Incisional Hernia Repair Clinical Trial
Official title:
Prospective Evaluation of Laparoscopic and Open Hernia Repair: a Multicenter Cohort Study
Nowadays incisional hernia are primarily repaired using prosthetic meshes. In Switzerland
such meshes are mainly implanted via open or laparoscopic approach. The differential impact
of these two types of surgical technique on recurrence rate will be investigated with this
study.
With this multicenter cohort study the outcomes of laparoscopic and open incisional hernia
repair will be investigated prospectively. Hernia recurrence is the main outcome measure.
Hypothesis:
Laparoscopic incisional hernia repair is associated with a lower recurrence rate compared to
open incisional hernia repair.
Background
Incisional hernia is a common long-term complication following abdominal surgery and is
estimated to occur in 11-23% 1-3. Incisional hernia can be repaired by an open or by a
laparoscopic approach. For incisional hernia prosthetic meshes are nowadays implanted for
virtually all open and laparoscopic procedures.
The use of laparoscopy for the treatment of incisional hernia was first reported in 1993 by
LeBlanc and Booth 4. Short term follow-up studies show that laparoscopic surgery is
associated with decreased postoperative pain, reduced risks of surgical site infections due
to minimal tissue dissection, a shorter length of hospital stay and a shorter overall
recovery period 5-9.
Important long- term outcome parameters are recurrence rate and chronic pain 10,11.
Recurrence after incisional hernia repair varies widely and ranges from 1% to 35% 1,3. Morbid
obesity, a previous failed open repair, large defect size and postoperative complications are
associated with an increased risk for recurrence 12. Heterogeneity of hernia size and
follow-up further complicate comparison of the recurrence rate between different techniques.
On average, 74% of recurrences occur within the first 3 years after initial repair 13. Series
with an acceptable follow-up of at least 24 months report a recurrence rate in open and
laparoscopic repair of approximately 10% 1. Currently, no well designed prospective study is
available comparing the incidence of recurrence between open and laparoscopic incisional
hernia repair.
Such variability of patients characteristics, surgical techniques and surgical skills are
likely to confound a prospective randomized trial. Consequently, a cohort study is performed
allowing each surgeon to perform the technique he is most familiar with.
The aim of this multicenter cohort study is to assess the incidence of recurrence 36 months
after open and laparoscopic incisional hernia repair, performed in swiss hospitals.
Objective
All patients undergoing elective incisional hernia repair who meet the inclusion criteria
(see below) are eligible for inclusion into the study. These patients will be informed about
the details of the study preoperatively. After a patient has agreed to enroll into the study
and has signed written informed consent, he/she will be advised to attend follow-up
assessments according to the study plan.
Methods
All patients undergoing elective incisional hernia repair who meet the inclusion criteria
(see below) are eligible for inclusion into the study. These patients will be informed about
the details of the study preoperatively. After a patient has agreed to enroll into the study
and has signed written informed consent, he/she will be advised to attend follow-up
assessments according to the study plan.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00646334 -
Comparative Study of AESCULAP Optilene® Mesh Elastic Versus Ethicon Ultrapro® Mesh in Incisional Hernia Repair
|
N/A |