Hernia reduction following laparotomy using small stitch abdominal wall closure with and without mesh augmentation (the HULC trial): study protocol for a randomized controlled trial

Table 2 Timetable of the trial according to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines [29]

Activity	Visit 1 (screening)	Visit 2 (surgery, randomization)	Visits 3–5 (PODs 5–7, 10–14, 30–35)	Visits 6–8 (postoperative months 6, 12, 24)
Inclusion/exclusion criteria	X
Informed consent	X
Medical history	X
Clinical examination	X		X	X
Surgery		X
Randomization		X
Incisional hernia assessment^a				X
Assessment of SSI^b			X	X (not at 24 months)^f
Assessment of postoperative morbidity^c			X
Assessment of non-infectious wound complications			X	X
Assessment of burst abdomen			X
Quality of life assessment^d	X			X
Length of hospital stay			X
Assessment of wound pain^e			X
Assessment of re-operations			X	X
Assessment of SAE		X	X	X

POD postoperative day, SAE serious adverse event, SSI surgical site infection
^aVia blinded assessor: clinical and radiologic assessment
^bVia blinded assessor according to CDC Definition [25]
^cAccording to Dindo-Clavien
^dAccording to SF-36 and EQ-5D questionnaires
^eUsing a numeric pain rating scale (NRS 1–10)
^fAs defined by the Centers for Disease Control CDC: “follow-up should be 30 days after the operation if no implant is left in place or 1 year if implant is in place” [25]

ISSN: 1745-6215