Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

A Long Term Follow up of Anterior Meshes for Recurrent Prolapse

17. september 2017 oppdatert av: Professor Jonathan Duckett, Medway NHS Foundation Trust

A Long Term Follow up of Perigee Anterior Meshes Performed for Recurrent Prolapse

Prolapse of the vaginal wall and uterus are common conditions affecting up to 50% of parous women. The socioeconomic, psychological and physical impacts of prolapse are considerable. 11% of women will undergo a surgical repair by the age of 80 years. The commonest compartment affected is the anterior vaginal wall. Unfortunately there is a significant rate of recurrent prolapse or a failure of the primary procedure. This has lead to the introduction of new techniques and the use of different materials to augment the repair. Mesh augmented repairs aim to reduce the rate of recurrent prolapse. However, the use of synthetic mesh is associated with complications which are not found in non mesh repairs. 10% of women will have a mesh complication of which 70% will require a further surgical procedure to manage the complication. There are extra costs associated with purchasing the mesh, with longer operating times to insert the mesh and managing complications caused by the mesh. Balancing the extra risks of mesh surgery against the benefits is probably one of the most contentious issues in urogynaecology at the present time.

Regulatory authorities in the USA (FDA) and UK (MHRA) have become increasingly interested in the use of mesh to support the vaginal wall in prolapse surgery due to risks and complications being reported. To date there is little evidence regarding the long term safety and efficacy of anterior mesh repairs. This study aims to rectify this deficiency for Perigee.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This will be a consecutive cohort study of patients identified from a surgical database of Perigees performed in a single centre. All patients will have had the procedure performed between 2007 and 2011. This will be a single centre study. The principle investigator has both electronic and hand written records of all Perigee repairs performed since the introduction of this technique in 2007. The patients will be identified from both the paper and electronic databases and cross referenced.

After obtained appropriate ethical approval, patients identified as having a perigee mesh inserted will be asked to attend Medway Hospital for a full clinical evaluation. They will be sent a letter with an appointment to come to the hospital. They will be asked to complete the Pelvic floor distress inventory questionnaire to assess their symptoms. They will have a pelvic examination to determine if they have any mesh erosion and will undergo a POP-Q score. This visit will take 1 hour.

Studietype

Observasjonsmessig

Registrering (Faktiske)

48

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Storbritannia
    • Kent
      • Gillingham, Kent, Storbritannia, ME5 7NY
        • Medway NHS Foundation Trust

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 100 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Consecutive patients having previously undergone a mesh repair

Beskrivelse

Inclusion Criteria:

  • Women undergoing a perigee procedure after January 2007

Exclusion Criteria:

  • Patient having non mesh repairs over the same time scale

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
The Number of Participants With a Current Mesh Erosion or Treated for a Mesh Erosion Since Inserted
Tidsramme: 1 hour
clinic visit. 5 patients were interviewed by phone and were not examined - hence this figure is out of 43 not 48.
1 hour

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Participants With no Physical Evidence of Recurrent Prolapse as Determined by Physical Examination
Tidsramme: 1 hour

The presence of less than stage 2 prolapse (eg stage 1) anterior wall prolapse determined as anatomical success. A stage one prolapse is higher than 1cm above the vaginal entrance.

A stage 2 prolapse means that the leading edge of the prolapse is between 1cm above the entrance to the vagina up to 1cm below the entrance to the vagina.
1 hour
Number of Participants Complaining of a Bulge. Recurrent Prolapse
Tidsramme: 1 hour
Efficacy determined by the question in the pelvic floor prolapse distress inventory "usually have a bulge or something falling out that you can see or feel in your vaginal area". Determined at clinic visit by questioning
1 hour
Number of Participants Requiring Treatment for Recurrent Prolapse - Prolapse in the Same Part of the Vagina
Tidsramme: 1 hour
clinic visit; number of participants who underwent reoperation of recurrent prolapse in the same compartment
1 hour
Number of Participants Who Underwent Reoperation for Prolapse in a Different Compartment
Tidsramme: 1 hour
This is where the mesh has held up and there is no prolapse where it was inserted. This measure refers to when a different part of the vagina has prolapsed.
1 hour
Number of Participants Who Developed New Stress Incontinence
Tidsramme: 1 hour
The mesh has caused the prolapse to be successfully repaired but the patient has developed stress incontinence as a separate issue. clinic visit
1 hour
Number of Participants Who Rated Their Improvement as Better or Very Much Better
Tidsramme: 1 hour
The patient global impression of Improvement scale (PGI-I) is a global improvement scale filled out by the patient. It is graded as very much better, much better, a little better. no change, a little worse, much worse or very much worse.clinic visit
1 hour
Number of Participants Who Needed Surgical Mesh Removal for Erosion
Tidsramme: 1 hour
A mesh erosion is when the body rejects the mesh and it is visible in the vagina rather than being buried under the vaginal epithelium. clinic visit
1 hour
Number of Participants Who Needed Reoperations for Pain
Tidsramme: 1 hour
patients may develop pain after the original operation which needs a second surgical procedure to try and help. clinic visit
1 hour
Number of Participants Who Experienced Intraoperative Complications
Tidsramme: 1 hour
This records any problems that were encountered at the original insertion of the mesh. clinic visit
1 hour

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Medway NHS Foundation Trust

Etterforskere

  • Hovedetterforsker: Jonathan Duckett, FRCOG, Medway NHS Foundation Trust

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. august 2015

Primær fullføring (Faktiske)

1. mars 2016

Studiet fullført (Faktiske)

1. mars 2016

Datoer for studieregistrering

Først innsendt

27. august 2015

Først innsendt som oppfylte QC-kriteriene

27. desember 2015

Først lagt ut (Anslag)

30. desember 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. mai 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

17. september 2017

Sist bekreftet

1. mars 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 9/12/14

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere