Synthetic vs biologic mesh for the repair and prevention of parastomal hernia

Table 1 Patient demographics, study characteristics and critical appraisal of included studies

Ref.	Year	Inclusion period	Level of evidence	Mean age, years	Male (%)	Newcastle-Ottawa Scale			Cochrane risk of bias
Târcoveanu et al[44]	2014	2010-2011	1	NS	NS				?	?	-	-	+	-	?
Ventham et al[63]	2012	2003-2010	2	I: 69, C: 68	I: 42%, C: 35%	****	**	***
Hansson et al[8]	2013	2005-2010	3	63	35%	***		***
López-Cano et al[40]	2012	2007-2010	1	I: 72, C: 66	I: 58%, C: 42%				+	+	-	+	+	+	+
Hauters et al[16]	2012	2008-2010	3	69 (median)	40%	***		***
Fei et al[34]	2012	2008-2010	3	63	45%	***		***
Mizrahi et al[2]	2012	2005-2010	3	64	34%	***		***
Wara et al[5]	2011	1997-2008	3	62 (median)	50%	***		***
Janson et al[64]	2010	2003-2007	3	65	40%	***		**
Jänes et al[42]	2010	2003-2006	2	63	66%	****		**
Pastor et al[26]	2009	1999-2006	2	I: 60, C: 54	I: 42%, C: 54%	****	*	***
Lüning et al[65]	2009	1997-2006	3	65	27%	***		**
Serra-Aracil et al[6]	2009	2004-2006	1	I: 68, C: 67	I: 70%, C: 59%				?	+	-	+	+	+	-
Hansson et al[31]	2009	2002-2006	3	63	49%	***		***
Vijayasekar et al[45]	2008	2002-2007	3	61	52%	***		***
Jänes et al[43]	2009	2001-2003	1	I: 70, C: 71	I: 56%, C: 59%				?	+	-	-	+	+	-
Berger et al[35]	2009	2004-2008	3	69 (median)	NS	***		***
Muysoms et al[27]	2008	2001-2007	2	70	54%	****	*	***
Guzmán-Valdivia et al[32]	2008	NS	3	67	64%	***		**
Berger[39]	2008	2006-2007	3	72 (median)	64%	***		**
Craft et al[66]	2008	2004-2006	3	66	NS	***		***
Berger et al[7]	2007	1999-2006	3	70 (median)	39%	***		***
Mancini et al[29]	2007	2001-2005	3	60	44%	***		**
Marimuthu et al[46]	2006	2002-2005	3	67	44%	***		**
Gögenur et al[22]	2006	2003-2005	3	71 (median)	60%	***		**
van Sprundel et al[37]	2005	2000-2003	3	57	31%	***		***
de Ruiter et al[33]	2005	1988-2002	3	NS	NS	***		***
Longman et al[67]	2005	2000-2004	3	NS	NS	***		**
LeBlanc et al[28]	2005	NS	3	42-89	NS	***		***
Stelzner et al[36]	2004	1994-2002	3	70 (median)	60%	***		**
Steele et al[30]	2003	1988-2002	3	64	50%	***		***
Hofstetter et al[38]	1998	NS	3	NS	NS	***		***
Viermaa et al[23]	2015	2010-2013	1	I: 67	I: 51%				+	+	-	+	+	+	+
				C: 65	C: 54%
Asif et al[17]	2012	2004-2011	3	62	60%	***		**
Figel et al[62]	2012	2005-2008	3	63	67%	***		**
Smart et al[4]	2011	2007-2009	3	72 (median)	44%	***		*
Taner et al[25]	2009	2006-2007	3	NS	39%	***		**
Hammond et al[68]	2008	NS	1	I: 43, C: 50	I: 30%, C: 40%				?	+	-	-	+	+	?
Hammond et al[21]	2008	NS	3	NS	NS			*
Aycock et al[18]	2007	2004-2006	3	56	36%	***		**
Araujo et al[24]	2005		3	57	27%	***		***
Ellis et al[19]	2010	2004-2007	3	64	65%	***		***
Fleshman et al[20]	2014	2010-2012	1	I: 60, C: 59	I: 55%, C: 50%				+	+	-	+	+	+	-
Williams et al[41]	2015	2011-?	2	I: 49, C: 59	I: 27%, C: 45%	***		**

Level of evidence: 1: (Systematic reviews, meta-analyses) randomized controlled trials; 2: Two groups, non-randomized studies (e.g., cohort, case-control); 3: One group, non-randomized; 4: Descriptive studies that include analysis of outcomes; and 5: Case reports and expert opinion that include narrative reviews and consensus statements. NS: Not significant.

Table 2 Characteristics of synthetic and biologic prostheses used for parastomal hernia repair

Name	Material	Coating	Absorbable	Pore size	Weight
StomaMesh Surgipro Prolene Central ring enforced polypropylene	Polypropylene	None	No	Small to medium 0.8 mm or large 1.0-3.6 mm	Heavy weight or light weight
DUALMESH	Composite multifilament expanded polytetrafluoroethylene	None	No	Very small 3/22 µm	Heavy weight
Proceed	Polypropylene Encapsulated in polydioxanone	Oxidized regenerated cellulose	Partially 180 d and 28 d	Large	Light weight
Parietex	Composite multifilament Polyester/collagen	Type I collagen, polyethylene glycol, and glycerol layer	Partially 20 d	Large > 3 mm	Medium weight
ULTRAPRO	Composite monofilament Polypropylene	Poliglecaprone-25 (monocryl)	Partially 140 d	Large > 3 mm	Light weight
VICRYL	Multifilament polyglactin	None	Yes, 60-90 d	Small 0.4 mm	Medium weight
Vypro	Polypropylene	PG910	Partially 42 d	Large > 3 mm	Light weight
Composix Parastomal hernia patch	Polypropylene/expanded polytetrafluoroethylene	None	No	Medium 0.8 mm	Light weight
DynaMesh	Polypropylene	PVDF	Partially	Large 1-2 mm	Medium weight
Surgisis	Porcine small intestine submucosa	None
AlloDerm	Human acellular dermis	None
Permacol	Cross-linked acellular porcine collagen	Yes, hexamethylene diisocyanate
Peri-Guard	Bovine pericardium	Yes; glutaraldehyde
STRATTICE	Non-crosslinked porcine-derived acellular dermal matrix	None

Table 3 Study characteristics and outcomes of synthetic mesh and biologic mesh repair of parastomal hernia n (%)

Ref.	No. patients (completed follow-up)		Type of stoma	Material; technique	Recurrence of parastomal hernia1		Wound infection		Mesh infection	Other3		Mortality	Follow-up (mo)
	Mesh	No mesh			Mesh	No mesh	Mesh	No mesh	Mesh	Mesh	No mesh
Hansson et al[8]	61	-	C: 55 I: 4 U: 2	L: 55; IPOM: SB; ePTFE	4 (7)	-	1 (2)	-	1 (2)	21 (34)	-	12 (2)	26
Fei et al[34]	11	-	C: 6 I: 5	O: 11 Sublay: K; PP	1 (9)	-	0	-	NS	3 (27)	-	0	24
Mizrahi et al[2]	29 (28)	-	C: 18 I: 10 U: 1	L: 29 IPOM: K; ePTFE	13 (46)	-	NS	-	1 (4)	3 (11)	-	12 (4)	28
Wara et al[5]	72	-	C: 48 I: 24	L: 72 IPOM: K; PP+ePTFE	2 (3)	-	1 (1)	-	3 (4)	20 (28)	-	22 (3)	36
Pastor et al[26]	12	13	C: 10 I: 15	L: 12 O: 13 IPOM: K 3 SB: 7, lateral slit: 1 e-PTFE	4 (33)	7 (54)	2 (17)	2 (15)	0	1 (8)	0	0	14
Lüning et al[65]	15	-	C: 12 I: 3	O: 16 Onlay PP 7; PE 6; VICRYL 1; CRE-PPM 2	3 (20)	-	0	-	1 (7)	1 (7)	-	NS	33
Hansson et al[31]	55	-	C: 47 I: 5 U: 3	L 55 IPOM; K ePTFE	20 (36)	-	0	-	2 (4)	29 (53)	-	0	36 (median)
Berger et al[35]	47	-	NS	L: 46 O: 1 Sandwich PVDF-PP	1 (2)	-	1 (2)	-	NS	3 (6)	-	0	20 (median)
Muysoms et al[27]	24	-	C:20 I: 4	L: 24 IPOM K:11 non-slit SB 13 Parietex 11; DUALMESH 10; Composix 3	10 (42)	-	NS	-	NS	2 (8)	-	52 (21)	K: 31 SB: 14
Guzmán-Valdivia et al[32]	25	-	C:25	O: 25; Sublay PP	2 (8)	-	2 (8)	-	0	2 (8)	-	0	12
Craft et al[66]	21	-	C: 5 I: 7 U: 9	L: 21; IPOM K: 5 SB: 16 DUALMESH	1 (5)	-	1 (5)	-	2 (10)	8 (38)	-	0	14
Berger et al[7]	66	-	C:58 I:7 U:1	L: 66; IPOM SB: 41 Sandwich: 25 DUALMESH (until 4-2004) and Polyvinylidene	8 (12)	-	1 (2)	-	2 (3)	5 (8)	-	0	24 (median)
Mancini et al[29]	25	-	C: 15 I: 5 U: 6	L: 25; IPOM SB DUALMESH	1 (4)	-	1 (4)	-	1 (4)	3 (12)	-	12 (4)	19 (median)
van Sprundel et al[37]	16	-	C: 8 I: 5 U: 4	O: 16; IPOM K DUALMESH	1 (6)	-	0	-	0	5 (31)	-	0	29 (median)
de Ruiter et al[33]	46	-	C: 46	O: 46 Onlay CRE-PPM	7 (15)	-	0	-	3 (7)	2 (4)	-	0	51
Longman et al[67]	10	-	C: 7 I: 3	O: 10 Sublay K PP	0	-	0	-	0	1 (10)	-	0	30 (median)
LeBlanc et al[28]	12	-	C: 8 I: 2 U: 2	L: 12 IPOM SB 7, K 5 e-PTFE	1 (8)	-	0	-	0	2 (17)	-	12 (8)	20
Stelzner et al[36]	20 (19)	-	C: 20	O: 20 IPOM SB e-PTFE	3 (16)	-	1 (5)	-	0	3 (16)	-	0	42
Steele et al[30]	58	-	C: 31 I: 27	O: 58 Onlay “Stove pipe hat” PP	15 (26)	-	2 (3)	-	0	9 (16)	-	0	51
Hofstetter et al[38]	13	-	C: 13	O: 13 IPOM K e-PTFE	0	-	0	-	0	0	-	0	NS
Asif et al[17]	33		C: 12 I: 21	L: 33 SB:14 K:19 DUALMESH	11 (33)4	-	4 (12)		0	9 (27)		0	SB: 7 K: 36
Weighted pooled % (95%CI)					15.1% (9.7-21.6)		2.8% (1.6-4.4)		3,1% (1.8-4.6) FE	17,8% (12.0-24.4)		1.9 (0.9-3.2)
Smart et al[4]	27	-	C: 20 I:7	O: 20 Onlay: K; Permacol	15 (55)	-	1 (4)	-	0	0	-	12 (4)	17
Taner et al[25]	13	-	NS	O: 13 Overlay + Underlay (sandwich) AlloDerm	2 (15)	-	1 (8)	-	0	4 (31%)	-	0	10
Aycock et al[18]	11	-	C:2 I:9	O: 11 Inlay 8; Onlay 3; AlloDerm	3 (27)	-	2 (18)	-	NS	1 (9)	-	0	9
Araujo et al[24]	13	-	C: 13	O: 13 Onlay; Peri-Guard	1 (8)	-	0	-	NS	NS	-	0	50
Ellis[19]	20	-	C: 17 I: 3	O: 20 IPOM; SB; Surgisis	2 (10)	-	0	-	0	4 (20)	-	0	18
Weighted pooled % (95%CI)					24% (8.6-44.1)		5.6% (1.4-12.1)		0% (0-5.4) FE	13.4% (1.9-32.7)		2.6% (0.3-6.9) FE

Synthetic mesh repair:

¹With regard to lost after follow-up;

²Unrelated to mesh;

³Seroma 41 (48, 74, 121, 149, 171, 178, 201, 257); Cardiopulmonary 11 (48, 121, 171, 203, 487); Urinary tract infection 1 (243); Cutaneous/ fascial dehiscence 1 (252); Stoma complication 8 (121, 243, 245, 285); Ileus 13 (48, 87, 171, 212, 272); Post-operative bleeding 5 (48, 121, 171); Haematoma 6 (74, 171); Bowel stenosis 19 (121, 161, 178, 203, 207, 243, 272, 285, 487); Fistula formation 2 (285); Renal failure 4 (179, 203); Peritonitis 3 (121, 171); Other 18 (87, 171, 203, 207, 212, 243, 257, 272, 487);

⁴All keyhole. Biologic mesh repair: ¹With regard to lost after follow-up; ²Unrelated to mesh; ³Complications other: Seroma 6 (165, 429), Incisional separation 2 (165), Epidural infection 1 (242). FE: Fixed-effect model. L: Laparoscopic; O: Open; C: Colostomy; I: Ileostomy; SB: Sugarbaker; K: Keyhole PP: Polypropylene mesh; IPOM: Intraperitoneal mesh; PCM: Parietex composite mesh; ePTFE: Expanded polytetrafluoroethylene; CRE-PPM: Central ring enforced polypropylene mesh; PP + ePTFE: Polypropylene-based mesh covered with ePTFE.

Table 4 Summary of pooled proportions of outcome measures of biologic mesh repair vs synthetic mesh repair

Hernia repair	No of studies	No of mesh repairs	Recurrence	Complications
				Wound infection	Mesh infection	Other
Biologic mesh	5	84	24% (8.6-44.1)	5.6% (1.4-12.1)	0% (0-5.4) FE	13.4% (1.9-32.7)
Synthetic mesh	21	669	15.1% (9.7-21.6)	2.8% (1.6-4.4)	3.1% (1.8-4.6) FE	17.8% (12.0-24.4)
P value			0.01	0.32	0.39	0.15

Two-tailed Fisher’s exact test was used because of too small frequencies. FE: Fixed-effect model.

Table 5 Summary of pooled proportions of outcome measures of open synthetic mesh repair vs laparoscopic synthetic mesh repair

Hernia repair	No. of studies	No. of mesh repairs	Recurrence	Complications
				Wound infection	Mesh infection	Other
Open repair	9	213	13.5% (8.1-20.2)	3% (1.2-5.7) FE	2.3% (0.7-4.8) FE	12.8% (7.4-19.4)
Laparoscopic repair	10	397	18% (8.9-29.5)	2.4% (0.804.8) FE	3.6% (1.9-5.7) FE	23.8% (14.5-34.6)
P value			0.37	0.79	0.5	≤ 0.0001

FE: Fixed-effect model.

Table 6 Study characteristics and outcomes of prophylactic mesh placement of parastomal hernia n (%)

Ref.	No. Patients (completed follow-up)		Type of stoma	Material; technique	Parastomal hernia1		Wound infection		Mesh infection	Other3		Mor-tality	Follow-up (mo)
	Mesh	No mesh			Mesh	No mesh	Mesh	No mesh	Mesh	Mesh	No mesh
Târcoveanu et al[44]	20	22	C: 42	O: 42; Sublay; PP	0	6 (27)	0	2 (9)	0	9 (45)	11 (50)	0	9 (median)
Ventham et al[63]	17	24	C: 42	O: 42; Sublay; PP	6 (35)	13 (54)	2 (12%)	1 (4)	NS	0	0	0	12
López-Cano et al[40]	19 (18)	17 (16)	C: 36	L: 36; IPOM; SB; Proceed	9 (50)	15 (94)	8 (44)	3 (19)	0	16 (89)	5 (31)	12 (3)	12
Hauters et al[16]	20	-	C: 20	L: 17 O: 3; IPOM; SB: 20; PCM	1 (5)	-	0	-	0	6 (30)	-	0	24
Figel et al[62]	16	-	C: 16	O: 16; IPOM; SB: 12; K: 4; Surgisis	0	-	0	-	0	NS	-	0	38 (median)
Janson et al[64]	25	-	C: 25	L: 25; Sublay; ULTRAPRO	3 (15)	-	2 (8)	-	0	1 (4)	-	0	19
Jänes et al[42]	75 (61)	18 (12)	C: 79 I: 14	O: 93; Sublay; ULTRAPRO	8 (13)	8 (67)	6 (8)	4 (22)	0	0	0	52 (5)	15
Serra-Aracil et al[6]	27	27	C: 54	O: 54; Sublay; ULTRAPRO	6 (22)	12 (44)	4 (15)	4 (15)	0	1 (4)	1 (4)	0	29
Vijayasekar et al[45]	42	-	C: 33 I: 9	O: 42; Sublay; PP	4 (10)	-	1 (2)	-	0	1 (2)	-	0	31
Jänes et al[43]	27 (15)	27 (21)	C:54	O: 54; Sublay; Vypro	2 (13)	17 (81)	0	0	0	0	0	0	65
Hammond et al[68]	10	10	NS	O: 20; Sublay; Permacol	0	3 (30)	0	0	0	0	0	0	6.5
Hammond et al[21]	15	-	NS	O: 15; Onlay: 6; Sublay 9; Permacol	1 (7)	-	NS	-	NS	NS	-	0	7 (median)
Berger[39]	25 (24)	-	C: 24 I: 1	L: 6, O: 19; IPOM; K; DynaMesh	0	-	0	-	0	0	-	12 (4)	11
Marimuthu et al[46]	18	-	NS	O: 18; Sublay; Surgipro	0	-	1 (6)	-	0	1 (6)	-	0	16
Gögenur et al[22]	25 (24)	-	C: 25	O: 25; Sublay; StomaMesh	2 (8)	-	4 (17)	-	0	6 (25)	-	12 (4)	12
Vierimaa et al[23]	42 (35)	41 (32)	C: 83	L: 83; IPOM; K; DynaMesh	5 (14)	12 (38)	1 (3)	2 (6)	NS	9 (21)	10 (24)	12 (1)	12
Fleshman et al[20]	55 (49)	58 (53)	C: I:23/ C:35 I: I:19/ C:36	O: 113; Sublay; STRATTICE	6 (12)	7 (136)	2 (4)	3 (6)	0	21 (38)	30 (52)	112 (10)	24
Williams et al[41]	22 (21)	11	C: I:4/ C:7 I: I:11/ C:11	I: O = 18 L = 4 C: O = 11 SMART Onlay; Permacol	4 (19)	8 (73)	NS	NS	0	2 (9)	0	12 (3)	I: 18 C: 9
Weighted pooled %; (95%CI)					11.5% (7.1-16.8)	51.5% (33.7-69.1)	6.90% (3.6-11.1)	9.30% (4.8-15.1)	0% (0-2.0) FE	14.20% (5.5-26.0)	13.80% (3.0-30.7)	2.6% (1.3-4.4)

¹With regard to lost after follow-up;

²Unrelated to mesh;

³Seroma 9 (10); Cardiopulmonary event 6 (10, 436); Urinary tract infection 7 (10, 436); Cutaneous/fascial dehiscence 5 (53, 231,436); Stoma (mucosal/intestinal) necrosis 16 (53, 126, 163, 173, 227,436); Intra-abdominal/pelvic infection 2 (436, 489); Intestinal occlusion 4 (436,489); Stoma-related problems 2 (436); Other 27 (10, 53, 54, 231); Severe events not further specified 51 (488). L: Laparoscopic; O: Open; C: Colostomy; I: Ileostomy; SB: Sugarbaker; PP: Polypropylene mesh; IPOM: Intraperitoneal mesh; PCM: Parietex composite mesh; SMART: Stapled mesh stoma reinforcement technique.