NCT02542085

Brief 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). 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)

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2012

Longer than P75 for not_applicable

Status
unknown

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

November 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

3.8 years

First QC Date

August 31, 2015

Last Update Submit

September 4, 2015

Conditions

Incisional Hernia

Keywords

incisional hernialaparoscopic repairhybrid repairseromarecurrent hernia

Outcome Measures

Primary Outcomes (2)

  • number of patients with seroma formation

    1 month

  • number of patients with hernia recurrence

    1 year

Secondary Outcomes (3)

  • number of patients with peri/postoperative complications

    up to 1 year

  • VAS pain scale

    1 year

  • Quality of Life

    preoperative-1month-1year

Study Arms (2)

laparoscopic repair

ACTIVE COMPARATOR

patients who are randomized to have a laparoscopic mesh repair

Procedure: Laparoscopic repair

hybrid repair

ACTIVE COMPARATOR

patients who are randomized to have a laparoscopic mesh repair and fascial closure

Procedure: Hybrid repair

Interventions

Laparoscopic repairPROCEDURE

operative method

laparoscopic repair
Hybrid repairPROCEDURE

operative method

hybrid repair

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with incisional hernia

You may not qualify if:

  • BMI \>40
  • ASA IV
  • a Prior mesh repair
  • Hernia defect size \<2 or \>7 cm
  • Emergency operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (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 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.

    PMID: 30941550DERIVED

  • 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.

    PMID: 29882170DERIVED

MeSH Terms

Conditions

Incisional HerniaSeromaHernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesInflammation

Study Officials

  • Tero Rautio, MD, PhD

    Oulu University Hospital

    STUDY DIRECTOR

  • Mirella Ahonen-Siirtola, MD

    Oulu University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 31, 2015

First Posted

September 4, 2015

Study Start

November 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

September 7, 2015

Record last verified: 2015-09