Per-operative Ultrasonographic Assessement of the Placement of the Mesh in Laparoscopic Sacral Colpo/Hysteropexy

NCT03410303 | Completed DMC

• 1 other identifier: K160801J
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted in order to determinate the faisability of an intraoperative ultrasound to mesure the positioning of prostheses during laparoscopic promontofixation.

Conditions

LAPAROSCOPY; Sacrum; Anomaly

Outcome Measures

Primary Outcomes (1)

• Measure the distance (in mm) between the most distal part of the anterior prosthesis and the bladder neck.

  Comparaison of intraoperative measurement to postoperative measurement

  at two months (± 1 month) of follow-up

Secondary Outcomes (4)

• Stage of prolapse

  until 2 months post-operative

• Evaluate the symptoms with the PFDI-20 questionnaire

  during 2 months post-operative

• Evaluate patient satisfaction with the PGI-I questionnaire (1-7)

  until 2 months post-operative

• Evaluate the symptoms with the PFIQ-7 questionnaire

  during 2 months post-operative

Study Arms (1)

Intraoperative ultrasound

OTHER

An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.

Diagnostic Test: Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)

Interventions

Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month) DIAGNOSTIC_TEST

An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.

Intraoperative ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult women (\>18 years-old)
• patient who undergo laparoscopic sacral copopexy/hysteropexy
• Affiliation to a public health insurance system
• Written and informed consent given by the patient

You may not qualify if:

• Pregnancy, breast-feading
• woan involved in an interventional research
• Patient under tutorship or curatorship
• Pregnancy and breast feeding

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Xavier DEFFIEUX

Clamart, France

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Xavier DEFFIEUX

  AP-HP, Antoine Béclère Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: January 25, 2018
• Study Start: January 15, 2018
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-11

Locations

FR (1)