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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D-laparoscopy | Experimental | patients who underwent 3D laparoscopic ventral rectopexy |
|
| 2D-laparoscopy | Active Comparator | patients who underwent conventional 2D laparoscopic ventral rectopexy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic ventral mesh rectopexy | Procedure | Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore |
|
| Measure | Description | Time Frame |
|---|---|---|
| objective cure rate | objective cure rate according to clinical POP-Q assesment | 12 months postop |
| Measure | Description | Time Frame |
|---|---|---|
| obstructive defecation cure | 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) | 12 months postop |
| incontinence cure |
| Measure | Description | Time Frame |
|---|---|---|
| intraoperative blood loss | intraoperative blood loss (ml) | intraoperatively |
| length of hospital stay | length of hospital stay (days) | through study completion, an average of 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anastasiya Golovina | Contact | +79518319720 | a_anastacia@icloud.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don" | Recruiting | Rostov-on-Don | 344010 | Russia |
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a prospective randomized comparative study in parallel groups
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Outcomes are assessed by 2 independent blinded coloproctologists
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)
| 12 months postop |
| patient's satisfaction | according to PGII (Patient Global Impression of Improvement) questionnaire | 12 months postop |
| postop pain severity | VAS (Visual Analog Scale) | 24 hours postop |
| postop stress urinary incontinence | Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence) | 12 months |
| complications rate | early and remote complications | 12 months |
| surgeon's tiredness | Profile of Mood States Questionnaire | 1 hour after the surgery |
| postoperative seroma/hematoma volume | size of liquid cavity surrounding mesh on 2-3 postoperative day and on 2-3 postoperative week (ml) | 3 weeks |
| postop pain syndrom duration | pain medications consumption | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D020047 | Rectocele |
| D011391 | Prolapse |
| D012005 | Rectal Prolapse |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D056887 | Pelvic Organ Prolapse |
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