Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03040921 |
| Other study ID # |
HEG01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2017 |
| Est. completion date |
April 1, 2021 |
Study information
| Verified date |
January 2022 |
| Source |
Hospital Erasto Gaertner |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This prospective nonrandomized multicenter phase I study, will evaluate the feasibility of
performing uterine transposition before chemoradiation for rectal cancer and uterine
reimplantation after the treatment.
Description:
Patients with pelvic cancer frequently require radiotherapy, which causes infertility even at
low doses. Oocytes are highly sensitive to radiation, as a dose of 2 Gy is able to destroy up
to 50% of the oocyte population.
Pelvic radiotherapy with fertility preservation is not yet available for women with pelvic
tumors. In such cases, the only options are egg and/or embryo freezing and ovarian
transposition (OT), which might preserve reproductive and hormonal function, respectively.
While ovarian tissue cryopreservation and transplantation are possible, they are still
experimental.
Uterine and adnexal transposition (UT) to the upper abdomen before radiotherapy might protect
these organs, and the later repositioning of the uterus into the pelvis after radiotherapy
might allow the patients to experience a normal pregnancy.
Methods:
Patients with pelvic cancer who will need pelvic radiation will be offered the possibility to
performed the uterine transposition before the radiation therapy and after the treatment the
uterus will be replaced in it's natural position. The study period is 2 years or 10 patients,
that happens first.
The suggested treatment consisted of oocyte or embryos vitrification or before the uterine
transposition, but this is not mandatory.
Patient preparation, equipment and trocars placement will be performed as usual for pelvis
procedures and retroperitoneal dissection. The following provides each step of the surgical
procedure: sealing and section of the round ligament; opening of the broad ligament;
dissection of the vesicovaginal space; sealing and section of the uterine vessels at the
level of the cervix; sealing and sectioning of the pericervical vessels and uterosacral
ligaments; Section of the vagina. Closure of the vagina with absorbable sutures; dissection
of the infundibulopelvic (IP) ligaments up to their intersection with the iliac vessels;
separation of the terminal ileum, right, sigmoid and descending colon from the
retroperitoneal space to allow dissection of the gonadal vessels up to their origin;
transposition of the uterus to the upper abdomen, and repositioning of the colon and ileum
bellow the arch formed by the uterus, adnexa and the corresponding vessels; fixation of the
round ligaments and gonadal vessels to the upper abdomen by means of a transparietal suture
to avoid herniation or by moving them into the pelvis; draining the pneumoperitoneum and
placement of transabdominal sutures at the site; fixation of the cervix to the umbilical
incision to allow for menstruation from the navel; and visual inspection of the cervix, which
indicates the end of the surgical procedure. The adnexa should not be contacted at any time
during surgery.
Postoperative care will be performed as for major procedures in gynecology. Visual inspection
of the cervix will be performed twice per day, and uterine perfusion was assessed every 2
days by Doppler ultrasound of the ovarian vessels. The patient is discharged 2-4 days after
surgery if no complications occur. Three-dimensional radiotherapy or Intensity-Modulated
Radiation Therapy following the standard treatment for the disease will start 10 to 14 days
later. Chemotherapy may be used, also following the usual treatment. Chemotherapy and
radiotherapy protocols must follow the standard treatment of the disease, no adaptations are
accepted.
Five weeks after the end of radiotherapy, in rectal cancer cases, rectosigmoidectomy with
total mesorectal excision (TME) and repositioning of the uterus will be performed. Patients
with other tumors that do not need surgery as part of its treatment, the uterine
repositioning will be performed 7 - 30 days after the end of the treatment.
The repositioning procedures is performed as follows: First, the cervix is separated from the
navel, and the first trocar is inserted. Second, adhesions are removed, and the uterus and
adnexa are repositioned into the pelvis. Rectosigmoidectomy with laparoscopic TME then
followed the usual technique., Chromotubation is performed at the end of the procedure to
demonstrate tubal patency. Patients without complications are expected to be discharged 2 - 4
days after surgery.
Seven days after surgery, cervical inspection is performed. Image exams will be performed as
clinically indicated in the postoperative period. Clinical evaluation with pelvic examination
will be performed every week for 4 weeks, then every months for 6 months and after that every
3 months for 2 years. Complications form will be filled in all clinical evaluations. Every 3
months, quality of life protocols will be applied. Abdominal and pelvic Magnetic resonance
will be performed 1, 6 and 12 months after the surgery. Transvaginal ultrasound will be
performed 2, 4 and 6 months after the surgery. Hormonal evaluation will be performed every 3
months. Tumor follow-up will be performed according to the institution protocols. It is
recommend to the patients to wait for 1 year before trying pregnancy.
Reports concerning safety will be presented every 6 months to the local Ethics Committee. No
uterine necrosis is expected and in case of 2 uterine necrosis, the study will be stoped. Up
to two local recurrences in the study period are accepted, but in case of a third recurrence,
the study will be stoped. All complication will be reviewed by the local board and the study
will be under permanent evaluation. Every 6 months the local board will provide a report
allowing the study to continue or not.
