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

N/ACompletedNCT01320215

Centre Hospitalier Universitaire de Nīmes365 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

365

Conditions

Pelvic Organ Prolapse

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, France

Groupe Urologie Saint Augustin

Bordeaux, France

APHP - Centre Hospitalier Henri Mondor

Créteil, France

CHU de Dijon

Dijon, France

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, France

CHU de Nancy - Hôpitaux de Brabois

Nancy, France

CHU de Nantes

Nantes, France

CHU de Nice - Hôpitaux L'Archet 1 et 2

Nice, France

Clinique Kennedy

Nîmes, France

Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly

Paris, France

...and 8 more locations

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

Time needed to prep the operation room (min)

Time frame: 1 day

length of hospital stay (days)

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

Time frame: 1 month

Operative time (min)

The time elapsed between incision and closure of the patient

Time frame: 1 day

Anesthesia time (min)

The time elapsed between anethesia induction and awakening

Time frame: 1 day

Equipment installation time (min)

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

Time frame: 1 day

Surgical time (min)

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

Time frame: 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

Time frame: Day 1

presence/absence of a re-intervention

Time frame: 30 days

Presence/absence of urinary incontinence

Time frame: 3 months

Presence/absence of urinary incontinence

Time frame: 12 months

Presence/absence of urinary incontinence

Time frame: 36 months

Presence/absence of urinary incontinence

Time frame: 60 months

presence/absence of constipation

Time frame: 3 months

presence/absence of constipation

Time frame: 12 months

presence/absence of constipation

Time frame: 36 months

presence/absence of constipation

Time frame: 60 months

Presence/absence of fecal incontinence

Time frame: 3 months

Presence/absence of fecal incontinence

Time frame: 12 months

Presence/absence of fecal incontinence

Time frame: 36 months

Presence/absence of fecal incontinence

Time frame: 60 months

presence/absence of dysparunia

Time frame: 3 months

presence/absence of dysparunia

Time frame: 12 months

presence/absence of dysparunia

Time frame: 36 months

presence/absence of dysparunia

Time frame: 60 months

POP-Q score

Time frame: 3 months

POP-Q score

Time frame: 12 months

POP-Q score

Time frame: 36 months

POP-Q score

Time frame: 60 months

Urodynamic exam Q max (ml/s)

Urination rate il ml/s

Time frame: 3 months

Urodynamic exam Q max (ml/s)

Urination rate il ml/s

Time frame: 12 months

Urodynamic exam Q max (ml/s)

Urination rate il ml/s

Time frame: 36 months

Urodynamic exam Q max (ml/s)

Urination rate il ml/s

Time frame: 60 months

Urodynamic exam, volume urinated (ml)

the volume urinated in ml

Time frame: 3 months

Urodynamic exam, volume urinated (ml)

the volume urinated in ml

Time frame: 12 months

Urodynamic exam, volume urinated (ml)

the volume urinated in ml

Time frame: 36 months

Urodynamic exam, volume urinated (ml)

the volume urinated in ml

Time frame: 60 months

Urodynamic exam: post-mictionnel residu (ml)

Time frame: 3 months

Urodynamic exam: post-mictionnel residu (ml)

Time frame: 12 months

Urodynamic exam: post-mictionnel residu (ml)

Time frame: 36 months

Urodynamic exam: post-mictionnel residu (ml)

Time frame: 60 months

Urodynamic exam: fonctional bladder capacity (ml)

bladder capacity in ml

Time frame: 3 months

Urodynamic exam: fonctional bladder capacity (ml)

bladder capacity in ml

Time frame: 12 months

Urodynamic exam: fonctional bladder capacity (ml)

bladder capacity in ml

Time frame: 36 months

Urodynamic exam: fonctional bladder capacity (ml)

bladder capacity in ml

Time frame: 60 months

Urodynamic exam: urethral closure pressure (cm water)

urethral closure pressure in cm of water

Time frame: 3 months

Urodynamic exam: urethral closure pressure (cm water)

urethral closure pressure in cm of water

Time frame: 12 months

Urodynamic exam: urethral closure pressure (cm water)

urethral closure pressure in cm of water

Time frame: 36 months

Urodynamic exam: urethral closure pressure (cm water)

urethral closure pressure in cm of water

Time frame: 60 months

Wexner anal incontinence score

Time frame: 3 months

Wexner anal incontinence score

Time frame: 12 months

Wexner anal incontinence score

Time frame: 36 months

Wexner anal incontinence score

Time frame: 60 months

ODS constipation score

Time frame: 3 months

ODS constipation score

Time frame: 12 months

ODS constipation score

Time frame: 36 months

ODS constipation score

Time frame: 60 months

Visual analog scale for pain

Time frame: day 1

Visual analog scale for pain

Time frame: day 2

Visual analog scale for pain

Time frame: day 3

Visual analog scale for pain

Time frame: day 4

Visual analog scale for pain

Time frame: 3 months

Visual analog scale for pain

Time frame: 12 months

Visual analog scale for pain

Time frame: 36 months

Visual analog scale for pain

Time frame: 60 months

Patient satisfaction