Clinical trial NCT03400007: Clinical and Dynamic Floor MRI Evaluation Before and After Prolapse Surgery
Official title: Pre- and Postoperative Dynamic Floor MRI in Order to Evaluate the Anatomical and Functional Changes of the Different Pelvic Floor Organs, Before and After Prolapse Surgery.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolapse
Keywords: dynamic floor magnetic resonance imaging
colpocystodefecagraphy
prolapse surgery
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who will be operated for symptomatic rectal intussusception or prolapse, enterocele and/or urogenital prolapse, though abdominal and persineal approach as well.

Brief summary: Pelvic organ prolapsed, associated with defecation disorders and urinary tracts symptoms are common and affect up to 25% of the population, mostly parous women. The pelvic floor must be seen as one entity, with multiple anatomical and physiological interactions between the various compartments (rectum, vagina, uterus and bladder) which are embedded in the same anatomical region. The often complex pathologies of this region should therefore be treated in a multidisciplinary setting.

Besides clinical evaluation, functional dynamic imaging of anorectal and pelvic floor disfunctions has an important role in the diagnosis and management of these disorders. Although the colpocystodefecography is still considered to be the golden standard in imaging this complex anatomical region, there is clearly a need for more precise imaging of the structural details, preferentially without any irradiation. Transperineal ultrasound is an option but the investigators have chosen to evaluate the use of dynamic magnetic resonance imaging. In contrast to colpocystodefecography, dynamic pelvic floor magnetic resonance imaging is an evolving technology and its precise role in functional imaging of the pelvic floor still remains to be determined.

Prolapse surgery is commonly performed and therefore it is important to assess the efficacy of the operations in correcting the anatomical defects and the symptoms associated without creating new, pelvic floor related symptoms. Few studies exist today allowing the assessment of the anatomical changes and symptoms after surgery, through abdominal or perineal approach.

This study will evaluate the reliability of the dynamic pelvic floor imaging, done in a sitting position, compared to colpocystodefecography, done in a sitting position. It will also compare clinical objective and subjective results related to pelvic floor abnormalities with imaging. Finally, it will evaluate the anatomical changes in correlation with the clinical results, organ position and inter-compartments relationships after surgery.

This study will allow to understand and explain some relapses and failures and could lead to an improvement of the indications for surgery and surgical techniques used.


Eligibility criteria: Inclusion Criteria:

All patients who will undergo internal or external rectal prolapse, enterocele or urogenital prolapse surgery in CHU Brugmann and CHU St Pierre.

Exclusion Criteria:

* MRI contra-indications
* Patients with prior pelvic floor surgery

Primary outcomes:
measure: recto-anal angle -relax position
timeFrame: 6 months post surgery
measure: recto-anal angle -retain position
timeFrame: 6 months post surgery
measure: recto-anal angle -push position
timeFrame: 6 months post surgery
measure: recto-anal angle -relax position
timeFrame: 6 months post surgery
measure: recto-anal angle -retain position
timeFrame: 6 months post surgery
measure: recto-anal angle -push position
timeFrame: 6 months post surgery
measure: Dynamic MRI: anterior compartment
timeFrame: 6 months post surgery
measure: Dynamic MRI: medium compartment
timeFrame: 6 months post surgery
Secondary outcomes:
measure: Fecal Incontinence Severity Index (FISI)
timeFrame: 6 months post surgery
measure: Constipation scoring system (CCS)
timeFrame: 6 months post surgery
measure: Prolapse Quality of Life (P-QOL) questionnaire
timeFrame: 6 months post surgery
measure: Sexual function questionnaire (PISQ-IR)
timeFrame: 6 months post surgery
measure: Visual analogic Scale (VAS)
timeFrame: 6 months post surgery
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU St Pierre
city: Brussel
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Katleen Jottard, MD
role: PRINCIPAL_INVESTIGATOR
References: