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Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures (RoboLaps)

Primary Purpose

Pelvic Organ Prolapse

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Robot-assisted promontofixation
Non-robot assisted promontofixation
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pelvic Organ Prolapse focused on measuring da Vinci Robot, uterine prolapse, vaginal prolapse, sacrohysteropexy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage II (POP-Q classification) requiring surgery
  • The patient must have given her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 60 months of follow-up

Exclusion Criteria:

  • The patient is participating in another study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant
  • Patient has a stage-1 prolapse (POP-Q classification)
  • Patient has asymptomatic prolapse
  • The patient has a prolapse recurrence (i.e. this is not the first case of prolapse)
  • The patient is not available for 60 months of follow-up
  • Patient has a vaginal or urinary infection
  • Patient has poorly-adjusted diabetes
  • Patient on long-term corticotherapy
  • Patient has previously had pelvic radiotherapy
  • Patient has contraindication for anesthesia
  • Patient has an intestinal inflammatory disease

Sites / Locations

  • CHU de Nîmes - Hôpital Universitaire Carémeau
  • Groupe Urologie Saint Augustin
  • APHP - Centre Hospitalier Henri Mondor
  • CHU de Dijon
  • CHU de Montpellier - Hôpital Lapeyronie
  • CHU de Nancy - Hôpitaux de Brabois
  • CHU de Nantes
  • CHU de Nice - Hôpitaux L'Archet 1 et 2
  • Clinique Kennedy
  • Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly
  • APHP - Groupe Hospitalier Pitié-Salpetrière
  • CHU de Lyon - Centre Hospitalier Lyon Sud
  • CHU de Rennes - Hôpital PontChaillou
  • Clinique Belledonne
  • CHRU de Strasbourg - Hôpital Civil
  • Hôpital Foch
  • CHRU de Toulouse - Hôpital de Rangueil
  • CHRU de Tours - Hôpital Bretonneau

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robot arm

Non-robot arm

Arm Description

The patients in this arm will have a robot-assisted promontofixation.

The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.

Outcomes

Primary Outcome Measures

presence/absence of complications (composite score)
The occurrence (in the per-operative phase or within 30 days post-op) of at least one of the following: 1) bleeding complications: hemoperitoneum, blood loss> = 500 ml, transfusion; 2) infectious complications: wound infection, abscess, discitis, mesh infection; 3) any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; (4) medical complications: deep vein thrombosis, pulmonary embolism, pneumopathy; 5) trocart sites: infection, hernia; 6) conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; 7) reintervention; 8) neurological complications: neurological disorders, complications of the central neurological system, sciatica; 9) others: complete urinary retention, lower urinary tract infection, extrusion, erosion of the mesh, hospitalization in intensive care; 10) death.

Secondary Outcome Measures

Time needed to prep the operation room (min)
length of hospital stay (days)
The number of days the patient stays in the hospital following promontofixation
Operative time (min)
The time elapsed between incision and closure of the patient
Anesthesia time (min)
The time elapsed between anethesia induction and awakening
Equipment installation time (min)
Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)
Surgical time (min)
The time spent manipulating endoscopic intruments or console time for robotic techniques.
Presence/absence of conversion
In the robot arm: the need to convert to laparoscopic procedure or open procedure; in the non-robot arm: the need to convert to an open procedure
presence/absence of a re-intervention
Presence/absence of urinary incontinence
Presence/absence of urinary incontinence
Presence/absence of urinary incontinence
Presence/absence of urinary incontinence
presence/absence of constipation
presence/absence of constipation
presence/absence of constipation
presence/absence of constipation
Presence/absence of fecal incontinence
Presence/absence of fecal incontinence
Presence/absence of fecal incontinence
Presence/absence of fecal incontinence
presence/absence of dysparunia
presence/absence of dysparunia
presence/absence of dysparunia
presence/absence of dysparunia
POP-Q score
POP-Q score
POP-Q score
POP-Q score
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Urodynamic exam Q max (ml/s)
Urination rate il ml/s
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Urodynamic exam, volume urinated (ml)
the volume urinated in ml
Urodynamic exam: post-mictionnel residu (ml)
Urodynamic exam: post-mictionnel residu (ml)
Urodynamic exam: post-mictionnel residu (ml)
Urodynamic exam: post-mictionnel residu (ml)
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Urodynamic exam: fonctional bladder capacity (ml)
bladder capacity in ml
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Urodynamic exam: urethral closure pressure (cm water)
urethral closure pressure in cm of water
Wexner anal incontinence score
Wexner anal incontinence score
Wexner anal incontinence score
Wexner anal incontinence score
ODS constipation score
ODS constipation score
ODS constipation score
ODS constipation score
Visual analog scale for pain
Visual analog scale for pain
Visual analog scale for pain
Visual analog scale for pain
Visual analog scale for pain
Visual analog scale for pain
Visual analog scale for pain
Visual analog scale for pain
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Patient satisfaction
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Questionnaire PFDI-20
Questionnaire PFDI-20
Questionnaire PFDI-20
Questionnaire PFDI-20
Questionnaire PFIQ-7
Questionnaire PFIQ-7
Questionnaire PFIQ-7
Questionnaire PFIQ-7
Questionnaire PISQ-12
Questionnaire PISQ-12
Questionnaire PISQ-12
Questionnaire PISQ-12
Questionnaire SF36
Questionnaire SF36
Questionnaire SF36
Questionnaire SF36

Full Information

First Posted
March 21, 2011
Last Updated
October 20, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
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1. Study Identification

Unique Protocol Identification Number
NCT01320215
Brief Title
Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
Acronym
RoboLaps
Official Title
Complications Associated With Promontofixation for Pelvic Organ Prolapse: a Randomized Trial Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 2011 (Actual)
Primary Completion Date
September 12, 2017 (Actual)
Study Completion Date
September 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to compare 30-day complication rates associated with promontofixation for pelvic organ prolapse performed via a robot-assisted laparoscopic technique versus a non-robot-assisted laparoscopic technique. Secondary objectives include comparing technical data, anatomical correction, prolapse recurrence, incontinence, quality of life and medico-economic data between the two techniques. The patient diary did not allow the collection of sufficiently precise data to meet the secondary medico-economic objective of the study. Access to data from the National Health Data System (SDNS), which was not available at the time of the initial drafting of this protocol, now makes it possible to obtain a complete picture of patients' health care consumption. We propose, therefore, to extract data from the SNIIRAM via the SNDS (matching of patients' NIR to their health care consumption) in order to retrieve and accurately estimate the cost of follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pelvic Organ Prolapse
Keywords
da Vinci Robot, uterine prolapse, vaginal prolapse, sacrohysteropexy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot arm
Arm Type
Experimental
Arm Description
The patients in this arm will have a robot-assisted promontofixation.
Arm Title
Non-robot arm
Arm Type
Active Comparator
Arm Description
The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.
Intervention Type
Procedure
Intervention Name(s)
Robot-assisted promontofixation
Intervention Description
Sacrohysteropexy with robotic assistance (da Vinci robot)
Intervention Type
Procedure
Intervention Name(s)
Non-robot assisted promontofixation
Intervention Description
Laparoscopic sacrohysteropexy, without robot assistance
Primary Outcome Measure Information:
Title
presence/absence of complications (composite score)
Description
The occurrence (in the per-operative phase or within 30 days post-op) of at least one of the following: 1) bleeding complications: hemoperitoneum, blood loss> = 500 ml, transfusion; 2) infectious complications: wound infection, abscess, discitis, mesh infection; 3) any wound caused by a surgeon movement: bladder, digestive, ureteral, or vascular injuries; (4) medical complications: deep vein thrombosis, pulmonary embolism, pneumopathy; 5) trocart sites: infection, hernia; 6) conversion to a laparoscopic or open surgical technique not related to pre-existing adhesions; 7) reintervention; 8) neurological complications: neurological disorders, complications of the central neurological system, sciatica; 9) others: complete urinary retention, lower urinary tract infection, extrusion, erosion of the mesh, hospitalization in intensive care; 10) death.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time needed to prep the operation room (min)
Time Frame
1 day
Title
length of hospital stay (days)
Description
The number of days the patient stays in the hospital following promontofixation
Time Frame
1 month
Title
Operative time (min)
Description
The time elapsed between incision and closure of the patient
Time Frame
1 day
Title
Anesthesia time (min)
Description
The time elapsed between anethesia induction and awakening
Time Frame
1 day
Title
Equipment installation time (min)
Description
Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)
Time Frame
1 day
Title
Surgical time (min)
Description
The time spent manipulating endoscopic intruments or console time for robotic techniques.
Time Frame
1 day
Title
Presence/absence of conversion
Description
In the robot arm: the need to convert to laparoscopic procedure or open procedure; in the non-robot arm: the need to convert to an open procedure
Time Frame
Day 1
Title
presence/absence of a re-intervention
Time Frame
30 days
Title
Presence/absence of urinary incontinence
Time Frame
3 months
Title
Presence/absence of urinary incontinence
Time Frame
12 months
Title
Presence/absence of urinary incontinence
Time Frame
36 months
Title
Presence/absence of urinary incontinence
Time Frame
60 months
Title
presence/absence of constipation
Time Frame
3 months
Title
presence/absence of constipation
Time Frame
12 months
Title
presence/absence of constipation
Time Frame
36 months
Title
presence/absence of constipation
Time Frame
60 months
Title
Presence/absence of fecal incontinence
Time Frame
3 months
Title
Presence/absence of fecal incontinence
Time Frame
12 months
Title
Presence/absence of fecal incontinence
Time Frame
36 months
Title
Presence/absence of fecal incontinence
Time Frame
60 months
Title
presence/absence of dysparunia
Time Frame
3 months
Title
presence/absence of dysparunia
Time Frame
12 months
Title
presence/absence of dysparunia
Time Frame
36 months
Title
presence/absence of dysparunia
Time Frame
60 months
Title
POP-Q score
Time Frame
3 months
Title
POP-Q score
Time Frame
12 months
Title
POP-Q score
Time Frame
36 months
Title
POP-Q score
Time Frame
60 months
Title
Urodynamic exam Q max (ml/s)
Description
Urination rate il ml/s
Time Frame
3 months
Title
Urodynamic exam Q max (ml/s)
Description
Urination rate il ml/s
Time Frame
12 months
Title
Urodynamic exam Q max (ml/s)
Description
Urination rate il ml/s
Time Frame
36 months
Title
Urodynamic exam Q max (ml/s)
Description
Urination rate il ml/s
Time Frame
60 months
Title
Urodynamic exam, volume urinated (ml)
Description
the volume urinated in ml
Time Frame
3 months
Title
Urodynamic exam, volume urinated (ml)
Description
the volume urinated in ml
Time Frame
12 months
Title
Urodynamic exam, volume urinated (ml)
Description
the volume urinated in ml
Time Frame
36 months
Title
Urodynamic exam, volume urinated (ml)
Description
the volume urinated in ml
Time Frame
60 months
Title
Urodynamic exam: post-mictionnel residu (ml)
Time Frame
3 months
Title
Urodynamic exam: post-mictionnel residu (ml)
Time Frame
12 months
Title
Urodynamic exam: post-mictionnel residu (ml)
Time Frame
36 months
Title
Urodynamic exam: post-mictionnel residu (ml)
Time Frame
60 months
Title
Urodynamic exam: fonctional bladder capacity (ml)
Description
bladder capacity in ml
Time Frame
3 months
Title
Urodynamic exam: fonctional bladder capacity (ml)
Description
bladder capacity in ml
Time Frame
12 months
Title
Urodynamic exam: fonctional bladder capacity (ml)
Description
bladder capacity in ml
Time Frame
36 months
Title
Urodynamic exam: fonctional bladder capacity (ml)
Description
bladder capacity in ml
Time Frame
60 months
Title
Urodynamic exam: urethral closure pressure (cm water)
Description
urethral closure pressure in cm of water
Time Frame
3 months
Title
Urodynamic exam: urethral closure pressure (cm water)
Description
urethral closure pressure in cm of water
Time Frame
12 months
Title
Urodynamic exam: urethral closure pressure (cm water)
Description
urethral closure pressure in cm of water
Time Frame
36 months
Title
Urodynamic exam: urethral closure pressure (cm water)
Description
urethral closure pressure in cm of water
Time Frame
60 months
Title
Wexner anal incontinence score
Time Frame
3 months
Title
Wexner anal incontinence score
Time Frame
12 months
Title
Wexner anal incontinence score
Time Frame
36 months
Title
Wexner anal incontinence score
Time Frame
60 months
Title
ODS constipation score
Time Frame
3 months
Title
ODS constipation score
Time Frame
12 months
Title
ODS constipation score
Time Frame
36 months
Title
ODS constipation score
Time Frame
60 months
Title
Visual analog scale for pain
Time Frame
day 1
Title
Visual analog scale for pain
Time Frame
day 2
Title
Visual analog scale for pain
Time Frame
day 3
Title
Visual analog scale for pain
Time Frame
day 4
Title
Visual analog scale for pain
Time Frame
3 months
Title
Visual analog scale for pain
Time Frame
12 months
Title
Visual analog scale for pain
Time Frame
36 months
Title
Visual analog scale for pain
Time Frame
60 months
Title
Patient satisfaction
Description
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Time Frame
Day 4
Title
Patient satisfaction
Description
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Time Frame
3 months
Title
Patient satisfaction
Description
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Time Frame
12 months
Title
Patient satisfaction
Description
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Time Frame
36 months
Title
Patient satisfaction
Description
Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?
Time Frame
60 months
Title
Questionnaire PFDI-20
Time Frame
3 months
Title
Questionnaire PFDI-20
Time Frame
12 months
Title
Questionnaire PFDI-20
Time Frame
36 months
Title
Questionnaire PFDI-20
Time Frame
60 months
Title
Questionnaire PFIQ-7
Time Frame
3 months
Title
Questionnaire PFIQ-7
Time Frame
12 months
Title
Questionnaire PFIQ-7
Time Frame
36 months
Title
Questionnaire PFIQ-7
Time Frame
60 months
Title
Questionnaire PISQ-12
Time Frame
3 months
Title
Questionnaire PISQ-12
Time Frame
12 months
Title
Questionnaire PISQ-12
Time Frame
36 months
Title
Questionnaire PISQ-12
Time Frame
60 months
Title
Questionnaire SF36
Time Frame
3 months
Title
Questionnaire SF36
Time Frame
12 months
Title
Questionnaire SF36
Time Frame
36 months
Title
Questionnaire SF36
Time Frame
60 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient has a first,(primo-event), symptomatic, genito-urinary prolapse of at least stage II (POP-Q classification) requiring surgery The patient must have given her informed and signed consent The patient must be insured or beneficiary of a health insurance plan The patient is available for 60 months of follow-up Exclusion Criteria: The patient is participating in another study The patient is under judicial protection, under tutorship or curatorship The patient refuses to sign the consent It is impossible to correctly inform the patient The patient is pregnant Patient has a stage-1 prolapse (POP-Q classification) Patient has asymptomatic prolapse The patient has a prolapse recurrence (i.e. this is not the first case of prolapse) The patient is not available for 60 months of follow-up Patient has a vaginal or urinary infection Patient has poorly-adjusted diabetes Patient on long-term corticotherapy Patient has previously had pelvic radiotherapy Patient has contraindication for anesthesia Patient has an intestinal inflammatory disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphane Droupy, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nîmes - Hôpital Universitaire Carémeau
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
Groupe Urologie Saint Augustin
City
Bordeaux
ZIP/Postal Code
33074
Country
France
Facility Name
APHP - Centre Hospitalier Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU de Montpellier - Hôpital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nancy - Hôpitaux de Brabois
City
Nancy
Country
France
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
CHU de Nice - Hôpitaux L'Archet 1 et 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
Clinique Kennedy
City
Nîmes
ZIP/Postal Code
30900
Country
France
Facility Name
Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
APHP - Groupe Hospitalier Pitié-Salpetrière
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
CHU de Lyon - Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69310
Country
France
Facility Name
CHU de Rennes - Hôpital PontChaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Clinique Belledonne
City
St Martin d'Héres
ZIP/Postal Code
38400
Country
France
Facility Name
CHRU de Strasbourg - Hôpital Civil
City
Strasbourg Cedex
ZIP/Postal Code
67091
Country
France
Facility Name
Hôpital Foch
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
CHRU de Toulouse - Hôpital de Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU de Tours - Hôpital Bretonneau
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Learn more about this trial

Complications Associated With Promontofixation for Pelvic Organ Prolapse: Comparing Robot Assisted Laparoscopic and Non-robot Assisted Laparoscopic Surgical Procedures

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