NCT04699201 Trocar Site Incisional Hernia Prevention
| NCT ID | NCT04699201 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Joan XXIII de Tarragona. |
| Condition | Incisional Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2021-03-02 |
| Primary Completion | 2024-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2021-03-02 with a primary completion date of 2024-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: To test the preventive effect of the placement of an onlay mesh versus the use of a fascial closure device at the umbilical trocar site closure in order to prevent incisional hernia after laparoscopic surgery. Methods: We designed a Two Center Randomized Controlled Trial were adult participants presenting for elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct will be recruited, with allocation of each of them in 2 groups (prosthesis and control). Abdominal ultrasound scan focused on aponeurosis defects at the trocar sites will be performed at 12 postoperative months. An ultrasound scan will be performed to avoid underdiagnosis bias since incisional hernia is frequently under detected by clinical examination. Relevance: The prevalence of incisional hernia after laparoscopy might be as high as 30%, due to this reason is paramount to find a better closure technique. There are few studies about incisional hernia including radiological exams in order to provide the exact prevalence of this pathology, even fewer literature exists about incisional hernia after laparoscopic procedures.
Eligibility Criteria
Inclusion Criteria: * Patients undergoing elective laparoscopic cholecystectomy, with or without an exploration of the common bile duct, undergoing surgery in our hospital * ASA (American Society of Anesthesiologists) \<IV Exclusion Criteria: * Allergy or intolerance to any of the mesh components * Patients presenting already primary or incisional hernia of the abdominal wall * ASA ≥IV * Intraoperative conversion to laparotomy * Emergency surgery * Pregnancy
Contact & Investigator
Carles Olona Casas, MD
STUDY DIRECTOR
Hospital Universitari de Tarragona
Frequently Asked Questions
Who can join the NCT04699201 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Incisional Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04699201 currently recruiting?
Yes, NCT04699201 is actively recruiting participants. Contact the research team at joanfs8@gmail.com for enrollment information.
Where is the NCT04699201 trial being conducted?
This trial is being conducted at Tarragona, Spain, Valls, Spain.
Who is sponsoring the NCT04699201 clinical trial?
NCT04699201 is sponsored by Hospital Universitari Joan XXIII de Tarragona.. The principal investigator is Carles Olona Casas, MD at Hospital Universitari de Tarragona. The trial plans to enroll 94 participants.