- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07608653
Outcomes of Laparoscopic Keyhole Surgery (TAPP) for Recurrent Inguinal Hernia
Clinical Outcomes of Laparoscopic Transabdominal Preperitoneal (TAPP) Approach for Recurrent Inguinal Hernia
The goal of this clinical trial is to learn if a laparoscopic surgery called Transabdominal Preperitoneal (TAPP) repair is safe and works well for adults with a recurrent inguinal hernia (a groin hernia that has returned after a previous operation).
The main questions it aims to answer are:
Does the TAPP technique lower the number of complications after surgery? How well do participants recover during the early postoperative period and long-term follow-up? Fixing a hernia that has returned is hard because of old scar tissue. In this study, researchers will use the TAPP technique to work through a different layer of tissue to provide a stronger repair.
Participants will:
Undergo the TAPP laparoscopic surgery for their recurrent hernia. Visit the clinic for close health monitoring shortly after surgery. Complete regular follow-up checkups to track their long-term recovery.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: marwa Saber, Resident
- Telefonnummer: 01017659722
- E-mail: marwaelkholy93@gmail.com
Studiesteder
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Sohag, Egypten
- Rekruttering
- Faculty of medicine
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Kontakt:
- marwa elkholy, Resident
- Telefonnummer: 01017659722
- E-mail: marwaelkholy93@gmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adult patients. Patients diagnosed with recurrent inguinal hernia. Patients fit for general anesthesia. Patients who provide informed consent.
Exclusion Criteria:
- Non recurrent inguinal hernia Patients with complicated inguinal hernia. Patients unfit for general anesthesia. Patients refusing participation in the study.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Laparoscopic TAPP Repair
Patients with recurrent inguinal hernia who will undergo laparoscopic transabdominal preperitoneal (TAPP) repair using a synthetic mesh.
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The surgical procedure will be performed under general anesthesia.
Standard laparoscopic instruments will be used to access the peritoneal cavity.
The peritoneum over the recurrent inguinal hernia site will be incised to enter the preperitoneal space.
After reduction of the hernia sac and clearing of post-operative adhesions, a synthetic mesh will be placed to cover the hernia defects.
The mesh will be secured if necessary, and the peritoneal flap will be closed using sutures or tacks.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Feasibility and Technical Success of Laparoscopic TAPP
Tidsramme: During the intraoperative procedure (Day of surgery)
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Evaluation of the feasibility of the TAPP approach in recurrent inguinal hernias, measured by the rate of successful laparoscopic completion without the need for intraoperative conversion to open surgery due to severe scar tissue or adhesions.
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During the intraoperative procedure (Day of surgery)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Post-operative Pain
Tidsramme: At 24 hours, 1 week, and 1 month post-operatively
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Assessment of pain severity using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst possible pain).
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At 24 hours, 1 week, and 1 month post-operatively
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Hernia Recurrence
Tidsramme: 4 months
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The percentage of patients who experience another clinical return of the inguinal hernia after the TAPP repair.
Recurrence will be detected through physical examination during follow-up, and confirmed by groin ultrasound or CT scan if a hernia is clinically suspected.
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4 months
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Operative Time
Tidsramme: During the surgical procedure (Day of surgery)
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The total duration of the surgical procedure calculated in minutes from the skin incision to the final closure
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During the surgical procedure (Day of surgery)
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Length of Hospital Stay
Tidsramme: From the day of surgery up to hospital discharge (typically 1-2 days)
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The total number of hours or days from the end of the surgery until the patient is officially discharged from the hospital.
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From the day of surgery up to hospital discharge (typically 1-2 days)
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Incidence of Post-operative Complications
Tidsramme: Up to 4 months post-operatively
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Detection of any early complications like seroma, hematoma, or wound infection.
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Up to 4 months post-operatively
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Incidence of Intraoperative Complications
Tidsramme: During the surgical procedure (Day of surgery)
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The percentage of patients experiencing any surgical complications during the operation, such as urinary bladder injury, bowel injury, or major vascular bleeding
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During the surgical procedure (Day of surgery)
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Time to Return to Normal Daily Activities
Tidsramme: Up to 4 months post-operatively
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The total number of days taken by the patient to independently resume their baseline activities of daily living and return to light work/routine post-surgery.
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Up to 4 months post-operatively
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Soh-Med-26-5-3MS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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Kliniske forsøg med Recurrant Inguinal Hernia
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Sohag UniversityRekrutteringİnguinal HerniaEgypten
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Kahramanmaras Sutcu Imam UniversityAfsluttetİnguinal HerniaKalkun
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Sahar MughisSindh Institute of Urology and TransplantationAfsluttetSmerter, postoperativ | Komplikation, postoperativ | İnguinal HerniaPakistan
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Medipol UniversityIkke rekrutterer endnuPostoperative smerter | İnguinal HerniaTyrkiet (Türkiye)
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Adichunchanagiri Institute of Medical Sciences,...AfsluttetPostoperative komplikationer | Brok | Ventral brok | Infektion på det kirurgiske sted | Incisional brok | Mavevægsbrok | İnguinal HerniaIndien
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Cairo UniversityRekrutteringErector Spinae Plane Block | Pædiatrisk | Termografi | Forudsigelse | Infrarød | Ensidig inguinal brokkirurgiEgypten
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Ain Shams UniversityAfsluttetHoftehalvartroplastik | Perikapsular nervegruppeblok | Lateral femoral kutan nerveblok | Supra-inguinal Fascia Iliaca BlokEgypten
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Rigshospitalet, DenmarkAfsluttetVedvarende smerte efter inguinal herniotomiDanmark
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SB Istanbul Education and Research HospitalRekrutteringTotal knæarthroplastik | Adduktorkanalblok | Ultralydsguidet Supra-inguinal Fascia Iliaca BlockTyrkiet (Türkiye)
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CMR Surgical LtdDivision of General Oncologic and Minimally Invasive Surgery, Niguarda...Ikke rekrutterer endnuRobotassisteret Inguinal HernieoperationItalien
Kliniske forsøg med Laparoscopic Transabdominal Preperitoneal (TAPP) Repair
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Tepecik Training and Research HospitalAfsluttetPostoperativ smerte | LyskebrokKalkun
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Second Hospital of Jilin UniversityAfsluttet
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Larissa University HospitalUniversity of ThessalyAfsluttetPostoperativ smerteGrækenland
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Mansoura UniversityAfsluttet
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Bengt NovikUppsala University; Swedish Hernia Registry; Skaraborg Hospital Research...AfsluttetTilbagevenden | Brok | Brok, lyskebrok | Laparoskopi | Brok, lårben | Kirurgisk Mesh | Fikseringsanordning; Komplikationer | Kirurgiske procedurer, minimalt invasive | Kirurgiske hæftemaskiner
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GSVM Medical CollegeAktiv, ikke rekrutterende
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Cairo UniversityAfsluttet
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Umeå UniversityRegion Jämtland HärjedalenAfsluttetBrok, lyskebrok | Brok, lårben