To evaluate the duration of admission, feasibility, patient satisfaction and complication rate of vNOTES hysterectomy with BSO and compare it with laparoscopic hysterectomy with BSO in case of clinical stage 1 low grade endometrial cancer.
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Uterine, pelvic and broad ligament disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is percentage of women discharged on the same day as the
hysterectomy (day 0).
We calculated a sample size of 147 women assuming a 30% same day discharge
difference with an alpha of 0.05 and a power of 90%. We plan to perform a
follow up study of this trial to proof oncological safety of the procedure.
Secondary outcome
Secondary outcomes are removal of uterus via allocated technique, major
complications, minor complications, operating time, conversion rate, blood
loss, hospital stay, usage of analgesics, pain scores, costs and quality of
life (QoL).
Background summary
The treatment of clinical stage 1 low-grade endometrial cancer consists of
hysterectomy and bilateral salpingo-oophorectomy (BSO). Nowadays total
laparoscopic hysterectomy (TLH) with BSO is the principal mode of surgery in
these cases, resulting in shorter hospital stay, less pain and earlier recovery
after surgery when compared to laparotomy1,2. Vaginal Natural Orifice
Transluminal Endoscopic Surgery (vNOTES) is a new surgical endoscopic technique
that can be applied to perform a hysterectomy. Recent research has demonstrated
that vNOTES hysterectomy leads to a shorter hospital stay, lower self-reported
VAS pain scores and less postoperative use of analgesics compared to
laparoscopic hysterectomy3.
Study objective
To evaluate the duration of admission, feasibility, patient satisfaction and
complication rate of vNOTES hysterectomy with BSO and compare it with
laparoscopic hysterectomy with BSO in case of clinical stage 1 low grade
endometrial cancer.
Study design
Multicentre randomized controlled trial
Intervention
Patients are randomized between hysterectomy and bilateral
salpingo-oophorectomy with vNOTES or conventional laparoscopy.
Study burden and risks
Standard of care in women diagnosed with clinical stage 1 low-grade endometrial
cancer is to perform a chest X-ray. If there are no signs of metastatic disease
and no advanced stage patients are planned for hysterectomy and BSO. Patients
with the indication of laparoscopic hysterectomy with BSO for endometrial
cancer or atypical hyperplasia and no contraindications for vNOTES hysterectomy
are asked if they want to participate in this study. At this moment, TLH with
BSO is the standard surgical technique in these patients. All included women
will be randomized between vNOTES or laparoscopic hysterectomy with BSO in a
2:1 ratio. Standard postoperative contact by phone or out patient department
visits at 2 and 6 weeks will be planned and patients will be asked to complete
QoL questionnaires after 1 and 2 days, 1,4,6 and 12 weeks. Studies have shown
that vNOTES hysterectomy is associated with a shorter hospital stay, less pain,
less usage of analgesics, no scars and a quicker resumption to daily activity
and no higher risk of complications when compared to laparoscopic hysterectomy.
Permission will be asked to consult the national pathology database (PALGA) and
the database of the Dutch Integrated Cancer Centre (IKNL) up to 5 years
postoperative to ensure oncological follow up. Besides this follow-up we plan
to perform a follow up study of all patients with low-grade endometrial cancer
treated by vNOTES hysterectomy and BSO to ensure oncologic safety.
It is expected that patients treated with vNOTES will have a shorter hospital
stay without increased risk of major complications and have a less pain, less
usage of analgesics and a quicker resumption to daily activity.
Michelangelolaan 2
Eindhoven 5623EJ
NL
Michelangelolaan 2
Eindhoven 5623EJ
NL
Listed location countries
Age
Inclusion criteria
clinical stage 1 endometrial cancer
Exclusion criteria
non-endometrioid endometrial cancer, high stage disease
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL77309.100.21 |
| OMON | NL-OMON24941 |