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• To update your knowledge of radiation proctitis and rectal bleeding in patients with pelvic organ cancer
• To learn about the use of nurse-led patient education followed by self-administration of sucralfate enemas
• To consider how self-administration of sucralfate enemas can reduce rectal bleeding and reduce hospital admission
Radiation proctitis is relatively common in patients with pelvic organ cancer and manifests primarily as rectal bleeding. Topical sucralfate is thought to minimise radiation-induced rectal bleeding. Compared with argon plasma coagulation (APC) or formalin instillation, sucralfate enemas do not require hospital admission and have minimal adverse effects. This prospective service evaluation investigated the effectiveness of nurse-led patient education followed by self-administration of sucralfate enemas for reducing rectal bleeding in patients with radiation proctitis. Participants (n=42) were recruited via convenience sampling among patients with radiation proctitis seen in the colorectal outpatient clinic of Queen Mary Hospital in Hong Kong. Participants followed a treatment protocol of self-administered sucralfate enemas accompanied by nurse-led education. The primary outcome was a reduction in rectal bleeding. The secondary outcomes were reductions in hospital admissions, use of APC and use of blood transfusions. The authors propose that self-administered sucralfate enemas can effectively control rectal bleeding in patients experiencing radiation proctitis but that this needs to be accompanied by optimal nurse-led patient education. Further research is needed to determine the long-term comparative effectiveness of these interventions.
Cancer Nursing Practice. doi: 10.7748/cnp.2024.e1866
Peer reviewThis article has been subject to external double-blind peer review and checked for plagiarism using automated software
Correspondence Conflict of interestNone declared
Shum NF, Choi HK, Wei R et al (2024) Evaluating self-administered sucralfate enemas for reducing rectal bleeding in patients with radiation proctitis. Cancer Nursing Practice. doi: 10.7748/cnp.2024.e1866
Published online: 16 September 2024
Radiation proctitis – also called radiation proctopathy – refers to injuries or damage to the rectum secondary to radiotherapy (Denton et al 2002). It is relatively common in patients with pelvic organ cancer such as colorectal cancer, prostate cancer or ovarian cancer. Approximately 5-20% of patients who undergo radiotherapy for pelvic organ cancer report radiotherapy-induced rectal injuries (Gilinsky et al 1983, Hasleton et al 1985, Haboubi et al 1988, Counter et al 1999, Halkett et al 2010, Bansal et al 2016).
Radiation proctitis can be classified as acute or chronic; chronic radiation proctitis occurs in 5-10% of patients who undergo radiotherapy for a pelvic organ cancer (Garg et al 2006). However, it has been suggested that the actual incidence of radiation proctitis could be as high as 20-30% due to under-reporting and/or underdiagnosis (Tagkalidis and Tjandra 2001). The severity of radiation proctitis tends to vary depending on the modality, duration and intensity of radiotherapy. Due to the improvements in the treatment of cancer and consequent longer survival rates, an increasing number of patients are living with cancer, which means that radiation proctitis will be seen more often.
Radiation proctitis manifests primarily as rectal bleeding. Patients may also experience gastrointestinal symptoms such as irregular bowel movements, anal pain or bowel urgency. Patients usually require the regular prescription of medicines for sitz baths or local steroidal analgesics for relieving anal pain. Patients with severe radiation proctitis may need regular oral steroid treatment or steroid foam retention enemas (Halkett et al 2010). Patients with radiation proctitis who experience persistent rectal bleeding may develop anaemia and require emergency admission to hospital for blood transfusions, which exposes them to the risks associated with transfusions.
One endoscopic treatment option for controlling rectal bleeding in patients with radiation proctitis is argon plasma coagulation (APC), also called argon beam ablation. In APC, ionised argon and an electric current are used to transmit high-frequency energy to the mucosal tissues, causing blood to clot or scar tissue to form. Medical treatment options include formalin (also known as formaldehyde solution) instillation and sucralfate enemas. There are several other treatment options, including medical, endoscopic and surgical options (Sarin and Safar 2013), but it is beyond the scope of this article to describe them all.
To better understand the burden of radiation proctitis on the healthcare system, the authors of this article retrospectively reviewed emergency admissions related to radiation-induced rectal bleeding at Queen Mary Hospital in Hong Kong between 2017 and 2021. In that period, there were 220 emergency admissions, and 138 patients required APC to control rectal bleeding. APC treatment is expensive, there are additional costs associated with inpatient hospital stays, and patients may need other interventions such as blood transfusions and antibiotics.
It has been suggested that topical sucralfate can minimise the symptoms of radiation proctitis (Sarin and Safar 2013). Compared with treatments such as APC or formalin instillation, sucralfate enemas are a relatively simple treatment that does not require hospital admission. Sucralfate enemas can be self-administered at home and have minimal adverse effects (Kudaravalli et al 2024). The authors of this article therefore decided to implement and evaluate a treatment protocol of patient self-administered sucralfate enemas accompanied by nurse-led education. They conducted this evaluation between April 2021 and April 2023.
• Radiation proctitis – also called radiation proctopathy – refers to injuries or damage to the rectum secondary to radiotherapy
• Radiation proctitis manifests primarily as rectal bleeding
• It has been suggested that topical sucralfate can minimise the symptoms of radiation proctitis
• Sucralfate enemas can be self-administered at home and have minimal adverse effects
• Most patients demonstrated clinical improvement after self-administering sucralfate enemas twice daily for four weeks. There was an overall reduction of rectal bleeding among participants
• Nurses have an important role in maximising the outcomes of treatment with sucralfate enemas by enhancing patient self-management and adherence to treatment
The authors first conducted a systematic review of the literature on the effectiveness of treatment for rectal bleeding in patients with radiation proctitis. Four databases were searched – PubMed, MEDLINE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL) Plus and the Cochrane Library – for studies assessing treatment for radiation proctitis published in English or Chinese between 2015 and 2022, using the search terms ‘rectal bleeding’, ‘rectum’, ‘radiation proctitis’, ‘sucralfate enema’ and ‘randomised controlled trial’ in various combinations. The search generated 77 potentially relevant studies, of which 19 were selected for inclusion in the review.
Among the 19 included studies, nine were systematic reviews or literature reviews (Denton et al 2002, Leiper and Morris 2007, Rustagi and Mashimo 2011, Hanson et al 2012, Stacey and Green 2013, Mendenhall et al 2014, Weiner et al 2016, van de Wetering et al 2016, Paquette et al 2018); four were randomised controlled trials (O’Brien et al 1997, 2002, Sanguineti et al 2003, Nelamangala Ramakrishnaiah et al 2012); three were prospective studies (Kochhar et al 1990, Rolachon et al 2000, Gul et al 2002); two were retrospective studies (McElvanna et al 2014, Yuan et al 2016); and one was a case report (Stockdale and Biswas 1997). Most studies had relatively small sample sizes and could not be easily compared. A summary of the 19 studies can be found in Table 1, available online at rcni.com/sucralfate-enemas
In all nine systematic reviews or literature reviews, the authors had concluded that the evidence for the effectiveness of treatment for rectal bleeding in patients with radiation proctitis was unclear and/or at high risk of bias. APC was often used in clinical practice to reduce rectal bleeding but had not been tested in a randomised trial. The evidence for the effectiveness of non-surgical interventions for radiation proctitis was limited and there were no common standards to measure effectiveness.
The findings regarding the effectiveness of sucralfate enemas for radiation proctitis were inconsistent. Four studies (Kochhar et al 1990, Gul et al 2002, Sanguineti et al 2003, Leiper and Morris 2007) had found that sucralfate enemas were effective while four studies (O’Brien et al 1997, 2002, Rustagi and Mashimo 2011, Hanson et al 2012) had concluded that there was no consensus on the use of sucralfate enemas for radiation proctitis. No prospective randomised trials had been conducted to test the effectiveness of sucralfate enemas.
The aim of the evaluation was to assess the effectiveness of nurse-led patient education followed by self-administration of sucralfate enemas for reducing rectal bleeding in patients with radiation proctitis.
For this prospective service evaluation, participants were recruited among patients with radiation proctitis seen in the colorectal outpatient clinic at the department of surgery of Queen Mary Hospital in Hong Kong. Convenience sampling was used. To participate, patients had to be aged at least 18 years, have a history of pelvic organ cancer and have developed radiation proctitis. Furthermore, they had to be able to adhere to, and agree to follow, a treatment protocol of self-administered sucralfate enemas accompanied by nurse-led education.
Patients who agreed to participate had to commit to self-administer sucralfate enemas, prepared using two 1g packages of sucralfate gel mixed with 40mL of water to produce a paste-like consistency, twice a day for four weeks.
Before starting treatment, participants attended an initial appointment at a nurse-led clinic with their carer to provide them with knowledge and skills regarding radiation-induced rectal bleeding and its treatment using sucralfate enemas. The nurse-led education included the techniques for self-administration of sucralfate enemas including preparation of the product, handling of tools and the administration itself. Participants received a leaflet illustrating the steps of sucralfate enema self-administration.
After four weeks of treatment, participants attended a follow-up appointment at the nurse-led clinic, where their adherence to the treatment protocol, the outcomes of treatment and any potential complications were discussed. If participants felt they needed an additional appointment at the nurse-led clinic to check their self-administration technique before the end of the four-week treatment period, they could request one.
The primary outcome was a reduction in rectal bleeding and the secondary outcomes were reductions in hospital admissions, in the use of APC and in blood transfusions.
The primary outcome (reduction in rectal bleeding) was measured using the European Organisation for Research and Treatment of Cancer (EORTC) Severity of Radiation Proctitis Scale (Table 2) and the modified Radiation Therapy Oncology Group (RTOG) Rectal Toxicity Scale (Table 3) (Cox et al 1995).
(Adapted from Cox et al 1995)
(Adapted from Cox et al 1995)
The EORTC Severity of Radiation Proctitis Scale grades the severity of chronic radiation proctitis, while the modified RTOG Rectal Toxicity Scale grades the severity of rectal side effects of radiotherapy. Participants’ severity of radiation proctitis grade and rectal toxicity grade were measured before and after treatment at the first and second nurse-led clinic appointments.
Baseline numbers of hospital admissions of patients receiving APC and of patients receiving blood transfusions during the four-week treatment period were obtained by checking patient admission records. The numbers of hospital admissions, of cases of use of APC and of cases of use of blood transfusions during the four-week treatment period, were obtained by checking patient records.
Between April 2021 and April 2023, 42 patients (22 men and 20 women) with a mean age of 71.6 years participated in the evaluation. All participants had received radiotherapy: three (7%) for rectal cancer, 20 (48%) for prostate cancer and 19 (46%) for uterine or cervical cancer. Table 4 summarises participants’ demographic characteristics.
All participants received nurse-led education, following which they self-administered sucralfate enemas twice a day for four weeks – except for one participant (2%) who died of pneumonia after attending the initial nurse-led clinic appointment. A large majority of participants (n=35, 83%) attended only two appointments at the nurse-led clinic – the initial and follow-up appointment – while seven participants (17%) attend one additional clinic appointment during the four-week treatment period to check their self-administration technique.
Most patients demonstrated clinical improvement after self-administering sucralfate enemas twice daily for four weeks. There was an overall reduction of rectal bleeding among participants.
Figure 1 shows participants’ pre-treatment and post-treatment severity of radiation proctitis grade on the EORTC Severity of Radiation Proctitis Scale. The mean grade was 2.55 (SD 0.62) before treatment and 0.47 (SD 0.50) after treatment. The difference in grading before and after treatment was statistically significant.
Figure 2 shows participants’ pre-treatment and post-treatment rectal toxicity grade on the modified RTOG Rectal Toxicity Scale. The mean grade was 2.43 (SD 0.62) before treatment and 0.57 (SD 0.50) after treatment. The difference in grading before and after treatment was statistically significant.
Participants’ need for hospitalisation and interventional treatments had decreased, as shown by the following data:
• Within the 42 participants admitted to hospital before the start of the four-week sucralfate enema treatment programme, 22 (52%) required APC, which decreased to 15 (36%) during the four-week treatment period.
• Within the 42 participants, 14 (33%) had required blood transfusion, which was reduced to seven (17%) during the four-week treatment period.
As opposed to treatments such as APC or formalin instillation, sucralfate enemas are relatively simple and do not require hospital admission. APC has to be performed in an endoscopy unit and involves a colonoscopy, and before treatment patients need to maintain a low-residue or no-residue diet. APC controls bleeding immediately after administration, but the effects are not long-lasting (Sultania et al 2019) and it may be necessary to repeat treatment at intervals of three-to-four weeks. Moreover, patients with a pacemaker or implantable defibrillator, which are susceptible to electrical interference, cannot receive APC without special preparation and preventive measures (Samuels et al 2021). Although APC is currently the first-choice treatment for chronic haemorrhagic radiation proctitis, its indication based on long-term follow-up is still unclear because there are no long-term follow-up data to support its use (Zhong et al 2019).
Topical formalin instillation has to be performed under sedation because it can be complicated and painful. Formalin is an aldehyde and induces coagulative tissue necrosis on contact (Coelho dos Santos Omer et al 2022). The rationale for using formalin in radiation proctitis is that when applied to tissues with actively growing neo-vasculature it induces a chemically mediated necrosis, sclerosing and shutting these vessels (Hayakawa et al 2019, Weiner et al 2016). However, formalin instillation needs to be performed repetitively (Haas et al 2007, Nelamangala Ramakrishnaiah et al 2012) and formalin has more side effects than sucralfate (Dziki et al 2015).
Topical sucralfate works by reducing the extent of microvascular injury and by protecting epithelial surfaces (Sarin and Safar 2013). Sucralfate is a complex salt composed of aluminium hydroxide and sucrose octasulfate, which is primarily used for the treatment of oesophageal and duodenal ulcers (Dziki et al 2015). It creates a protective gel coating that promotes ulcer healing and protects the mucosal lining from further damage and irritation.
Sucralfate is not highly absorbed into the body and is therefore relatively safe to use (www.drugs.com/mtm/sucralfate.html). Sucralfate enemas have minimal adverse effects, including in comparison with hydrocortisone enemas, which contain corticosteroids (Javadi et al 2003).
There are other agents that promote the healing of ulcers, for example omeprazole. Omeprazole has been found to be significantly superior to sucralfate in inducing gastric ulcer healing after four and eight weeks of treatment (Bianchi Porro et al 1998). However, ulcer-healing agents such as omeprazole are not available as an alternative to sucralfate because their effectiveness as enemas for the treatment of radiation proctitis has not been demonstrated. Further studies are needed to explore alternatives to sucralfate for the treatment of radiation proctitis.
As shown in this evaluation, sucralfate enemas self-administered by patients at home can have benefits in terms of reducing healthcare costs. The evaluation demonstrated reductions in hospital admissions, in the use of APC and in blood transfusions. Hospital stays of patients with radiation proctitis admitted for rectal bleeding – including room charges, nursing care and interventions such as APC and blood transfusions – are expensive. By contrast, in the evaluation and at the time of writing, sucralfate enemas cost less than 20 Hong Kong dollars (the equivalent of about £2) per day and per patient.
In this evaluation, the nurse-led education on the self-administration of sucralfate enemas is likely to have supported participants to use the correct techniques, adhere to treatment and obtain good outcomes. Establishing rapport and developing trust with participants and their carers is likely to have helped them establish and maintain the regular self-administration of sucralfate enemas at home. Participants and their carers were also educated on the need to maintain a balanced diet, adequate hydration and regular bowel habits, as well on the need to avoid cigarette smoking and alcohol consumption. Furthermore, they were taught how to prevent rectal bleeding by avoiding straining. Educating patients and reviewing their self-administration technique and adherence to treatment was crucial to avoid complications such as rectal perforation and bleeding (Cirocchi et al 2020).
Nurses have an important role in maximising the outcomes of treatment with sucralfate enemas by enhancing patient self-management and adherence to treatment. For that role, nurses need to be experienced and knowledgeable and possess good communication and counselling skills. Carefully selecting patients who are highly motivated, committed and cooperative for the self-administration of sucralfate enemas can help obtain good outcomes.
Participants were recruited using convenience sampling, however the sample may not have been representative of patients with radiation-induced rectal bleeding.
Recruitment depended on the time, skills and motivation of nurses seeing patients in the colorectal outpatient clinic and on the availability of suitable patients. Furthermore, recruitment was negatively affected by the fact that the evaluation was partly conducted during the coronavirus disease 2019 (COVID-19) pandemic. Therefore, the sample size was small, which affects the generalisability of the findings.
The evaluation did not assess the long-term effectiveness of sucralfate enemas in controlling rectal bleeding and there was no control group of participants who did not receive the intervention or received a different intervention. A well-designed randomised controlled trial is needed to assess the long-term comparative effectiveness of sucralfate enemas for the treatment of rectal bleeding in patients with radiation proctitis.
Sucralfate enemas self-administered by patients at home are a medical treatment option for controlling radiation-induced rectal bleeding. In this prospective service evaluation undertaken at a hospital in Hong Kong, a small sample of patients with radiation proctitis received nurse-led education and then self-administered sucralfate enemas at home twice a day for four weeks. A reduction in rectal bleeding was seen as well as reductions in hospital admissions, in the use of APC and in blood transfusions. As opposed to treatments such as APC or formalin instillation, self-administered sucralfate enemas do not require hospital admission, are less expensive and have minimal adverse effects.
The authors propose that self-administered sucralfate enemas can produce good outcomes provided they are accompanied by optimal nurse-led education to enhance patient self-administration technique and adherence to treatment. Further research is needed to determine the long-term comparative effectiveness of treatment with sucralfate enemas before it can be recommended.
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