The aim of this study is to evaluate the safety and the outcomes of laparoscopic correction of a recurrent inguinal hernia after previous repair.
ID
Source
Brief title
Condition
- Connective tissue disorders (excl congenital)
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcomes
To evaluate the safety of a laparoscopic correction of a recurrent hernia after
previous posterior hernia repair, the following outcomes will be assessed:
• Complications during surgery, such as collateral damage or conversion
• Complications after surgery, such as wound infection, hematoma or seroma
• Pain or discomfort in the groin and possible restrictions in daily activities
• Presence of a recurrence
• Presence of a port site hernia
• Days of admission
Secondary outcome
none
Background summary
Inguinal herniorrhaphy is the most common operation performed by a general
surgeon. Annually over 20 million groin hernias are repaired worldwide.
Inguinal hernia repairs account for 10-15% of all general surgical procedures.
There are many different surgical techniques described in the literature for
hernia repair, divided in open and laparoscopic repairs. Most techniques
include placement of a tension-free mesh to cover the defect. This mesh can be
positioned in two ways; it can be placed anteriorly of the defect, or
posteriorly of the defect.
During the laparoscopic technique the defect is approached from the
intra-abdominal side and the tension-free mesh is positioned posteriorly of the
defect. The laparoscopic technique has gained increasing popularity the last
couple of years due to promising results, such as lower rates of post-operative
pain, rapid return to normal activities and a lower incidence of infection. The
most common used methods of repairing an inguinal hernia laparoscopicly are the
transabdominal pre-peritoneal (TAPP) and the totally extraperitoneal technique
(TEP). So far, neither technique seems to be superior to the other. There are
no statistical differences found between the two techniques in the literature
with regards to recurrence rates, operating time, complications and time to
return to normal activities. Some suggest that the TEP procedure is technically
more challenging and requires more procedures before one becomes an experienced
operator. However, for both procedures the learning curve takes between 30 and
100 procedures to become experienced.
The recurrence rate after laparoscopic repair of a primary hernia is about 1-3%
and is comparable to open conventional techniques. There is still controversy
about the technique how to repair a recurrent hernia after previous
laparoscopic repair. The laparoscopic approach is usually a more difficult
operation, requiring a profound knowledge of the anatomy of the groin and great
surgical experience. Some prefer an anterior approach over a posterior
approach. The posterior approach is considered to be more difficult, due to the
scarring intra-peritoneally that has occurred following the previous posterior
approach and the possible increase in complication.
From 1993 onwards, 100-200 laparoscopic inguinal hernias repairs are done
annually at the Slotervaartziekenhuis. Approximately 50 patients had a
recurrent inguinal hernia after previous posterior repair, of which some had
their previous posterior repair done elsewhere. The aim of this retrospective
study is to evaluate our results and analyze the safety of the laparoscopic
repair of a recurrent inguinal hernia after previous posterior repair.
Study objective
The aim of this study is to evaluate the safety and the outcomes of
laparoscopic correction of a recurrent inguinal hernia after previous repair.
Study design
Method
All patients that underwent laparoscopic repair of a recurrent hernia after
previous hernia repair in the Slotervaartziekenhuis are identified in a
database. In this database all patients are set out who were laparoscopicly
operated on an inguinal hernia in our hospital since 1993. All operations are
done by one single surgeon dr. B.J. Dwars, or under his supervision. The
patients will be approached by telephone and invited to visit our outdoor
patient clinic. During this visit we will evaluate the following outcomes by a
short questionnaire, a physical examination and by a potential ultrasound of
the abdomen:
• Complications after surgery, such as wound infection, hematoma or seroma
(also evaluated by file examination)
• Pain or discomfort in the groin and possible restrictions in daily
activities. The pain in the groin will be assessed by a Visual Analogue Scale.
The restrictions in daily activities will be assessed by a 3-point Likert
scale.
• Presence of a recurrence by physical examination (and in case of doubt by an
additional ultrasound of the abdomen)
• Presence of a port site hernia by physical examination (and in case of doubt
by an additional ultrasound of the abdomen)
We will also examine the patient*s file and the following aspects will be
studied:
• Complications during surgery, such as collateral damage or conversion
• Complications after surgery, such as wound infection, hematoma or seroma
• Days of admission
Data
Every participant will receive a code, including three letters and three
numbers. The three letters will refer to the hospital where the patient is
included, in this case SLZ. The three numbers will refer to the number of the
patient. The first patient will receive the code SLZ001 and so on.
A key document will be generated, in which is states which code refers to which
patient. This document will be kept at a secured computer. The two researchers
only will have access to this computer. For every patient a document is
generated at this secured computer. In this document the outcome of the
questionnaire, the physical examination, the file analysis and the possible
abdominal ultrasound will be saved. The paper forms will be destroyed.
Power-analysis
Not applicable.
Statistical analysis
In this descriptive retrospective analysis we will evaluate our results after
laparoscopic repair of a recurrent inguinal hernia after posterior repair. We
will assess the prevalence of complications and calculate the mean of the
VAS-score and the Likert scale. These numbers will be calculated in Windows 7
XL Office.
Inclusion criteria
• Laparoscopic correction of a recurrent inguinal hernia after posterior repair
done at the Slotervaartziekenhuis from 1993 onward.
Exclusion criteria
• none
Study burden and risks
The patient will be requested to visit the outdoor patient clinic at least
once. This visit will take approximately 20 mintues in time. During this visit
a questionnaire is answered and a physical examination is done. There are no
risks for the patient participating in this study. The possible knowledge of
having a recurrent hernia or a port site hernia might be unwanted.
Louwesweg 6
1066 EC Amsterdam
NL
Louwesweg 6
1066 EC Amsterdam
NL
Listed location countries
Age
Inclusion criteria
patients who had laparoscopic recurrent inguinal hernia repair, after previous posterior repair
Exclusion criteria
none
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 | NL34519.048.10 |