Uterine Transposition: Feasibility Study
Condition: Postoperative Complications; Intraoperative Complications; Tissue Damage; Ovarian Failure; Uterus Disorder
MeSH terms: Postoperative Complications; Intraoperative Complications
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Uterine transposition.
Intervention type(s): Procedure
Intervention description(s): Surgical transposition of the uterus to the upper abdomen. After the end of radiotherapy, rectosigmoidectomy is performed and the uterus is repositioned into the pelvis.
Intervention model: Single Group Assignment
Intervention model description: Recruitment completed. Final data collection in April/2020.
Masking: None (Open Label)
Primary purpose: Other