An interventional study of robotic and hybrid in Pain, Quality of Life and Recurrence, sponsored by Kuopio University Hospital. Recruiting at 1 site in Finland. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-10.
Sponsored by Kuopio University Hospital · Not applicable, Interventional, and Treatment
Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).
Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Kuopio University Hospital is the lead sponsor of 135 studies on the registry; 24 are open to participants now.
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Exclusion Criteria:
Fifteen patients undergo rVHR operation.
Device: robotic
Fifteen patients undergo hybrid operation.
Device: hybrid
fifteen patients undergo robotic operation
fifteen patients undergo hybrid operation
Robotic-assisted ventral hernia repair vs hybrid. Change in pain
VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain
Time frame: 1-year
Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.
SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome
Time frame: 1-year
Plan to share: No
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