Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04878146 |
| Other study ID # |
CHUV |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
June 30, 2028 |
Study information
| Verified date |
May 2021 |
| Source |
Centre Hospitalier Universitaire Vaudois |
| Contact |
Chahin Achtari, MD |
| Phone |
+41213143237 |
| Email |
chahin.achtari[@]chuv.ch |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Prolapse is a condition that causes up to 13% of women to have surgery in their lifetime.
There are many surgical techniques for the treatment of prolapse, each with its advantages
and disadvantages. The techniques by vaginal approach aim to put back in tension the
supporting tissue, the endopelvic fascia, damaged and released. This technique has the
advantage of not causing an abdominal scar, a quick recovery and often little pain. In
contrast, the use of already damaged native tissue results in a recurrence rate of up to 15%
to 30%.
The other technique is the abdominal route either by laparotomy or by a minimally invasive
approach such as laparoscopy, assisted or not by robotics. With this technique, we use
prosthetic material introduced around the vaginal wall without opening the latter, therefore
without contamination and without dissection of the vaginal wall.
During upper surgery, a subtotal hysterectomy is performed, that is to say that the uterine
cervix is preserved and serves as an anchoring point for the synthetic nets which are
attached to the cervix and then sutured to the promontory of the sacrum. (sacrocervicopexy).
In the vaginal route, a total hysterectomy is traditionally performed and the vaginal dome is
sutured to the sacro-spinal ligament (Richter's operation). The stitches are then passed
through the thickness of the often thin vaginal wall constituting a possible release point of
the assembly. There are currently no studies that compare prosthetic sacrocervicopexy with
fixation of the remaining cervix to the sacro-spinal ligament without prosthesis, and repair
of the endopelvic fascia with native tissue. The study consists of performing a subtotal
hysterectomy by minimally invasive approach in both cases and then randomize for either a
prosthetic sacrocervicopexy or fixation of the remaining cervix to the sacro-spinal ligament
via the abdominal or vaginal route.
Description:
Genital prolapse is caused by the collapse of the supporting structures of the pelvic organs.
This results in the organs sliding down through the pelvic hiatus. The pelvic organs involved
are the bladder, which rests on the anterior vaginal wall like a hammock made of supportive
connective tissue called the anterior endopelvic fascia. When too much stress is placed on
this support tissue, microtrauma or tears gradually weaken this tissue, which relaxes and
causes the bladder to gradually lower. In the same way, the rectum is separated from the
posterior vaginal wall by this same endopelvic fascia which can suffer the same kind of
lesion with the same consequences. The middle compartment, i.e. the top of the vagina is made
up of the cervix which is supported by a condensation of this endopelvic tissue in the form
of ligaments that suspend this cervix in the center of the pelvic cavity. If these ligaments
weaken, the uterus, or the "vaginal cuff" in the event of a previous hysterectomy, will also
gradually lower, or even externalize. The middle compartment is considered the keystone of
pelvic organ support. All interventions to correct severe prolapse should include suspension
of the middle compartment. Traditionally, the sacro-spinal ligament is used during the
intervention via the low approach and the sacral promontory via the high approach.
There is a classification (Pelvic Organ Prolapse Quantification or POP-Q) in stages of
descent of the pelvic organs. At the first stage, the organs are not exteriorized and in most
cases asymptomatic. In the second stage, the vaginal walls reach the vaginal introitus and
begin to cause symptoms such as pelvic discomfort or heaviness, whether or not associated
with functional disorders of the organs involved. In the following stages, the patients are
generally symptomatic.
Prolapse is a condition that causes up to 13% of women to have to have surgery in their
lifetime. It causes both an impairment of the quality of life by the discomfort caused by the
externalization of the organs and by the functional disorders that it causes, such as urinary
or fecal incontinence, bladder emptying disorder, sexual disorders, etc. all of these
disorders can be measured by dedicated questionnaires and validated in this population.
There are many surgical techniques for the treatment of prolapse, each with its advantages
and disadvantages. The techniques by vaginal approach aim to put back in tension of the
native supporting tissue damaged and released. This technique has the advantage of not
causing an abdominal scar, a quick recovery and often little pain. On the other hand, the use
of already damaged tissue results in a recurrence rate of up to 15-30%. In an attempt to
reduce this rate of recurrence, by taking the example of abdominal hernia surgery, prosthetic
reinforcements have started to be used in order to make the repair more solid and durable.
The prostheses were introduced through a vaginal incision (naturally contaminated medium) and
directly under the mucosa. It turned out that a reduction in recurrence was achieved,
especially in the anterior compartment, but at the cost of complications directly linked to
the use of prostheses such as erosions of the vaginal mucosa, infections and, when using
implantation kits supplied by industry, pain that is often difficult to treat.
The other technique is the abdominal route either by laparotomy or by a minimally invasive
approach such as laparoscopy, assisted or not by robotics. With this technique, prosthetic
material is also used but it is introduced around the vaginal wall without opening it,
therefore without contamination and without dissection of the vaginal wall, with a much lower
rate of erosion or other complication.
Many studies have compared these different techniques without reaching a definitive
conclusion on the best approach. The use of synthetic material introduced vaginally using
kits has recently been the subject of warnings from the FDA due to the sometimes severe
complications followed by a gradual withdrawal of these products or even a ban in most
Anglo-Saxon countries. On the other hand, the use by the abdominal route not causing the same
complications has not been questioned by the FDA
. In our department, the management of symptomatic prolapse involves two techniques, vaginal
without prosthesis or minimally invasive abdominal with prosthesis, according to various
criteria such as age, surgical history or severity of the prolapse. During upper surgery, a
subtotal hysterectomy is performed, i.e. the uterine cervix is preserved and serves as an
anchoring point for the synthetic nets which are attached to the cervix and then sutured to
the promontory of the sacrum. (sacro-cervicopexy). In the vaginal route, a total hysterectomy
is traditionally performed and the vaginal dome is sutured to the sacro-spinal ligament
(Richter's operation). The stitches are then passed through the thickness of the often thin
vaginal wall constituting a possible release point of the assembly. There are currently no
studies that compare prosthetic sacro-cervicopexy with fixation of the remaining cervix to
the sacro-spinal ligament without prosthesis and repair of the endopelvic fascia with native
tissue. The study consists of performing a subtotal hysterectomy by minimally invasive first
in both cases and then randomise for the mode of suspension of the uterine cervix, either a
prosthetic sacro-cervicopexy or to fix the remaining cervix to the sacro-sinous ligament by
abdominal or vaginal route. We would thus obtain more solid anchoring points at the level of
the middle compartment with less risk of dropping and a more lasting result.
The main objective is to demonstrate that this new intervention gives similar results to the
reference intervention by the upper route. For this we use a composite definition of the
success of the intervention which takes into account the anamnestic aspect, the absence of a
sensation of prolapse, the clinical examination, the absence of measurable prolapse, and the
absence of secondary surgery. The secondary objectives are to ensure a similar improvement in
the quality of life in the two groups by relying on specific questionnaires validated for
this indication.
