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Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair

27. juni 2026 opdateret af: Adam Abdirashid Ahmed, Cairo University

Evaluating the Effect of Drainage on the Incidence of Seroma After Laparoscopic Trans Abdominal Preperitoneal Inguinal Hernia Repair

The aim of the study is to evaluate the effect of drainage on the incidence of seroma after laparoscopic transabdominal preperitoneal inguinal hernia repair.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Egypten
      • Cairo, Egypten, 12613
        • Cairo University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Group A
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
Procedure: Trans-abdominal preperitoneal repair + Drainage
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique with closed suction drain was placed through the lateral 5 mm port.
Eksperimentel: Group B
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.
Procedure: Trans-abdominal preperitoneal repair
Patients underwent the trans-abdominal preperitoneal (TAPP) repair technique but the drain wasn't applied.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of patients suffering from Seroma
Tidsramme: 6 months post-procedure
Incidence of patients suffering from Seroma in each group after Transabdominal preperitoneal inguinal hernia repair.
6 months post-procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Degree of pain
Tidsramme: 24 hours post-procedure
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.
24 hours post-procedure
Degree of patient satisfaction
Tidsramme: 24 hours post-procedure
Degree of patient satisfaction was assessed using 3-likert point scale where (1, Neutral; 2, Satisfied; 3, Very satisfied)
24 hours post-procedure
Measurement of operative time
Tidsramme: Till closure of the skin (Up to 60 minutes).
Measurement of operative time was done from skin incision to closure.
Till closure of the skin (Up to 60 minutes).
Incidence of recurrence
Tidsramme: 6 months post-procedure
Incidence of recurrence of hernia was assessed during follow-up visits.
6 months post-procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. december 2024

Primær færdiggørelse (Faktiske)

1. oktober 2025

Studieafslutning (Faktiske)

1. oktober 2025

Datoer for studieregistrering

Først indsendt

27. juni 2026

Først indsendt, der opfyldte QC-kriterier

27. juni 2026

Først opslået (Faktiske)

2. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • MS-55-2025 (28-4-2025)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD-delingstidsramme

After the end of study for one year.

IPD-delingsadgangskriterier

The data will be available upon a reasonable request from the corresponding author.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

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