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NCT Number: NCT01320215

Complications Associated With Promontofixation for Pelvic Organ Prolapse: 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.

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Key information

Conditions

Pelvic Organ Prolapse Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse Urogenital Diseases Uterine Diseases Uterine Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau, Nîmes, Gard, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robot-assisted promontofixation

Procedure

Sacrohysteropexy with robotic assistance (da Vinci robot)

Non-robot assisted promontofixation

Procedure

Laparoscopic sacrohysteropexy, without robot assistance

Primary outcomes

  1. presence/absence of complications (composite score)

    Time frame: 30 days

    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 outcomes

  1. Time needed to prep the operation room (min)

    Time frame: 1 day

  2. length of hospital stay (days)

    Time frame: 1 month

    The number of days the patient stays in the hospital following promontofixation

  3. Operative time (min)

    Time frame: 1 day

    The time elapsed between incision and closure of the patient

  4. Anesthesia time (min)

    Time frame: 1 day

    The time elapsed between anethesia induction and awakening

  5. Equipment installation time (min)

    Time frame: 1 day

    Time elapsed between installation of trocarts and insertion of endoscopic instruments (robot arms or coelioscopic tools)

  6. Surgical time (min)

    Time frame: 1 day

    The time spent manipulating endoscopic intruments or console time for robotic techniques.

  7. Presence/absence of conversion

    Time frame: Day 1

    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

  8. presence/absence of a re-intervention

    Time frame: 30 days

  9. Presence/absence of urinary incontinence

    Time frame: 3 months

  10. Presence/absence of urinary incontinence

    Time frame: 12 months

  11. Presence/absence of urinary incontinence

    Time frame: 36 months

  12. Presence/absence of urinary incontinence

    Time frame: 60 months

  13. presence/absence of constipation

    Time frame: 3 months

  14. presence/absence of constipation

    Time frame: 12 months

  15. presence/absence of constipation

    Time frame: 36 months

  16. presence/absence of constipation

    Time frame: 60 months

  17. Presence/absence of fecal incontinence

    Time frame: 3 months

  18. Presence/absence of fecal incontinence

    Time frame: 12 months

  19. Presence/absence of fecal incontinence

    Time frame: 36 months

  20. Presence/absence of fecal incontinence

    Time frame: 60 months

  21. presence/absence of dysparunia

    Time frame: 3 months

  22. presence/absence of dysparunia

    Time frame: 12 months

  23. presence/absence of dysparunia

    Time frame: 36 months

  24. presence/absence of dysparunia

    Time frame: 60 months

  25. POP-Q score

    Time frame: 3 months

  26. POP-Q score

    Time frame: 12 months

  27. POP-Q score

    Time frame: 36 months

  28. POP-Q score

    Time frame: 60 months

  29. Urodynamic exam Q max (ml/s)

    Time frame: 3 months

    Urination rate il ml/s

  30. Urodynamic exam Q max (ml/s)

    Time frame: 12 months

    Urination rate il ml/s

  31. Urodynamic exam Q max (ml/s)

    Time frame: 36 months

    Urination rate il ml/s

  32. Urodynamic exam Q max (ml/s)

    Time frame: 60 months

    Urination rate il ml/s

  33. Urodynamic exam, volume urinated (ml)

    Time frame: 3 months

    the volume urinated in ml

  34. Urodynamic exam, volume urinated (ml)

    Time frame: 12 months

    the volume urinated in ml

  35. Urodynamic exam, volume urinated (ml)

    Time frame: 36 months

    the volume urinated in ml

  36. Urodynamic exam, volume urinated (ml)

    Time frame: 60 months

    the volume urinated in ml

  37. Urodynamic exam: post-mictionnel residu (ml)

    Time frame: 3 months

  38. Urodynamic exam: post-mictionnel residu (ml)

    Time frame: 12 months

  39. Urodynamic exam: post-mictionnel residu (ml)

    Time frame: 36 months

  40. Urodynamic exam: post-mictionnel residu (ml)

    Time frame: 60 months

  41. Urodynamic exam: fonctional bladder capacity (ml)

    Time frame: 3 months

    bladder capacity in ml

  42. Urodynamic exam: fonctional bladder capacity (ml)

    Time frame: 12 months

    bladder capacity in ml

  43. Urodynamic exam: fonctional bladder capacity (ml)

    Time frame: 36 months

    bladder capacity in ml

  44. Urodynamic exam: fonctional bladder capacity (ml)

    Time frame: 60 months

    bladder capacity in ml

  45. Urodynamic exam: urethral closure pressure (cm water)

    Time frame: 3 months

    urethral closure pressure in cm of water

  46. Urodynamic exam: urethral closure pressure (cm water)

    Time frame: 12 months

    urethral closure pressure in cm of water

  47. Urodynamic exam: urethral closure pressure (cm water)

    Time frame: 36 months

    urethral closure pressure in cm of water

  48. Urodynamic exam: urethral closure pressure (cm water)

    Time frame: 60 months

    urethral closure pressure in cm of water

  49. Wexner anal incontinence score

    Time frame: 3 months

  50. Wexner anal incontinence score

    Time frame: 12 months

  51. Wexner anal incontinence score

    Time frame: 36 months

  52. Wexner anal incontinence score

    Time frame: 60 months

  53. ODS constipation score

    Time frame: 3 months

  54. ODS constipation score

    Time frame: 12 months

  55. ODS constipation score

    Time frame: 36 months

  56. ODS constipation score

    Time frame: 60 months

  57. Visual analog scale for pain

    Time frame: day 1

  58. Visual analog scale for pain

    Time frame: day 2

  59. Visual analog scale for pain

    Time frame: day 3

  60. Visual analog scale for pain

    Time frame: day 4

  61. Visual analog scale for pain

    Time frame: 3 months

  62. Visual analog scale for pain

    Time frame: 12 months

  63. Visual analog scale for pain

    Time frame: 36 months

  64. Visual analog scale for pain

    Time frame: 60 months

  65. Patient satisfaction

    Time frame: Day 4

    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?

  66. Patient satisfaction

    Time frame: 3 months

    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?

  67. Patient satisfaction

    Time frame: 12 months

    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?

  68. Patient satisfaction

    Time frame: 36 months

    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?

  69. Patient satisfaction

    Time frame: 60 months

    Is the patient very satisfied, satisfied, somewhat unsatisfied, or very unsatisfied in relation to the procedure?

  70. Questionnaire PFDI-20

    Time frame: 3 months

  71. Questionnaire PFDI-20

    Time frame: 12 months

  72. Questionnaire PFDI-20

    Time frame: 36 months

  73. Questionnaire PFDI-20

    Time frame: 60 months

  74. Questionnaire PFIQ-7

    Time frame: 3 months

  75. Questionnaire PFIQ-7

    Time frame: 12 months

  76. Questionnaire PFIQ-7

    Time frame: 36 months

  77. Questionnaire PFIQ-7

    Time frame: 60 months

  78. Questionnaire PISQ-12

    Time frame: 3 months

  79. Questionnaire PISQ-12

    Time frame: 12 months

  80. Questionnaire PISQ-12

    Time frame: 36 months

  81. Questionnaire PISQ-12

    Time frame: 60 months

  82. Questionnaire SF36

    Time frame: 3 months

  83. Questionnaire SF36

    Time frame: 12 months

  84. Questionnaire SF36

    Time frame: 36 months

  85. Questionnaire SF36

    Time frame: 60 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: RoboLaps

Important dates

Study start
2011
Primary completion
2022
Study completion
2022
First posted
Mar 22, 2011
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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