Primary: To study the long-term testicular position, volume and vascularisation of patients who have undergone the single stage Fowler-Stephens orchidopexy and the 2-stage Fowler-Stephens orchidopexy.Secondary: 1) To determine which of the…
ID
Source
Brief title
Condition
- Male genital tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main endpoint: volume of the FSO-testis
Secondary outcome
Secondary endpoints: testicular position and testicular vascularisation.
Background summary
The Fowler-Stephens orchidopexy is a surgical technique for high
intra-abdominal testes in which the testicular artery and vein are ligated to
create sufficient length for tension free placement of the testis in the
scrotum. To increase collateral circulation prior to mobilization of the
testis, a 2-stage Fowler-Stephens orchidopexy was devised in which mobilization
of the testis and fixation in the scrotum occurs in a second tempo. Although
both techniques are widely applied, superiority of either technique has not
been proven. Success rates published to date are mainly retrospective analyses
of medical records and lack long-term follow-up of treated patients. Long-term
results are needed as patients included in these studies were relatively young
and had not yet undergone final growth of the testes. Long-term growth
potential of the treated testes is functionally and cosmetically important for
patients. It is possible the success of the procedures may only be determined
during puberty or in the postpubertal period.
We hypothesize that both procedures are equally effective. Therefore the single
stage Fowler-Stephens orchidopexy is the preferred technique as it spares
patients a second operation.
Study objective
Primary: To study the long-term testicular position, volume and vascularisation
of patients who have undergone the single stage Fowler-Stephens orchidopexy and
the 2-stage Fowler-Stephens orchidopexy.
Secondary: 1) To determine which of the procedures, the single stage
Fowler-Stephens orchidopexy or the 2-stage Fowler-Stephens orchidopexy, is
superior in terms of testicular functionality and cosmetics.
2) To determine if and when growth of the operated testicle stagnates in the
postoperative period.
3) To determine if quality of life is affected by the outcome of the operation.
Study design
A multi-center long-term follow-up study.
Study burden and risks
We did not identify any risks for participating patients. Patients will have to
travel to a nearby Academic hospital as to undergo clinical examination and a
color Doppler ultrasound of both testes. Travel expenses will be refunded.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet the following criteria: Primarily the subject must have undergone either the single stage Fowler-Stephens orchidopexy or 2-stage Fowler-Stephens orchidopexy after January 1st 1995 and be aged between 12 * 17 years at time of inclusion.
Exclusion criteria
We will exclude subjects if any of the following is present in their medical history: prune-belly syndrome, epidydimitis, chromosomal or hormonal abnormalities, hormonal medication or presence of a testicular germ cell tumor.
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 | NL45599.018.13 |