Rectal Prolapse, Rectocele and Complete Uterovaginal Prolapse, Rectocele and Incomplete Uterine Prolapse, Rectocele; Female
Conditions
Brief summary
The aim is to compare proximate and remote results of 3D and conventional 2D laparoscopic interventions in terms of efficacy and safety in treatment of symptomatic rectocele and rectal prolapse. This is a prospective randomized comparative study in parallel groups conducted in single Colorectal unit. Inclusion criteria: female patients with stage 3 rectocele (3-4 POP-Q \[pelvic organ prolapse quantification\] grade) and/or full-thickness rectal prolapse. Intervention - laparoscopic ventral rectopexy. The primary outcome is objective cure rate of pelvic prolapse. Secondary outcomes include obstructive defecation and incontinence symptoms according to Wexner and Cleveland Clinic scales, and satisfaction according to Patient Global Impression of Improvement questionnaire. Operative times, intraoperative blood loss, length of hospital stay, postop pain severity, urinary incontinence, as well as surgical and mesh complications are also assessed. The specific point of interest in this study is surgeon's tiredness after the operation assessed with Profile of Mood States questionnaire.
Interventions
PROCEDURELaparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
Sponsors
Alexander Khitaryan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Outcomes are assessed by 2 independent blinded coloproctologists
Intervention model description
a prospective randomized comparative study in parallel groups
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse * age 18-70 y.o.
Exclusion criteria
* severe concomitants chronic diseases (American Society of Anesthesiologists class III - IV), * ongoing oncological diseases, * ongoing hematological diseases, * ongoing inflammatory diseases of the colon and pelvic organs, * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| objective cure rate | 12 months postop | objective cure rate according to clinical POP-Q assesment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| obstructive defecation cure | 12 months postop | according to Wexner scale score (Cleveland Clinic Constipation Scoring System, scale of 0-30, with 0 = minimum, healthy individual and 30 = maximum, severe obstructive defecation) |
| incontinence cure | 12 months postop | according to Cleveland Clinic scale score (Cleveland Clinic Incontinence Scoring System, scale of 0-20, with 0 = minimum, perfect continence and 20 = maximum, complete incontinence) |
| patient's satisfaction | 12 months postop | according to PGII (Patient Global Impression of Improvement) questionnaire |
Other
| Measure | Time frame | Description |
|---|---|---|
| complications rate | 12 months | early and remote complications |
| surgeon's tiredness | 1 hour after the surgery | Profile of Mood States Questionnaire |
| intraoperative blood loss | intraoperatively | intraoperative blood loss (ml) |
| postop pain syndrom duration | through study completion, an average of 1 year | pain medications consumption |
| postoperative seroma/hematoma volume | 3 weeks | size of liquid cavity surrounding mesh on 2-3 postoperative day and on 2-3 postoperative week (ml) |
| length of hospital stay | through study completion, an average of 1 year | length of hospital stay (days) |
| postop pain severity | 24 hours postop | VAS (Visual Analog Scale) |
| postop stress urinary incontinence | 12 months | Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence) |
Countries
Russia
Contacts
Primary ContactAnastasiya Golovina
Outcome results
None listed