3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study
NCT ID: NCT04817150
Last Updated: 2021-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-03-10
2022-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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3D-laparoscopy
patients who underwent 3D laparoscopic ventral rectopexy
Laparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
2D-laparoscopy
patients who underwent conventional 2D laparoscopic ventral rectopexy
Laparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
Interventions
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Laparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
Eligibility Criteria
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Inclusion Criteria
* age 18-70 y.o.
Exclusion Criteria
* ongoing oncological diseases,
* ongoing hematological diseases,
* ongoing inflammatory diseases of the colon and pelvic organs,
* pregnancy
18 Years
70 Years
FEMALE
Yes
Sponsors
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Alexander Khitaryan
OTHER
Responsible Party
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Alexander Khitaryan
Professor
Locations
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Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
Rostov-on-Don, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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LARC1
Identifier Type: -
Identifier Source: org_study_id
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