- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: marwa Saber, Resident
- Telefonnummer: 01017659722
- E-post: marwaelkholy93@gmail.com
Studieorter
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Sohag, Egypten
- Rekrytering
- Faculty of Medicine
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Kontakt:
- marwa elkholy, Resident
- Telefonnummer: 01017659722
- E-post: marwaelkholy93@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Feasibility and Technical Success of Laparoscopic TAPP
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Post-operative Pain
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Soh-Med-26-5-3MS
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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