- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07616830
Outcomes of Midline Stoma
Outcomes of Midline Stoma: A Prospective Study.
- Ileostomy or colostomy is a common surgical procedure used for diverting the lower gastrointestinal content away from distal pathology or anastomotic insufficiency. Once the distal problem has been fixed, the plan is to reverse the stoma. However, the reversal of a stoma is associated with complications, including anastomotic leaks, wound infection, and incisional hernias which can reach up to 33-50%.
- The ideal site for a stoma on the abdominal wall depends on several factors, including the patient's anatomy, the type of stoma (colostomy or ileostomy), operative findings, and the patient's preferences. Stomas have traditionally been fashioned through the rectus muscle, away from the midline of the abdomen, and below the umbilicus.
Management of a stoma placed at the center of a long midline laparotomy wound is challenging with the risk of faecal contamination of midline incision. However in many scenarios, the surgeon is left without options rather than to exteriorize the bowel loop through the midline. Moreover, advantages of midline stoma may include:
- Easy to create and save operative time.
- Minimize destruction of the anterior abdominal wall (less tissue injury).
- Eliminate the long-term risk of incisional hernia at the site of previous stoma.
Only, few reports assess the outcomes of midline ostomy as a temporary stoma
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Mohamad Raafat, MD
- Telefonnummer: 0201067877622
- E-post: mohamad_raafat10@yahoo.com
Studer Kontakt Backup
- Navn: Faculty of Medicine-Assiut University
Studiesteder
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Asyut Governorate
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Asyut, Asyut Governorate, Egypt, 71515
- Rekruttering
- Faculty of Medicine-Assiut University
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Ta kontakt med:
- Mohamad Raafat, MD
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients who will undergo temporary stoma (ileostomy/colostomy) through midline incision.
Exclusion Criteria:
- Patients with jejunostomy.
- Patients with severe sepsis.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Midline stoma group
Patients who will undergo temporary stoma (ileostomy/colostomy) through midline incision
|
stoma (ileostomy/colostomy) through midline incision
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Conversion rate
Tidsramme: During surgery
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Need for stoma revision (failure of midline stoma) and creation of conventional trans-rectus stoma.
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During surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of peristomal skin complications
Tidsramme: 1 month after surgery
|
Number and percentage of patients with peristomal skin complications around stoma including erythema, erosion, ulceration and tissue overgrowth (hypergranulation)
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1 month after surgery
|
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Incidence of Incisional hernia after stoma reversal
Tidsramme: 1 year after surgery
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Number and percentage of patients developing incisional hernia at the previous stoma site (after stoma reversal) confirmed clinically or radiologically (ultrasound or CT)
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1 year after surgery
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Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Nguyen MT, Phatak UR, Li LT, Hicks SC, Moffett JM, Arita NA, Berger RL, Kao LS, Liang MK. Review of stoma site and midline incisional hernias after stoma reversal. J Surg Res. 2014 Aug;190(2):504-9. doi: 10.1016/j.jss.2014.01.046. Epub 2014 Jan 29.
- Erwin-Toth P, Barrett P. Stoma site marking: a primer. Ostomy Wound Manage. 1997 May;43(4):18-22, 24-5.
- Eto K, Omura N, Haruki K, Uno Y, Ohkuma M, Nakajima S, Anan T, Kosuge M, Fujita T, Ishida K, Yanaga K. Transumbilical defunctioning ileostomy: A new approach for patients at risks of anastomotic leakage after laparoscopic low anterior resection. Anticancer Res. 2013 Nov;33(11):5011-5.
- Borejsza-Wysocki M, Bobkiewicz A, Ledwosinski W, Szmyt K, Banasiewicz T, Krokowicz L. Stoma close to the abdominal wound: a real technical problem. A description of a novel care strategy. Pol Przegl Chir. 2023 Feb 17;95(4):1-5. doi: 10.5604/01.3001.0016.2731.
- DeVito R, Shoukry S, Yglesias B, Fullmer R, Zarnoth B, Kerestes T. A case of simultaneous abdominal wall reconstruction and creation of diverting ostomy in a ventral hernia with loss of domain. Int J Surg Case Rep. 2020;76:361-363. doi: 10.1016/j.ijscr.2020.10.012. Epub 2020 Oct 7.
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RF-2-6-2025
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