Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

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.

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.