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3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study

Not Applicable
Conditions
Rectocele and Complete Uterovaginal Prolapse
Rectal Prolapse
Rectocele; Female
Rectocele and Incomplete Uterine Prolapse
Registration Number
NCT04817150
Lead Sponsor
Alexander Khitaryan
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
60
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
objective cure rate12 months postop

objective cure rate according to clinical POP-Q assesment

Secondary Outcome Measures
NameTimeMethod
incontinence cure12 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 satisfaction12 months postop

according to PGII (Patient Global Impression of Improvement) questionnaire

obstructive defecation cure12 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)

Trial Locations

Locations (1)

Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"

🇷🇺

Rostov-on-Don, Russian Federation

Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
🇷🇺Rostov-on-Don, Russian Federation
Anastasiya Golovina, Dr
Contact
+79518319720
a_anastacia@icloud.com

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