NCT06072456

Brief Summary

Sacrocolpopexy remains the preeminent modality in addressing apical prolapse surgically. Nevertheless, amplified morbidity rates within cohorts characterized by obesity and advanced age constrain the advantages conferred by the procedure. Recent years have witnessed a proliferation of inquiries appraising the efficacy of laparoscopic lateral suspension, pectopexy, and sacrospinous ligament fixation interventions, which have, over time, garnered extensive clinical application, in relation to recurrence rates. A multitude of investigations have been undertaken to delineate the optimal vaginal axis. In the present investigation, we have delineated a research protocol aimed at scrutinizing these alternative surgical modalities with regard to their impact on the vaginal axis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2023

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

4 months

First QC Date

October 3, 2023

Last Update Submit

December 27, 2023

Conditions

Pelvic Organ Prolapse

Keywords

pelvic organ prolapseapical prolapsepectopexysacrospinous ligament fixationLateral suspension

Outcome Measures

Primary Outcomes (2)

  • Vaginal axis

    From the images obtained in the sagittal plane, the vagina, which will be observed as a high signal intensity linear structure in T2A images, and the levator plate extending as a flow-signal intensity flat structure in T1A images, will be evaluated.

    at 4th months after the operation

  • Vaginal distances

    The distance between the posterior vaginal fornix and the midpoint of the anterior side of the 2nd vertebra will be measured in the mid-sagittal plane (PF-S2). The distance between the right spina ischiadica and right vaginal fornix (RSI-RF), and, the distance between the left spina ischiadica and left vaginal fornix (LSI-LF) will be measured on T2A images acquired in the axial plane.

    at 4th months after the operation

Secondary Outcomes (7)

  • Prolapse symptoms, Colorectal-Anal Impact Questionnaire

    at 4th months after the operation

  • Prolapse symptoms

    at 4th months after the operation

  • Urinary Symptoms

    at 4th months after the operation

  • Postoperative de novo dyspareunia

    at 4th months after the operation

  • Sexual functions

    at 4th months after the operation

  • +2 more secondary outcomes

Study Arms (5)

lateral suspension

EXPERIMENTAL

Suspending the cervix to the bilateral abdominal wall through subperitoneal tunnels may properly mimic cardinal ligament and restore the normal vaginal axis. Preoperative and postoperative MRI results were evaluated

Procedure: laparoscopic lateral suspension

pectopexy

EXPERIMENTAL

The cervix or vaginal cuff was suspended by the Cooper ligament.Preoperative and postoperative MRI results were evaluated

Procedure: laparoscopic pectopexy

sacrospinous ligament fixation

EXPERIMENTAL

vaginal cuff/uterus was sutured to the unilateral sacrospinous ligament.Preoperative and postoperative MRI results were evaluated

Procedure: Sacrospinous ligament fixation

hysterectomized patients

NO INTERVENTION

Vaginal axis MRI of women who have previously been hysterectomized and who do not have apical prolapse

Nulliparous women

NO INTERVENTION

MRI of nulliparous women was evaluated for vaginal axis.

Interventions

laparoscopic lateral suspensionPROCEDURE

Lateral suspension involves the lateral attachment or suspension of vaginal tissue to a stable structure, often using mesh or sutures, to provide support and stability to the pelvic organs. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.

lateral suspension
laparoscopic pectopexyPROCEDURE

Pectopexy involves attaching or suspending the vaginal vault to the pectineal ligament, which is a strong ligament in the pelvis. Control groups consist of hysterectomized women without cuff prolapse and nulliparous women.

pectopexy
Sacrospinous ligament fixationPROCEDURE

Sacrospinous ligament fixation entails the attachment or fixation of the vaginal vault to the sacrospinous ligament, which is a strong fibrous band located in the pelvis

sacrospinous ligament fixation

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female with genital prolapse

You may not qualify if:

  • Patients who had pouch of Douglas obliteration
  • Patients with enterocele
  • Patients who have any congenital or acquired anatomic and reproductive anomaly

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cemil Taşcıoğlu Hospital

Istanbul, 34320, Turkey (Türkiye)

Location

Prof.Dr.Cemil Taşcıoğlu Hospital

Istanbul, 34320, Turkey (Türkiye)

Location

Related Publications (2)

  • Senturk MB, Kilicci C, Aydin S, Polat M, Abide Yayla C, Karateke A. Vaginal axis on MRI after unilateral and bilateral sacral hysteropexy: a controlled study. J Obstet Gynaecol. 2018 Jan;38(1):115-120. doi: 10.1080/01443615.2017.1336754. Epub 2017 Aug 17.

    PMID: 28816554RESULT

  • Pulatoglu C, Yassa M, Turan G, Turkyilmaz D, Dogan O. Vaginal axis on MRI after laparoscopic lateral mesh suspension surgery: a controlled study. Int Urogynecol J. 2021 Apr;32(4):851-858. doi: 10.1007/s00192-020-04596-8. Epub 2020 Nov 11.

    PMID: 33175232RESULT

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

ProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 10, 2023

Study Start

August 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 27, 2023

Last Updated

December 28, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

TU(2)