Back to results3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study (LARC)
Primary Purpose
Rectocele; Female, Rectocele and Incomplete Uterine Prolapse, Rectocele and Complete Uterovaginal Prolapse
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Laparoscopic ventral mesh rectopexy
Sponsored by
About this trial
This is an interventional treatment trial for Rectocele; Female
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
Sites / Locations
- Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D-laparoscopy
2D-laparoscopy
Arm Description
patients who underwent 3D laparoscopic ventral rectopexy
patients who underwent conventional 2D laparoscopic ventral rectopexy
Outcomes
Primary Outcome Measures
objective cure rate
objective cure rate according to clinical POP-Q assesment
Secondary Outcome Measures
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)
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)
patient's satisfaction
according to PGII (Patient Global Impression of Improvement) questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04817150
Brief Title
3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study
Acronym
LARC
Official Title
LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2021 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexander Khitaryan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele; Female, Rectocele and Incomplete Uterine Prolapse, Rectocele and Complete Uterovaginal Prolapse, Rectal Prolapse
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a prospective randomized comparative study in parallel groups
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes are assessed by 2 independent blinded coloproctologists
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
3D-laparoscopy
Arm Type
Experimental
Arm Description
patients who underwent 3D laparoscopic ventral rectopexy
Arm Title
2D-laparoscopy
Arm Type
Active Comparator
Arm Description
patients who underwent conventional 2D laparoscopic ventral rectopexy
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic ventral mesh rectopexy
Intervention Description
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
Primary Outcome Measure Information:
Title
objective cure rate
Description
objective cure rate according to clinical POP-Q assesment
Time Frame
12 months postop
Secondary Outcome Measure Information:
Title
obstructive defecation cure
Description
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
Title
incontinence cure
Description
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
Title
patient's satisfaction
Description
according to PGII (Patient Global Impression of Improvement) questionnaire
Time Frame
12 months postop
Other Pre-specified Outcome Measures:
Title
intraoperative blood loss
Description
intraoperative blood loss (ml)
Time Frame
intraoperatively
Title
length of hospital stay
Description
length of hospital stay (days)
Time Frame
through study completion, an average of 1 year
Title
postop pain severity
Description
VAS (Visual Analog Scale)
Time Frame
24 hours postop
Title
postop stress urinary incontinence
Description
Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence)
Time Frame
12 months
Title
complications rate
Description
early and remote complications
Time Frame
12 months
Title
surgeon's tiredness
Description
Profile of Mood States Questionnaire
Time Frame
1 hour after the surgery
Title
postoperative seroma/hematoma volume
Description
size of liquid cavity surrounding mesh on 2-3 postoperative day and on 2-3 postoperative week (ml)
Time Frame
3 weeks
Title
postop pain syndrom duration
Description
pain medications consumption
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anastasiya Golovina
Phone
+79518319720
Email
a_anastacia@icloud.com
Facility Information:
Facility Name
Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
City
Rostov-on-Don
ZIP/Postal Code
344010
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anastasiya Golovina, Dr
Phone
+79518319720
Email
a_anastacia@icloud.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study
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