Hernia, Ventral Clinical Trial
Official title:
Less Postoperative Pain and Length of Stay After Robotic-assisted Laparoscopic Transabdominal Repair With Retro Rectus Mesh Placement (rTARUP) Compared With Laparoscopic Intraperitoneal Onlay Mesh Repair (IPOM) for Small and Medium-sized Ventral Hernias
| NCT number | NCT05320055 |
| Other study ID # | IPOM vs TARUP |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 1, 2021 |
| Est. completion date | October 1, 2021 |
| Verified date | August 2023 |
| Source | Bispebjerg Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Comparison of results after rTARUP and lap IPOM in patients with small- and medium-sized ventral hernia. Retrospective cohort study of consecutive patients undergoing rTARUP or IPOM repair for small or medium-sized primary ventral and incisional hernias. The primary outcome was the postoperative need for transverse abdominis plane (TAP) block or epidural catheter, secondary outcomes were 30-day complications, and length of stay. All patients underwent elective surgery and were followed for 30 days postoperatively.
| Status | Completed |
| Enrollment | 59 |
| Est. completion date | October 1, 2021 |
| Est. primary completion date | September 1, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | Inclusion Criteria: - all patients undergoing elective minimally invasive repair for small or medium-sized primary ventral or incisional hernia repairs at one academic hernia center with an unrestricted patient referral. Consecutive patients undergoing IPOM (December 1st, 2017 - December 1st, 2018) and rTARUPrRetrorectus (March 1st, 2021 - June 1st, 2021). Exclusion Criteria: - open repairs |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Bispebjerg Hospital | Copenhagen |
| Lead Sponsor | Collaborator |
|---|---|
| Bispebjerg Hospital |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | epidural blockade or TAP block | postoperative pain requiring epidural or TAP block | 0-1 postoperative day | |
| Secondary | readmissison | if the patients get readmitted during the follow-up | 30 days | |
| Secondary | complications | if the patients get any medical or surgical complication during the follow-up | 30 days |
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