Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair
Evaluating the Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair
Studieoversikt
Status
Detaljert beskrivelse
Inguinal hernia repair is one of the most common surgical conditions encountered in primary care settings. Globally, around 20 million groin hernia repairs are performed each year. Surgical procedure is the gold standard treatment for inguinal hernia repair.
Laparoscopic hernioplasty is suitable for patients with inguinal hernia who can undergo general anesthesia, especially in cases like hernia recurrence after open repair, bilateral hernias, and simultaneous procedures like cholecystectomy.
Although open mesh repair has already demonstrated a low recurrence rate, laparoscopic mesh repair has become increasingly popular in recent years due to its benefits, including a better view of the groin anatomy, ease in addressing bilateral hernias, and superior cosmetic outcomes. The two most widely used laparoscopic mesh repair techniques are Totally Extra peritoneal (TEP) and Trans abdominal Preperitoneal (TAPP) repair, both of which are based on the myopectineal orifice theory. The key difference between TEP and TAPP lies in the method used to access the preperitoneal space.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Cairo, Egypt, 12613
- Cairo University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged from18 to 70 years.
- Both sexes.
- Patients were diagnosed with all types of inguinal hernia who are candidates for elective trans-abdominal Preperitoneal (TAPP) repair.
Exclusion Criteria:
- Previous history of pelvic or lower abdominal surgery.
- Coagulopathy.
- Any condition contraindicating laparoscopic surgery.
- Patients with complicated hernia (irreducible/incarcerated or obstructed/strangulated hernia).
- Active infections.
- Uncorrected medical comorbidities.
- Bilateral inguinal hernia either preoperative or intraoperative diagnosis.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Group A
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
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Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
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Eksperimentell: Group B
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.
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Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of patients suffering from Seroma
Tidsramme: 6 months post-procedure
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Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.
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6 months post-procedure
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Degree of pain
Tidsramme: 24 hours post-procedure
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Pain was assessed using Visual Analogue Scale (VAS) in which the pain score is defined from 0 (no pain) to 10 (maximum pain) at rest and during activity recorded at similar intervals.
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24 hours post-procedure
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Degree of patient satisfaction
Tidsramme: 24 hours post-procedure
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Degree of patient satisfaction was assessed using 3-likert point scale where (1, Neutral; 2, Satisfied; 3, Very satisfied)
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24 hours post-procedure
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Measurement of operative time
Tidsramme: Till closure of the skin (Up to 60 minutes).
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Measurement of operative time was done from skin incision to closure.
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Till closure of the skin (Up to 60 minutes).
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Incidence of recurrence
Tidsramme: 6 months post-procedure
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Incidence of recurrence of hernia was assessed during follow-up visits.
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6 months post-procedure
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MS-55-2025 (28-4-2025)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
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