The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for Ostomy Surgery

The American Society of Colon and Rectal Surgeons ensures high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Clinical Practice Guidelines Committee comprises society members who are chosen because they have expertise in the specialty of colon and rectal surgery. This committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus and develop clinical practice guidelines based on the best available evidence. Although not proscriptive, these guidelines provide information on which decisions can be made and do not dictate a specific treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information on the management of the conditions addressed by the topics covered. These guidelines should not be deemed inclusive of all proper methods of care nor exclusive of methods of care reasonably directed toward obtaining the same results. The judgment regarding the propriety of any specific procedure must be made by the physician considering all the circumstances of a patient. STATEMENT OF THE PROBLEM Statistics regarding ostomy-related metrics remain elusive in the United States because of underreporting and coding limitations. The estimated number of ostomates in the United States is 750,000 to 1 million, with approximately 150,000 new ostomies created each year.1 Stoma creation has a relatively high rate of associated morbidity, ranging from 20% to 80%; peristomal skin complications and parastomal hernia (PSH) are the most common associated morbidities.2 A population-based study using the Michigan Surgical Quality Collaborative, which included 4250 patients, identified a 37% unadjusted surgical complication rate for elective cases involving an ostomy and 55% unadjusted surgical complication rate for emergency cases involving an ostomy.1 In this study, risk-adjusted stoma-related morbidity rates varied significantly among hospitals, indicating a potential to improve outcomes in outlying institutions. Beyond the typical short-term metrics captured in standard databases, the morbidity of ostomy surgery may also be measured in terms of the stoma-related negative effects on the quality of life and other long-term morbidities related to having an ostomy.3–8 Many patients have ostomies that are considered "problematic" and present with management problems like skin irritation and pouching difficulties that require prolonged and specialized care and result in increased utilization of health care resources and increased costs.9–15 The incidence and impact of short- and long-term stoma-related complications can be mitigated by perioperative education and marking, proper surgical technique, and attention to postoperative care pathways. The purpose of these clinical practice guidelines (CPG) is to guide surgeons and other health care providers to improve the quality of care and outcomes for patients undergoing ostomy surgery. METHODOLOGY This CPG focuses on the surgical care of patients requiring an ostomy and addresses issues like choosing an ostomy type, technical aspects of ostomy creation and closure, prevention and management of ostomy-related complications, and perioperative care. The guideline does not address whether an ostomy should be created in a given clinical scenario because this evidence base was reviewed in other American Society of Colon and Rectal Surgeons (ASCRS) CPG related to specific diseases (eg, diverticulitis, rectal cancer, and ulcerative colitis).16–18 Urostomies, continent ileostomies, stomas in the pediatric population, and a comprehensive review of nursing ostomy care (eg, skin care, use of different appliances, or other management systems) are beyond the scope of these guidelines. These guidelines are based on the last ASCRS CPG for Ostomy Surgery published in 2015.19 Because of the changes in the strength or quality of the evidence (Table 1), this updated CPG contains 2 new statements, 9 modified statements, and omission of 1 statement from the 2015 CPG. The remaining statements were not changed, but the literature review and supporting statements were updated. A systematic search of MEDLINE, PubMed, Scopus EMBASE, and the Cochrane Database of Systematic Reviews was performed from January 1, 2014, to December 1, 2021. Individual literature searches were conducted for each statement within the guidelines and were restricted to English language and adult patients (Fig. 1). Search strategies were based on the concepts of intestinal stomas, and the various relevant diagnostic procedures, surgical interventions, and care pathways related to these diagnoses using multiple subject headings, text words, and descriptors. The 4008 screened articles were evaluated for level of evidence, favoring randomized clinical trials, meta-analyses and systematic reviews, comparative studies, and large registry retrospective studies over single-institutional series, retrospective reviews, and observational studies. Additional references identified through embedded references and other resources as well as practice guidelines or consensus statements from relevant societies were also reviewed. A final list of 205 tabulated citations was evaluated for methodologic quality, the evidence base was evaluated, and a treatment guideline was formulated by the subcommittee for this guideline. The final grade of recommendation and level of evidence for each statement were determined using the Grades of Recommendation, Assessment, Development, and Evaluation system (Table 2).20 When agreement was incomplete regarding the evidence base or treatment guideline, consensus from the committee chair, vice chair, and 2 assigned reviewers determined the outcome. Members of the ASCRS CPG Committee worked in joint production of these guidelines from inception to final publication. Recommendations formulated by the subcommittee were reviewed by the entire CPG Committee. Final recommendations were approved by the ASCRS Executive Council and peer-reviewed in Diseases of the Colon and Rectum. In general, each ASCRS CPG is updated every 5 years. No funding was received for preparing this guideline, and the authors have declared no competing interests related to this material. This guideline conforms to the Appraisal of Guidelines for Research and Evaluation checklist. TABLE 1. - What is new in the 2022 ASCRS Ostomy Surgery Clinical Practice Guidelines Topic Recommendation 2022 New recommendations Ostomy closure 11. Routine water-soluble contrast studies in the absence of a clinical suspicion of anastomotic dehiscence or stricture may not be necessary before closure of a protective ostomy. Grade of recommendation: weak recommendation based on low-quality evidence, 2C 12. Early closure of protective ileostomies may be performed in select low-risk patients with a colorectal anastomosis without clinical evidence of anastomotic leak. Grade of recommendation: weak recommendation based on moderate quality evidence, 2B 2022 Updated recommendations Perioperative management 2. Appropriate potential ostomy sites should be marked preoperatively by a trained provider when possible. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B Ostomy creation 5. When indicated, a loop ileostomy or a loop colostomy is effective for fecal diversion. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B 7. In nonobese patients, the routine use of a support rod at the time of loop ileostomy construction is not necessary. Grade of recommendation: strong recommendation based on high-quality evidence, 1A 8. The routine use of prophylactic mesh to prevent parastomal hernia at the time of ostomy creation is not recommended. Grade of recommendation: weak recommendation based on high-quality evidence, 2A 9. Extraperitoneal tunneling of an end colostomy may decrease the risk of parastomal hernia. Grade of recommendation: weak recommendation based on moderate-quality evidence, 2B 10. Managing patients with a new ileostomy with a perioperative care pathway may decrease the risk of hospital readmission. Grade of recommendation: weak recommendation based on moderate-quality evidence, 2B Ostomy closure 13. Loop ileostomy closure can be performed using stapled or handsewn techniques. Grade of recommendation: strong recommendation based on high-quality evidence, 1A 14. Ostomy-site skin approximation should be performed when feasible, and purse string skin closure has advantages compared with other techniques. Grade of recommendation: strong recommendation based on high-quality evidence, 1A 15. Minimally invasive Hartmann's reversal is a safe alternative to open reversal. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B 2015 Recommendations excluded Ostomy creation Use of antiadhesion materials may be considered to decrease adhesions at temporary ostomy sites. Grade of recommendation: weak recommendation based on moderate-quality evidence, 2B ASCRS = American Society of Colon and Rectal Surgeons. TABLE 2. - The GRADE system—grading recommendations Description Benefits vs risks and burdens Methodologic quality of supporting evidence Implications 1A Strong recommendation: high-quality evidence Benefits clearly outweigh risks and burdens or vice versa RCTs without important limitations or overwhelming evidence from observational studies Strong recommendation: can apply to most patients in most circumstances without reservation 1B Strong recommendation: moderate-quality evidence Benefits clearly outweigh risks and burdens or vice versa RCTs with important limitations (inconsistent results, methodologic flaws, indirect, or imprecise) or exceptionally strong evidence from observational studies Strong recommendation: can apply to most patients in most circumstances without reservation 1C Strong recommendation: low- or very low–quality evidence Benefits clearly outweigh risks and burdens or vice versa Observational studies or case series Strong recommendation: may change when higher quality evidence becomes available 2A Weak recommendation: high-quality evidence Benefits closely balanced with risks and burdens RCTs without important limitations or overwhelming evidence from observational studies Weak recommendation: best action may differ depending on circumstances or patients' or societal values 2B Weak recommendation: moderate-quality evidence Benefits closely balanced with risks and burdens RCTs with important limitations (inconsistent results and methodologic flaws, indirect or imprecise) or exceptionally strong evidence from observational studies Weak recommendation: best action may differ depending on circumstances or patients' or societal values 2C Weak recommendation: low- or very low–quality evidence Uncertainty in the estimates of benefits, risks, and burdens; benefits, risks, and burdens may be closely balanced Observational studies or case series Very weak recommendation: other alternatives may be equally reasonable GRADE = Grades of Recommendation, Assessment, Development, and Evaluation; RCTs = randomized controlled trials. FIGURE 1.: PRISMA literature search flow sheet. PRISMA = Preferred Reporting Items for Systematic Reviews and Meta-Analysis.PERIOPERATIVE MANAGEMENT 1. Patients undergoing elective stoma creation should receive preoperative and postoperative ostomy education by a specialized provider such as a wound ostomy and continence nurse. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B Stoma education in the perioperative setting has been shown to reduce length of hospital stay, patient anxiety, and the rate of peristomal complications while increasing patients' self-reported quality of life.21–28 A trial that randomized 42 patients to an intensive preoperative educational program before ostomy surgery or postoperative teaching found that preoperative education decreased length of stay (8 versus 10 d; p = 0.02), decreased need for unplanned health care interventions postdischarge, decreased time to ostomy care proficiency (5.5 versus 9 d; p < 0.001), and resulted in significant cost savings.21 Some of these findings were replicated in a more recent retrospective study that incorporated preoperative stoma education into an enhanced recovery care pathway, and, in this setting, preoperative education was still associated with a length of stay benefit (8 versus 9 d; p = 0.02).29 A meta-analysis of 68 studies reported that lack of preoperative stoma site marking and wound ostomy nurse specialist consultation before stoma surgery was 1 of 6 risk factors associated with an increased likelihood of stoma-related complications; other risk factors included age more than 65 years, female sex, BMI more than 25 kg/m2, diabetes mellitus, and abdominal malignancy as the underlying reason for ostomy surgery.30 Another retrospective study evaluated the impact of a 2-hour preoperative stoma education class led by a certified Wound Ostomy and Continence Nurse (WOCN) for patients undergoing colorectal surgery in which a stoma was anticipated and found that educated patients (n = 124) experienced significantly fewer stoma complications than uneducated patients (n = 94). In this study, the study group had less leakage from the ostomy pouching system and less peristomal skin damage (20% versus 45%; p = 0.002) but had no improvement in the length of stay or in the 30-day readmission rate.31 A meta-analysis evaluating ostomy patients included 38 studies and reported that several modifiable factors were associated with improved quality of life, including having had preoperative stoma site marking and education (exercise, family support, maintenance of social networks, spirituality, and financial stability were also related factors).32 In a multicenter prospective trial of 402 patients evaluating the impact of specialized ostomy nursing on the health-related quality of life of patients with new ostomies, patients treated in hospitals with specialized ostomy nurses were less concerned with appearance and were more comfortable with cleaning, changing, and disposing of ostomy appliances. In addition, study patients reported less fearfulness, improvements in sleep, and better overall health.33 2. Appropriate potential ostomy sites should be marked preoperatively by a trained provider, when possible. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B Preoperative ostomy-site marking is associated with reduced postoperative stoma and peristomal complications and improved patient self-care and health care quality of life. In a systematic review of 10 studies including 2109 patients, preoperative stoma site marking was associated with reduced stoma and peristomal complications (both early and late) including prolapse, retraction, necrosis, skin complications (OR, 0.52; 95% CI, 0.42–0.64), and hernias (OR, 0.25; 95% CI, 0.09–0.71).34 Another systematic review of 20 studies found that preoperative stoma site marking was associated with a reduction in complication rates (OR, 0.47; 95% CI, 0.36–0.62), improvement in self-care deficits (OR, 0.34; 95% CI, 0.18–0.64), and increased health-related quality of life (standardized mean difference, 1.05; 95% CI, 0.70–1.40).35 Although site marking by a certified ostomy nurse is considered ideal, other trained providers may site stomas and counsel patients preoperatively, especially in emergency situations. When surgeons and surgical trainees were evaluated after choosing ostomy sites, investigators found that the sites chosen by surgeons were a median 2 cm away from the sites chosen by ostomy nurses. In this study, most "badly sited" ostomies were placed too low on the abdominal wall.36 In this study, "seniority" had no impact on the results as trainees and attending surgeons had similar outcomes and colorectal surgeons sited locations more concordantly with the ostomy nurse specialists than general surgeons. A survey of surgical trainees showed that their training in ostomy-site selection was haphazard and infrequently involved an ostomy nurse specialist.36 In 2015, the ASCRS and the WOCNs Society published a Joint Position Statement of the value of preoperative stoma marking for patients undergoing fecal ostomy surgery and subsequently expanded these recommendations in 2021.37,38 Surgeons who choose ostomy sites should be familiar with the principles of proper ostomy site selection, including evaluating patients in multiple positions to identify adequate sites, avoiding folds and scars, considering the beltline, and siting the ostomy within the rectus abdominus muscle. Although preoperative site marking is strongly recommended, it is acknowledged that intraoperative circumstances may not allow for the optimal skin site to be used in all situations. Given the cumulative evidence and, in particular, the 2 large systematic reviews published in 2020 and 2021, the grade of this recommendation was changed from 1C in 2015 to 1B. 3. Patients benefit from follow-up for ostomy teaching, care, and support. Grade of recommendation: strong recommendation based on low-quality evidence, 1C Patients living with an ostomy may experience negative effects on their quality of life, sexual difficulties, depression, dissatisfaction with their appearance, and challenges with self-image and travel.4,13,15,39–44 Stoma creation can also result in feelings of embarrassment or shame; patient concern about disclosing their stoma status to others can lead to self-imposed limits and isolation.45 One randomized trial and several observational studies support the value of postdischarge ostomy nursing care, which can be provided in the home, outpatient, or telephone setting.46–50 Follow-up stoma care is associated with increased ability of patients to care for themselves independently, fewer ostomy-related problems, improved ostomy adjustment, increased satisfaction with care, and improved quality of life.46,47,51,52 Over time, patients with permanent ostomies may continue to have untreated ostomy-related complications and challenges.12,53–57 A multicenter noncomparative study of 743 long-term ostomy patients revealed that 61% of patients had objective evidence of peristomal skin problems, 28% experienced frequent leakage, and 87% used various accessories to facilitate pouching their ostomy; meanwhile, 55% had not seen a WOCN in more than 12 months. After 2 visits with a WOCN, participants experienced significant decreases in the frequency of pouch leakage (p < 0.001) and accessory use, improvement in skin condition, and a small improvement in the mean overall quality-of-life scores (Stoma-QOL: 56.8 versus 58.9; p < 0.001). The greatest change in the Stoma-QOL scores was observed in patients who were in the lowest QOL at baseline; their mean QOL scores rose from 43.8 at visit 1 to 50.1 at visit 2 (p < 0.001).53 These data suggest that even long-term ostomy patients have difficulty with ostomy care and may benefit from expert counseling. Trained ostomy nurses provide an essential service to patients with ostomies beyond the immediate perioperative period.58,59 OSTOMY CREATION 4. When feasible, laparoscopic ostomy formation is preferred to ostomy formation via laparotomy. Grade of recommendation: strong recommendation based on low-quality evidence, 1C There are no randomized trials comparing ostomy creation utilizing a conventional open surgical approach versus minimally invasive approach (MIS). However, multiple observational studies have documented safety and favorable short-term outcomes of laparoscopic ostomy creation compared with open ostomy creation. Reported advantages of a laparoscopic approach include reduced pain and narcotic requirements, shorter hospitalization, earlier return of bowel function, and fewer overall complications than open surgery.60–62 A propensity-matched cohort of 358 patients who underwent elective open or laparoscopic colostomy formation reported decreased length of stay (5 versus 7 d; p < 0.05) and wound complications (13% versus 27%; p < 0.05) in the laparoscopic cohort.61 A case-matched analysis of 196 patients (63 laparoscopic and 133 open) indicated that open surgery was associated with increased estimated blood loss (p = 0.01), longer hospital stay (p < 0.001), and higher postoperative ileus (p = 0.03) and readmission rates (p = 0.002).62 Conversion to open surgery during stoma creation is uncommon, ranging from 0% to 16%, with more recent series reporting rates in the single digits.60,63 Although data are limited, laparoscopically created ostomies may also be easier to reverse. In a retrospective study, patients who underwent loop ileostomy closure were evaluated based on whether the index procedure had been laparoscopic (n = 145) or open (n = 206).64 Patients in the laparoscopic group had a significantly shorter mean operative time (60.9 versus 82.6 min; p < 0.001), shorter hospital stay (4.9 versus 5.8 d; p = 0.04), and a lower overall complication rate (14.5% versus 24%; p = 0.02). 5. When indicated, a loop ileostomy or loop colostomy is effective for fecal diversion. Grade of recommendation: strong recommendation based on moderate-quality evidence, 1B Although proximal diversion of the fecal stream can be with an ileostomy or loop stomas are preferred for temporary fecal diversion because of their of The of loop ileostomy versus loop colostomy loop colostomy has been evaluated in 5 randomized controlled trials and several observational studies in an to whether 1 approach is meta-analyses have also been performed but results in large because of the among and the fecal and the of anastomotic The in an versus is the rate of complications at the time of creation and A meta-analysis that evaluated temporary (n = and (n = found that an was associated with significantly lower incidence of stoma or (OR, 95% CI, and rate of (OR, 0.52; 95% CI, but was associated with a significantly higher incidence of (OR, 95% CI, compared with an The incidence of parastomal stoma and morbidity related to stoma reversal was the same in the 2 ileus was significantly more common closure (OR, 95% CI, reversal was significantly more to have a surgical site 95% CI, or hernia (OR, 95% CI, Loop ileostomy patients may have a better quality of life to colostomy patients because of decreased less need to to prolapse, and of ostomy However, 1 small randomized trial not a in the patients assigned to a colostomy (n = versus ileostomy (n = This recommendation was changed from the 2015 CPG in which a loop ileostomy was preferred to a loop Given the of the an and an are effective of and each approach has an associated a recommendation strongly in of 1 over be When ileostomies and should be to the skin Grade of recommendation: strong recommendation based on low-quality evidence, 1C Surgical the incidence of stoma-related morbidity, and stoma in particular, has been reported as a modifiable risk for In a of stoma patients, were identified with significant risk factors for having a stoma were having a a stoma a higher emergency and lack of preoperative site In this study, patients with stomas were associated with having a significantly longer hospital stay and requiring increased Another retrospective study of patients who underwent loop ileostomy formation found that surgical the incidence of parastomal stoma retraction, and stoma In this study, it was the of the stoma that was associated with and not the of the proximal most other studies have a stoma and the likelihood of having a In general, ileostomies should at 2 cm over the skin should at 1 However, it is acknowledged that this of is not in all clinical In patients with a abdominal a or or it may be to an ostomy with an stoma surgeons should ostomies with the skin when possible. that may be used to length for an ostomy include ostomies, and choosing an abdominal site in 7. In nonobese patients, the routine use of a support rod at the time of loop ileostomy construction is not necessary. Grade of recommendation: strong recommendation based on high-quality evidence, 1A In a small compared ileostomies with a versus no and no significant in stoma have been RCTs and 2 cohort studies evaluating the use of support for loop and A meta-analysis of these studies included patients with a loop stoma patients had a support and found no in stoma rates (OR, 95% CI, patients with a support rod had significantly higher rates of stoma necrosis, peristomal and no studies have evaluated the of support in patients, and the BMI in the studies from to a support rod is small observational studies have shown that such as a may easier and of stoma the evidence this recommendation has been the 2015 which on the of a support 8. The routine use of prophylactic mesh to prevent parastomal hernia at the time of ostomy creation is not recommended. Grade of recommendation: weak recommendation based on high-quality evidence, 2A The high rate of has led surgeons to a mesh at the time of stoma creation as a potential systematic reviews a reduction in rates with prophylactic and this approach was shown to be A meta-analysis published in of 7 RCTs including patients found that of mesh at the time of stoma creation reduced the incidence of versus p = 0.001) and versus p = without increasing the incidence stoma-related However, a study randomized patients to a mesh versus no mesh at the time of permanent end colostomy creation and found no significant the 2 in the rates of or by at In this study, was no significant in perioperative complications the A 2020 trial randomized patients to end colostomy creation with or without a mesh in the and found no significant in the rates of versus at was no in stoma-related complications in this A trial randomized patients undergoing end colostomy creation to utilizing a = a made with and a that was of the of the bowel (n = or a prophylactic mesh in the (n = In this study, were no significant the regarding the However, increasing age and BMI were associated with a A meta-analysis of 7 studies evaluating the use of a mesh at the time of colostomy formation to prevent found no significant benefit to mesh at In a meta-analysis of studies, prophylactic mesh reduced the rate of clinical (OR, 95% CI, and (OR, 95% CI, in patients with a of However, a analysis that included studies with a low risk of showed no significant benefit of prophylactic mesh in A 2015 randomized trial of patients who underwent