Vaginal Vault ProlapsePREFAPNCT05628831
Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair
A study testing vNOTES suspension with autologous tissue and Vaginal surgery in people with Vaginal Vault Prolapse, run by General Hospital Zadar at 1 site in Croatia.
Trial summary
The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of re-operation for anterior, posterior or apical prolapse within the study period. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Vault Prolapse
- What is being tested?
- vNOTES suspension with autologous tissue and Vaginal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteCroatia
- Study dates
- 18 Mar 2023to 10 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- patients older than 18 years old with no desire to preserve fertility, POP-Q 3 or 4 stage of prolapse with indication for hysterectomy (abnormal uterine bleeding, enlarged fibrous uterus, premalignant cervical findings)
Who cannot join
- Virginity, pregnancy, acute urinary infection were considered contraindications; malignancy, previous PID or rectal surgery. Rectovaginal endometriosis. Contraindication for general anaesthesia, pneumoperitoneum or Trendelenburg position. Previous pelvic radiotherapy
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
Luka Matak MD
Zadar, 23000
Luka Matak, MD, LMATAK1011@GMAIL.COM
About this study
Official title: COMPARISON BETWEEN AUTOLOGOUS TISSUE RECONSTRUCTION USING vNOTES AND TRADITIONAL SURGERY IN TREATMENT OF PELVIC ORGAN PROLAPSE
The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of re-operation for anterior, posterior or apical prolapse within the study period.
Participants with a POP-Q (Pelvic Organ Prolapse Quantification) of 3 or 4 and an indication for hysterectomy and prolapse repair will be selected and randomly divided in two groups. One group will be operated with standard technique for pelvic organ prolapse and in the other autologous graft will be used using vNOTES ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used as a subjective measurement of operative treatment.
Read more
Objective evaluation of the effect of postoperative results will be done using transperineal ultrasound before operation, 6 and 12 months after procedure.
EXPECTED CONTRIBUTION: In this research we will evaluate the feasibility and surgical outcome of vaginal NOTES (vNOTES) prolapse repair using posterior rectus fascia (PREFAP- Posterior Rectus Fascia Prolapse repair)
Read the detailed description
All patients will be operated by the same surgeon. Antibiotic prophylaxis will be given pre-operatively according hospital protocols 30 minute before surgery. Surgery will be performed under general anesthesia in the lithotomy position with legs in stirrups The following peri-operative and patient data will be collected and analyzed: preoperative POP- Q, body mass index (BMI), age, parity, history of vaginal delivery, previous pelvic surgery, total operating time, estimated bloodloss, serum hemoglobin (Hb) drop (change between preoperative Hb and postoperative Hb 1 day after surgery), peri-operative complications, post- operative pain score and POP-Q after 6 and 12 months.
The ICIQ-LUTSqol questionnaire (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) is a psychometrically robust patient- completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients with particular reference to social effects. It has 20 items to response with overall score between 19- 76 indicating increased impact on quality of life with greater values.
Subjective surgical outcome was measured using the Patient Global Impression of Improvement (PGI-I), which is a validated tool as a global index of response to prolapse surgery. The PGI-I is a seven-scale response for women comparing the postoperative condition with the pre-operative state, 1 being very much better and 7 being very much worse.
The women's prolapse symptoms and their impact will be evaluated before surgical treatment. A subjective assessment of the prolapse was made using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) before and 12 months after treatment. The PISQ-IR is designed as a condition-specific measure of sexual function in women with pelvic floor dysfunction, including urinary and anal incontinence and pelvic organ prolapse. It consists on 18-21 questions depending weather respondent indicates having a sexual partner or not. The cutoff score of 2.68 for PISQ-IR Summary Score allowed to diagnose sexual dysfunction in sexually active women with pelvic floor disorders.
Pelvic floor ultrasound will be performed before the operation and at 6 and 12 months after the operation. The inspection methods are as follows: Before the inspection, patients emptied the stool and moderately filled the bladder. The following parameters will be measured in resting state using the maximal Valsalva maneuver: Posterior vesicourethral angle (PVA):This included the angle between the proximal urethra and posterior wall of the bladder. Urethral tilt angle: This included the angle between the proximal urethra and vertical axis of the human body. Value is negative if the urethral axis deviated to the ventral side, and the value was positive when it is deviated to the dorsal side. Postoperative rotation angle of the urethra (UR): This refers to the difference in PVA between the Valsalva state and resting state. Bladder neck descent (BND): This refers to the vertical displacement of the bladder neck between the Valsalva state and resting state.
- Conditions
- Vaginal Vault Prolapse
- Being tested
- vNOTES suspension with autologous tissue, Vaginal surgery
- Keywords
- Autologous graft, vNOTES, Pelvic organ prolapse
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vNOTES suspension with autologous tissueProcedure or surgery
Autologous tissue will be fixated on solid points in pelvis using vNOTES.
Vaginal surgeryProcedure or surgery
Vaginal hysterectomy will be done with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Uterosacral and cardinal ligaments will be repositioned and attached to the vaginal vault after hysterectomy at the time of vault closure. A modified McCall culdoplasty will be done in this group to prevent enterocele and further apical prolapse
| Study group | Role | What they receive |
|---|---|---|
| Traditional surgery | Placebo comparator | This group of patients will be treated with standard technique (vaginal hysterectomy with anterior and/or posterior vaginal repair) for pelvic organ prolapse . Receives: Procedure: Vaginal surgery |
| vNOTES PREFAP | Active comparator | This group of patients will be treated with vNOTES aproach using autologous graft isolated from posterior rectus fascia for pelvic organ prolapse. Receives: Procedure: vNOTES suspension with autologous tissue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Traditional surgery vrs vNOTES PREFAP
Compare the efficacy of vNOTES autograft repair and traditional surgery between the two groups by determining the risk of reoperation for anterior, posterior or apical prolapse within the study period
Measured: 1 year
Secondary outcomes (5)
Complications
Diagnosis of an autologous tissue or vNOTES-associated complication.
Measured: 1 year
QoL
Compare quality of life in both groups before operation and 6 months after procedure using ICIQ-LUTSqol questionnaire
Measured: 1 year
Subjective pelvic floor outcomes
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used before and 12 months after treatment to compare subjective impression of procedure
Measured: 1 year
Ultrasound measurement
Objective evaluation of the effect of postoperative results using transperineal ultrasound before operation, 6 and 12 months after procedure
Measured: 1 year
Learning curve
To assess the learning curve of harvesting the PREFAP autologous tissue measuring time and complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start18 Mar 2023
- Primary completion10 Sep 2023 (estimated)
- Study completion10 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Vaginal Vault ProlapseStudies 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
- In one group of patients vaginal hysterectomy will be done with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Second group will be treated with minimally invasive technique (vNOTES-vaginal natural orifice transluminal surgery) in which we will remove uterus and support pelvic floor with autologous tissue. Tissue graft will be isolated from abdominal rectus muscle. Fixation will be done using vNOTES aproach.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital Zadar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luka Matak M.D., General Hospital Zadar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628831
- Sponsor's protocol ID
- GHZadar
- Acronym
- PREFAP
- Status last verified
- May 2023
- First submitted
- 8 Nov 2022
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data relevant to the research results will be published
Publications
Hokenstad ED, Glasgow AE, Habermann EB, Occhino JA. Readmission and Reoperation After Surgery for Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):131-135. doi: 10.1097/SPV.0000000000000379.
PubMed 28067747Glazener CM, Breeman S, Elders A, Hemming C, Cooper KG, Freeman RM, Smith AR, Reid F, Hagen S, Montgomery I, Kilonzo M, Boyers D, McDonald A, McPherson G, MacLennan G, Norrie J; PROSPECT study group). Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet. 2017 Jan 28;389(10067):381-392. doi: 10.1016/S0140-6736(16)31596-3. Epub 2016 Dec 21.
PubMed 28010989Seth J, Toia B, Ecclestone H, Pakzad M, Hamid R, Greenwell T, Ockrim J. The autologous rectus fascia sheath sacrocolpopexy and sacrohysteropexy, a mesh free alternative in patients with recurrent uterine and vault prolapse: A contemporary series and literature review. Urol Ann. 2019 Apr-Jun;11(2):193-197. doi: 10.4103/UA.UA_85_18.
PubMed 31040607Sharifiaghdas F. Autologous rectus fascia graft in the treatment of high-stage apical vaginal prolapse: preliminary results of a new surgical approach with native tissue. Int Urol Nephrol. 2022 May;54(5):1017-1022. doi: 10.1007/s11255-022-03167-8. Epub 2022 Mar 14.
PubMed 35286581Gon LM, Riccetto CLZ, Coltro Neto F, Achermann APP, Pereira TA, Palma PCR. Sacrospinous hysteropexy with an autologous rectus fascia sling for treatment of advanced apical pelvic organ prolapse. Int Urogynecol J. 2021 Aug;32(8):2291-2293. doi: 10.1007/s00192-021-04747-5. Epub 2021 Mar 17.
PubMed 33730231Lee JC, Olaitan OK, Lopez-Soler R, Renz JF, Millis JM, Gottlieb LJ. Expanding the envelope: the posterior rectus sheath-liver vascular composite allotransplant. Plast Reconstr Surg. 2013 Feb;131(2):209e-218e. doi: 10.1097/PRS.0b013e3182789c28.
PubMed 23358016Agarwal S, Dorafshar AH, Harland RC, Millis JM, Gottlieb LJ. Liver and vascularized posterior rectus sheath fascia composite tissue allotransplantation. Am J Transplant. 2010 Dec;10(12):2712-6. doi: 10.1111/j.1600-6143.2010.03331.x.
PubMed 21114648Ravindra KV, Martin AE, Vikraman DS, Brennan TV, Collins BH, Rege AS, Hollenbeck ST, Chinappa-Nagappa L, Eager K, Cousino D, Sudan DL. Use of vascularized posterior rectus sheath allograft in pediatric multivisceral transplantation--report of two cases. Am J Transplant. 2012 Aug;12(8):2242-6. doi: 10.1111/j.1600-6143.2012.04088.x. Epub 2012 May 17.
PubMed 22594310Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BWJ, Bosteels JJA. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial. BMJ Open. 2018 Jan 10;8(1):e018059. doi: 10.1136/bmjopen-2017-018059.
PubMed 29326183
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON BETWEEN AUTOLOGOUS TISSUE RECONSTRUCTION USING vNOTES AND TRADITIONAL SURGERY IN TREATMENT OF PELVIC ORGAN PROLAPSE
- ClinicalTrials.gov ID
- NCT05628831
- Acronym / sponsor ID
- PREFAP / GHZadar
- Conditions
- Vaginal Vault Prolapse
- Keywords
- Autologous graft, vNOTES, Pelvic organ prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- General Hospital ZadarUniversity, hospital or other
- Study start
- 18 Mar 2023 (actual)
- Primary completion
- 10 Sep 2023 (estimated)
- Study completion
- 10 Sep 2024 (estimated)
- First posted
- 29 Nov 2022 (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.
The goal of this randomized, non blind, one center study is to compare the efficacy of vNOTES (vaginal natural orifice transluminal surgery) and traditional vaginal operation between the two groups by determining the risk of re-operation for anterior, posterior or apical prolapse within the study period.
Participants with a POP-Q (Pelvic Organ Prolapse Quantification) of 3 or 4 and an indication for hysterectomy and prolapse repair will be selected and randomly divided in two groups. One group will be operated with standard technique for pelvic organ prolapse and in the other autologous graft will be used using vNOTES ICIQ-LUTSqol (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) will be used as a subjective measurement of operative treatment.
Objective evaluation of the effect of postoperative results will be done using transperineal ultrasound before operation, 6 and 12 months after procedure.
EXPECTED CONTRIBUTION: In this research we will evaluate the feasibility and surgical outcome of vaginal NOTES (vNOTES) prolapse repair using posterior rectus fascia (PREFAP- Posterior Rectus Fascia Prolapse repair)
Detailed description
All patients will be operated by the same surgeon. Antibiotic prophylaxis will be given pre-operatively according hospital protocols 30 minute before surgery. Surgery will be performed under general anesthesia in the lithotomy position with legs in stirrups The following peri-operative and patient data will be collected and analyzed: preoperative POP- Q, body mass index (BMI), age, parity, history of vaginal delivery, previous pelvic surgery, total operating time, estimated bloodloss, serum hemoglobin (Hb) drop (change between preoperative Hb and postoperative Hb 1 day after surgery), peri-operative complications, post- operative pain score and POP-Q after 6 and 12 months.
The ICIQ-LUTSqol questionnaire (International Consultation on Incontinence Questionnaire Lower Urinary Tract Symptoms Quality of Life Module) is a psychometrically robust patient- completed questionnaire evaluating quality of life (QoL) in urinary incontinent patients with particular reference to social effects. It has 20 items to response with overall score between 19- 76 indicating increased impact on quality of life with greater values.
Subjective surgical outcome was measured using the Patient Global Impression of Improvement (PGI-I), which is a validated tool as a global index of response to prolapse surgery. The PGI-I is a seven-scale response for women comparing the postoperative condition with the pre-operative state, 1 being very much better and 7 being very much worse.
The women's prolapse symptoms and their impact will be evaluated before surgical treatment. A subjective assessment of the prolapse was made using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire IUGA revised (PISQ-IR) before and 12 months after treatment. The PISQ-IR is designed as a condition-specific measure of sexual function in women with pelvic floor dysfunction, including urinary and anal incontinence and pelvic organ prolapse. It consists on 18-21 questions depending weather respondent indicates having a sexual partner or not. The cutoff score of 2.68 for PISQ-IR Summary Score allowed to diagnose sexual dysfunction in sexually active women with pelvic floor disorders.
Pelvic floor ultrasound will be performed before the operation and at 6 and 12 months after the operation. The inspection methods are as follows: Before the inspection, patients emptied the stool and moderately filled the bladder. The following parameters will be measured in resting state using the maximal Valsalva maneuver: Posterior vesicourethral angle (PVA):This included the angle between the proximal urethra and posterior wall of the bladder. Urethral tilt angle: This included the angle between the proximal urethra and vertical axis of the human body. Value is negative if the urethral axis deviated to the ventral side, and the value was positive when it is deviated to the dorsal side. Postoperative rotation angle of the urethra (UR): This refers to the difference in PVA between the Valsalva state and resting state. Bladder neck descent (BND): This refers to the vertical displacement of the bladder neck between the Valsalva state and resting state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- In one group of patients vaginal hysterectomy will be done with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Second group will be treated with minimally invasive technique (vNOTES-vaginal natural orifice transluminal surgery) in which we will remove uterus and support pelvic floor with autologous tissue. Tissue graft will be isolated from abdominal rectus muscle. Fixation will be done using vNOTES aproach.
| Arm | Type | Receives |
|---|---|---|
| Traditional surgery | Placebo comparator | Procedure: Vaginal surgeryThis group of patients will be treated with standard technique (vaginal hysterectomy with anterior and/or posterior vaginal repair) for pelvic organ prolapse . |
| vNOTES PREFAP | Active comparator | Procedure: vNOTES suspension with autologous tissueThis group of patients will be treated with vNOTES aproach using autologous graft isolated from posterior rectus fascia for pelvic organ prolapse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients older than 18 years old with no desire to preserve fertility, POP-Q 3 or 4 stage of prolapse with indication for hysterectomy (abnormal uterine bleeding, enlarged fibrous uterus, premalignant cervical findings)
Key exclusion criteria (1 listed)
- Virginity, pregnancy, acute urinary infection were considered contraindications; malignancy, previous PID or rectal surgery. Rectovaginal endometriosis. Contraindication for general anaesthesia, pneumoperitoneum or Trendelenburg position. Previous pelvic radiotherapy
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 |
|---|---|---|
| vNOTES suspension with autologous tissueAutologous tissue will be fixated on solid points in pelvis using vNOTES. | Procedure or surgery | vNOTES PREFAP |
| Vaginal surgeryVaginal hysterectomy will be done with anterior and/or posterior repair depending on the judgment of the surgeon at the time of the operation. Uterosacral and cardinal ligaments will be repositioned and attached to the vaginal vault after hysterectomy at the time of vault closure. A modified McCall culdoplasty will be done in this group to prevent enterocele and further apical prolapse | Procedure or surgery | Traditional surgery |
Primary outcome
Traditional surgery vrs vNOTES PREFAP
Time frame: 1 year
Compare the efficacy of vNOTES autograft repair and traditional surgery between the two groups by determining the risk of reoperation for anterior, posterior or apical prolapse within the study period
5 secondary outcomes
Complications
Time frame: 1 year
QoL
Time frame: 1 year
Subjective pelvic floor outcomes
Time frame: 1 year
Ultrasound measurement
Time frame: 1 year
Learning curve
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Results publication: PubMed 28067747Hokenstad ED, Glasgow AE, Habermann EB, Occhino JA. Readmission and Reoperation After Surgery for Pelvic Organ Prolapse. Female Pelvic Med Reconstr Surg. 2017 Mar/Apr;23(2):131-135. doi: 10.1097/SPV.0000000000000379.
- Results publication: PubMed 28010989Glazener CM, Breeman S, Elders A, Hemming C, Cooper KG, Freeman RM, Smith AR, Reid F, Hagen S, Montgomery I, Kilonzo M, Boyers D, McDonald A, McPherson G, MacLennan G, Norrie J; PROSPECT study group). Mesh, graft, or standard repair for women having primary transvaginal anterior or posterior compartment prolapse surgery: two parallel-group, multicentre, randomised, controlled trials (PROSPECT). Lancet. 2017 Jan 28;389(10067):381-392. doi: 10.1016/S0140-6736(16)31596-3. Epub 2016 Dec 21.
- Results publication: PubMed 31040607Seth J, Toia B, Ecclestone H, Pakzad M, Hamid R, Greenwell T, Ockrim J. The autologous rectus fascia sheath sacrocolpopexy and sacrohysteropexy, a mesh free alternative in patients with recurrent uterine and vault prolapse: A contemporary series and literature review. Urol Ann. 2019 Apr-Jun;11(2):193-197. doi: 10.4103/UA.UA_85_18.
- Results publication: PubMed 35286581Sharifiaghdas F. Autologous rectus fascia graft in the treatment of high-stage apical vaginal prolapse: preliminary results of a new surgical approach with native tissue. Int Urol Nephrol. 2022 May;54(5):1017-1022. doi: 10.1007/s11255-022-03167-8. Epub 2022 Mar 14.
- Results publication: PubMed 33730231Gon LM, Riccetto CLZ, Coltro Neto F, Achermann APP, Pereira TA, Palma PCR. Sacrospinous hysteropexy with an autologous rectus fascia sling for treatment of advanced apical pelvic organ prolapse. Int Urogynecol J. 2021 Aug;32(8):2291-2293. doi: 10.1007/s00192-021-04747-5. Epub 2021 Mar 17.
- Results publication: PubMed 23358016Lee JC, Olaitan OK, Lopez-Soler R, Renz JF, Millis JM, Gottlieb LJ. Expanding the envelope: the posterior rectus sheath-liver vascular composite allotransplant. Plast Reconstr Surg. 2013 Feb;131(2):209e-218e. doi: 10.1097/PRS.0b013e3182789c28.
- Results publication: PubMed 21114648Agarwal S, Dorafshar AH, Harland RC, Millis JM, Gottlieb LJ. Liver and vascularized posterior rectus sheath fascia composite tissue allotransplantation. Am J Transplant. 2010 Dec;10(12):2712-6. doi: 10.1111/j.1600-6143.2010.03331.x.
- Results publication: PubMed 22594310Ravindra KV, Martin AE, Vikraman DS, Brennan TV, Collins BH, Rege AS, Hollenbeck ST, Chinappa-Nagappa L, Eager K, Cousino D, Sudan DL. Use of vascularized posterior rectus sheath allograft in pediatric multivisceral transplantation--report of two cases. Am J Transplant. 2012 Aug;12(8):2242-6. doi: 10.1111/j.1600-6143.2012.04088.x. Epub 2012 May 17.
- Results publication: PubMed 29326183Baekelandt JF, De Mulder PA, Le Roy I, Mathieu C, Laenen A, Enzlin P, Weyers S, Mol BWJ, Bosteels JJA. Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) adnexectomy for benign pathology compared with laparoscopic excision (NOTABLE): a protocol for a randomised controlled trial. BMJ Open. 2018 Jan 10;8(1):e018059. doi: 10.1136/bmjopen-2017-018059.
- Individual participant dataSharing planned: Yes. All data relevant to the research results will be published
Related trials for Vaginal Vault Prolapse
Active, not recruiting
Apical Suspension Repair for Vault Prolapse In a Three-Arm Randomized Trial Design
Visceral Prolapse
Recruiting
Vaginal Vault Native Tissue Suspension
Pelvic Organ Prolapse
Recruiting
Vaginal Mesh Surgery Versus Robotic-assisted Abdominal Mesh Surgery in the Treatment of Apical Prolapse - Prospective Randomized Non-inferiority Study
Pelvic Organ Prolapse (POP), Pelvic Organ Prolapse Vaginal Surgery
Recruiting
Transvaginal Mesh vs. Laparoscopic Colposacropexy- Study
Prolapse, Vaginal Vault
Recruiting
Post-Hysterectomy Vaginal Length: Horizontal vs. Vertical Closure
Prolapse, Vaginal, Vaginal Vault Prolapse
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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing vNOTES suspension with autologous tissue and Vaginal surgery in people with Vaginal Vault Prolapse, run by General Hospital Zadar at 1 site in Croatia.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luka Matak, MD (+38523505340, LMATAK1011@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Traditional surgery vrs vNOTES PREFAP (time frame: 1 year). 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 NCT05628831, which also lists 9 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 9 May 2023.