The aim of this pilot study is to validate the telephonic survey to evaluate the outcomes of laparoscopic correction of an inguinal hernia after previous repair.Hypothesis: The Q-Phone can detect telephonic recurrence in patients who underwent…
ID
Source
Brief title
Condition
- Soft tissue therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Operated groin
Complaints: Yes / No. If so? Which?
Self noticed something: Yes / No
Coughing, sneezing, press: Yes / No
Blow on back of hand: Yes / No
On physical examination the presence of recurrence: Yes / No
Any presence of echo recurrences: Yes / No
Port side hernia
Complaints: Yes / No. If so? Which?
Self noticed something: Yes / No
Coughing, sneezing, press: Yes / No
Blow on back of hand: Yes / No
On physical examination the presence of recurrence: Yes / No
Any presence of echo recurrences: Yes / No
Secondary outcome
-
Background summary
Groin hernia therapie is the most common operation performed by general
surgeons. Annually, over 20 million groin hernias are repaired worldwide. The
long-term complications of a groin hernia are mainly recurrence and pain. The
recurrence rate of a primary inguinal hernia, after open or laparoscopic
repair, is between 1-3%. The laparoscopic technique is getting more support,
given the presumably better outcomes regarding postoperative pain, faster
recovery after surgery and a lower risk of wound infections. The most common
laparoscopic techniques for inguinal hernia repair are transabdominal
preperitoneal (TAPP) repair and totally extraperitoneal (TEP) repair. Up till
now, neither of these techniques is superior. In literature no significant
differences are described considering recurrence rates.
Retrospective and prospective studies of laparoscopic hernia correction go back
to the early 1990s. Most of these studies do not explain how follow-up was
conducted. For example, it is unclear where physical examination has taken
place in order to detect recurrences. It is now clear that recurrence depends
not only on the surgical expertise or surgical technique, but also on the
length and method of follow-up. Long-term follow-up in this population remains
difficult, since there is a benign disease, patients are asymptomatic or died.
That is why patients disappear in the follow-up. The number of patients that
are lost because of this, will affect the outcome of the follow-up.
There are several studies on follow-up in hernia patients. Kald and co-workers
concluded that a method of follow-up by questionnaire, followed by selective
physical examination (only patients with symptoms / recurrence of the
questionnaire were seen again) is only suitable to detect symptomatic
recurrences. Asymptomatic recurrences remained undiscovered. Vos and Simons
(1994) compared a questionnaire on paper with an outpatient physical
examination, with the result that half of the recurrences in a questionnaire
without a physical examination were not detected. Besides, there was a large
number of false positives (8 of 15). The conclusion of the study was that the
only reliable way of follow-up is outpatient physical examination.
In literature there are different types of recurrences described, namely
symptomatic, asymptomatic and occult recurrences. The number of asymptomatic
and occult inguinal hernias is unclear, because these patients do not report
themselves at the policlinic. It is therefore important to find a good
follow-up method for hernia patients, so that all recurrences, including the
asymptomatic and occult, will be discovered. There is no evidence in literature
that the telephone survey is a valid method to follow-up operated hernia
patients. More targeted questions can be asked in the telephone survey. It is a
practical and time saving way to approach a large amount of patients. In the
guideline 2009, the European Hernia Society emphasizes the usefulness of the
accurate follow-up, after inguinal hernia surgery.
In the Slotervaart Hospital we have access to a large patient database (3000).
All of these patients underwent surgery by the same surgeon and with the same
technique (TAPP). This study is a pilot study to examine the value of the
telephone survey assessed by comparing it to the gold standard: physical
examination. The purpose of this pilot study is to validate a telephone survey
to follow-up patients that underwent a laparoscopic hernia surgery.
The literature describes a hernia recurrence of 2%, where part of which is
unknown. To detect telephonic recurrence in hernia patients, even if it shows
no symptoms, there is a large number of patients (at least 600) necessary to
obtain a good confidence interval. There has been chosen to do a pilot study
first because the number false positives must be observed.
Study objective
The aim of this pilot study is to validate the telephonic survey to evaluate
the outcomes of laparoscopic correction of an inguinal hernia after previous
repair.
Hypothesis: The Q-Phone can detect telephonic recurrence in patients who
underwent laparoscopic correction of an inguinal hernia, even if they do not
give symptoms.
Study design
All patients that underwent laparoscopic correction of an inguinal hernia by
TAPP done at the Slotervaart Hospital from 1993 onward are identified in a
database.
All procedures were performed by, or supervised by an experienced surgeon, dr.
B.J. Dwars.
The database will be a random selected group of 250 patients. These patients
will be approached by telephone to inform them about the study. If patients are
interested in participating, we will send the patient a leaflet with
information about the study with a inform consent which the patient can return
by the enclosed envelope. After ten days the patient will be re-contacted by
telephone and will be asked if he or she wants to cooperate in the study. If
patients want to participate, a telephone and outpatient appointment will be
made.
The survey done by telephone contains the following questions:
1. Do you have symptoms in your operated groin? If so, what?
2. Did you notice anything in your operated groin? (yes / no)
3. Do you notice something in the operated groin when coughing, sneezing,
pressing? (yes / no)
4. Could you please stand up and blow on the back of your hand? Then, please
with your other hand touch your operated groin. Do you feel something in your
operated groin? (yes / no)
5. Do you have symptoms of the port-side insertions in your abdomen? If so,
what?
6. Did you notice anything at the insertion of the port-side? (yes / no)
7. Do you notice something at the port-side insertions when coughing, sneezing
or straining?(yes / no)
8. Could you please stand up and blow on the back of your hand? Then, please
with your other hand touch your port-side insertions. Do you feel something at
your port-side insertion? (yes / no)
Patients with bilateral inguinal hernias will get about each groin a separately
question.
At the clinic we will evaluate the following outcomes through questions and a
physical examination:
- The questions of the telephone survey will be repeated
- Presence of a recurrence by physical examination
- Presence of a port site hernia by physical examination
If there is doubt about the presence of recurrence or port site hernia, an
abdominal ultrasound will be made.
All these results will be listed on an outcome form.
Study burden and risks
There are in this study no disadvantages, except that the patient has an
additional visit to our outpatient clinic. This time load can be seen as a
disadvantage.
Louwesweg 6
Amsterdam 1066 EC
NL
Louwesweg 6
Amsterdam 1066 EC
NL
Listed location countries
Age
Inclusion criteria
Laparoscopic correction by TAPP (transabdominal pre-peritoneal technique) of an inguinal hernia done at the Slotervaartziekenhuis from 1993 onward
Exclusion criteria
Recurrence hernia after primary correction hernia wherefor medical consultation
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 |
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CCMO | NL37042.048.11 |