Use of Prophylactic Mesh When Creating a Colostomy Does not Prevent Parastomal Hernia

A Randomized Controlled Trial-STOMAMESH

Christoffer Odensten, MD; Karin Strigård, MD, PhD; Jörgen Rutegård, MD, PhD; Michael Dahlberg, MD, PhD; Ulrika Ståhle, MD; Ulf Gunnarsson, MD, PhD; Pia Näsvall, MD, PhD

Disclosures

Annals of Surgery. 2019;269(3):427-431. 

In This Article

Results

Eight hospitals participated in the study: 4 university hospitals (Karolinska University Hospitals in Huddinge and Solna, Stockholm, Uppsala University Hospital, and Umeå University hospital); 2 regional hospitals (Sunderby Regional Hospital and Helsingborg Regional Hospital); and 2 county hospitals (Mora County Hospital and Nyköping County Hospital). The total catchment area of the 8 hospitals is approximately 1,475,000 individuals; approximately 15% of the Swedish population.

From December 2007 through October 2015, 240 patients were enrolled in the trial (Figure 1). All operations were planned and performed according to a standard protocol within the National Health Service. Eight patients were enrolled in the study but had to be excluded because of change in surgical approach during the operation. Seven of these patients had been excluded and 21 new patients included and randomized according to the study design. Unfortunately, when all CRFs had reached the study center, one more patient had to be excluded, and could not be replaced as the trial had been closed.

Figure 1.

Consort diagram.

There was no significant difference in baseline data between the mesh group and the nonmesh group (Table 1) apart from duration of surgery, which was significantly longer in the mesh group (P = 0.019).

Comparison of patients in the "not included" group, that is, meeting the inclusion criteria but not included, with those in the STOMAMESH trial group, showed significantly lower proportions undergoing emergency surgery (P < 0.001) and with ASA-class 3 (P < 0.001) in the study group. Furthermore, patients in the study population were older (P = 0.010) (Table 2).

When excluding emergency procedures from both groups differences in age, ASA, and operation time between the 2 groups remained (Table 3).

No significant differences were found when data were stratified according to hospital.

After 1 year, 211 of 232 patients included (91%) were followed up clinically, and 198 of 232 patients (85%) were examined with CT (Figure 1). According to the requisites for the original power calculation, this gives a de facto power of 91%. Reasons for being lost to follow up were: incomplete follow up because of surgical complication (3 patients); progression of disease (1 patient); development of dementia (1 patient); refusal of patient to participate further in the study (9 patients); and death (7 patients). When comparing the mesh and nonmesh groups, there was no significant difference in the rate of bulge (P = 0.631), clinically judged PSH (P = 0.866), or PSH on the CT (P = 0.748) (Table 4). There was no difference in complication rates at 1-month follow up between the groups (Table 5). Reoperations performed during the first postoperative month were because of small bowel obstruction requiring adhesiolysis (1 in each group), conversion to transverse colostomy (1 in the mesh group), revision of the enterostomy (2 in the mesh group and 3 in the nonmesh group), bleeding (2 in the mesh group), superficial/deep infection (1 in each group), and wound rupture (1 in the nonmesh group). A further 2 patients in the nonmesh group and 4 patients in the nonmesh group were reoperated within the first postoperative year. At the 1-year follow up, a total of 8 patients in the nonmesh and 12 in the mesh group had been reoperated.

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