The main objective is to asses functional anatomical restoration of the linea alba through functioning in mean peak torque, and ultrasound examination.
ID
Source
Brief title
Condition
- Other condition
- Soft tissue therapeutic procedures
Synonym
Health condition
littekenbreuk
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this study is to assess anatomical restoration and
function of the linea alba one year after surgery by ultrasonography and
measuring the mean peak torque during trunk flexion using a BioDexTM machine.
Secondary outcome
The secondary endpoints will be blood loss, hemostasis, hematoma,
intra-operative complications, mesh fixation technique (single crown or double
crown), position of the mesh (according to ICAP classification), type of
sutures used (absorbable or non-absorbable), serosa injury, enterotomy, time to
normal intestinal functioning (days), seroma formation (assessed by
ultrasound), time to return to work (weeks), anatomical restoration after two
years (ultrasound), abdominal wall function after two years (using BioDexTM),
postoperative complications (through Clavien-Dindo classification), use of
additional analgesia, CDC assessment, SSI (according to SSO and SSOPI), mesh
infections, 30-day reoperation rate, hernia recurrence (through ultrasound),
patient satisfaction with their scar after one- and two year(s) (Likert-scale),
mesh comfort (by Carolina's Comfort Scale questionnaire), postoperative pain
(VAS of pain) and quality of life (SF-36).
Background summary
Abdominal wall functioning has been reported to be higher in patients that
underwent open incisional hernia repair compared to laparoscopic incisional
hernia repair. With the use of a recently developed hybrid approach, we aim for
a functional anatomical restoration of the linea alba while also achieving the
technical advantages of the hybrid approach.
Study objective
The main objective is to asses functional anatomical restoration of the linea
alba through functioning in mean peak torque, and ultrasound examination.
Study design
Multicentre prospective cohort study.
Study burden and risks
No risk is associated with participation, known complications for incisional
hernia repair will also occur when patients do not participate in this study.
HYDRA is part of standard care in the Alrijne Hospital, and the technique has
previously been published. The mesh used in this study is being used on a
world-wide scale. We do not expect additional risks with this study. As
participants have to visit the Erasmus MC an additional three times and have to
fill in additional questionnaires, there is a burden for enrolled patients.
There is a possibility that during the ultrasonography incisional hernias are
found, which would not have been found or later have been found when patients
did not participate in this study. This might lead to an extra mental and/or
physical burden for the participant.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
Inclusion criteria
- 18 years or older
- Elective HYDRA-surgery
- Midline incisional hernia larger than 4 centimetres in mean width
- Sufficient knowledge of the Dutch language to be able to understand and fill
in the questionnaires
- Signed informed consent form by patient
Exclusion criteria
- Pregnant at inclusion - Inclusion in other trials with interference of the
primary and secondary endpoints - ASA >3 - Hernia defect larger than 10
centimetres in mean width - Incarcerated hernias or emergency procedure -
Unable to perform a trunk flexion - Incapacitated patients
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL83150.078.23 |
| Other | Volgt nog - is bij clinicaltrials.gov aangevraagd. |