An interventional study of Laparoscopic ventral mesh rectopexy in Rectocele; Female, Rectocele and Incomplete Uterine Prolapse and Rectocele and Complete Uterovaginal Prolapse, sponsored by Alexander Khitaryan. Status unknown at 1 site in Russian Federation. Open to female participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-19.
Sponsored by Alexander Khitaryan · Not applicable, Interventional, and Treatment
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's planned enrollment of 60 is close to the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →This is the only study on the registry with Alexander Khitaryan as lead sponsor.
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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.
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.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients who underwent 3D laparoscopic ventral rectopexy
Procedure: Laparoscopic ventral mesh rectopexy
patients who underwent conventional 2D laparoscopic ventral rectopexy
Procedure: Laparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
objective cure rate
objective cure rate according to clinical POP-Q assesment
Time frame: 12 months postop
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)
Time frame: 12 months postop
incontinence cure
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)
Time frame: 12 months postop
patient's satisfaction
according to PGII (Patient Global Impression of Improvement) questionnaire
Time frame: 12 months postop
intraoperative blood loss
intraoperative blood loss (ml)
Time frame: intraoperatively
length of hospital stay
length of hospital stay (days)
Time frame: through study completion, an average of 1 year
postop pain severity
VAS (Visual Analog Scale)
Time frame: 24 hours postop
postop stress urinary incontinence
Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence)
Time frame: 12 months
complications rate
early and remote complications
Time frame: 12 months
surgeon's tiredness
Profile of Mood States Questionnaire
Time frame: 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)
Time frame: 3 weeks
postop pain syndrom duration
pain medications consumption
Time frame: through study completion, an average of 1 year
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2021 (actual). Primary completion is estimated for Jun 2022, 15 months after the start.
Of 16 interventional studies with no phase under Rectocele, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's planned 15 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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