Double-blind randomized controlled trial of collagen mesh for the prevention of abdominal incisional hernia in patients having a vertical rectus abdominis myocutaneus flap during surgery for advanced pelvic malignancy.
OBJECTIVE
The study investigated the effect of collagen mesh-assisted closure at the donor site in preventing the formation of incisional hernia following construction of a vertical rectus abdominis myocutaneus (VRAM) flap as part of pelvic surgery for recurrent colorectal cancer.


METHODS
The study was a double-blinded randomized controlled superiority trial that was designed and performed according to the Consolidated Standards of Reporting Trials (CONSORT) Statement. Eligible patients undergoing surgery that included a VRAM flap for advanced colorectal pelvic malignancy were prospectively randomized to conventional abdominal wound closure or collagen mesh-assisted closure. The primary end-point was incisional herniation at 1 year confirmed by CT. Secondary end-points were CT-verified incisional herniation at 3 and 36 months, clinically recognizable incisional herniation, donor-site and reconstructive-site complications, surgical mortality, postoperative morbidity, postoperative recovery and survival.


RESULTS
In total, 58 (29 conventional closure; 29 mesh-assisted closure) patients were included. At 1 year, incisional herniation on the CT scan was found in 12 (50%) of 24 patients in the conventional closure group, and in 8 (33%) of 24 in the mesh-assisted closure group (P = 0.38). No significant difference between the groups was found in surgical mortality, early or late complications or survival. Donor-site morbidity was comparable between the two groups.


CONCLUSIONS
No preventative effect of collagen mesh-assisted closure was observed following VRAM flap reconstruction.
Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
A R
http://orcid.org/0000-0003-2125-2402
AR
Mortensen
Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
I
I
Grossmann
Department of Radiology, Aarhus University Hospital, Aarhus, Denmark.
M
M
Rosenkilde
Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
P
P
Wara
Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
S
S
Laurberg
Department of Surgery, Aarhus University Hospital, Aarhus, Denmark.
P
P
Christensen
D058107:Abdominal Wound Closure Techniques / Q000009:adverse effects*; D000368:Aged; D003094:Collagen; D004311:Double-Blind Method; D005260:Female; D046449:Hernia, Abdominal / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D000069290:Incisional Hernia / Q000209:etiology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D064827:Myocutaneous Flap / Q000637:transplantation; D010386:Pelvic Neoplasms / Q000473:pathology / Q000601:surgery; D011446:Prospective Studies; D017568:Rectus Abdominis / Q000637:transplantation; D013526:Surgical Mesh; D016896:Treatment Outcome
D003094:Collagen
VRAM flap; hernia prophylaxis; incisional hernia; mesh; mesh closure; ventral hernia