Rectocele; FemaleLARCNCT04817150
3D vs 2D-laparoscopy for Rectocele and Rectal Prolapse Correction: a Prospective, Randomized, Single Center Study
A study testing Laparoscopic ventral mesh rectopexy in people with Rectocele; Female and Rectocele and Incomplete Uterine Prolapse, run by Alexander Khitaryan at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rectocele; Female, Rectocele and Incomplete Uterine Prolapse, Rectocele and Complete Uterovaginal Prolapse
- What is being tested?
- Laparoscopic ventral mesh rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRussia
- Study dates
- 10 Mar 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse
- age 18-70 y.o.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Private Healthcare Institution Clinical Hospital "RGD-Medicine" Rostov-on-Don"
Rostov-on-Don, 344010
Anastasiya Golovina, Dr, +79518319720, a_anastacia@icloud.com
About this study
Official title: LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.
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.
Read more
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.
- Conditions
- Rectocele; Female, Rectocele and Incomplete Uterine Prolapse, Rectocele and Complete Uterovaginal Prolapse, Rectal Prolapse
- Being tested
- Laparoscopic ventral mesh rectopexy
- Medical subject headings
- Rectocele, Prolapse, Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic ventral mesh rectopexyProcedure or surgery
Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
| Study group | Role | What they receive |
|---|---|---|
| 3D-laparoscopy | Experimental | patients who underwent 3D laparoscopic ventral rectopexy Receives: Procedure: Laparoscopic ventral mesh rectopexy |
| 2D-laparoscopy | Active comparator | patients who underwent conventional 2D laparoscopic ventral rectopexy Receives: Procedure: Laparoscopic ventral mesh rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective cure rate
objective cure rate according to clinical POP-Q assesment
Measured: 12 months postop
Secondary outcomes (3)
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)
Measured: 12 months postop
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)
Measured: 12 months postop
patient's satisfaction
according to PGII (Patient Global Impression of Improvement) questionnaire
Measured: 12 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start10 Mar 2021
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectocele; FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a prospective randomized comparative study in parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexander Khitaryan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alexander Khitaryan, Private Healthcare Institution Clinical Hospital RGD-Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817150
- Sponsor's protocol ID
- LARC1
- Acronym
- LARC
- Status last verified
- Mar 2021
- First submitted
- 19 Mar 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LARC Study: Three-dimensional Versus Conventional 2D-laparoscopy for Rectocele and Rectal Prolapse Repair: a Prospective, Randomized, Single Center Study.
- ClinicalTrials.gov ID
- NCT04817150
- Acronym / sponsor ID
- LARC / LARC1
- Conditions
- Rectocele; Female, Rectocele and Incomplete Uterine Prolapse, Rectocele and Complete Uterovaginal Prolapse, Rectal Prolapse
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alexander KhitaryanUniversity, hospital or other
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- a prospective randomized comparative study in parallel groups
| Arm | Type | Receives |
|---|---|---|
| 3D-laparoscopy | Experimental | Procedure: Laparoscopic ventral mesh rectopexypatients who underwent 3D laparoscopic ventral rectopexy |
| 2D-laparoscopy | Active comparator | Procedure: Laparoscopic ventral mesh rectopexypatients who underwent conventional 2D laparoscopic ventral rectopexy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- stage 3 rectocele (3-4 POP-Q grade) and/or full-thickness rectal prolapse
- age 18-70 y.o.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic ventral mesh rectopexyConventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore | Procedure or surgery | 2D-laparoscopy, 3D-laparoscopy |
Primary outcome
objective cure rate
Time frame: 12 months postop
objective cure rate according to clinical POP-Q assesment
3 secondary outcomes
obstructive defecation cure
Time frame: 12 months postop
incontinence cure
Time frame: 12 months postop
patient's satisfaction
Time frame: 12 months postop
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic ventral mesh rectopexy in people with Rectocele; Female and Rectocele and Incomplete Uterine Prolapse, run by Alexander Khitaryan at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anastasiya Golovina (+79518319720, a_anastacia@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
objective cure rate (time frame: 12 months postop). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2021.