Prevention of Incisional Hernia in Emergency Surgery Clinical Trial
Official title:
Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.
| NCT number | NCT04578561 |
| Other study ID # | 20198240I |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 2010 |
| Est. completion date | January 2020 |
| Verified date | October 2020 |
| Source | Hospital del Mar |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.
| Status | Completed |
| Enrollment | 187 |
| Est. completion date | January 2020 |
| Est. primary completion date | January 2019 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Patients undergoing emergency midline laparotomy Exclusion Criteria: - Those with need of concomitant hernia repair. - Those who received incisions outside the midline. - Those with delayed abdominal closure. - Those who died in the immediate postoperative period. - Those without a minimum 2 years of follow-up. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| José A. Pereira |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incisional hernia | Detection of clinical or subclinical incisional hernia during postoperative longterm followup | 2 years |