Clinical trial NCT04886791: Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy
Official title: Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysterectomy
Natural Orifice Transluminal Endoscopic Surgery
Vaginal Hysterectomy
Keywords: NOTES surgery
vNOTES
VANH
Vaginal hysterectomy
Hysterectomy
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Catharina Ziekenhuis Eindhoven
First posted: 2021-05-14
Enrollment: 124
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded, multicentre, randomised controlled trial
Primary purpose: TREATMENT

Brief summary: Rationale: Natural orifice transluminal endoscopic surgery (NOTES) is a minimal invasive technique using the natural body orifices like stomach, oesophagus, bladder, rectum and vagina to access the human body for surgery. In 2012, the first vaginal NOTES (vNOTES) hysterectomy was performed. Potential benefits of vNOTES hysterectomy, also called the vaginal assisted NOTES hysterectomy (VANH) are no visible scars, less pain and a shorter hospital stay compared with laparoscopic hysterectomy as shown in the HALON trial. Up to now, no studies have compared the vNOTES hysterectomy with vaginal hysterectomy.

Objective: The aim of this study is to compare the vNOTES hysterectomy with the vaginal hysterectomy for same day-discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.

Study design: The study concerns a single-blinded, multicentre, randomised controlled trial.

Study population: Eligible women who fulfill the inclusion criteria and will undergo a hysterectomy for benign indication.

Intervention: The study population will be randomly allocated to the VANH-group, who undergo a vaginal assisted NOTES hysterectomy (intervention group) or the vaginal hysterectomy group (control-group) and the participants will be single blinded. The pre- and postoperative care will be the same for both groups.

Main study parameters/endpoints: Primary outcome is the percentage of patients that underwent the hysterectomy as in SDD setting. A total of 41 patients should be included in the control group and a total of 83 patients in the intervention group, using an enrollment ratio of 1:2, with an alpha of 0.05 and a power of 0.8.

The secondary outcomes are complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

vNOTES is a new surgical technique, but a combination of two existing techniques namely the vaginal hysterectomy and the laparoscopic hysterectomy. Only one randomized controlled trial has been published, comparing the total laparoscopic hysterectomy (TLH) with the VANH, which shows no inferiority of the vNOTES technique compared to a laparoscopy. A recent case series study has been published about the complication rate in VANH. There was a total complication rate in the hysterectomy group of 5.2%, in which 1.4% was intra-operative and 3.8% postoperative. Theoretically it is possible that the VANH causes less intra-operative complications because of an improved view during the procedure. No further literature is known about VH versus VANH. Participants of the study should fill in multiple questionnaires before randomization and postoperative about their general health, pain experience and used analgesics.

Detailed description: The hysterectomy is one of the most performed gynaecological surgeries worldwide.

In the Netherlands about 14.500 hysterectomies are performed yearly. The most common benign indications to perform a hysterectomy are abnormal uterine bleeding, uterine leiomyomas, endometriosis or adenomyosis, chronic pelvic pain, uterine prolapse, benign ovarian neoplasm, hyperplasia or atypia of the endometrium or cervical dysplasia.

The four approaches to perform a hysterectomy for benign disease are abdominal hysterectomy (AH), vaginal hysterectomy (VH), (total) laparoscopic hysterectomy ((T)LH) and robotic-assisted hysterectomy (RH).

VH appears to be superior to the AH, resulting in a quicker recovery. The LH results in a quicker recovery than the AH and VH, but increases the risks of damage to the bladder or ureter. That is why a recent Cochrane review advises to perform a VH when feasible for women undergoing a hysterectomy for a benign indication. When VH is technically not feasible, a LH or AH is performed. LH resulted in more rapid recovery, fewer febrile episodes and less wound complications compared to AH. The RH is not superior compared to the LH and is associated with higher costs.

Since the introduction of laparoscopy, the VH and AH decreased and the rate of LH significantly increased between 2002 and 2012. Performing a LH gives the opportunity to inspect the abdominal cavity and to easily perform an opportunistic salpingectomy compared to VH. An opportunistic salpingectomy during a hysterectomy for benign indication might reduce the overall risk of ovarian cancer.

Additionally, patients experience less postoperative pain after a LH compared to a VH and therefore need less post-operative pain medication. Advantages of the VH compared to the LH are a shorter operation duration, no visible scars and a lower chance of dehiscence of the vaginal cuff.

In 2004, a novel approach of endoscopic surgery was described, 'Natural Orifice Transluminal Endoscopic Surgery (NOTES) by researchers at the John Hopkins University. It is a surgical technique using natural orifices of the body (e.g. mouth, anus, urethra, vagina) to perform scarless surgery. The vaginal approach is called the vNOTES technique. NOTES is an emerging field within minimal access surgery, evolves and presents multiple possibilities for innovation and development. The initial approach was trans gastric, but subsequently, NOTES has been evolved, resulting in trans rectal, trans gastric, transvaginal, and transurethral approaches nowadays.

In 2012, the first vNOTES hysterectomy, also called vaginal assisted NOTES hysterectomy (VANH) was performed. vNOTES surgery can be used for different indications, for example hysterectomy, adnexectomy or salpingectomy in case of an ectopic pregnancy.

In 2018, the first randomised controlled trial (RCT) comparing TLH with VANH in 70 women was published. This HALON trial showed VANH was non-inferior to TLH. Compared to TLH, surgery time was significantly shorter, patients experience less post-operative pain and same day discharge (SDD) was possible in 77% of the women who underwent the VANH compared to 43% after TLH. Besides, the VANH showed less post-operative complications.

Except for the HALON trial and two retrospective studies and case-control studies, there is little literature about VANH.

No studies have been performed comparing the VH with the VANH. Because the VH is the preferred method to perform a hysterectomy for a benign indication, there is a need to compare VH with VANH and to explore the indications to perform a VANH.

The aim of this study is to compare the VANH with the VH for same day discharge (SDD), complications, treatment related outcomes, post-operative recovery, quality of life and cost-effectiveness.

We hypothesize that patients who underwent a VANH procedure are more often able to be treated in SDD setting.

Eligibility criteria: Inclusion Criteria:

* Written and orally given informed consent
* 18 years and older
* Native Dutch speaker or in control of the Dutch language in speaking and writing
* Indication for hysterectomy for benign indication
* Possible to perform a VH judged by experienced (resident) gynaecologist during gynaecological examination

Exclusion Criteria:

* Any contra-indication for VH (for example, large uterus myomatosus, not enough descensus, etc) as judged by experienced gynaecologist
* History of more than 1 caesarean section
* History of endometriosis
* History of rectal surgery
* History of pelvic radiation
* Suspected rectovaginal endometriosis
* History of pelvic inflammatory disease, especially prior tubo-ovarian or pouch of Douglas abscess or suspected adhesions due to (ruptured) inflammatory disease (for example ruptured appendicitis)
* Virginity
* Pregnancy
* Indication for anterior or posterior colporrhaphy during the same surgery
* Indication of mid urethral slings
* Uterus myomatosus will not be an exclusion criteria but the surgeon will indicate if it is possible to remove the uterus vaginally.

Primary outcomes:
measure: Percentage of same day discharge
timeFrame: First 24hours after surgery
Secondary outcomes:
measure: Complications
timeFrame: Week 6 after surgery
measure: Treatment related outcomes-1
timeFrame: During surgery
measure: Intended number of salphingectomies in each group
timeFrame: During surgery
measure: Performed number of salphingectomies in each group
timeFrame: During surgery
measure: Recovery Index-10 (RI-10) pre- and postoperative
timeFrame: Week 12 after surgery
measure: Health- related Quality of LIfe (EQ-5D-5L questionnaire)
timeFrame: Week 12 after surgery
measure: Costs
timeFrame: Week 12 after sugery
measure: Cost effectiveness
timeFrame: Week 12 after surgery
measure: Treatment related outcomes-2
timeFrame: During surgery
measure: Treatment related outcomes- 3
timeFrame: During surgery
measure: Treatment related outcomes -4
timeFrame: During surgery
measure: Treatment related outcomes -5
timeFrame: First 24 hours after surgery
measure: Treatment related outcomes -6
timeFrame: Day 7 after surgery
measure: Treatment related outcomes - 7
timeFrame: Day 7 after surgery
measure: Treatment related outcomes - 8
timeFrame: Week 6 after surgery
measure: Treatment related outcomes - 9
timeFrame: Week 6 after surgery
Other outcomes:
Locations:
city: Eindhoven
country: Netherlands
facility: Catharina Medical Centre
state: Noord Brabant
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Centre
state: Noord-Brabant
Study officials:
affiliation: Zuyderland Medical Centre
name: Martine Wassen
role: PRINCIPAL_INVESTIGATOR
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