The study M2R2 is a multicentre registry based on the still ungoing monocentre study in the
University Hospital of Antwerp.
Pelvic organ prolapse (POP) is a benign condition in which pelvic organs prolapse beyond
their normal anatomical position due to weakening or damage to the pelvic floor muscles and
other supporting tissues.[1] The incidence increases with age, multiparity, vaginal delivery
and obesity.[2] POP can cause urinary, sexual and bowel complaints with a huge impact on
quality of life.[3,4] Patients with posterior compartment prolapse may include symptoms of
vaginal swelling, heaviness, perineal pressure and/or obstructive defecation with fragmented
stools, need for hard straining, feeling of incomplete emptying, splinting, faecal urgency
and even incontinence.[4] Ventral mesh rectopexy is surgical technique used to treat
posterior compartment prolapse (rectocele, enterocele, sigmoidocele, rectal prolapse,
combination) in patients with symptoms where conservative therapy fails or is ineffective. In
this procedure, a mesh is placed between the back wall of the vagina and the rectum, the
rectovaginal septum. This is attached at the level of the bone higher up (the promontorium)
so that the back wall of the vagina is reinforced, preventing the prolapse to recurre.This
technique was first described as technique to treat rectal prolapse by d'Hoore, a colorectal
surgeon and widely accepted given the feasible transabdominal technique with good functional
results. However, whether this technique gives also effective long-term anatomical and
functional outcomes for rectoceles, enteroceles/sigmoidoceles +/- perineal descent, besides
rectal prolapse, is not known.[5,6] Sometimes a combined procedure is necessary in which the
anterior compartment (bladder) and/or middle compartment (cervix/vagina tip) is also
reinforced.
The main objective of this registry 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.
The patients will be recruited from outpatient clinic of abdominal surgery in the
participating centers. The treating physician recruits patients.
Methods and analysis
Data registry Parameters will be registered by means of case record form: History of the
patient, urinary, prolapse, defecatory complaints, MRI or CR CCD if performed, anal
manometry if performed, results of pelvic floor physiotherapy if performed. Surgical
technique, operation time/length of stay and complications.
Questionnaire send to the patients at 5 time points
Preoperative - 3 months - 1 year - 3 years - 5 years postoperative
Questionnaires consisting of different topics I. In female: questions about childbirth
(only preoperative) II. Medication III. Inventarisation of pelvic floor (dys)- function:
PFDI-20 IV. Intestinal function and constipation
Wexner Vaizey-score
Low anterior resection syndrome score (LARS)
Bristol stool chart
Rome IV criteria functionam obstipation
Rome IV criteria IBS
CCS (Wexner constipation score)
V. Urinary (ICIQ-SF) VI. Seksuality (PISC-IR) VII. Impact of pelvic floor problem on
quality of life (PISQ-7) VIII. Subjective satisfaction after surgery
Data management
Collected data will be entered in a case record form by the treating physician of the
participating centre or by assigned study staff using the RedCap platform. Patients will be
coded to insure patient anonymity.