Abdominal Rectus Diastasis Mikroskopi og Rehabilitering (AMIRE) (AMIRE)
Abdominal Rectus Diastasis Mikroskopi og Rehabilitering
The goal of this randomised controlled trial is to evaluate the effect of a postoperative rehabilitation program after surgical correction of abdominal rectus diastasis. The main questions to answer are:
- Does structured postoperative abdominal exercise improve abdominal wall function in three months and twelve months after surgical correction of abdominal rectus diastasis
- Does connective tissue components differ in patients with abdominal rectus diastasis when compared to healthy individuals?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The investigators want to include patients in Sweden that are eligible for surgical correction of their abdominal rectus diastasis. Patients will be recruited at the surgical clinic at four hospitals in Sweden. After being informed about the study and potential risks, all patient give written informed consent. Randomisation is performed upon inclusion.
All patients undergo surgery by plication of the linea alba. A blood sample is collected prior to the surgery. During the surgery the skin, connective tissue and rectus muscle are biopsied. On the first postoperative day, another blood sample is collected. Follow up is conducted three and twelve months after surgery.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Dalarna County
-
Mora, Dalarna County, Sverige, 79251
- Surgical clinic at Mora Hospital
-
-
Norrbotten County
-
Gällivare, Norrbotten County, Sverige, 98234
- Surgical clinic at Gällivare Hospital
-
-
Västerbotten County
-
Skellefteå, Västerbotten County, Sverige, 93141
- Surgical clinic at the district hospital of Skellefteå
-
Umeå, Västerbotten County, Sverige, 90737
- University Hospital of Umeå
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Diastasis > 3 cm
- At least 1 year since child birth
- One year of steady weight after weightloss
- BMI < 30
- Males with diastasis above and below umbilicus
Exclusion Criteria:
- New planned pregnancy
- Smoker
- Connective tissue disease
- Immunosuppressive treatment
- Umbilical hernia > 2 cm
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervention
24 patients that receive a postoperative rehabilitation program to follow after they undergo surgery for abdominal rectus diastasis. |
The rehabilitation program is created by a physical therapist |
|
Ingen inngripen: Control
24 patients that undergo surgery for abdominal rectus diastasis and can exercise freely after surgery. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
5 times sit to stand test time
Tidsramme: Three and twelve months after surgery
|
Abdominal wall function measured with the 5 times sit to stand test |
Three and twelve months after surgery
|
|
Number of repetitions of deadlift with 20 kilograms
Tidsramme: Three and twelve months after surgery
|
Abdominal wall function measured |
Three and twelve months after surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
VHPQ
Tidsramme: Three and twelve months after surgery
|
Ventral hernia pain questionnaire collect information on the patients experience of pain |
Three and twelve months after surgery
|
|
PDI-score
Tidsramme: Three and twelve months after surgery
|
Pain disability index collect information on how pain influence daily life attributes. Minimum score 0, maximum score 70. A lower score means less disability. |
Three and twelve months after surgery
|
|
PGPQ
Tidsramme: Three and twelve months after surgery
|
Patient goal priority questionnaire collect information on activities the patient wish to improve using the intervention |
Three and twelve months after surgery
|
|
PFDI-20 short form
Tidsramme: Three and twelve months after surgery
|
Pelvic floor disability index short form collect information on symptoms from the urogenital organs. Minimum score 0, maximum score 40. Absence of symptoms (score 0), symptoms with mild distress (1-15), symptoms with moderate distress (16-34), symptoms with severe distress (35-40). |
Three and twelve months after surgery
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2022-06512-01
Plan for individuelle deltakerdata (IPD)
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