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Slow rate of enrollment . Additionally it was observed during the course of the trial that changes to the standard of care pain management protocols at some of the institutions, which are not aligned with the study protocol requirements
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The study aims to evaluate outcomes relating to pain and QOL after robotic-assisted or laparoscopic non-complex ventral hernia repair.
This is a prospective, observational, study across robotic-assisted and laparoscopic primary (non-recurrent) umbilical and incisional hernia repair. The study aims to evaluate pain and QOL outcomes through 30 days. During the post-operative period through 30 days, pain medication intake, subject reported pain and quality of life and incidence of intra-operative and post-operative adverse events related to the ventral hernia repair will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic ventral hernia repair | These subjects will undergo a laparoscopic primary umbilical or incisional hernia repair. | ||
| Robotic-assisted ventral hernia repair | These subjects will undergo a robotic-assisted primary umbilical or incisional hernia repair. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| robotic-assisted ventral hernia repair | Procedure | Laparoscopic ventral hernia repair With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care. Robotic-assisted ventral hernia repair With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain score assessed by the PROMIS 3a from baseline to 14 days | Change in patient reported pain scores assessed by the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity 3a survey, with a scale from 1-5; 1 meaning no pain and 5 meaning severe pain. | 14 days |
| Change in narcotic usage from 1 day post-procedure to 14 days post-procedure | Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log. | 14 days |
| Change in pain score assessed by the NRS from baseline to 14 days | Change in patient reported pain scores assessed by the Numeric Rating Scale (NRS) from 1-10, where 0 indicates no pain and 10 indicates the worst pain imaginable. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change in narcotic usage from 1 day post-procedure to 30 days post-procedure | Narcotic usage after the ventral hernia repair as determined through use of a patient reported pain medication log. | 30 days |
| Change in OTC pain medication usage from 1 day post-procedure to 30 days post-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who will undergo an elective non-complex ventral hernia repair procedure and who meet all eligibility criteria will be considered for enrollment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Surgical Specialists | Phoenix | Arizona | 85027 | United States |
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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Over the counter (OTC) pain medication usage after the ventral hernia repair as determined through use of a patient reported pain medication log. |
| 30 days |
| Need for refill prescription pain medication usage from 1 day post-procedure to 30 days post-procedure | Need for refill narcotic prescription pain medication usage | 30 days |
| Change in Quality of Life assessment: EQ-5D-3L (EQ) from baseline to 14 days | Quality of life assessment using the EQ-5D-3L (EQ) assessment tool, with scores on individual questions ranging from no problems to extreme problems, with a scale of health ranging from 0 (the worst health you can imagine) to 100 (the best health you can imagine) | 14 days |
| Change in Quality of Life assessment: EuraHS-QOL from baseline to 30 days | Quality of life using the EuraHS-QOL assessment tool, with scores on questions relating to pain, restrictions of movement, and cosmetic discomfort; with a scale ranging from 0 (no pain/no restriction/very beautiful) to 10 (worst pain/completely restricted/extremely ugly). | 30 days |
| Length of hospital stay (LOS) | How long the patient was admitted to the hospital | Procedure start time to discharge from the hospital (check out time), up to an approximate of one week |
| Incidence of intraoperative adverse events related to the ventral hernia repair | Intraoperative adverse events related to the ventral hernia repair | Intraoperative |
| Incidence of postoperative adverse events related to the ventral hernia repair through 30 days post-procedure | Post-operative adverse events related to the ventral hernia repair | 30 days |