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Comparison of Vaginal Axis on MRI in Alternative Apical Prolapse Surgeries to Sacrocolpopexy

NCT ID: NCT06072456

Last Updated: 2023-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-01

Study Completion Date

2023-12-27

Brief Summary

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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.

Detailed Description

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The study objective pertains to the assessment of vaginal axis in patients undergoing apical prolapse surgery, whether they have undergone hysterectomy or not. The investigation is designed to test the null hypothesis by means of a comparative analysis of preoperative and postoperative Magnetic Resonance Imaging images capturing the vaginal axis. This examination will be conducted on patients slated to receive lateral mesh suspension, pectopexy, and sacrospinous ligament fixation procedures for the correction of apical prolapse.

Conditions

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Pelvic Organ Prolapse

Keywords

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pelvic organ prolapse apical prolapse pectopexy sacrospinous ligament fixation Lateral suspension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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lateral suspension

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

Group Type EXPERIMENTAL

laparoscopic lateral suspension

Intervention Type PROCEDURE

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.

pectopexy

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

Group Type EXPERIMENTAL

laparoscopic pectopexy

Intervention Type PROCEDURE

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.

sacrospinous ligament fixation

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

Group Type EXPERIMENTAL

Sacrospinous ligament fixation

Intervention Type PROCEDURE

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

hysterectomized patients

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Nulliparous women

MRI of nulliparous women was evaluated for vaginal axis.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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laparoscopic lateral suspension

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.

Intervention Type PROCEDURE

laparoscopic pectopexy

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.

Intervention Type PROCEDURE

Sacrospinous ligament fixation

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Female with genital prolapse

Exclusion Criteria

* Patients who had pouch of Douglas obliteration
* Patients with enterocele
* Patients who have any congenital or acquired anatomic and reproductive anomaly
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

OTHER

Sponsor Role lead

Responsible Party

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fatih sahin

Principal Investigator, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cemil Taşcıoğlu Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Prof.Dr.Cemil Taşcıoğlu Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type RESULT
PMID: 28816554 (View on PubMed)

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.

Reference Type RESULT
PMID: 33175232 (View on PubMed)

Other Identifiers

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E-10840098-772.02-4704

Identifier Type: -

Identifier Source: org_study_id