Ambulatory Prolapse Surgery

Genital Prolapse Clinical Trial

— PROLAMBU  

Official title:

Ambulatory Prolapse Surgery: Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585544
• Other study ID #: 69HCL15_0215
• Secondary ID: 2015-A00599-40
• Status: Completed
• Phase: N/A
• Start date: October 15, 2015
• Est. completion date: September 3, 2019

Study information

• Verified date: October 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Day surgery is performed in the same way as in full hospital admission, allowing same-day discharge without increased risk. It provides many grounds for patient satisfaction. Progress in surgical and anesthesia techniques now allows this form of management to be developed and prioritized.

Day-care surgery for prolapse has been little studied. The present study is intended to help extend its future implementation, the primary objective being to assess the feasibility of the day-care approach in prolapse surgery. The secondary objectives are to study criteria of non-eligibility for day-care prolapse surgery, reasons for patients' refusal, causes of failure, predictive factors for failure, patient satisfaction, postoperative complications, 2-year anatomic and functional results, pain, quality of life and sexuality, and postoperative onset of dyspareunia and urinary incontinence.

The design is for a prospective non-randomized study conducted in 3 gynecologic surgery sites managed by the Lyon hospitals board (Hospices Civils de Lyon).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage III or IV anterior genital prolapse (cystocele) on the Pelvic Organ Prolapse Quantification (POP-Q) classification and/or vaginal floor prolapse

• Vaginal approach with prosthetic reinforcement planned

• Patient eligible for day-surgery

• Patient consenting to participate

• Informed and signed consent

Exclusion Criteria:

• Interview revealing disorder entailing unacceptable risk of postoperative complications: coagulation disorder, immune system disorder, progressive disease, etc.

• Patient with =1 ineligibility criterion for day-surgery

• Impaired lower-limb range of motion preventing positioning for surgery

• Pregnancy, ongoing or planned during the study period

• Progressive or latent infection or signs of tissue necrosis on clinical examination

• Non-controlled diabetes (glycated hemoglobin >8%)

• Treatment impacting immune response (immunomodulators), ongoing or within previous month

• History of pelvic region radiation therapy, at any time

• History of pelvic cancer

• Non-controlled progressive spinal pathology

• Known hypersensitivity to one of the implant components (polypropylene)

• Inability to understand information provided

• Not covered by a national health insurance scheme, prisoner or under administrative supervision.

Related Conditions & MeSH terms

• Genital Prolapse
• Prolapse
• Vaginal Floor Prolapse

Intervention

Procedure:
• day-care surgery
day-care surgery

Locations

Country	Name	City	State
France	Hopital Femme Mère Enfant	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patient with success for ambulatory surgery	Number of prolapse surgery patients actually managed on a day-care basis	Day 1 (postoperative)
Secondary	causes of non-eligibility for day-care management analysis	list and percentage	Day 1 (before surgery)
Secondary	reasons for patients' refusal analysis	list and percentage	Day 1 (before surgery)
Secondary	causes of failure of day-surgery analysis	list and percentage	Day 1 (postoperative)
Secondary	Number of patients satisfied with day-surgery		Day 1 (postoperative)
Secondary	Post-surgery complications	number and percentage of cases of infection, hematoma, urinary retention, healing defect (exposure or erosion), retraction, death	Day 1 (postoperative), month 1, year 1 and year 2
Secondary	Number of prolapse correction failure		month 1, year 1 and year 2
Secondary	pain score analysis	0 to 10 scale	month 1, year 1 and year 2
Secondary	quality of life scores analysis	SF- 12 Short Form (12) Health Survey PFDI-20 : Pelvic Floor Distress Inventory PFIQ-7 : Pelvic Floor Impact Questionnaire PGI-I : Patient Global Impression of Improvement	month 1, year 1 and year 2
Secondary	quality of life scores analysis	SF- 12 Short Form (12) Health Survey	month 1, year 1 and year 2
Secondary	quality of life scores analysis	PFDI-20 : Pelvic Floor Distress Inventory	month 1, year 1 and year 2
Secondary	quality of life scores analysis	PGI-I : Patient Global Impression of Improvement	month 1, year 1 and year 2
Secondary	quality of life scores analysis	PFIQ-7 : Pelvic Floor Impact Questionnaire	month 1, year 1 and year 2
Secondary	sexuality score analysis	PISQ-12 questionnaire	month 1, year 1 and year 2
Secondary	percentage dyspareunia		month 1, year 1 and year 2
Secondary	number of onset of urinary incontinence		month 1, year 1 and year 2