- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: marwa Saber, Resident
- Telefoonnummer: 01017659722
- E-mail: marwaelkholy93@gmail.com
Studie Locaties
-
-
-
Sohag, Egypte
- Werving
- Faculty of Medicine
-
Contact:
- marwa elkholy, Resident
- Telefoonnummer: 01017659722
- E-mail: marwaelkholy93@gmail.com
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Laparoscopic TAPP Repair
Patients with recurrent inguinal hernia who will undergo laparoscopic transabdominal preperitoneal (TAPP) repair using a synthetic mesh.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Feasibility and Technical Success of Laparoscopic TAPP
Tijdsspanne: During the intraoperative procedure (Day of surgery)
|
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.
|
During the intraoperative procedure (Day of surgery)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Post-operative Pain
Tijdsspanne: At 24 hours, 1 week, and 1 month post-operatively
|
Assessment of pain severity using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (worst possible pain).
|
At 24 hours, 1 week, and 1 month post-operatively
|
|
Hernia Recurrence
Tijdsspanne: 4 months
|
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.
|
4 months
|
|
Operative Time
Tijdsspanne: During the surgical procedure (Day of surgery)
|
The total duration of the surgical procedure calculated in minutes from the skin incision to the final closure
|
During the surgical procedure (Day of surgery)
|
|
Length of Hospital Stay
Tijdsspanne: From the day of surgery up to hospital discharge (typically 1-2 days)
|
The total number of hours or days from the end of the surgery until the patient is officially discharged from the hospital.
|
From the day of surgery up to hospital discharge (typically 1-2 days)
|
|
Incidence of Post-operative Complications
Tijdsspanne: Up to 4 months post-operatively
|
Detection of any early complications like seroma, hematoma, or wound infection.
|
Up to 4 months post-operatively
|
|
Incidence of Intraoperative Complications
Tijdsspanne: During the surgical procedure (Day of surgery)
|
The percentage of patients experiencing any surgical complications during the operation, such as urinary bladder injury, bowel injury, or major vascular bleeding
|
During the surgical procedure (Day of surgery)
|
|
Time to Return to Normal Daily Activities
Tijdsspanne: Up to 4 months post-operatively
|
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.
|
Up to 4 months post-operatively
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Soh-Med-26-5-3MS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .