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Evaluation of the Position of Promontofixation Prostheses in Perineal Ultrasound (PROMONOTECHO)

P

Poitiers University Hospital

Status

Completed

Conditions

Prolapse of the Uterus

Treatments

Other: perineal ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT03634878
PROMONTECHO

Details and patient eligibility

About

Indirect promontofixation with prostheses is the standard surgical technique for the reference of uterine prolapse. There is no validated examination to control the position of the prostheses postoperatively.

These prostheses are echogenic and perineal ultrasound could be a means of postoperative monitoring. There is no data in the literature on the relationship between prosthesis position and postoperative symptoms

Enrollment

50 patients

Sex

Female

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years of female sex
  • Patient with double laparoscopic promontofixation without associated hysterectomy

Exclusion criteria

  • History of hysterectomy
  • Anterior cure (before index intervention) of prolapse with placement of prosthetic material.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Perineal ultrasound to visualize the strips and their position
Experimental group
Treatment:
Other: perineal ultrasound

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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