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Clinical Trials/NCT04817150
NCT04817150
Unknown
N/A

LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.

Alexander Khitaryan1 site in 1 country60 target enrollmentMarch 10, 2021

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2021
End Date
July 2022
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Alexander Khitaryan
Responsible Party
Sponsor Investigator
Principal Investigator

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)

Study Sites (1)

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