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

Sponsor
Alexander Khitaryan (Other)
Overall Status
Recruiting
CT.gov ID
NCT04817150
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
15.7
Anticipated Duration (Months)
3.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Laparoscopic ventral mesh rectopexy
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a prospective randomized comparative study in parallel groupsa prospective randomized comparative study in parallel groups
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Outcomes are assessed by 2 independent blinded coloproctologists
Primary Purpose:
Treatment
Official Title:
LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.
Actual Study Start Date :
Mar 10, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 3D-laparoscopy

patients who underwent 3D laparoscopic ventral rectopexy

Procedure: Laparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
Active Comparator: 2D-laparoscopy

patients who underwent conventional 2D laparoscopic ventral rectopexy

Procedure: Laparoscopic ventral mesh rectopexy
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore

Outcome Measures

Primary Outcome Measures

  1. objective cure rate [12 months postop]

    objective cure rate according to clinical POP-Q assesment

Secondary Outcome Measures

  1. obstructive defecation cure [12 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)

  2. incontinence cure [12 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)

  3. patient's satisfaction [12 months postop]

    according to PGII (Patient Global Impression of Improvement) questionnaire

Other Outcome Measures

  1. intraoperative blood loss [intraoperatively]

    intraoperative blood loss (ml)

  2. length of hospital stay [through study completion, an average of 1 year]

    length of hospital stay (days)

  3. postop pain severity [24 hours postop]

    VAS (Visual Analog Scale)

  4. postop stress urinary incontinence [12 months]

    Valsalva test (positive - urinary incontinence presents, negative - no stress urinary incontinence)

  5. complications rate [12 months]

    early and remote complications

  6. surgeon's tiredness [1 hour after the surgery]

    Profile of Mood States Questionnaire

  7. postoperative seroma/hematoma volume [3 weeks]

    size of liquid cavity surrounding mesh on 2-3 postoperative day and on 2-3 postoperative week (ml)

  8. postop pain syndrom duration [through study completion, an average of 1 year]

    pain medications consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don" Rostov-on-Don Russian Federation 344010

Sponsors and Collaborators

  • Alexander Khitaryan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alexander Khitaryan, Professor, Private Healthcare Institution Clinical Hospital RGD-Medicine
ClinicalTrials.gov Identifier:
NCT04817150
Other Study ID Numbers:
  • LARC1
First Posted:
Mar 26, 2021
Last Update Posted:
Apr 19, 2021
Last Verified:
Mar 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Rectal Prolapse
Rectocele
Uterine Prolapse
Prolapse

Study Results

No Results Posted as of Apr 19, 2021