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

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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Procedure: Robot-assisted promontofixation; Procedure: Non-robot assisted promontofixation

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33074
    • Groupe Urologie Saint Augustin
  • Créteil, France, 94000
    • APHP - Centre Hospitalier Henri Mondor
  • Dijon, France, 21079
    • CHU de DIJON
  • Montpellier, France, 34295
    • CHU de Montpellier - Hôpital Lapeyronie
  • Nancy, France
    • CHU de Nancy - Hôpitaux de Brabois
  • Nantes, France, 44000
    • Chu de Nantes
  • Nice, France, 06202
    • CHU de Nice - Hôpitaux L'Archet 1 et 2
  • Nîmes, France, 30900
    • Clinique Kennedy
  • Paris, France, 75651
    • APHP - Groupe Hospitalier Pitié-Salpetrière
  • Paris, France, 75012
    • Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly
  • Pierre-Bénite, France, 69310
    • CHU de Lyon - Centre Hospitalier Lyon Sud
  • Rennes, France, 35033
    • CHU de Rennes - Hôpital Pontchaillou
  • Saint Martin d'Héres, France, 38400
    • Clinique Belledonne
  • Strasbourg, France, 67091
    • CHRU de Strasbourg - Hôpital Civil
  • Suresnes, France, 92151
    • Hopital Foch
  • Toulouse, France, 31059
    • CHRU de Toulouse - Hôpital de Rangueil
  • Tours, France, 37044
    • CHRU de Tours - Hôpital Bretonneau
  • Gard
    • Nîmes, Gard, France, 30029
      • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot arm; The patients in this arm will have a robot-assisted promontofixation.	Procedure: Robot-assisted promontofixation; Sacrohysteropexy with robotic assistance (da Vinci robot)
Active Comparator: Non-robot arm; The patients in this arm with have a promotofixation via a laparoscopy, but without robot assistance.	Procedure: Non-robot assisted promontofixation; Laparoscopic sacrohysteropexy, without robot assistance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire PISQ-12		12 months
Questionnaire PISQ-12		36 months
Time needed to prep the operation room (min)		1 day
length of hospital stay (days)	The number of days the patient stays in the hospital following promontofixation	1 month
Operative time (min)	The time elapsed between incision and closure of the patient	1 day
Anesthesia time (min)	The time elapsed between anethesia induction and awakening	1 day
Equipment installation time (min)	Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)	1 day
Surgical time (min)	The time spent manipulating endoscopic intruments or console time for robotic techniques.	1 day
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	Day 1
presence/absence of a re-intervention		30 days
Presence/absence of urinary incontinence		3 months
Presence/absence of urinary incontinence		12 months
Presence/absence of urinary incontinence		36 months
Presence/absence of urinary incontinence		60 months
presence/absence of constipation		3 months
presence/absence of constipation		12 months
presence/absence of constipation		36 months
presence/absence of constipation		60 months
Presence/absence of fecal incontinence		3 months
Presence/absence of fecal incontinence		12 months
Presence/absence of fecal incontinence		36 months
Presence/absence of fecal incontinence		60 months
presence/absence of dysparunia		3 months
presence/absence of dysparunia		12 months
presence/absence of dysparunia		36 months
presence/absence of dysparunia		60 months
POP-Q score		3 months
POP-Q score		12 months
POP-Q score		36 months
POP-Q score		60 months
Urodynamic exam Q max (ml/s)	Urination rate il ml/s	3 months
Urodynamic exam Q max (ml/s)	Urination rate il ml/s	12 months
Urodynamic exam Q max (ml/s)	Urination rate il ml/s	36 months
Urodynamic exam Q max (ml/s)	Urination rate il ml/s	60 months
Urodynamic exam, volume urinated (ml)	the volume urinated in ml	3 months
Urodynamic exam, volume urinated (ml)	the volume urinated in ml	12 months
Urodynamic exam, volume urinated (ml)	the volume urinated in ml	36 months
Urodynamic exam, volume urinated (ml)	the volume urinated in ml	60 months
Urodynamic exam: post-mictionnel residu (ml)		3 months
Urodynamic exam: post-mictionnel residu (ml)		12 months
Urodynamic exam: post-mictionnel residu (ml)		36 months
Urodynamic exam: post-mictionnel residu (ml)		60 months
Urodynamic exam: fonctional bladder capacity (ml)	bladder capacity in ml	3 months
Urodynamic exam: fonctional bladder capacity (ml)	bladder capacity in ml	12 months
Urodynamic exam: fonctional bladder capacity (ml)	bladder capacity in ml	36 months
Urodynamic exam: fonctional bladder capacity (ml)	bladder capacity in ml	60 months
Urodynamic exam: urethral closure pressure (cm water)	urethral closure pressure in cm of water	3 months
Urodynamic exam: urethral closure pressure (cm water)	urethral closure pressure in cm of water	12 months
Urodynamic exam: urethral closure pressure (cm water)	urethral closure pressure in cm of water	36 months
Urodynamic exam: urethral closure pressure (cm water)	urethral closure pressure in cm of water	60 months
Wexner anal incontinence score		3 months
Wexner anal incontinence score		12 months
Wexner anal incontinence score		36 months
Wexner anal incontinence score		60 months
ODS constipation score		3 months
ODS constipation score		12 months
ODS constipation score		36 months
ODS constipation score		60 months
Visual analog scale for pain		day 1
Visual analog scale for pain		day 2
Visual analog scale for pain		day 3
Visual analog scale for pain		day 4
Visual analog scale for pain		3 months
Visual analog scale for pain		12 months
Visual analog scale for pain		36 months
Visual analog scale for pain		60 months
Patient satisfaction	Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?	Day 4
Patient satisfaction	Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?	3 months
Patient satisfaction	Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?	12 months
Patient satisfaction	Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?	36 months
Patient satisfaction	Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?	60 months
Questionnaire PFDI-20		3 months
Questionnaire PFDI-20		12 months
Questionnaire PFDI-20		36 months
Questionnaire PFDI-20		60 months
Questionnaire PFIQ-7		3 months
Questionnaire PFIQ-7		12 months
Questionnaire PFIQ-7		36 months
Questionnaire PFIQ-7		60 months
Questionnaire PISQ-12		3 months
Questionnaire PISQ-12		60 months
Questionnaire SF36		3 months
Questionnaire SF36		12 months
Questionnaire SF36		36 months
Questionnaire SF36		60 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Stéphane Droupy, MD PhD, Centre Hospitalier Universitaire de Nīmes

Publications and helpful links

General Publications

• Gris JC, Chea M, Bouvier S, Pereira FR. Antiphospholipid Antibodies in Mental Disorders. Semin Thromb Hemost. 2025 Jun;51(4):448-456. doi: 10.1055/s-0044-1788696. Epub 2024 Jul 24.

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2011
• Primary Completion (Actual): January 25, 2022
• Study Completion (Actual): January 25, 2022

Study Registration Dates

• First Submitted: March 21, 2011
• First Submitted That Met QC Criteria: March 21, 2011
• First Posted (Estimated): March 22, 2011

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: vaginal prolapse; sacrohysteropexy; da Vinci Robot; uterine prolapse
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Uterine Diseases; Genital Diseases, Female; Prolapse; Pathological Conditions, Signs and Symptoms; Pelvic Organ Prolapse; Uterine Prolapse
• Other Study ID Numbers: PHRC-N/2010/SD-01; 2010-A01110-39 (Other Identifier: ANSM)