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Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Randomized Double Blind Controlled Trial of the Value of Robotic Rectopexy for the Treatment of Complex Pelvic Floor Dysfunction

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01346436
Enrollment
50
Registered
2011-05-03
Start date
2011-04-30
Completion date
2020-05-31
Last updated
2017-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse, Rectal Prolapse

Brief 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.

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.

Interventions

PROCEDUREMinimally invasive rectopexy

Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy

Sponsors

Nicolas C. Buchs
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* women * proven pelvic floor dysfunction * informed consent

Exclusion criteria

* Age \<18 years old * Patient unable to communicate or to understand the study * Patient refusing to participate to the study * contraindication to laparoscopy

Design outcomes

Primary

MeasureTime frameDescription
Perioperative outcomesup to 30 daysIncluding: blood loss, operative time, conversion rate, quality of dissection, pain, complications, hospital stay.

Secondary

MeasureTime frameDescription
Functional resultsAt 12 monthsConstipation score Incontinence score Quality of life score Sexuality score

Countries

Switzerland

Contacts

Primary ContactNicolas C Buchs, MD
nicolas.c.buchs@hcuge.ch+41 79 553 2683

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026