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.

Conclusions

In routine surgical care, no difference in rate of PSH can be seen when creating an elective colostomy with or without a reinforcing mesh. The management of PSH is still a considerable surgical challenge and there is no generally accepted method for its prevention. Further research should focus on developing preventive measures and improving methods for PSH repair.

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Acknowledgments
The authors would like to thank research nurse Lisa Eskilsson, Department of Surgery, Sunderby hospital, Region Norrbotten; Robert Lundqvist, statistician, Region Norrbotten; and all hospitals participating in the study.

Table 1. Basic Demographic Data.
	Nonmesh Group n = 118	Mesh Group n = 114	P
Age, yrs, range	69.9 (35–89)	69.7 (41–86)	0.877
Sex: male	62 (52%)	74 (65%)	0.056
ASA 1+2*	78 (70%)	82 (74%)	0.578
ASA 3*	34 (29%)	28 (26%)	0.578
Smoker^†	8 (7%)	12 (11%)	0.326
BMI, range	26.3 (18.5–43.7)	26.1 (16.7–37.8)	0.766
Cancer	106 (90%)	106 (93%)	0.392
Operation time, mins, range	287 (84–625)	323 (70–616)	0.019
Planned surgery	118 (100%)	113 (99%)	0.308
Length of stay, d, range	12 (2–44)	12 (4–44)	0.792

Basic Demographic Data in the Trial Population.
*ASA-class was stated in 222 patients.
†Smoking habit was stated in 216 patients. Median values are shown for: age, BMI, operation time and length of stay.

Table 2. Study population vs ''Not included''.
	STOMAMESH Population n = 232	Not Included n = 434	P
Age, yrs, range	69.8	67.5	0.010
ASA 1+2	167 (71.9%)	229 (52.8%)	<0.001
ASA 3	65 (28.1%)	205 (47.2%)	<0.001
Sex: male	135 (58.0%)	217 (50%)	0.020
Planned surgery	231 (99.6%)	337 (77.6%)	<0.001

The group of patients included in the STOMAMESH trial compared with the patients who could have been but were ''Not included'' at 3 hospitals (Sunderby hospital, Umeå University hospital, and Mora hospital) during the inclusion period. Median values are shown for age.

Table 3. Study population vs "Not included" emergency cases excluded.
	STOMAMESH Population n = 231	Not Included n = 337	P
Age, yrs, range	69.8	67.7	0.043
ASA 1+2	166 (71.9%)	200 (59.3%)	0.002
ASA 3	65 (28.1%)	137 (40.7%)	0.002
Sex: male	135 (58.0%)	164 (48.7%)	0.029

Table 4. Hernia rate at one year.
	Nonmesh Group n = 107	Mesh Group n = 104	P
Hernia (judged clinically)	32 (30%)	30 (29%)	0.866
Bulge, no hernia (judged clinically)	18 (17%)	15 (14%)	0.631
Hernia classified 2 and 3 on CT	28 (26%)	25 (24%)	0.748
Hernia classified 1, 2, and 3 on CT	36 (34%)	33 (32%)	0.765

Follow Up at 1 Year Evaluating Presence of Parastomal Hernia.
CT-scan was performed on 99 patients in each group and the findings were classified according to the model by Moreno-Matias.
Bulge was defined as a protrusion around the stoma judged not to be a hernia.

Table 5. Complications at one month.
	Nonmesh Group n = 112	Mesh Group n = 110	P
Overall complications	36 (32%)	38 (34%)	0.668
Surgical complications	31 (28%)	30 (27%)	0.947
Wound infection	16 (14%)	17 (15%)	0.785
Deep infection	9 (8%)	7 (6%)	0.644
Intestinal obstruction	1 (1%)	2 (2%)	0.618*
Stoma necrosis	8 (7%)	5 (4%)	0.570*
Reoperation within 30 days	6 (5%)	7 (6%)	0.783*
Other complications
Acute myocardial infarction	2 (2%)	2 (2%)	1.000*
Pneumonia	1 (1%)	2 (2%)	0.618*
Thrombosis	0	2 (2%)	0.242*
Urinary tract infection	1 (1%)	5 (4%)	0.116*

Complications at the 1-Month Follow Up in the Trial Population.
*The assumption for the x ² test was not fulfilled in these comparisons and Fischer exact test was used.