*Vaginal hysterectomy versus vaginal Assisted NOTES Hysterectomy (VANH)*: a randomised controlled trial

The hysterectomy is one of the most performed gynaecological surgeries
worldwide [2, 3].
In the Netherlands about 14.500 hysterectomies are performed yearly [4]. 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 [5-7].

The four approaches to perform a hysterectomy for benign disease are
abdominal hysterectomy (AH), vaginal hysterectomy (VH),
laparoscopic hysterectomy (LH) and robotic-assisted hysterectomy (RH) [3, 8].
VH appears to be superior to the AH, resulting in a quicker recovery [5]. The
LH results in a quicker recovery than the AH and VH, but increases the risks of
damage to the bladder or ureter [5]. That is why a recent Cochrane review
advises to perform a VH when feasible for women undergoing a hysterectomy for a
benign indication [5]. 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 [5]. The RH is not superior compared to the
LH and is associated with higher costs [10].

Since the introduction of laparoscopy, the VH and AH decreased and the rate of
LH significantly increased between 2002 and 2012 [9]. Performing a LH gives the
opportunity to inspect the abdominal cavity and to easily perform an
opportunistic salpingectomy compared to VH [10]. An opportunistic salpingectomy
during a hysterectomy for benign indication might reduce the overall risk of
ovarian cancer [11].
Additionally, patients experience less postoperative pain after a LH compared
to a VH and therefore need less post-operative pain medication [10]. 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 [10].

In 2004, a novel approach of endoscopic surgery was described, *Natural Orifice
Transluminal Endoscopic Surgery (NOTES) by researchers at the John Hopkins
University [12]. It is a surgical technique using natural orifices of the body
(e.g. mouth, anus, urethra, vagina) to perform scarless surgery [13]. 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 [14-16].
In 2012, the first vNOTES hysterectomy, also called vaginal assisted NOTES
hysterectomy (VANH) was performed [17]. vNOTES surgery can be used for
different indications, for example hysterectomy, adnexectomy, tubectomy or
salpingectomy in case of an ectopic pregnancy [18].

In 2018, the first randomised controlled trial (RCT) comparing TLH with VANH in
70 women was published [1]. This HALON trial showed VANH was non-inferior to
TLH [1]. 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 [1].
Besides, the VANH showed less post-operative complications [1].

Except for the HALON trial and two retrospective studies [19, 20] and
case-control studies [21, 22] 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 [23],
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 evaluate same day discharge (SDD), postoperative
pain, safety, recovery and cost-effectiveness within 6 weeks after surgery, in
woman undergoing two different surgical techniques; VANH or VH

The design of this study is a single-blind, multicentre, randomised controlled
trial (RCT). Eligible patients will be randomised in either the VH group and
receive a vaginal hysterectomy or in the VANH-group and the hysterectomy is
performed by vaginal assisted NOTES surgery.

VANH-hysterectomy

All planned VANH hysterectomies are scheduled in the morning before 12.00u pm.
All VANH procedures will be performed by surgeons who have the skills to
perform a VANH. This means that the surgeons will be experiences in performing
a VANH and must have performed at least 25 VANH independently, as it is
demonstrated that he learning curve consists of 25 cases [28].
Elective salpingectomy will be performed after counselling on the outpatient
clinic, subsequently on patients request. Pre-operative cefazolin 2 gram and
500 mg metronidazole is administered intravenously.
The patient is placed in lithotomy position. After disinfection and sterile
draping, a urinary bladder catheter is inserted into the bladder. At start of
the procedure descensus uteri will be classified according to the
POPQ-classification.
Access to the peritoneal cavity will be performed similar to vaginal surgery by
a circular incision around the cervix, anterior and posterior colpotomy and
transsecting the sacro-uterine ligaments.
The vNOTES port (GelPOINT V-Path, Applied Medical) will be placed to get access
to the abdominal cavity and a pneumoperitoneum will be created. After
positioning in 20o degree Trendelenburg laparoscopic instruments will be
introduced (30o laparoscope, a grasping forceps and sealing device through
three trocars). The peritoneal cavity and ureters are inspected. The
hysterectomy is performed by dissecting from caudally to cranially. The
fallopian tubes will be removed elective after counselling in the outpatient
clinic and the ovaries will be removed on indication only.
Finally, haemostasis is checked and the vNOTES port and the uterus are removed
trans-vaginally and the pneumoperitoneum is deflated. The vaginal cuff will be
closed using a running Vicryl-1 suture. The urinary bladder catheter will be
removed directly postoperative.

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 with the VANH, which shows no inferiority of the
vNOTES technique compared to the TLH. 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.