Study reference

Study

characteristic s

Patient characteristics 2

Intervention (I)

Comparison / control

(C) 3

Follow-up

Outcome measures and effect size 4

Comments

Jin, 2007

Type of study: Retrospective cohort study (Database)

Setting: University Hospitals Case Medical Center

Country: USA

Source of funding:

Not reported

Inclusion criteria: all patients undergoing abdominal wall reconstructions with acellular human dermal matrix from January 2004 to

December 2005 at the University Hospitals Case Medical Center.

Exclusion criteria: NR

N total at baseline: Intervention: 11

Control: 26

Important prognostic factors2:

Sex (%male): Intervention: 4/11

(36%)

The bridged group had HAD placed as an intraperitoneal interposition graft using interrupted transfascial mattress sutures providing a single layer repair from the edges of the fascia under tension with variable underlay. The exact amount of underlay was often not reported in the operative note. In discussions with each of the surgeons, most reported between 2 cm and 4 cm of underlay as their standard practice.

The reinforced group placed the graft using an onlay, underlay, or sandwich technique after primary fascial reapproximation. In the onlay repair, the prosthetic was secured with a running suture to the anterior fascia. With the sandwich repair, HAD was first placed intraperitoneally as an underlay with a 3- to

5-cm overlap, using interrupted transfascial mattress sutures. The midline fascia was then reapproximated primarily and an onlay sheet of HAD was secured with a running suture with 3 to 5 cm of overlap.

Length of follow-up:

22.2 months (range 15 to 37 months).

Loss-to-follow-up: Intervention: 1 (died)

Control: 6 (2 patients died; 4 patients were lost to follow up)

Incomplete outcome data:

Not reported

Recurrence N (%)

I: 7 (80%)

C: 4 (20%)

P= 0.009

Complications were not reported

The authors report to meadure outcomes on postoperative complications, wound complications requiring any intervention including antibiotics or debridement, length of followup, hernia recurrence, and the type of subsequent reoperation for repair if necessary.

The publication only reports recurrence.

Control: 9/26 (35%)

Groups seemed to be comparable on reported outcomes (gender, BMI, ASA score, albumin, previous abdominal operation. Since there was no randomization treatment was chosen on patient

characteristics

Holihan, 2016

Type of study:

A

multicenter, retrospective database

Setting: different institutions identifying (unknown how many and which institutions)

Country: USA

Inclusion criteria:

• open VHR
• mesh reinforcement;
• defect size ≥8 cm width or loss of domain
• a bridged repair, CS, or both, and
• follow-up of at least 1 month.

Exclusion criteria: NR

N total at baseline: Intervention: 84

Control: 24

Describe intervention (treatment/procedure/ test):

Patients undergoing ventral hernia repair (VHR) with component separation (CS) with primary fascial closure and mesh reinforcement

(PFC-CS).

Describe control (treatment/procedure

/test):

Patients undergoing ventral hernia repair (VHR) with a bridging repair (mesh spanning the hernia defect).

Length of follow-up: Minimum follow-up was 1 month. Mean follow- up was not reported.

Loss-to-follow-up: Not mentioned

Incomplete outcome data:

Not mentioned

Outcome measures and effect size (include 95%CI and p-value if available):

Recurrence N (%) I: 14 (16.7%)

C: 6 (25.0%)

P= 0.354

SSI

I: 16 (19.0%)

C: 7 (29.2%)

P= 0.286

Major SSI I: 4 (4.8%)

C: 4 (16.7%)

P=0.050

Het is niet bekend hoeveel en welke instituten participeerden

Source of

Important

funding:

prognostic

SSO

Not reported

factors2:

I: 22 (26.2%)

C: 11 (45.8 %)

Sex:

P= 0.065

41,2% M

Groups were

comparable at

baseline, except

for BMI, gender,

ethnicity and

whether the case

was an

emergency.

Booth, 2013

Type of study:

A

retrospective cohort

Setting: The

University of Texas MD Anderson Cancer Center Country: USA

Source of funding:

Inclusion criteria: Patients who underwent abdominal wall reconstruction (AWR) between 2000 and 2011.

Exclusion criteria:

• patients with defects that did not involve the midline
• primary closure of abdominal

wall fascia without mesh

• onlay mesh reconstructions
• defects bridged

with the fascia from free or

Describe intervention (treatment/procedure/ test):

Patients undergoing abdominal wall reconstruction with mesh-reinforced primary fascial closure.

with component separation (CS) with primary fascial closure and mesh reinforcement

(PFC-CS).

Describe control (treatment/procedure

/test):

Patients undergoing abdominal wall reconstruction with a bridged fascial closure with mesh.

Length of follow-up: Minimum follow-up was 1 year. Mean follow-up was 31.1±14,2 months.

Loss-to-follow-up: Not mentioned

Incomplete outcome data:

Not mentioned

Outcome measures and effect size (include 95%CI and p-value if available):

Recurrence N (%) I: 7.7%

C: 55.6%

P< 0.001

Multivariate analyses: HR 7.3, p<0.001

Overall complications I: 32.3%

C: 74.1% OR=6.0, p<0.001

Seroma

I: 6 (3.1%)

C: 3 (11.1%) P=0.082

Authors recommentadion: we recommend that surgeons strive to

obtain a mesh-reinforced primary fascial closure and

avoid bridged repairs where possible.

regional musculo- cutaneous or fasciocutaneous flaps, defects reconstructed with autologous fascial grafts

- < 1 year of postoperative follow-up

N total at baseline: Intervention: 195

Control: 27

Important prognostic factors2: Age:

I: 58.7±12.9

C: 56.6±13.6

Sex:

I: 47.7%M C: 51.9%M

Groups were comparable at

baseline.

Wennergre n, 2015

Type of study:

A

multicenter, retrospective database

Inclusion criteria: Patients who had undergone ventral hernia repairs from January of 2010 through

Describe intervention (treatment/procedure/ test):

Patients undergoing LVHR with closure of the primary fascial

Describe control (treatment/procedure

/test):

Patients undergoing laparoscopic ventral hernia repair (LVHR)

Length of follow-up: mean follow-up was 17,5 months

Loss-to-follow-up: Not mentioned

Outcome measures and effect size (include 95%CI and p-value if available):

Recurrence N (%)

Het is niet bekend welke instituten participeerden

Setting: seven different institutions identifying (unknown which institutions)

Country: USA

Source of funding:

December of 2012.

Exclusion criteria: Patients who underwent open ventral hernia repairs, those undergoing laparoscopic converted to open ventral hernia repairs, those patients who had undergone laparoscopic hernia repair without the use of mesh, those with CDC wound class 2–4, those undergoing concomitant surgical procedures and/or concomitant component separation as well as those with <1- month follow-up time.

N total at baseline: Intervention: 97

Control: 99

defect and placement of intraperitoneal mesh for reinforcement of the closure. Closure of the defects was left to the discretion of the operating surgeon.

with placement of intraperitoneal mesh without closure of the fascial defect effectively leading to a bridged repair.

Incomplete outcome data:

Not mentioned

I: 19 (19.6 %)

C: 18 (18.2 %)

P= 0.801

SSI

I: 20 (20.6 %)

C: 24 (24.2 %)

P= 0.543

Deep/organ space SSI I: 6 (6.2 %)

C: 11 (11.1 %) P=0.221

Readmission I: 22 (22.7 %)

C: 18 (18.2 %)

P= 0.435

Reoperation I: 13 (13.4 %)

C: 9 (9.1 %)

P= 0.339

Seroma

I: 8 (8.3 %)

C: 14 (14.1 %)

P= 0.191

Important prognostic factors2:

Sex:

I: 46 % M C: 57% M

Groups were comparable at

baseline

Richmond,

Type of

Inclusion criteria:

Describe intervention

Describe control

Length of follow-up:

Outcome measures and

2014

study:

identified using

(treatment/procedure/

(treatment/procedure

effect size (include

Retrospective

CPT codes of

test):

/test):

Mean follow-up was 33.1

95%CI and p-value if

analysis

primary ventral

months.

available):

Setting:

hernia (49560),

Component

Conventional bridged

strangulated

separationwith

VHR using synthetic or

Loss-to-follow-up:

Postoperative Wound

ventral hernia

noncrosslinked PADM

biological mesh;

Not mentioned

Complications N (%)

(49561), and

(Strattice; Lifecell,

Incomplete outcome

Charleston

recurrent ventral

Branchburg, NJ)

For the conventional

data:

Fistula

Area Medical

hernia (49565)

reinforcement

bridged VHR group, all

All data were complete

I: 1 (3%)

Center,

combined with

(CS/PADM).

patients underwent

C: 1 (3%)

virginia

the implantation

placement of an intra-

Hernia recurrence (N)

P=1.00

of mesh (49568).

The operative

abdominal underlay

C: N= 2

Country:

For the CS group,

technique for the CS

with a minimum fascial

I: N=0

Wound

USA

these codes were

group involved the

overlap of 5 cm. The

dehiscence/necrosis,

used as was the

development of

prosthesis, the choice

seroma, or hematoma

Source of

additional code

subcutaneous flaps and

of which was left to

I: 12 (30%)

funding:

15734 for trunk,

the performance of an

the operating surgeon,

C: 5 (13%)

Not

open-component

anterior external

was secured with

P= 0.10

mentioned

separation repair

oblique release as

circumferential non-

described by Ramirez

absorbable mattress

Surgical site infection

Exclusion criteria:

et al.9 After the release

sutures placed 2 cm

I: 7 (18%)

Patients who

was performed, a piece

apart. The fascia was

C: 6 (15%)

underwent

of PADM was placed

not reapproximated

P: 1.00

laparoscopic VHR,

intra-abdominally as an

over the mesh. Drains

nonmidline VHR,

underlay with a

were placed and

Mesh infection

or umbilical or

minimum fascial

maintained until the

I: 0 (0%)

inguinal hernia

overlap of 5 cm and

daily output was less

C: 9 (23%)

repair.

secured with non-

than 30 ml.

P= 0.002

absorbable mattress

N total at

sutures placed 2 cm

VHR failure: recurrence

baseline:

apart. The fascia was

or complication requiring

Intervention: 40

then approximated in

reoperation N (%)

Control: 40

the midline using a

I: 7 (17.5%)

running non-

C: 21 (52.5%)

Important

absorbable suture,

P= 0.002

prognostic

drains were placed,

factors2:

and the skin edges

Hernia recurrence N (%)

For example

were trimmed 3 to 5

I: 5 (13.2%)

age ± SD:

cm and closed. Drains

C: 15 (37.5%)

I: 59.0 ± 10.7

were maintained until

P= 0.02

C: 54.8 ± 11.6

the daily output was

less than 30 ml.

Sex:

I: % M

C: % M

Groups were

comparable at

baseline

Zeichen, 2013

Type of study: Retrospective analysis of two patient populations

Setting: Retrospective review of patients who underwent

Inclusion criteria:

Exclusion criteria:

N total at baseline: Intervention: 93 Control:35

Important prognostic factors2:

For example

Describe intervention (treatment/procedure/ test):

.

was similar to the technique described above for non-closure. The only difference was that we performed a primary approximation of the

fascial edges of the

Describe control (treatment/procedure

/test):

It

Repair with mesh alone

(non-closure group) Hernia defect closure

Length of follow-up:

1 week, 3 months, 1 year, and thereafter as clinically indicated.

Loss-to-follow-up: Complete current follow- up was achieved in 105 patients (82.03 %, 73 patients of non-closure group and 32 of closure

group) with a mean of

Outcome measures and effect size (include 95%CI and p-value if available):

Recurrence rate N (%) I: 2 (6.25) 0

C: 14 (19.18)

Not significant

Niet

laparoscopic ventral hernia repair for small- and mediumsized hernias between July 2000 and September 2011.

Country:

Source of funding:

Mean age (range): I: 63.08 (26–91)

C: 63.43 (27–80)

Sex:

I: 41 % M C: 43 % M

Groups were comparable at baseline.

hernia defect with polyester sutures (Ethibond excel, Ethicon, Johnson & Johnson) prior to mesh placement using one of three techniques. The hernia defect was closed percutaneously using a suture-passer as has been described. Intracorporeal defect closure was performed using (2) a needle and standard laparoscopic needle drivers or (3) an Endo StitchTM (Covidien) suturing device. Several interrupted figures of eight sutures were placed, and then, tied with a knot pusher.

After closing the defect primarily, an appropriately sized mesh was tailored to overlap all margins of the defect by 3–5 cm.

and mesh reinforcement (closure group).

The patient was placed on the table in the supine position. After adequate general anesthesia was obtained, the abdomen was prepped and draped in the usual sterile manner. Pneumoperitoneum was established by veress needle when possible or open ‘‘Hasson’’ technique when surgical scars present. The position of the trocars varied depending on the size, location and number of existing hernia defects. In general, two 5-mm and one 12- mm trocars were placed along the left lateral abdomen as shown. Adhesions to the anterior abdominal wall surrounding the hernia were lysed and the hernia contents reduced. The peritoneal sac is left in situ. After completion

of the dissection, the

797.20 days (range 7– 3,286 days)

hernia defect was measured, and a mesh chosen to overlap all margins of the defect by at least 3–5 cm. For larger hernias, 0- prolene stay sutures were placed at four corners of the mesh and retrieved individually with a suture passer to provide fascial fixation. The mesh was placed through the 12-mm trocar and inserted into the abdominal cavity. A centering stitch was used in most of the cases; the mesh was serially fixed to the abdominal wall circumferentially at 1- cm intervals with the hernia tacker. A second crown of tacks was placed and additional tacks were placed as necessary.

The trocars were removed under direct vision. In several cases, the 12-mm trocar was placed through the skin at the defect for mesh introduction.

These sites were

covered by mesh and, therefore, were not routinely closed. The fascia for any exposed 12-mm port site was routinely closed with 0-Vicryl suture; skin incisions were closed

in subcuticular fashion

Study reference

(first author, year of publication)

Bias due to a non-representative or ill-defined sample of patients?1

(unlikely/likely/unclear)

Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?2

(unlikely/likely/unclear)

Bias due to ill-defined or inadequately measured outcome

?3

(unlikely/likely/unclear)

Bias due to inadequate adjustment for all important prognostic factors?4

(unlikely/likely/unclear)

Wennergren et

al., 2015

Likely

Likely

Unlikely

unclear

Richmond et al.,

2014

Likely

Likely

Unlikely

unclear

Zeichen et al., 2013

Likely

Likely

Unlikely

unclear

Holihan, 2016

Likely

Likely

Unlikely

Likely

Booth. 2013

Likely

Likely

Unlikely

Likely

Jin, 2007

Likely

Not likely

Likely

Likely