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Comparison of Hybrid and Laparoscopic Incisional Hernia Repair

NCT02542085 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2015-09-07

No results posted yet for this study

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)

Conditions

  • Incisional Hernia

Interventions

PROCEDURE

Laparoscopic repair

operative method

PROCEDURE

Hybrid repair

operative method

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • Kymenlaakso Central Hospital Kotka Finland

    collaborator OTHER

  • Päijät Häme Central Hospital

    collaborator OTHER

  • Seinajoki Central Hospital

    collaborator OTHER

  • Kuopio University Hospital

    collaborator OTHER

  • Oulu University Hospital

    lead OTHER

Principal Investigators

  • Tero Rautio, MD, PhD · Oulu University Hospital

  • Mirella Ahonen-Siirtola, MD · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2016-08-31
Completion
2016-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02542085 on ClinicalTrials.gov