Multicenter Ventral Mesh Rectopexy Registry Collaborative

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Antwerp

About this trial

The goal of this multicenter observational study is to collect data prospectively of patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined) by laparoscopy or robotic surgery and to evaluate the longterm functional outcomes.

Secondly complications (mesh erosions, recurrence, reoperations) are evaluated.

Following main questions will be analysed - other can follow in consultation with the collaborative

1. Is VMR the technique of choice for treatment of rectoceles? Functional results - recurrence - mesh related complications 2. Has a perineal descent an impact on the functional outcome of ventral mesh rectopexy perfored for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidcele or combined pelvic organ prolapse?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of posterior pelvic organ prolaps planned for laparoscopie or robotic ventral mesh rectopexy with or without concomittant surgery.

All patients 18 years or older and are able to complete a written informed conscent are eligble for inclusion.

Disqualifiers

Inability to complete a written informed conscent

Pregnant women

No email adress available to send the questionnaires to

Language barrier or impossiblity to fill in the questionnaires (at the discretion oft he treating physician)

Trial population

Patients with pelvic organ prolapse undergoing ventral mesh rectopexy (as well as rectoceles, entero-/sigmoidoceles/ intussusception/ rectal prolapse or combined)

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Functional outcome

Evaluation of the long-term functional outcomes of ventral mesh rectopexy (VMR) for posterior organ prolapse. Is VMR the surgical technique of choice for treatment of rectoceles?

Time frame
5 years
2

Has perineal descent has an impact on the functional outcome of ventral mesh rectopexy performed for external rectal prolaps, internal rectal prolaps, rectocele, enterocele, sigmoidocele or combined pelvic organ prolapse?

Time frame
5 years

Secondary outcomes

1

recurrence of posterior pelvic organ prolapse - new onset of symptoms

Time frame
5 years
2

mesh related complications

Time frame
5 years

Other outcomes

Sponsors and contacts

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