None listed
Conditions
Brief summary
Although 5-10% of women with endometriosis will have bowel involvement, currently it is very difficult to predict this group preoperatively. This group of women require both gynaecological and colorectal input at surgery. Preoperative imaging is being increasingly utilised to predict the level of complexity of laparoscopic surgery for endometriosis. It has the potential to facilitate the triage of women with suspected bowel deep endometriosis (DE) to the most appropriate surgical expertise required for laparoscopic intervention for endometriosis. Transvaginal ultrasound (TVUS) (Guerriero S, et al. UOG, 2016) and magnetic resonance imaging (MRI) (Medeiros, et al. Arch Gyn Obs, 2015) have been shown to accurately diagnose the presence of rectosigmoid DE. Recently, positron emission tomography-computed tomography (PET-CT) with 16a-[18F]fluoro-17ß-estradiol ([18F]FES) has had promising results when compared with MRI. The study would be a prospective observational pilot study on women who present with suspected bowel DE diagnosed on TVUS and a plan for laparoscopic endometriosis surgery. Women would undergo a detailed history and clinical examination including a specialized TVUS, MRI and PET-CT with [18F]FES in a tertiary referral unit prior to laparoscopy.
Interventions
A history will be obtained and clinical examination performed on all women by gynaecologists/gynaecology fellows/registrars. Examination will include determination of site-specific tenderness and this will be measured using a verbal analogue score. A 2D transvaginal ultrasound (TVUS) with Doppler will be performed during this appointment by a gynaecology/gynaecology fellow to assess the pelvis for concurrent pathology as well as assessing for POD obliteration and site-specific tenderness (this w
A history will be obtained and clinical examination performed on all women by gynaecologists/gynaecology fellows/registrars. Examination will include determination of site-specific tenderness and this will be measured using a verbal analogue score. A 2D transvaginal ultrasound (TVUS) with Doppler will be performed during this appointment by a gynaecology/gynaecology fellow to assess the pelvis for concurrent pathology as well as assessing for POD obliteration and site-specific tenderness (this will be measured using a verbal analogue score). Next, an endometriosis scan will be performed to visualise the posterior pelvic compartment for the identification of deep infiltrating endometriosis. Women who have suspected bowel DE on TVUS (approx 20 min duration) will then undergo MRI (approx 30 min duration) and PET-CT using the isotope 16a-[18F]fluoro-17ß-estradiol (approx 30 min duration), administered by a nuclear medicine radiologist who will administer a weight-dependent, reduced tracer dose as well as a limited low radiation dose CT. The trial committee will comply with the recommendations outlined in the radiation safety officers report. Every effort will be made to ensure patient doses are consistent with the ALARA principle, within the boundaries outlined in the trial guidelines. Both MRI and PET-CT will be scheduled on the same day with all imaging modalities being performed within 6 months of surgery. MRI and PET-CT studies will be reviewed by two independent radiologists, blinded to the TVUS findings. If any incidental lesions are identified, a follow-up appointment for the study participant will be organised, during which they will be counselled regarding the findings and the appropriate referrals made. The MRI protocol on 1.5T involves • Axial, coronial, sagittal T2 weighted sequences; • Axial, sagittal T1 fat sat sequences; and • Axial sagittal SWI sequences In the event that a woman has an intra-uterine device, the metal-containing (gold/copper) and metal-free (Mirenas) IUDs and ESSURE are compatible with 1.5 T MRI. Stainless steel IUDs (used overseas in 1980s up till 2000) are not MRI compatible but unlikely to be in the population studied. Gadolinium will not be given.
Sponsors
Nepean Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
All women of reproductive age booked for laparoscopic excision of endometriosis with suspected bowel DE.
Exclusion criteria
– Malignancy – Menopause – Pregnancy
Outcome results
None listed