Traditional Vaginal Surgery VS Autologous Tissue in Pelvic Floor Repair

NCT05628831 | Unknown

• 1 other identifier: GHZadar
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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)

Conditions

Vaginal Vault Prolapse

Keywords

Autologous graft; vNOTES; Pelvic organ prolapse

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (5)

• Complications

  1 year

• QoL

  1 year

• Subjective pelvic floor outcomes

  1 year

• Ultrasound measurement

  1 year

• Learning curve

  1 year

Study Arms (2)

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 .

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.

Procedure: vNOTES suspension with autologous tissue

Interventions

vNOTES suspension with autologous tissue PROCEDURE

Autologous tissue will be fixated on solid points in pelvis using vNOTES.

vNOTES PREFAP

Vaginal surgery PROCEDURE

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

Traditional surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• General Hospital Zadar: lead

Study Sites (1)

Luka Matak MD

Zadar, 23000, Croatia

RECRUITING

Related Publications (9)

• 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.

  PMID: 28067747 RESULT

• 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.

  PMID: 28010989 RESULT

• 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.

  PMID: 31040607 RESULT

• 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.

  PMID: 35286581 RESULT

• 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.

  PMID: 33730231 RESULT

• 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.

  PMID: 23358016 RESULT

• 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.

  PMID: 21114648 RESULT

• 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.

  PMID: 22594310 RESULT

• 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.

  PMID: 29326183 RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luka Matak, MD

CONTACT

+38523505340; LMATAK1011@GMAIL.COM

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: univ.mag spec Luka Matak M.D.

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 29, 2022
• Study Start: March 18, 2023
• Primary Completion: September 10, 2023
• Study Completion: September 10, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of follow up period data will be available for one months

Locations

CR (1)