search
Back to results

Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair (PREFAP)

Primary Purpose

Vaginal Vault Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
vNOTES suspension with autologous tissue
Vaginal surgery
Sponsored by
General Hospital Zadar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Vault Prolapse focused on measuring Autologous graft, vNOTES, Pelvic organ prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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

Sites / Locations

  • Luka Matak MDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Traditional surgery

vNOTES PREFAP

Arm Description

This group of patients will be treated with standard technique (vaginal hysterectomy with anterior and/or posterior vaginal repair) for pelvic organ prolapse .

This group of patients will be treated with vNOTES aproach using autologous graft isolated from posterior rectus fascia for pelvic organ prolapse.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications
Diagnosis of an autologous tissue or vNOTES-associated complication.
QoL
Compare quality of life in both groups before operation and 6 months after procedure using ICIQ-LUTSqol questionnaire
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
Ultrasound measurement
Objective evaluation of the effect of postoperative results using transperineal ultrasound before operation, 6 and 12 months after procedure
Learning curve
To assess the learning curve of harvesting the PREFAP autologous tissue measuring time and complications

Full Information

First Posted
November 8, 2022
Last Updated
May 7, 2023
Sponsor
General Hospital Zadar
search

1. Study Identification

Unique Protocol Identification Number
NCT05628831
Brief Title
Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair
Acronym
PREFAP
Official Title
COMPARISON BETWEEN AUTOLOGOUS TISSUE RECONSTRUCTION USING vNOTES AND TRADITIONAL SURGERY IN TREATMENT OF PELVIC ORGAN PROLAPSE
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2023 (Actual)
Primary Completion Date
September 10, 2023 (Anticipated)
Study Completion Date
September 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
General Hospital Zadar

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Vault Prolapse
Keywords
Autologous graft, vNOTES, Pelvic organ prolapse

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Traditional surgery
Arm Type
Placebo Comparator
Arm Description
This group of patients will be treated with standard technique (vaginal hysterectomy with anterior and/or posterior vaginal repair) for pelvic organ prolapse .
Arm Title
vNOTES PREFAP
Arm Type
Active Comparator
Arm Description
This group of patients will be treated with vNOTES aproach using autologous graft isolated from posterior rectus fascia for pelvic organ prolapse.
Intervention Type
Procedure
Intervention Name(s)
vNOTES suspension with autologous tissue
Intervention Description
Autologous tissue will be fixated on solid points in pelvis using vNOTES.
Intervention Type
Procedure
Intervention Name(s)
Vaginal surgery
Intervention Description
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
Primary Outcome Measure Information:
Title
Traditional surgery vrs vNOTES PREFAP
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Complications
Description
Diagnosis of an autologous tissue or vNOTES-associated complication.
Time Frame
1 year
Title
QoL
Description
Compare quality of life in both groups before operation and 6 months after procedure using ICIQ-LUTSqol questionnaire
Time Frame
1 year
Title
Subjective pelvic floor outcomes
Description
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
Time Frame
1 year
Title
Ultrasound measurement
Description
Objective evaluation of the effect of postoperative results using transperineal ultrasound before operation, 6 and 12 months after procedure
Time Frame
1 year
Title
Learning curve
Description
To assess the learning curve of harvesting the PREFAP autologous tissue measuring time and complications
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luka Matak, MD
Phone
+38523505340
Email
LMATAK1011@GMAIL.COM
Facility Information:
Facility Name
Luka Matak MD
City
Zadar
ZIP/Postal Code
23000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luka Matak, MD
Email
LMATAK1011@GMAIL.COM

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All data relevant to the research results will be published
IPD Sharing Time Frame
After the end of follow up period data will be available for one months
Citations:
PubMed Identifier
28067747
Citation
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.
Results Reference
result
PubMed Identifier
28010989
Citation
Glazener 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 Reference
result
PubMed Identifier
31040607
Citation
Seth 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 Reference
result
PubMed Identifier
35286581
Citation
Sharifiaghdas 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 Reference
result
PubMed Identifier
33730231
Citation
Gon 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 Reference
result
PubMed Identifier
23358016
Citation
Lee 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 Reference
result
PubMed Identifier
21114648
Citation
Agarwal 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 Reference
result
PubMed Identifier
22594310
Citation
Ravindra 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 Reference
result
PubMed Identifier
29326183
Citation
Baekelandt 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.
Results Reference
result

Learn more about this trial

Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair

We'll reach out to this number within 24 hrs