Rationale
An ostomy, also called stoma, defines an artificial opening of an internal organ on the surface skin. An intestinal ostomy therefore comprises of an artificial bowel opening created on the skin to evacuate bowel content [
1]. Other forms of stomata include tracheostoma and urostoma [
2]. However, this systematic review (SR) focuses on intestinal ostomies which can be created using the small bowel (ileum) or the large bowel (colon). Furthermore, ostomies can be created electively or emergently and they can be either temporary or permanent. Temporary ostomies are routinely performed to ameliorate the consequences of anastomotic insufficiency following colorectal surgery [
1]. Permanent ostomies are used as a definite solution to an underlying problem which is usually not amendable via other methods. However, there is a considerable risk of temporary ostomies becoming permanent [
1,
3]. Another feature of intestinal ostomies is the number of openings on the skin. A terminal ostomy has just one opening because the entire bowel circumference is sutured to the skin following a complete disruption of the bowel continuity. Loop ostomies on the other hand have two openings at the level of the skin. The anterior wall of the bowel is opened and sutured to the skin while the posterior bowel wall remains intact. Loop ostomies are usually used in situations when bowel continuity can be restored [
1,
2]. Frequent indications for creating an intestinal ostomy include bowel cancer, bowel ischemia, inflammatory bowel disease, anal incontinence, chronic obstipation or complicated diverticular disease [
2].
Statistics on ostomates are relatively rare and vague. In the USA, the number of ostomates is estimated between 750,000 and 1 million [
4,
5] which corresponds to a prevalence of 0.2% and over 100,000 new procedures are performed each year [
3,
4]. The German health insurer BARMER estimated that the prevalence of ostomates was 0.2% in Germany in 2011, based on patients consuming stoma-related medical aids [
6], corresponding to a total of about 160,000 ostomates. These data include carriers of both intestinal and urinary ostomies [
6]. According to the Federal Bureau of Statistics of Germany, about 64,601 intestinal ostomy-related procedures were performed in Germany in 2019. This is approximately 79 ostomy-related procedures per 100,000 residents in Germany [
7]. This figure has increased by 24% since 2005, when it was 52,035 procedures. The global number of years lives with disability for patients with stoma due to colon and rectum cancers who survived beyond 10 years was 22,100 years (95% confidence interval: 15,300 to 30,000 years) in 2017 [
8].
In elective stoma creation, procedure-related mortality is extremely rare. A SR that included 18 randomised controlled trials (RCT) on intestinal ostomy found that no deaths were attributed to creation of the stoma [
9]. However, significant morbidity is associated with intestinal ostomy including both early complication, occurring within the first 30 days after stoma creation, and late complication, occurring after 30 days following stoma creation [
1,
3]. Such complications may include peristomal conditions, parastomal hernia, stoma prolapse, retraction, stoma stenosis, ischemia and necrosis and high output stoma [
1,
3,
9‐
11]. Some of these complications, e.g. stoma necrosis, prolapse, retraction, stenosis and parastomal hernia, may require surgical correction [
1,
3]. In 2019, over 9,656 revision procedures were performed in Germany [
7]. Furthermore, stoma-related complications have been shown to negatively affect the quality of life of ostomates [
12]. Besides the negative effects of these complications on the ostomates’ perspective (quality of life) [
13,
14], the management of stoma-related complications also constitutes a substantial burden to the health care system [
6].
Besides the height of the stoma above the skin [
15], a relevant predisposition to stoma-related complications is the stoma site [
10,
16]. An optimal ostomy position may prevent many stoma-related complications [
1]. Based on our clinical experience and limited, retrospective literature, choosing the right site for an ostomy may constitute a major step in reducing and preventing stoma-related complications [
17,
18].
The Charter of Ostomates Rights [
19], which was issued by the International Ostomy Association Coordination Committee in June 1993 and last revised by the World Council in 2007, states that:
The Ostomate shall […] have a well-constructed stoma placed at an appropriate site, and with full and proper consideration to the comfort of the patient.
The available data suggests that preoperative stoma site marking and education by wound and ostomy therapists significantly reduce early stoma-related complications [
17,
18,
20] and anxiety [
18] and increase quality of life [
20,
21]. On the contrary, a lack of preoperative stoma site marking was found to be a significant risk factor for problematic stomas [
10].
Preoperative marking of the potential stoma site is recommended in several guidelines, including the American [
22] and German guidelines [
23]. However, there is no consensus on how to mark and who does the marking. It is generally accepted that preoperative marking is best performed by the leading surgeon or an experienced member of the surgical team. Another accepted option is to have an ostomy and wound nurse do the marking [
23,
24]. Marking should be done during counselling, by either the surgeon or the ostomy nurse, and the potential stoma site should be marked with the patient in different positions: lying, sitting and standing [
23,
24]. It is recommendable to mark the bony structures of the abdominal walls as well as visible skin folds. This permits an optimal selection of the future stoma site away from folds and bony abdominal prominents. The patient should be encouraged to play an active part in this process. One could also let the patient try an ostomy bag, so they can find out if the selected position is optimal [
24].
To date, there is no high-quality SR investigating the effect of preoperative stoma site marking on stoma-related complications in patients with intestinal ostomy. The SR by Colwell and Gray published in 2007 [
25] includes three studies published between 1997 and 2006 [
17,
26,
27] with heterogeneous effects of preoperative stoma site marking on different outcomes. The authors conclude that preoperative site marking may reduce the incidence of postoperative complications but the evidence was sparse. This review has certain methodological limitations, for example it lacks a risk of bias (RoB) assessment of the included studies and is probably out of date as it is estimated that half of SRs are out of date after 5.5 years [
28]. A recent SR by Hsu et al. in 2020 [
29] focusing on intestinal and urinary stoma included 10 studies. This SR is largely limited by its low methodological quality: The authors did not publish a protocol, did not search reference lists nor trial registries and took a long time from search (January 2018) to publication (May 2020). They did not report having performed selection of studies in duplicate, did not use appropriate methods for statistical combination of results nor did they try to explain heterogeneity or evaluate the quality of the body of the evidence. Furthermore, we identified studies which were not included in that review [
29]: two studies included by Colwell and Gray [
26,
27] and a study published by Cakir and Ozbayir [
20] which indicated that the 6-month quality of life score of the patients receiving preoperative stoma marking was higher than that of the control group.