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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic | Active Comparator | Use of daVinci surgical system (Intuitive Surgical Inc, Sunnyvale, CA) for the treatment of complex pelvic floor dysfunction |
|
| Laparoscopy | Active Comparator | Use of standard laparoscopy for the treatment of complex pelvic floor dysfunction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Minimally invasive rectopexy | Procedure | Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Perioperative outcomes | Including: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay. | up to 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Functional results | Constipation score Incontinence score Quality of life score Sexuality score | At 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicolas C Buchs, MD | Contact | +41 79 553 2683 | nicolas.c.buchs@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| Nicolas C Buchs, MD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Geneva, Department of Surgery | Recruiting | Geneva | 1211 | Switzerland |
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| ID | Term |
|---|---|
| D012005 | Rectal Prolapse |
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |