LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Rectocele; Female
- Sponsor
- Alexander Khitaryan
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- objective cure rate
- Last Updated
- 5 years ago
Overview
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.
Investigators
Alexander Khitaryan
Professor
Private Healthcare Institution Clinical Hospital RGD-Medicine
Eligibility Criteria
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
Outcomes
Primary Outcomes
objective cure rate
Time Frame: 12 months postop
objective cure rate according to clinical POP-Q assesment
Secondary Outcomes
- incontinence cure(12 months postop)
- patient's satisfaction(12 months postop)
- obstructive defecation cure(12 months postop)