An observational study in Prolapse, sponsored by Tatiana Besse-Hammer. Completed at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-19.
Sponsored by Tatiana Besse-Hammer · Observational
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.
93 studies on the registry are indexed under Prolapse; 9 are open to participants now.
This study's enrollment of 34 is below the median of 150 across 27 observational studies indexed under Prolapse.
Browse Prolapse studies →Tatiana Besse-Hammer is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients who will be operated for symptomatic rectal intussusception or prolapse, enterocele and/or urogenital prolapse, though abdominal and persineal approach as well.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
All patients who will undergo internal or external rectal prolapse, enterocele or urogenital prolapse surgery in CHU Brugmann and CHU St Pierre.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: Dynamic floor magnetic resonance imaging · Device: Colpocystodefecography
Dynamic floor magnetic resonance imaging (MRI)
Colpocystodefecography (CCD)
recto-anal angle -relax position
Measured by dynamic floor MRI in left lateral decubitus position (141°)
Time frame: 6 months post surgery
recto-anal angle -retain position
Measured by dynamic floor MRI in left lateral decubitus position (163°)
Time frame: 6 months post surgery
recto-anal angle -push position
Measured by dynamic floor MRI in left lateral decubitus position (165°)
Time frame: 6 months post surgery
recto-anal angle -relax position
Measured by dynamic floor MRI in sitting position (141°)
Time frame: 6 months post surgery
recto-anal angle -retain position
Measured by dynamic floor MRI in sitting position (125°)
Time frame: 6 months post surgery
recto-anal angle -push position
Measured by dynamic floor MRI in sitting position (143°)
Time frame: 6 months post surgery
Dynamic MRI: anterior compartment
From the bladder, discrete inferior descent of the pubococcygeal line: max 1/3 (yes/no)
Time frame: 6 months post surgery
Dynamic MRI: medium compartment
Vagina horizontalization (yes/no)
Time frame: 6 months post surgery
Fecal Incontinence Severity Index (FISI)
This is a health tool that describes the severity of different types of incontinence for bowel contents.There are 4 items in the FISI scale with 6 answer choices. Points are awarded according to the gravity of the symptoms. The higher the FISI index (which ranges from 0 to 61), the higher the severity of the fecal incontinence.
Time frame: 6 months post surgery
Constipation scoring system (CCS)
Validated questionnaire. Minimum Score, 0 - Maximum Score, 30
Time frame: 6 months post surgery
Prolapse Quality of Life (P-QOL) questionnaire
Validated questionnaire covering nine domains: general health (1 item), prolapse impact (1 item), role (2 items), physical (2 items) and social limitations (3 items), personal relationships (2 items), emotions (3 items), sleep/energy (2 items), and severity measurement (4 items). The answers are categorized using a fourpoint Likert scale: "none/not at all," "slightly/a little," "moderately," and "a lot." A score is calculated for each domain ranging from 0 to 100. A higher score indicates a greater impairment of quality of life.
Time frame: 6 months post surgery
Sexual function questionnaire (PISQ-IR)
Validated questionnaire. The PISQ-12 measures three domains: behavioral-emotive (items 1 - 4), physical (items 5 - 9) and partner-related (items 10 - 12). It is a self-administered questionnaire, and responses are graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Items 1 - 4 are reversely scored and a total of 48 is the maximum score. Higher scores indicate better sexual function.
Time frame: 6 months post surgery
Visual analogic Scale (VAS)
The VAS scale (EVA in French) is a straight line of 100 mn length. One end is the absence of pain, the other end represents unbearable pain. The patient places a mark between these 2 extremities according to the intensity of his pain at a given time.
Time frame: 6 months post surgery
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2017 to primary completion in Oct 2021, 47 months.
Of 14 observational studies under Prolapse, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 58. This study's 47 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Tatiana Besse-Hammer