- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: marwa Saber, Resident
- Phone Number: 01017659722
- Email: marwaelkholy93@gmail.com
Study Locations
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Sohag, Egypt
- Recruiting
- Faculty of medicine
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Contact:
- marwa elkholy, Resident
- Phone Number: 01017659722
- Email: marwaelkholy93@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility and Technical Success of Laparoscopic TAPP
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Post-operative Pain
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-26-5-3MS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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