Rectal ProlapsePhase 4NCT01346436
Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction
A Phase 4 study testing Minimally invasive rectopexy in people with Rectal Prolapse and Pelvic Organ Prolapse, run by Nicolas C. Buchs at 1 site in Switzerland.
Trial summary
The purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectal Prolapse, Pelvic Organ Prolapse
- What is being tested?
- Minimally invasive rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2011to May 2020
- Phase
- Phase 4
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women
- proven pelvic floor dysfunction
- informed consent
Who cannot join
- Age <18 years old
- Patient unable to communicate or to understand the study
- Patient refusing to participate to the study
- contraindication to laparoscopy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital of Geneva, Department of Surgery
Geneva, 1211
Nicolas C Buchs, MD, +41 553 2683, nicolas.c.buchs@hcuge.ch
Nicolas C Buchs, MD
About this study
Official title: Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction
The purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.
Read the detailed description
Pelvic floor dysfunction is a common pathology. The management can be medical or surgical, depending on the location or the severity of the disease.
Since the large use of laparoscopy for the treatment of pelvic floor dysfunction, interesting and encouraging results have been published.
However, so far, a laparoscopic approach has some technical disadvantages like a poor ergonomy, a 2 dimensional vision, an unstable camera and the use of straight instruments. To overcome these natural limitations, robotics has been gaining increasing acceptance in general surgery.
Several groups have reported their encouraging experience with robotic rectopexy. Yet, these studies were not randomized or double blinded.
The aim of this study is to evaluate the role of robotics for complex pelvic floor dysfunction and to compare the outcomes to the laparoscopic approach.
- Conditions
- Rectal Prolapse, Pelvic Organ Prolapse
- Being tested
- Minimally invasive rectopexy
- Medical subject headings
- Rectal Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive rectopexyProcedure or surgery
Also called Surgery for rectal prolapse
Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy
| Study group | Role | What they receive |
|---|---|---|
| Robotic | Active comparator | Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction Receives: Procedure: Minimally invasive rectopexy |
| Laparoscopy | Active comparator | Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction Receives: Procedure: Minimally invasive rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative outcomes
Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.
Measured: up to 30 days
Secondary outcomes (1)
Functional results
Constipation score Incontinence score Quality of life score Sexuality score
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicolas C. Buchs
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicolas C. Buchs, University Hospital, Geneva
- Investigators
- Nicolas C Buchs, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346436
- Sponsor's protocol ID
- CER-11-047
- Status last verified
- May 2017
- First submitted
- 29 Apr 2011
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction
- ClinicalTrials.gov ID
- NCT01346436
- Acronym / sponsor ID
- CER-11-047
- Conditions
- Rectal Prolapse, Pelvic Organ Prolapse
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nicolas C. BuchsUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 3 May 2011 (estimated)
- 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 purpose of this randomized double blind controlled study is to assess the value of robotics for the treatment of complex pelvic floor dysfunction. The main aim is to compare perioperative and functional outcomes to the laparoscopic approach.
Detailed description
Pelvic floor dysfunction is a common pathology. The management can be medical or surgical, depending on the location or the severity of the disease.
Since the large use of laparoscopy for the treatment of pelvic floor dysfunction, interesting and encouraging results have been published.
However, so far, a laparoscopic approach has some technical disadvantages like a poor ergonomy, a 2 dimensional vision, an unstable camera and the use of straight instruments. To overcome these natural limitations, robotics has been gaining increasing acceptance in general surgery.
Several groups have reported their encouraging experience with robotic rectopexy. Yet, these studies were not randomized or double blinded.
The aim of this study is to evaluate the role of robotics for complex pelvic floor dysfunction and to compare the outcomes to the laparoscopic approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic | Active comparator | Procedure: Minimally invasive rectopexyUse of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction |
| Laparoscopy | Active comparator | Procedure: Minimally invasive rectopexyUse of standard laparoscopy for the treatment of complex pelvic floor dysfunction |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women
- proven pelvic floor dysfunction
- informed consent
Key exclusion criteria (4 listed)
- Age <18 years old
- Patient unable to communicate or to understand the study
- Patient refusing to participate to the study
- contraindication to laparoscopy
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 |
|---|---|---|
| Minimally invasive rectopexyAlso: Surgery for rectal prolapseUse of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy | Procedure or surgery | Laparoscopy, Robotic |
Primary outcome
Perioperative outcomes
Time frame: up to 30 days
Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.
1 secondary outcome
Functional results
Time frame: At 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
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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.
Nicolas C Buchs, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Minimally invasive rectopexy in people with Rectal Prolapse and Pelvic Organ Prolapse, run by Nicolas C. Buchs at 1 site in Switzerland.
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 3 inclusion and 4 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 5 May 2017. 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 Switzerland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Nicolas C Buchs, MD (+41 79 553 2683, nicolas.c.buchs@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative outcomes (time frame: up to 30 days). 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 5 May 2017.