Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy

Official title

Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial

Overview

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.

Interventions

• Procedure Vaginal NOTES hysterectomy
  Vaginal assited NOTES hysterectomy
• Procedure Vaginal hysterectomy
  Vaginal hysterectomy

Primary outcome measures

• Percentage of same day discharge [Time frame: First 24hours after surgery]

Secondary outcome measures (12)

• Complications [Time frame: Week 6 after surgery]
• Treatment related outcomes-1 [Time frame: During surgery]
• Intended number of salphingectomies in each group [Time frame: During surgery]
• Performed number of salphingectomies in each group [Time frame: During surgery]
• Recovery Index-10 (RI-10) pre- and postoperative [Time frame: Week 12 after surgery]
• Health- related Quality of LIfe (EQ-5D-5L questionnaire) [Time frame: Week 12 after surgery]
• Costs [Time frame: Week 12 after sugery]
• Cost effectiveness [Time frame: Week 12 after surgery]
• Treatment related outcomes-2 [Time frame: During surgery]
• Treatment related outcomes- 3 [Time frame: During surgery]
• Treatment related outcomes -4 [Time frame: During surgery]
• Treatment related outcomes -5 [Time frame: First 24 hours after surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Netherlands · 2 centers

• Catharina Medical Centre — Eindhoven
• Zuyderland Medical Centre — Heerlen

Publications

• Baekelandt J, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BW, Bosteels JJ. Authors' reply re: Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery versus laparoscopy as a daycare procedure: a randomised controlled trial. BJOG. 2019 Jul;126(8):1078-1079. doi: 10.1111/1471-0528.15744. Epub 2019 Apr 24. No abstract available. PMID 31020729
• Baekelandt J, Kapurubandara S. Benign Gynaecological procedures by vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES): Complication data from a series of 1000 patients. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:221-224. doi: 10.1016/j.ejogrb.2020.10.059. Epub 2020 Oct 28. PMID 33248377
• Hammer A, Rositch AF, Kahlert J, Gravitt PE, Blaakaer J, Sogaard M. Global epidemiology of hysterectomy: possible impact on gynecological cancer rates. Am J Obstet Gynecol. 2015 Jul;213(1):23-29. doi: 10.1016/j.ajog.2015.02.019. Epub 2015 Feb 25. PMID 25724402
• Committee Opinion No. 701 Summary: Choosing The Route Of Hysterectomy For Benign Disease. Obstet Gynecol. 2017 Jun;129(6):1149-1150. doi: 10.1097/AOG.0000000000002108. PMID 28538491
• Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5. PMID 26264829
• Neis KJ, Zubke W, Romer T, Schwerdtfeger K, Schollmeyer T, Rimbach S, Holthaus B, Solomayer E, Bojahr B, Neis F, Reisenauer C, Gabriel B, Dieterich H, Runnenbaum IB, Kleine W, Strauss A, Menton M, Mylonas I, David M, Horn LC, Schmidt D, Gass P, Teichmann AT, Brandner P, Stummvoll W, Kuhn A, Muller M, Fehr M, Tamussino K. Indications and Route of Hysterectomy for Benign Diseases. Guideline of the D PMID 27667852
• Johnson N, Barlow D, Lethaby A, Tavender E, Curr L, Garry R. Methods of hysterectomy: systematic review and meta-analysis of randomised controlled trials. BMJ. 2005 Jun 25;330(7506):1478. doi: 10.1136/bmj.330.7506.1478. PMID 15976422
• Driessen SR, Baden NL, van Zwet EW, Twijnstra AR, Jansen FW. Trends in the implementation of advanced minimally invasive gynecologic surgical procedures in the Netherlands. J Minim Invasive Gynecol. 2015 May-Jun;22(4):642-7. doi: 10.1016/j.jmig.2015.01.026. Epub 2015 Feb 3. PMID 25655043

Identifiers

NCT: NCT04886791 · NL76240.096.21

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗