|Year : 2019 | Volume
| Issue : 2 | Page : 506-510
Evaluation of the role of sucralfate cream in decreasing pain intensity and improving healing following open hemorrhoidectomy: a randomized controlled study
Yahia M Al Khateeb, Ahmed M Abdel Sattar, Ayman A Al Batanony
Department of General Surgery, Menoufia University Hospital, Menoufia, Egypt
|Date of Submission||20-Nov-2017|
|Date of Acceptance||31-Dec-2017|
|Date of Web Publication||25-Jun-2019|
Yahia M Al Khateeb
Department of General Surgery, Menoufia University Hospital, Menoufia
Source of Support: None, Conflict of Interest: None
The aim was to evaluate the role of sucralfate cream in decreasing postoperative pain intensity and in improving the rate of healing.
Hemorrhoids are one of the common anorectal complaints. Pain after hemorrhoidectomy is usual and multifactorial. Various topical applications were used to reduce pain from the open wound of hemorrhoidectomy. The aim of this study was to evaluate the role of sucralfate cream in decreasing postoperative pain intensity and in improving the rate of healing.
Patients and methods
In this prospective cohort study, all enrolled patients (n = 50) were presented to Menoufia University Hospital from May 2016 to December 2016 with third or fourth degree hemorrhoids and indicated for open hemorrhoidectomy. All surgeries were carried out by two consultant surgeons using the same technique. After the end of surgery, the patients were randomly assigned into two groups. Sucralfate group (n = 25) received topical 8% sucralfate cream. The placebo group (n = 25) received topical placebo.
Postoperative pain at day 1, the mean visual analog scale in the sucralfate group was significantly lower than the placebo group (5.72 vs. 8.20, P < 0.001). After 4 weeks, the degree of wound healing was significantly higher in the sucralfate group (P = 0.0001).
Sucralfate cream may be effective in reducing postoperative pain associated with open hemorrhoidectomy and it can improve the rate of wound healing.
Keywords: hemorrhoidectomy, postoperative pain, sucralfate, wound healing
|How to cite this article:|
Al Khateeb YM, Abdel Sattar AM, Al Batanony AA. Evaluation of the role of sucralfate cream in decreasing pain intensity and improving healing following open hemorrhoidectomy: a randomized controlled study. Menoufia Med J 2019;32:506-10
|How to cite this URL:|
Al Khateeb YM, Abdel Sattar AM, Al Batanony AA. Evaluation of the role of sucralfate cream in decreasing pain intensity and improving healing following open hemorrhoidectomy: a randomized controlled study. Menoufia Med J [serial online] 2019 [cited 2019 Sep 16];32:506-10. Available from: http://www.mmj.eg.net/text.asp?2019/32/2/506/260919
| Introduction|| |
Hemorrhoids are one of the common anorectal complaints. Hemorrhoids are defined as 'a symptomatic enlargement and distal displacement of the normal anal cushions'. It affects millions of people, and represents a major medical and socioeconomic problem.
Multiple factors were found in the etiology of hemorrhoidal development, including constipation and prolonged straining. The abnormal dilatation and distortion of the vascular channel with destructive changes in the supporting connective tissue within the anal cushion were an important finding of hemorrhoidal disease. The inflammatory reaction and vascular hyperplasia may be evident in hemorrhoids.
Although hemorrhoids were recognized as a common cause of rectal bleeding and anal discomfort, the true epidemiology of this disease is still unknown as patients have a tendency to use self-medications rather than seeking proper medical attention. Johanson et al. showed that about 10 million people in the USA complained of hemorrhoids (with a prevalence rate of 4.4%). In both sexes, peak prevalence occurred between the age of 45–65 years and the development of hemorrhoids before the age of 20 years was uncommon. Whites and higher socioeconomic status individuals were affected more frequently than others. However, this association may reflect differences in health seeking behavior not a true prevalence.
Treatment of hemorrhoids depends mainly on the stage of the disorder and symptoms. Hemorrhoidectomy is considered an effective method for third and fourth degree symptomatic hemorrhoids. Many surgical techniques have been proposed; however, open hemorrhoidectomy is still the most common performed operation for hemorrhoids.
Hemorrhoidectomy is associated with pain during the postoperative period. Pain after hemorrhoidectomy is usual and multifactorial, which is dependent on the surgical technique, anesthesia, postoperative analgesia, and individual tolerance. The two most main factors for this pain are discomfort from the surgical wound in the sensitive anoderm and perianal skin and the edema from tissue inflammation around the wound. Ligasure hemorrhoidectomy is associated with less postoperative pain, shorter hospitalization, faster wound healing, and convalescence compared with scissors or diathermy hemorrhoidectomy, but much more expensive.
Various topical applications were used to reduce pain from the open wound of hemorrhoidectomy with variable outcomes. It included metronidazole, local anesthetics, and other formulations. Sucralfate is 'a basic aluminum salt of sucrose octa-sulfate'. When applied to a wound, it absorbs bile salts and forms insoluble adherent complexes, which protect the wound from mechanical damage and prevent the release of inflammatory cytokines from damaged epithelial cells, resulting in pain reduction. Topical sucralfate has been found to have antibacterial activity and it was usually used in burns,,. The aim of this study was to evaluate the role of sucralfate cream in decreasing postoperative pain intensity and in improving healing after open hemorrhoidectomy.
| Patients and Methods|| |
After approval of IRB of Menoufia Faculty of Medicine (ethic committee) Department of General Surgery, informed consent was taken from all patients. After sample size calculation using Epi-info 7 software Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia (USA). a sample of 25 patients would be needed in each group to demonstrate a reduction of 20% in the overall rate of wound healing with a power of 80% at 95% confidence level.
This prospective randomized controlled trial was conducted on 50 patients (n = 50). All enrolled patients were presented to Menoufia University Hospital with third or fourth degree hemorrhoids and indicated for open hemorrhoidectomy. Inclusion criteria were the indication for open hemorrhoidectomy and surgery conducted following the standard Milligan–Morgan technique. Exclusion criteria included presence of concomitant anal or rectal pathologies (e.g. abscess, fistulae, prolapse, etc.), age younger than 21 years or older than 60 years and previous treatment with local ointment or surgery. Patients with debilitating disease (such as diabetes mellitus, cancer, severe anemia, hypoalbuminaemia, or immunocompromised) were also excluded.
All surgeries were carried out by two consultant surgeons, using the technique described by Kirk. All enrolled patients after the end of surgery were randomly (even–odd randomization according to their number of enrollment) assigned into two groups. The sucralfate group (25 patients) received topical 8% sucralfate cream in petrolatum (prepared under aseptic technique). The placebo group (25 patients) received topical placebo cream of petroleum jelly. Patients were instructed to apply a fixed amount of the cream (sucralfate or placebo) on the surgery site three times daily. Both creams were impossible to differentiate.
All participants received written instructions on postoperative wound care and a demonstration on the proper way to apply the topical treatment. Both groups were asked to avoid using any other antiseptics. As standard therapy, all patients received diclofenac sodium 50 mg tablets to be taken three times daily and metronidazole 250 mg tablets to be taken two times daily for 7 consecutive days after the operation. All patients were discharged on the first postoperative day and called every week by an independent consultant surgeon who was blinded to their treatment groups for follow-up and examination until complete wound healing achieved.
Postoperative pain was evaluated using the visual analog pain score scale, where pain was recorded by the patients in both groups by the end of day 1, week 1, and week 2 in a diary that was provided to them. Patients rated the level of pain from score 0 (no pain) to 10 (the severest pain could be imagined). The secondary outcome of the study was the proportion of patients with wounds that were completely healed at the end of fourth week after operation. Wounds that were fully epithelialized with no discharge were judged to be completely healed. The amount of mucosal covering of the wound was recorded according to a numerical scoring system at each visit for a maximum of 4 weeks or until complete wound healing occurred. Pain on defecation was also recorded on first passage of stool, by the end of first and second weeks. After 4 weeks, the degree of wound healing was recorded as inadequate, adequate, or complete healing.
Data were fed to the computer and analyzed using IBM SPSS Software Package Version 20.0 (International Business Machines Corporation (IBM) in Armonk, New York (USA)). Difference in categorical data was compared using the χ2-test. Continuous data were compared using Student's t-test. These data were represented as mean and SD. The Mann–Whitney U-test was used to assess the significance of differences between the groups regarding pain scores, which were expressed as medians and ranges (minimum and maximum). A P value of less than 0.05 was considered significant.
| Results|| |
Regarding demographic data and basic characteristics, 50 patients were enrolled in this study: 23 men and 27 women. The mean age was 41.28 years. There were no any significant differences between the two groups in age (P = 0.330) or sex (P = 1.000). There were not any significant differences between the two groups in basic characteristics as the degree of hemorrhoids (P = 0.475) or number of piles removed during surgery (P = 0.303) [Table 1].
|Table 1: Comparison between the two studied groups according to demographics and basic characteristics|
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Regarding the main study primary outcome, postoperative pain, it was assessed using the visual analog scale. At day 1, the mean visual analog scale (VAS) in the sucralfate group was significantly lower than the placebo group (5.72 vs. 8.20, P < 0.001). Then, the mean VAS in the sucralfate group was significantly lower than the placebo group (P < 0.001) [Table 2] and [Figure 1].
|Table 2: Comparison between the two studied groups according to visual analog pain score scale for postoperative pain|
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|Figure 1: The mean visual analog scale (VAS) in the sucralfate group was significantly lower than the placebo group (P < 0.001).|
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Regarding secondary outcomes, pain on defecation assessment using VAS showed that the mean VAS after first passage of stool in the sucralfate group was significantly lower than the placebo group (5.92 vs. 8.64, P < 0.001). Then, the mean VAS in the sucralfate group was significantly lower than the placebo group (P < 0.001) [Table 3]. After 4 weeks of follow-up, the degree of wound healing results showed that 68% of patients in the sucralfate group achieved complete healing whereas only 16% in the placebo group. The degree of wound healing showed statistically significant differences between the two groups in favor of the sucralfate group (P = 0.0001) [Table 4].
|Table 3: Comparison between the two studied groups according to visual analog score scale for pain during defecation|
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|Table 4: Comparison between the two studied groups according to degree of wound healing after 4 weeks|
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| Discussion|| |
Various factors may be responsible for postoperative pain after open hemorrhoidectomy such as incarceration of smooth muscle fibers and mucosa in the transfixed vascular pedicle and spasm of the internal sphincter. The development of linear wounds which appear similar to those of chronic anal fissure may also contribute.
In this study, postoperative pain was assessed using the visual analog scale. At day 1, the mean VAS in the sucralfate group was significantly lower than the placebo group (5.72 vs. 8.20). Then, the mean VAS in the sucralfate group was significantly lower than the placebo group till the end of the first and second weeks of study. Pain on defecation was also assessed using VAS; the results have shown that the mean VAS after first passage of stool in the sucralfate group was significantly lower than the placebo group (5.92 vs. 8.64). Then, the mean VAS in the sucralfate group was significantly lower than the placebo group till the end of the study.
These results were comparable to the results in a study by Gupta et al. which reported that the postoperative pain scores were lower for sucralfate than for placebo at each weekly assessment. The differences were statistically significant at the first week (3.7 vs. 6.1) and at the second week (1.6 vs. 3.1). Huang et al. and Eshghi et al. reported that the mean postoperative pain scores at the first week were 4 and 5.2, respectively, and at second week were 3 and 2.56, respectively. But, a higher score was reported by Pokharel et al. which was 6.9 without any topical treatment.
Ala et al. studied 48 patients after open hemorrhoidectomy, the sucralfate group showed a significant lower pain than the placebo group at 24th hour and at the 48th hour (4 ± 1.14 vs. 5.08 ± 0.97 and 3 ± 0.72 vs. 4.41 ± 0.8, respectively), and they consumed lower amounts of analgesics at the same time intervals (12.50 ± 16.48 vs. 21.87 ± 15.30 mg of pethidine and 152 ± 23 vs. 172 ± 29 mg of diclofenac, respectively).
In this study, by the end of the fourth week, the proportion of wound healing was significantly greater for the sucralfate group than for the placebo; complete wound healing occurred in 17 patients out of the 25 patients (68%) in the sucralfate group compared with only four patients out of the 25 patients (16%) in the placebo. Inadequate wound healing was seen in only 8% of the sucralfate group, whereas it was in 56% in patients of the placebo group.
Previous studies have shown that local sucralfate may increase the rate of wound healing after open hemorrhoidectomy. These results were comparable to the results of Gupta et al. which reported that by the end of the sixth week, complete wound healing achieved in all patients in the sucralfate group. Jóhannsson et al. and Arroya et al. showed healing rates of 80 and 70%, respectively, and the wound healing was between 6 and 8 weeks. Hwang et al. showed a complete wound healing at the sixth week follow-up after open hemorrhoidectomy. But, Malik et al. observed that complete wound healing occurred in all cases by the end of the sixth week using the standard therapy.
Sucralfate has long been known as an antiulcer drug. Topical form has been successfully studied in peristomal and perianal dermatoses, perineal ulcerations, vaginal ulceration, in second and third degree burns. Sucralfate was found to be effective in reducing pain in oral ulcers, ENT surgery, radiation proctitis, rectal ulcers, and burns. The diminished pain after sucralfate 8% application cream was probably related to diminished tissue edema and faster epithelization of the hemorrhoidectomy wounds.
Sucralfate acts as a protective mechanical barrier at sites of tissue injury, antibacterial, and may have angiogenic properties, as it is structurally similar to heparin. There is an evidence that sucralfate can promote local synthesis of prostaglandin E2 at the wound site, increasing blood flow, mitotic activity, and surface migration of cells. Application of it was shown to stimulate increased granulation tissue, new vascular tissue, and new collagen formation. Sucralfate also may activate the nitric oxide which cooperates in the protective action and may contribute to mucosal integrity and preservation of mucosal microcirculation.
Sucralfate has a multimodal action. It attaches to proteins on the surface of ulcers (as albumin and fibrinogen) to form stable insoluble complex. This complex serves as protective barriers at the ulcer surface to prevent further damage through prevention of the release of cytokines from damaged cells. Recently, evidence has shown that sucralfate can stimulate the increase of the b-fibroblast growth factor. Basic fibroblast growth factor can stimulate the production of granulation tissue, angiogenesis, and re-epithelization. That may lead to improve the quality of ulcer healing.
This study has some limitations. The used randomization technique (even/odd) is prone to selection bias and violation of allocation concealment. Further studies should consider large sample sizes and a more advanced randomization technique to avoid confounding and such selection bias.
| Conclusion|| |
Topical 8% sucralfate cream may be effective in reducing postoperative pain associated with open hemorrhoidectomy and it can improve the rate of wound healing. Our recommendations are further studies with different strength and doses of sucralfate cream, focusing on the reduction of oral analgesic doses when used with topical sucralfate.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]