Suture Techniques to reduce the Incidence of The inCisional Hernia

Incisional hernia is the most common complication after abdominal surgery with
a reported incidence of up to 15% at 1 year follow-up. In The Netherlands,
100.000 laparotomies and 4000 incisional hernia repairs are performed annually.
The costs of hernia repair (4 kEuro) hence amount to over 16 million euro.
Moreover, many patients with incisional hernia are not re-operated due to
anticipated recurrence rates of 30-60%. The major factor for development of
incisional hernia is the surgical wound failure due to insufficient suture
techniques. The latter complication, which occurs in 1-4% of abdominal surgery,
involves bursting of the abdominal wound and the muscle layers, which causes
the intestines to protrude from the incision. It is associated with a high
incidence of surgical site infections, prolonged hospital stay and high
mortality rates.

Recent clinical and experimental data suggest that a relatively new technique
with many small tissue bites should be more effective in the prevention of
incisional hernia when compared to the standard large bite technique.
We propose a multicenter double blind RCT to compare the routinely used large
bite technique with the small bites technique.

Primary question
• Which bite size should be used to close a midline incision to prevent
incisional hernia?
Secondary questions
• Is there a difference in postoperative complications between the two patient
groups?
• Is there a difference in postoperative pain between the two patient groups?
• Is there a difference in postoperative quality of life between the two
patient groups?
• Is it cost-effective to use the small bites technique?

The trial will be a double blinded randomized controlled prospective trial, in
which the large bites technique will be compared with the small bites
technique. Patients will be preoperatively randomized in two groups to either
receive closure with the large tissue bites technique or with the small tissue
bites technique. Patients will be kept unaware of the procedure until the
endpoint of the trial. Surgeons or surgical residents and radiologists blinded
for the procedure will do outpatient clinic controls.

In one group of 288 patients the conventional large bites technique will be
applied with bites widths of 1 cm and inter suture spacing of 1 cm with the use
of slowly absorbable 1-0 double loop suture material with a 48 mm needle.
In the other group of 288 patients the small bites technique will be applied
with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of
slowly absorbable 2-0 single suture material with a 31 mm needle only in the
linea alba. In the small bites technique there will be twice as many stitches
with a smaller needle and thinner suture material. In the Swedish hospitals
where the small bites techniques has been used for many years, this combination
proved the easiest and safest method to handle the small bites technique.

Suture length wound length ratios of 4:1 are aimed at and will be calculated by
the nurse after closure of the abdominal wall. In case of a lower ratio that
4:1 the surgeon will be advised to consider closing the fasia again. The number
of stitched will be count by the nurse to control the bite size.

Both techniques are already applied in the clinic, so we expect a very small
change of an increased complication rate. In case of a lower ratio that 4:1 the
surgeon will be advised to consider closing the fasia again. The questionnaires
will probably not be a big burden. The outpatient clinic visit after 30 days
and 1 year can be combined with a regular outpatient visit. The abdominal wall
ultrasounds will take some extra time and a few extra burdens.