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

Pelvic Organ Prolapse Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01320215
• Other study ID #: PHRC-N/2010/SD-01
• Secondary ID: 2010-A01110-39
• Status: Completed
• Phase: N/A
• Start date: June 22, 2011
• Est. completion date: September 27, 2023

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: September 27, 2023
• Est. primary completion date: September 12, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Robot-assisted promontofixation
Sacrohysteropexy with robotic assistance (da Vinci robot)
• Non-robot assisted promontofixation
Laparoscopic sacrohysteropexy, without robot assistance

Locations

Country	Name	City	State
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	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes	Gard
France	Clinique Kennedy	Nîmes
France	APHP - Groupe Hospitalier Pitié-Salpetrière	Paris
France	Groupe Hospitalier Diaconesses Croix Saint-Simon - Site Reuilly	Paris
France	CHU de Lyon - Centre Hospitalier Lyon Sud	Pierre Benite
France	CHU de Rennes - Hôpital PontChaillou	Rennes
France	Clinique Belledonne	St Martin d'Héres
France	CHRU de Strasbourg - Hôpital Civil	Strasbourg Cedex
France	Hôpital Foch	Suresnes
France	CHRU de Toulouse - Hôpital de Rangueil	Toulouse
France	CHRU de Tours - Hôpital Bretonneau	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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