A multicenter prospective study of patients undergoing open ventral hernia repair with intraperitoneal positioning using the monofilament polyester composite ventral patch: interim results of the PANACEA study

Figures & data

Table 1 Patient demographics, comorbidities, and operative details, N = 126

Age (years)	51.2 ± 12.2
Gender
Female	39 (31.0)
Male	87 (69.0)
BMI, kg/m^2	27.6 ± 4.4
<30	83 (65.9)
≥30	43 (34.1)
Hernia type
Umbilical	110 (87.3)
Epigastric	16 (12.7)
Subjects with at least one risk factor	90 (71.4)
Smoker (current or prior)	54 (42.9)
Obesity (BMI ≥30 kg/m^2)	43 (34.1)
Diabetes type II	10 (7.9)
COPD	9 (7.1)
Stable disease	6 (66.7)
Chronic disease requiring analgesic consumption	2 (1.6)
Chronic disease requiring corticoid consumption	3 (2.4)
Other disease leading to increased abdominal pressure
Benign prostatic hypertrophy	1 (0.8)
Liver cirrhosis/ascites/liver transplantation	2 (1.6)
Mean hernia diameter, cm	1.8 ± 0.8
Overlap, cm
<1	1 (0.8)
1.0–1.9	43 (34.1)
2.0–2.9	71 (56.3)
3.0–4.0	11 (8.7)
Mean ± SD	2.2 ± 0.6
Operative time, min (n = 124)	36.2 ± 15.6
Mesh positioning time, min (n = 124)	8.1 ± 3.4
Hospital length of stay, days
Median	0.0
Min–max	0–2

Notes: Data are presented as n (%), mean ± standard deviation, min–max, or median. Overlap = (size of mesh - hernia diameter)/2.

Abbreviations: BMI, body mass index; COPD, chronic obstructive pulmonary disease; SD, standard deviation; min, minimum; max, maximum.

Figure 1 Patient follow-up visit completion.

Notes: The number of patients who successfully completed each visit is shown as n (%). Twelve (9.5%) patients withdrew early from the study. Early end-of-study reasons included: loss to follow-up (n = 4), adverse event (n = 1), withdrawal by subject (n = 6), and patient was unable to participate in follow-up visits (n = 1).

Table 2 Mesh size recommendations and recurrence

Mesh size, cm	Hernia diameter, cm
	<1	1.0–1.9	2.0–2.9	3.0–4.0
4.6 (N = 39)	8 (20.5)	22 (56.4)a	8 (20.5)	1 (2.6)
6.6 (N = 66)	3 (4.5)	39 (59.1)	18 (27.3)	6 (9.1)
8.6 (N = 21)	0 (0.0)	1 (4.8)	10 (47.6)a	10 (47.6)a

Notes: Data are presented as n (%). Bold text indicates that the recommended mesh size for the corresponding defect size was used.

a The subsets that include a patient who exhibited hernia recurrence.

Figure 2 NRS pain assessment.

Notes: Pain levels were classified based on NRS scores: 0 = no pain, 1–3 = mild pain, 4–6 = moderate pain, and 7–10 = severe pain. (A) Patient pain levels at baseline, discharge, day 10, 1-, 6-, and 12-months postoperative. (B) Mean pain levels reported through 12 months. Standard deviation is shown. *P < 0.001 relative to baseline.
Abbreviation: NRS, Numeric Rating Scale.

Figure 3 Patient satisfaction at 1-, 6-, and 12-months postoperative and last known satisfaction for each patient.

Table 3 Procedure- and device-related adverse events, N = 126

Procedural pain	16 (12.7%)
Wound infection	5 (4.0%)
Hernia recurrence	3 (2.4%)
Postoperative hematoma at the incision site	2 (1.6%)
Seroma	2 (1.6%)
Abdominal pain due to recurrence	1 (0.8%)
Constipation	1 (0.8%)
Fever	1 (0.8%)
Hemoglobin down versus standard	1 (0.8%)
Hypotension	1 (0.8%)
Nausea	1 (0.8%)
Occasional feeling of tightness at the operative site	1 (0.8%)
Serous drainage at the incision site	1 (0.8%)
Skin irritation	1 (0.8%)
Swelling of left cheek	1 (0.8%)
Puncture of small bowel	1 (0.8%)
Vaginal bleeding	1 (0.8%)