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Anorectal surgery, postoperative pain, wound healing, haemorrhoids, fistula, anal fissures
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Agarwal N. Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:659 (https://doi.org/10.12688/f1000research.131836.1)
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Research Article
Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study
[version 1; peer review: 2 approved with reservations]
PUBLISHED 13 Jun 2023
OPEN PEER REVIEW
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Abstract
Corresponding author:
Niranjan Agarwal
Competing interests:
The author received a research grant from Abbott India Ltd. for the conduct of the study. The author is an independent clinician and approached Abbott India Ltd. for a grant and that this is the only relation the author has with the company.
Grant information:
The study was funded by Abbott India Ltd.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Copyright:
© 2023 Agarwal N.
This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Agarwal N. Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:659 (https://doi.org/10.12688/f1000research.131836.1)
First published: 13 Jun 2023, 12:659 (https://doi.org/10.12688/f1000research.131836.1)
Latest published: 13 Jun 2023, 12:659 (https://doi.org/10.12688/f1000research.131836.1)
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Introduction
Anorectal conditions are commonly seen in clinical settings and patients usually present with rectal pain, rectal bleeding, or purulent discharge.1 Common anorectal conditions include haemorrhoids, anal fissures, and anal fistulae. About 10 million people suffer from haemorrhoids every year. A study estimated that >50% of the US population aged above 50 years has experienced haemorrhoids. The common symptoms of haemorrhoids include painless rectal bleeding, itching, soiling, perianal irritation, or mucus discharge. Patients with grade 4 haemorrhoids or those in whom conservative treatment has failed require surgery.2 The overall prevalence of haemorrhoids is estimated to be 38.9%, with grades III and IV occurring in 8.16% and 0.53% of people, respectively.3 An anal fissure is an elongated ulcer in the longitudinal axis of the lower anal canal. Symptoms of anal fissure include pain on defecation, bright red bleeding, mucus discharge, and constipation. The pain causes contraction of the internal anal sphincter, which leads to further pain, especially during defecation.4 Many patients do not respond to conservative management, and surgery is necessary.5 A fistula-in-ano is a tract lined by epithelium, connecting the anal canal to the perianal skin. It usually occurs following an anorectal abscess. It requires surgical treatment in the majority of cases.6
Among patients undergoing anorectal surgeries, postoperative pain is common, which can be quite severe and delay return to daily activities. The causes of postoperative pain include internal anal sphincter spasm, inflammation, and bacterial contamination of the operative site; the cause of pain can also depend on the type of surgery.3,7 Opioids and non-steroidal anti-inflammatory drugs (NSAIDs) used for pain control have short duration of action and several adverse effects.3 Topical preparations are preferable because of better bioavailability and fewer adverse effects.7 Various topical applications have been used for pain control following anorectal surgery, e.g., botulinum toxin, calcium channel blockers, glyceryl trinitrate, local anaesthetics, metronidazole, opioids, sucralfate, and others, but their reported outcomes are variable.8 Metronidazole acts against enteric anaerobes, which can colonize the wound after haemorrhoidectomy leading to inflammatory pain. Sucralfate is the aluminium hydroxide salt of the disaccharide sucrose octasulphate. It has been used as a cytoprotective agent for the treatment of gastrointestinal ulcers. It has antimicrobial and antioxidant activity and stimulates prostaglandin E2 (PGE2) secretion leading to increased blood flow and mucus formation. It also enhances the production of epidermal growth factor (EGF), leading to increased angiogenesis.8 Lidocaine, a local anaesthetic agent, has analgesic and anti-inflammatory properties.10 While there are individual studies on the efficacy and safety of sucralfate, metronidazole, and lidocaine local applications in the management of postoperative symptoms after anorectal surgery, there are no studies on the outcomes using all the three drugs together as a single local application.
We evaluated the effectiveness and safety of a topical fixed-dose combination (FDC) of sucralfate 7% w/w, metronidazole 1% w/w, and lignocaine hydrochloride 4% w/w in the management of postoperative pain, itching, bleeding, burning and improving wound healing, following surgery for anorectal disorders (haemorrhoids, fistula, and anal fissures).
Methods
Study design
This was a prospective, single-arm, single-centre study (CTRI/2020/11/029298) conducted between December 2020 and December 2021 at the Salasar Nursing Home, Thane, Maharashtra, India. The study was conducted as per good clinical practices (GCP) and the applicable national regulations to ensure that the rights, safety, and well-being of all participants were protected, and in accordance with the ethical principles in the Declaration of Helsinki. The study protocol and the informed consent form were reviewed and approved by Suraksha Institutional Ethics Committee before the initiation of the study. The study has been registered in Cinical Trials Registry of India (CTRI) on 23 November 2020 (registration number: CTRI/2020/11/029298; https://ctri.nic.in/Clinicaltrials/showallp.php?mid1=49047&EncHid=&userName=CTRI/2020/11/029298). All patients provided written informed consent for participation in the study.
The total duration of the study was 6 weeks (± 5 days). Patients enrolled were prescribed topical FDC of sucralfate 7% w/w, metronidazole 1% w/w, and lignocaine hydrochloride 4% w/w (Cremagel Ano, Abbott India Limited), following surgery for anorectal disorders (haemorrhoids, fistula, and anal fissures), for a period of 6 weeks post-surgery. The ointment was to be applied with a special applicator after cleaning the affected area with mild soap and warm water, rinsing thoroughly, and pat drying. The number of applications of study medication was per physician discretion depending on the condition of the patient. Patients were followed up at weeks 3 and 6.
Eligibility criteria
Males and females aged 18-64 years undergoing surgery for haemorrhoids, fistulae, and/or anal fissures were recruited. All subjects provided signed informed consent for participation in the study.
The exclusion criteria were history of inflammatory bowel disease, multiple fistulae, perianal dermatitis, proctitis, pulmonary or cardiovascular complications, poorly controlled diabetes mellitus; presence of anal fistulae or fissures due to causes such as Crohn’s disease, anal suppuration, and abscesses; <2 weeks of chemotherapy history; diagnosis of active cancer, severe anaemia, hypoalbuminemia, immunocompromised status; and history of hypersensitivity to any of the ingredients of the study product, namely, metronidazole, lignocaine hydrochloride, sucralfate, or any other ingredient in the study formulation. Additionally, patients with conditions/diseases that the investigator considered inappropriate for a patient to participate in the study, those on class I anti-arrhythmic drugs or anticoagulant treatment, pregnant and lactating females, patients unwilling to undergo an examination of anal wounds and/or patients with the inability or unwillingness to comply with the study protocol were excluded from the study.
Study endpoints
The primary effectiveness endpoints of the study were 1) proportion of patients achieving minimal clinically important difference (MCID), defined as ≥10-point reduction on a 100 mm visual analogue scale (VAS), and 2) mean reduction in anal pain intensity as measured by the 100 mm VAS (0 = absence of pain to 10 = worst possible pain), from baseline to 3 and 6 weeks after surgery.
The secondary effectiveness endpoints were 1) proportion of patients achieving complete wound healing (defined as fully epithelialized wounds with no discharge), at 3 and 6 weeks after surgery; and 2) mean reduction in the intensity of itching sensation (evaluated on a 5-point scale from 1 = absent to 5 = unbearable), burning sensation (evaluated on a 4-point scale from 0 = no symptoms to 3 = severe symptoms), and bleeding score (calculated as the sum of frequency score [ranging from <1 episode in 2 weeks to >5 episodes in 1 week] and amount of bleeding score [ranging from 1 = non-existent to 4 = severe]), at 3 and 6 weeks after surgery.
Safety endpoints included incidence of all treatment-emergent adverse events (AEs), serious AEs, and AEs leading to treatment discontinuation throughout the study and global tolerability as assessed by patients and investigators at 3 and 6 weeks after surgery.
Statistical analysis
As this was a pilot study, no formal sample size calculation was performed. The intention-to-treat (ITT) population included all patients who were enrolled and assigned to the study medication. The safety population consisted of all patients who received at least 1 dose of the FDC. The per-protocol (PP) population included all patients who completed all the study visits as per protocol without major protocol deviations. Qualitative and quantitative variables are presented using descriptive statistics. Qualitative data are presented as numbers (n) and percentages (%) and quantitative data as n, mean and standard deviation (SD). Quantitative variables were further evaluated using paired t-test at a 5% level of significance. Data were analysed using R-studio (version: 4.2.1; RRID:SCR_000432; https://scicrunch.org/resolver/SCR_000432). The software was used for data analysis tabulation and primarily for modelling and hypothesis testing.
Results
Demographics and baseline characteristics
Of 52 screened patients, 50 (males:females = 29:21) with a mean (SD) age of 41.8 (10.93) years, who underwent surgery for anorectal disorders at our hospital, were enrolled in the study. All patients completed the study as per protocol and were included in the ITT, safety, and PP populations. Of the 50 patients, 9 (18.0%) underwent haemorrhoidectomy, 13 (26.0%) underwent surgery for anal fissure, and 28 (56.0%) underwent fistulectomy. The demographic and baseline characteristics of enrolled patients are summarized in Table 1.
Table 1. Patient demographics and baseline characteristics – safety population.
Effectiveness of the FDC
All patients achieved MCID i.e. at least 10-point reduction in VAS score at week 3 itself, and it was maintained till the end of the study visit at 6 weeks. Mean anal pain scores at postoperative weeks 3 and 6 in the total cohort and according to the type of surgery are presented in Figure 1. Compared to the baseline mean (SD) VAS score of 68.6 (14.2), there was a significant reduction by 38.9 (15.3; p < .001) and by 63.6 (14.1; p < .001) at weeks 3 and 6, respectively. Among patients who underwent haemorrhoidectomy, the mean (SD) anal pain score also reduced significantly by 36.5 (18.8; p < .001) and by 59.4 (20.3; p < .001) at weeks 3 and 6, respectively. It reduced by 43.5 (15.9; p < .001) and by 71.7 (9.3; p < .001) at weeks 3 and 6, respectively, in patients who underwent surgery for anal fissures. In patients who underwent fistulectomy, the mean (SD) pain score reduced by 37.6 (14.0; p < .001) and by 61.2 (12.6; p < .001) at weeks 3 and 6, respectively.
Figure 1. Change in anal pain score from baseline to 3 and 6 weeks after surgery – ITT population.
Mean (SD) anal pain intensity score on VAS at baseline and weeks 3 and 6 following treatment in overall cohort and by type of anorectal surgery.
*** indicates p < 0.001 by paired t-test at week 3 or week 6 versus baseline.
ITT, intention to treat; SD, standard deviation.
The mean scores for itching, bleeding, and burning also reduced significantly in the total cohort and in the subgroups at week 3 and 6 post-surgery (Table 2). Compared to the baseline mean (SD) score of 3.0 (0.99), the itching score reduced significantly (p < .001) by 1.1 (1.06) and 1.8 (1.07) at weeks 3 and 6, respectively. In patients who underwent haemorrhoidectomy, the mean (SD) itching score reduced significantly by 1.0 (1.22; p < .05) and 1.4 (1.24; p < .01); in those who underwent fissurectomy, the score reduced by 1.6 (0.96; p < .001) and 2.5 (0.88; p < .001) and in those who underwent fistulectomy, it reduced by 0.8 (0.98; p < .001) and 1.6 (0.96; p < .001) at weeks 3 and 6, respectively.
Table 2. Change in itching, bleeding, and burning scores from baseline to 3 and 6 weeks after surgery – ITT population.
| Parameter | Baseline Mean (SD) | Week 3 Mean (SD) | Difference Mean (SD) | P valuea | Week 6 Mean (SD) | Difference Mean (SD) | P valuea |
|---|---|---|---|---|---|---|---|
| Itching score | |||||||
| Overall (50) | 3.0 (0.99) | 1.9 (0.68) | −1.1 (1.06) | <.001 | 1.2 (0.40) | −1.8 (1.07) | <.001 |
| Haemorrhoids (09) | 2.4 (1.24) | 1.4 (0.53) | −1.0 (1.22) | <.05 | 1.0 (0.00) | −1.4 (1.24) | <.01 |
| Anal fissure (13) | 3.6 (0.77) | 2.0 (0.41) | −1.6 (0.96) | <.001 | 1.1 (0.28) | −2.5 (0.88) | <.001 |
| Fistulae (28) | 2.9 (0.88) | 2.1 (0.77) | −0.8 (0.98) | <.001 | 1.3 (0.48) | −1.6 (0.96) | <.001 |
| Bleeding score | |||||||
| Overall (50) | 5.9 (1.87) | 2.8 (0.97) | −3.1 (1.76) | <.001 | 2.0 (0.14) | −3.9 (1.88) | <.001 |
| Haemorrhoids (09) | 7.4 (1.24) | 2.6 (1.13) | −4.9 (1.36) | <.001 | 2.0 (0.00) | −5.4 (1.24) | <.001 |
| Anal fissure (13) | 6.4 (1.66) | 2.9 (0.95) | −3.5 (1.56) | <.001 | 2.1 (0.28) | −4.3 (1.70) | <.001 |
| Fistulae (28) | 5.2 (1.81) | 2.8 (0.94) | −2.4 (1.52) | <.001 | 2.0 (0.00) | −3.2 (1.81) | <.001 |
| Burning score | |||||||
| Overall (50) | 2.8 (0.90) | 1.7 (0.52) | −1.2 (0.98) | <.001 | 1.2 (0.39) | −1.6 (0.90) | <.001 |
| Haemorrhoids (09) | 2.3 (1.00) | 1.8 (0.44) | −0.6 (1.24) | >.05 | 1.0 (0.00) | −1.3 (1.00) | <.01 |
| Anal fissure (13) | 3.4 (0.51) | 1.6 (0.51) | −1.8 (0.73) | <.001 | 1.1 (0.28) | −2.3 (0.63) | <.001 |
| Fistulae (28) | 2.7 (0.90) | 1.6 (0.56) | −1.1 (0.86) | <.001 | 1.3 (0.46) | −1.4 (0.84) | <.001 |
The mean (SD) bleeding score at baseline was 5.9 (1.87), which decreased significantly (p < .001) by 3.1 (1.76) at week 3 and by 3.9 (1.88) at week 6. Compared to the baseline score, the mean (SD) bleeding score at weeks 3 and 6 reduced significantly (p < .001) by 4.9 (1.36) and 5.4 (1.24) in patients who underwent haemorrhoidectomy, by 3.5 (1.56) and 4.3 (1.70) in those who underwent fissurectomy, and by 2.4 (1.52) and 3.2 (1.81) in those who underwent fistulectomy, at weeks 3 and 6, respectively (Table 2).
The mean (SD) burning score also reduced significantly (p < .001) by 1.2 (0.98) at week 3 and by 1.6 (0.90) at week 6, compared to the baseline score of 2.8 (0.90). The mean (SD) burning score decreased by 0.6 (1.24; p > .05) at week 3 and by 1.3 (1.00; p < .01) at week 6 in patients who underwent haemorrhoidectomy. The score also reduced significantly (p < .001) in those who underwent fissurectomy by 1.8 (0.73) and 2.3 (0.63) and in those who underwent fistulectomy by 1.1 (0.86) and 1.3 (0.46), at weeks 3 and 6, respectively (Table 2).
Wound healing was evaluated at weeks 3 and 6. Two (4.0%) patients had complete wound healing at week 3 and this number increased to 20 (40.0%) patients at end of 6 weeks (Table 3).
Table 3. Proportion of patients with complete wound healing at 3 and 6 weeks after surgery – ITT population.
Discussion
The results of our study showed a significant decrease in postoperative anal pain score at weeks 3 and 6 with a topical application of an FDC of sucralfate 7% w/w, metronidazole 1% w/w, and lignocaine hydrochloride 4% w/w in patients undergoing anorectal surgery. The decrease in pain score was seen in the total cohort as well as in subgroups of patients undergoing haemorrhoidectomy, fistulectomy, and surgery for anal fissures. All 50 patients enrolled in the study achieved MCID at week 3.
The topical application of sucralfate ointment once or twice daily for two weeks post-haemorrhoidectomy has been reported to significantly reduce pain and decrease the time to wound healing compared with a placebo ointment.9 A study in 2017 compared outcomes of topical 8% sucralfate cream versus placebo in patients undergoing haemorrhoidectomy. On postoperative day 1, the mean VAS score in the sucralfate group was significantly lower than that in the placebo group (5.72 vs. 8.20; p < 0.001). The mean VAS after first defecation was significantly lower in the sucralfate group than in the placebo group (5.92 vs. 8.64).11 Another study reported that in patients undergoing haemorrhoidectomy, those in the sucralfate group had significantly less pain and consumed fewer analgesics (narcotic and nonsteroidal) on postoperative days 1, 7 and 14 than patients in the control group (p < 0.001).3 Similarly, results from another study found that patients in the sucralfate group had significantly less pain than those in the placebo group at 24 h and the 48 h after haemorrhoidectomy, and patients in the sucralfate group required a lesser amount of analgesics during the same period.12 A comparison of topical applications of sucralfate, lidocaine, and placebo in patients undergoing haemorrhoidectomy showed that the pain outcomes on postoperative days 1, 3, 7, 14, 21, and 28 were best with sucralfate followed by lidocaine. Despite being inferior to sucralfate, lidocaine ointment did reduce pain intensity compared with the placebo group.8 Another study compared the outcomes of topical cream containing lidocaine 2.5% and prilocaine 2.5% (EMLA group) versus placebo in patients undergoing haemorrhoidectomy. The VAS score and frequency and dosage of meperidine injections as rescue medication for uncontrolled pain were significantly lower in the EMLA group than in the placebo group (p < 0.01). The voiding time was significantly delayed in the placebo group (p = 0.04). Furthermore, the frequency of single catheterization was significantly lower in the EMLA group than in the control group (p = 0.03), and patient satisfaction with postoperative pain control was significantly higher in the EMLA.13
A systematic review and meta-analysis of four RCTs including 149 patients (76 treated with 10% metronidazole ointment and the others with placebo) reported that metronidazole significantly reduced post-haemorrhoidectomy pain throughout the first two weeks postoperatively. The mean difference in the VAS score for pain between the groups was -2 to -1.9 Results of a review of 13 studies in which oral or topical metronidazole was used after haemorrhoidectomy revealed that pain score decreased at all time points with both oral and topical metronidazole. However, postoperative pain score and analgesic consumption were lower in the topical metronidazole group.14 In another study, it was reported that topical application of metronidazole 10% significantly reduced discomfort after haemorrhoidectomy up to 14 days and eased postoperative pain during defecation compared with placebo.15 A significant reduction of post-haemorrhoidectomy discomfort and edema after using topical metronidazole 10% has also been reported.16 A study in which topical metronidazole was used in patients with “fissurectomy” wounds reported good results.17 However, studies conducted in the last two decades on the topical use of sucralfate, metronidazole, or lidocaine post fissurectomy are scarce.
The itching, bleeding, and burning scores in our study also reduced significantly in the overall cohort and in the three subgroups. The decrease in burning score at week 3 in patients who underwent haemorrhoidectomy was not statistically significant; however, it was statistically significant at week 6. We were unable to find studies that have reported the outcomes of these symptoms with local applications of sucralfate, metronidazole, or lidocaine except one, in which the authors reported that application of topical metronidazole in postoperative anorectal wounds after haemorrhoidectomy and fistulectomy increased the risk of bleeding. Though most of the episodes were controlled with conservative management, they caused considerable patient anxiety and apprehension.18
Out of our total cohort of 50 patients, 9 (18.0%) underwent haemorrhoidectomy, 13 (26.0%) underwent surgery for anal fissures, and 28 (56.0%) underwent fistulectomy. There are few studies on the efficacy of topical sucralfate, metronidazole, or lidocaine post-fistulectomy; most studies have been conducted in patients undergoing haemorrhoidectomy. A study in 2011 evaluated the effectiveness and safety of topical sucralfate in wound healing after anal fistulectomy. At 6-week follow-up, mucosal coverage of the wound was significantly greater with sucralfate than with placebo (p = 0.01). Postoperative pain scores were significantly lower with sucralfate than with placebo at 2 and 4 weeks.19 Similarly, a study in 2016 reported that in patients undergoing fistulectomy, patients in the sucralfate group had significantly less pain at rest and on defecation than those in the placebo group from weeks 1 to 5.20
In our study two (4.0%) patients had complete wound healing at week 3 and this number increased to 20 (40.0%) at the end of 6 weeks. However, this is lower than that in the study by Gupta et al. who reported complete wound healing after fistulectomy in 95% of patients in the sucralfate group and 73% in the placebo group (p = 0.009) at 6 weeks.19 Another study also reported a wound healing rate of 82.2% at 28 days with topical sucralfate in patients undergoing haemorrhoidectomy.3 Yet another study reported complete wound healing in 5.9 (0.8) weeks in the sucralfate group in patients undergoing fistulectomy.20 The lower rate of wound healing in our study might be explained by the varying frequency of application of the treatment in different patients. It has been reported that a 6-hourly application has better outcomes compared to those with a 12-hourly application.8
There are some limitations to our study. The sample size of the study was small. Additionally, we had no comparative groups. Furthermore, we captured outcomes only at 3 and 6 weeks. Capturing outcomes early after surgery might have provided insights on the effect of this FDC in the acute postoperative phase. Lastly, the number of applications per day were variable, which might have affected the outcomes. Hence, further studies with larger sample sizes and addressing the above limitations are necessary. Nevertheless, considering that there are few studies on the effect of topical applications of drugs in this FDC in patients undergoing fissurectomy or fistulectomy, our study makes a valuable contribution to the literature.
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how to cite this article
Agarwal N. Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:659 (https://doi.org/10.12688/f1000research.131836.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
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PUBLISHED 13 Jun 2023
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How to cite this report:
Rudiman R. Reviewer Report For: Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:659 (https://doi.org/10.5256/f1000research.144719.r192772)
The direct URL for this report is:
https://f1000research.com/articles/12-659/v1#referee-response-192772
https://f1000research.com/articles/12-659/v1#referee-response-192772
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 31 Aug 2023
Approved with Reservations
VIEWS 17
Being a single study with no comparative group, the main flaw of the study is whether the outcome variables are resulting solely on the effects of the experimental drug, or it may also results from naturally healed anorectal surgery wounds.
... Continue reading
... Continue reading
CITE
HOW TO CITE THIS REPORT
Rudiman R. Reviewer Report For: Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:659 (https://doi.org/10.5256/f1000research.144719.r192772)
The direct URL for this report is:
https://f1000research.com/articles/12-659/v1#referee-response-192772
https://f1000research.com/articles/12-659/v1#referee-response-192772
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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How to cite this report:
Mantoo S. Reviewer Report For: Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:659 (https://doi.org/10.5256/f1000research.144719.r179224)
The direct URL for this report is:
https://f1000research.com/articles/12-659/v1#referee-response-179224
https://f1000research.com/articles/12-659/v1#referee-response-179224
NOTE: it is important to ensure the information in square brackets after the title is included in this citation.
Reviewer Report 03 Jul 2023
Surendra Mantoo,
Department of Surgery, Khoo Teck Puat Hospital, Singapore, Singapore
Approved with Reservations
VIEWS 23
This is a prospective, single-arm, single-centre study with no control group. It is hard to draw any conclusions that whether the perceived benefit of the investigated topical application is a placebo effect or a real benefit to the patient. Most patients
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HOW TO CITE THIS REPORT
Mantoo S. Reviewer Report For: Outcomes of a fixed-dose combination of sucralfate, metronidazole, and lidocaine in patients undergoing anorectal surgery: Results from a prospective, single-centre study [version 1; peer review: 2 approved with reservations]. F1000Research 2023, 12:659 (https://doi.org/10.5256/f1000research.144719.r179224)
The direct URL for this report is:
https://f1000research.com/articles/12-659/v1#referee-response-179224
https://f1000research.com/articles/12-659/v1#referee-response-179224
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Author Response 25 Aug 2023Niranjan Agarwal, Salasar Nursing Home, Thane, India25 Aug 2023Author ResponseWe agree with the reviewer that patients will experience reduced discomfort as time progresses in the post-operative period.
While there are individual studies on the efficacy and safety of ... Continue reading
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Author Response 25 Aug 2023Niranjan Agarwal, Salasar Nursing Home, Thane, India25 Aug 2023Author ResponseWe agree with the reviewer that patients will experience reduced discomfort as time progresses in the post-operative period.
While there are individual studies on the efficacy and safety of ... Continue reading
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