A Phase 4 interventional study of Minimally invasive rectopexy in Rectal Prolapse and Pelvic Organ Prolapse, sponsored by Nicolas C. Buchs. Status unknown at 1 site in Switzerland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-05.
Sponsored by Nicolas C. Buchs · Phase 4, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's planned enrollment of 50 is close to the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →This is the only study on the registry with Nicolas C. Buchs as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction
Procedure: Minimally invasive rectopexy
Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction
Procedure: Minimally invasive rectopexy
Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy
Also known as: Surgery for rectal prolapse
Perioperative outcomes
Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.
Time frame: up to 30 days
Functional results
Constipation score Incontinence score Quality of life score Sexuality score
Time frame: At 12 months
This study is status unknown, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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