HysterectomyVANHNCT04886791
Vaginal NOTES Hysterectomy Versus Vaginal Hysterectomy
A study testing Vaginal NOTES hysterectomy and Vaginal hysterectomy in people with Hysterectomy and Natural Orifice Transluminal Endoscopic Surgery, run by Zuyderland Medisch Centrum at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hysterectomy, Natural Orifice Transluminal Endoscopic Surgery, Vaginal Hysterectomy
- What is being tested?
- Vaginal NOTES hysterectomy and Vaginal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 2 sitesNetherlands
- Study dates
- 5 Jul 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Martine Wassen contact
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Catharina Medical Centre
Eindhoven, North Brabant
Huib Van Vliet, Dr, 0031402399111, huib.v.vliet@catharinaziekenhuis.nl
- Recruiting
Zuyderland Medical Centre
Heerlen, North Brabant, 5644AD
Ilse Bekkers, 0640970334, il.bekkers@zuyderland.nl
Martine Wassen, m.wassen@zuyderland.nl
About this study
Official title: Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial
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.
Read more
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.
Read the 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.
- Being tested
- Vaginal NOTES hysterectomy, Vaginal hysterectomy
- Keywords
- NOTES surgery, vNOTES, VANH, Vaginal hysterectomy, Hysterectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal NOTES hysterectomyProcedure or surgery
Vaginal assited NOTES hysterectomy
Vaginal hysterectomyProcedure or surgery
Vaginal hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| VANH hysterectomy | Experimental | 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 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. 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. 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. Receives: Procedure: Vaginal NOTES hysterectomy |
| Vaginal hysterectomy | Active comparator | A circumferential incision is made around the cervix. Access to the peritoneal cavity will be performed through anterior and posterior colpotomy. The sacro-uterine ligaments, ligamenta cardinalia uterine arteries will be clamped and dissected. Finally, the ovarian ligament, round ligament and fallopian tubes will be dissected and tied. The uterus will be removed and the vagina will be closed. The urinary bladder catheter will be removed directly postoperative. Receives: Procedure: Vaginal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of same day discharge
Same day discharge
Measured: First 24hours after surgery
Secondary outcomes (16)
Complications
Severity scored by Clavien Dindo classifications
Measured: Week 6 after surgery
Treatment related outcomes-1
Conversion
Measured: During surgery
Intended number of salphingectomies in each group
Intended number of salphingectomies
Measured: During surgery
Performed number of salphingectomies in each group
Performed number of salphingectomies
Measured: During surgery
Recovery Index-10 (RI-10) pre- and postoperative
Recovery Index-10 (RI-10)
Measured: Week 12 after surgery
Health- related Quality of LIfe (EQ-5D-5L questionnaire)
EQ-5D-5L questionnaire
Measured: Week 12 after surgery
Costs
Intervention costs, hospital costs, health care costs outside the hospital (using iMCQ questionnaire)
Measured: Week 12 after sugery
Cost effectiveness
Cost effectiveness between vaginal NOTES hysterectomy versus vaginal hysterectomy comparing the costs as mentioned at outcome 8
Measured: Week 12 after surgery
Treatment related outcomes-2
Time in operating theatre in minutes
Measured: During surgery
Treatment related outcomes- 3
Surgery time in minutes
Measured: During surgery
Treatment related outcomes -4
blood loss in mL
Measured: During surgery
Treatment related outcomes -5
Pain after surgery measured on numeric rating scale
Measured: First 24 hours after surgery
Treatment related outcomes -6
Recovery of pain in first 7 days after surgery measured on numeric rating scale
Measured: Day 7 after surgery
Treatment related outcomes - 7
Use of analgesics
Measured: Day 7 after surgery
Treatment related outcomes - 8
resumption of daily activity
Measured: Week 6 after surgery
Treatment related outcomes - 9
hospital re-admission
Measured: Week 6 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2021
- Study start5 Jul 2021
- Primary completion1 Aug 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded, multicentre, randomised controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven
- Responsible party
- Principal investigator, Ilse Bekkers, Zuyderland Medisch Centrum
- Investigators
- Martine Wassen, Principal investigator, Zuyderland Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886791
- Sponsor's protocol ID
- NL76240.096.21
- Acronym
- VANH
- Status last verified
- Aug 2025
- First submitted
- 26 Apr 2021
- Last updated
- 14 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 31020729Baekelandt 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.
PubMed 33248377Hammer 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.
PubMed 25724402Committee 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.
PubMed 28538491Aarts 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.
PubMed 26264829Neis 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 DGGG, OEGGG and SGGG (S3 Level, AWMF Registry No. 015/070, April 2015). Geburtshilfe Frauenheilkd. 2016 Apr;76(4):350-364. doi: 10.1055/s-0042-104288.
PubMed 27667852Johnson 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.
PubMed 15976422Driessen 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.
PubMed 25655043van Lieshout LAM, Steenbeek MP, De Hullu JA, Vos MC, Houterman S, Wilkinson J, Piek JM. Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. Cochrane Database Syst Rev. 2019 Aug 28;8(8):CD012858. doi: 10.1002/14651858.CD012858.pub2.
PubMed 31456223Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004 Jul;60(1):114-7. doi: 10.1016/s0016-5107(04)01309-4.
PubMed 15229442Santos BF, Hungness ES. Natural orifice translumenal endoscopic surgery: progress in humans since white paper. World J Gastroenterol. 2011 Apr 7;17(13):1655-65. doi: 10.3748/wjg.v17.i13.1655.
PubMed 21483624Rolanda C, Lima E, Pego JM, Henriques-Coelho T, Silva D, Moreira I, Macedo G, Carvalho JL, Correia-Pinto J. Third-generation cholecystectomy by natural orifices: transgastric and transvesical combined approach (with video). Gastrointest Endosc. 2007 Jan;65(1):111-7. doi: 10.1016/j.gie.2006.07.050.
PubMed 17185089Nieuwenhuis D, Velthuis S, Bonjer J, Sietses C. [Transanal total mesorectal excision: a new treatment option for rectal cancer]. Ned Tijdschr Geneeskd. 2014;158(6):A7054. Dutch.
PubMed 24495374Penna M, Hompes R, Arnold S, Wynn G, Austin R, Warusavitarne J, Moran B, Hanna GB, Mortensen NJ, Tekkis PP; TaTME Registry Collaborative. Transanal Total Mesorectal Excision: International Registry Results of the First 720 Cases. Ann Surg. 2017 Jul;266(1):111-117. doi: 10.1097/SLA.0000000000001948.
PubMed 27735827Su H, Yen CF, Wu KY, Han CM, Lee CL. Hysterectomy via transvaginal natural orifice transluminal endoscopic surgery (NOTES): feasibility of an innovative approach. Taiwan J Obstet Gynecol. 2012 Jun;51(2):217-21. doi: 10.1016/j.tjog.2012.04.009.
PubMed 22795097
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vaginal Hysterectomy Versus Vaginal Assisted NOTES Hysterectomy (VANH): a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04886791
- Acronym / sponsor ID
- VANH / NL76240.096.21
- Keywords
- NOTES surgery, vNOTES, VANH, Vaginal hysterectomy, Hysterectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven
- Study start
- 5 Jul 2021 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blinded, multicentre, randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| VANH hysterectomy | Experimental | Procedure: Vaginal NOTES hysterectomyAccess 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 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. 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. 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. |
| Vaginal hysterectomy | Active comparator | Procedure: Vaginal hysterectomyA circumferential incision is made around the cervix. Access to the peritoneal cavity will be performed through anterior and posterior colpotomy. The sacro-uterine ligaments, ligamenta cardinalia uterine arteries will be clamped and dissected. Finally, the ovarian ligament, round ligament and fallopian tubes will be dissected and tied. The uterus will be removed and the vagina will be closed. The urinary bladder catheter will be removed directly postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal NOTES hysterectomyVaginal assited NOTES hysterectomy | Procedure or surgery | VANH hysterectomy |
| Vaginal hysterectomyVaginal hysterectomy | Procedure or surgery | Vaginal hysterectomy |
Primary outcome
Percentage of same day discharge
Time frame: First 24hours after surgery
Same day discharge
16 secondary outcomes
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
Treatment related outcomes -6
Time frame: Day 7 after surgery
Treatment related outcomes - 7
Time frame: Day 7 after surgery
Treatment related outcomes - 8
Time frame: Week 6 after surgery
Treatment related outcomes - 9
Time frame: Week 6 after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
- Background: PubMed 31020729Baekelandt 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.
- Background: PubMed 33248377Baekelandt 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.
- Background: PubMed 25724402Hammer 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.
- Background: PubMed 28538491Committee 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.
- Background: PubMed 26264829Aarts 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.
- Background: PubMed 27667852Neis 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 DGGG, OEGGG and SGGG (S3 Level, AWMF Registry No. 015/070, April 2015). Geburtshilfe Frauenheilkd. 2016 Apr;76(4):350-364. doi: 10.1055/s-0042-104288.
- Background: PubMed 15976422Johnson 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.
- Background: PubMed 25655043Driessen 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.
- Background: PubMed 31456223van Lieshout LAM, Steenbeek MP, De Hullu JA, Vos MC, Houterman S, Wilkinson J, Piek JM. Hysterectomy with opportunistic salpingectomy versus hysterectomy alone. Cochrane Database Syst Rev. 2019 Aug 28;8(8):CD012858. doi: 10.1002/14651858.CD012858.pub2.
- Background: PubMed 15229442Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004 Jul;60(1):114-7. doi: 10.1016/s0016-5107(04)01309-4.
- Background: PubMed 21483624Santos BF, Hungness ES. Natural orifice translumenal endoscopic surgery: progress in humans since white paper. World J Gastroenterol. 2011 Apr 7;17(13):1655-65. doi: 10.3748/wjg.v17.i13.1655.
- Background: PubMed 17185089Rolanda C, Lima E, Pego JM, Henriques-Coelho T, Silva D, Moreira I, Macedo G, Carvalho JL, Correia-Pinto J. Third-generation cholecystectomy by natural orifices: transgastric and transvesical combined approach (with video). Gastrointest Endosc. 2007 Jan;65(1):111-7. doi: 10.1016/j.gie.2006.07.050.
- Choosing a route of hysterectomy for benign uterine diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martine Wassen contact
Martine Wassen principal investigator
Zuyderland Medical Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaginal NOTES hysterectomy and Vaginal hysterectomy in people with Hysterectomy and Natural Orifice Transluminal Endoscopic Surgery, run by Zuyderland Medisch Centrum at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilse Bekkers (0031640970334, il.bekkers@zuyderland.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of same day discharge (time frame: First 24hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04886791, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2025.