia recurrence can be diminished.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic repair | Active comparator | Procedure: Laparoscopic repairpatients who are randomized to have a laparoscopic mesh repair |
| hybrid repair | Active comparator | Procedure: Hybrid repairpatients who are randomized to have a laparoscopic mesh repair and fascial closure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients with incisional hernia
Key exclusion criteria (5 listed)
- BMI >40
- ASA IV
- a Prior mesh repair
- Hernia defect size <2 or >7 cm
- Emergency operation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic repairoperative method | Procedure or surgery | laparoscopic repair |
| Hybrid repairoperative method | Procedure or surgery | hybrid repair |
Primary outcome
number of patients with seroma formation
Time frame: 1 month
number of patients with hernia recurrence
Time frame: 1 year
3 secondary outcomes
number of patients with peri/postoperative complications
Time frame: up to 1 year
VAS pain scale
Time frame: 1 year
Quality of Life
Time frame: preoperative-1month-1year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2015.
- Derived from this study: PubMed 30941550Ahonen-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.
- Derived from this study: PubMed 29882170Ahonen-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tero Rautio, MD, PhD study director
Oulu University Hospital
Mirella Ahonen-Siirtola, MD principal investigator
Oulu University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic repair and Hybrid repair in people with Incisional Hernia, run by Oulu University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients with seroma formation (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02542085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2015.