Short – Term Outcome After Use of Perianal Cleansing Cream After Open Diathermy Hemorrhoidectomy: a Single Center Retrospective Study on a Consecutive Cohort of Patients

doi:10.21203/rs.3.rs-3800281/v1

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Short – Term Outcome After Use of Perianal Cleansing Cream After Open Diathermy Hemorrhoidectomy: a Single Center Retrospective Study on a Consecutive Cohort of Patients

https://doi.org/10.21203/rs.3.rs-3800281/v1

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Background

The healing of hemorrhoidectomy wounds is a main concern of surgeons and patients. Various modalities can improve the quality of wound care after surgery. Several types of surgery, antibiotics and topical agents, such as solutions and ointments, have been evaluated. The current research investigates the effects of cleansing cream in the post – operative management after open diathermy hemorrhoidectomy in terms of wound healing and post – operative pain.

Methods

Between January 2022 and December 2022, 70 consecutive patients underwent open diathermy hemorrhoidectomy for III- and IV- degree hemorrhoids using a cleansing cream postoperatively and were evaluated.

Results

70 patients with third- (n = 46, 65%) and fourth- degree (n = 24, 35%) hemorrhoids were consecutively enrolled. The mean operative time was 21 minutes (range, 17 to 41 min). No intraoperative complications were detected. HSS and VAS score decreased over the time and all patients achieved complete wound healing at the last follow-up despite three of these developed posterior anal fissure. All patients had returned to normal activities (range, 10 days to 15 days).

Conclusion

The results suggest the safety and the effectiveness in terms of post operative pain and wound healing of cleansing crema after open diathermy hemorrhoidectomy. Further multicenter study comparing different ointments are needed to confirm this finding.

Health sciences/Gastroenterology

Health sciences/Diseases/Gastrointestinal diseases

Health sciences/Diseases/Skin diseases

Hemorrhoidectomy

Hemorrhoids

Diathermy

Cream

Wound Healing

Open Hemorrhoidectomy (OH) remains the widely used technique for grade III–IV hemorrhoids. It is one of the oldest proctological techniques and is still one of the most widely used [1]. Despite the good long-term results have been demonstrated, the post-operative period for hemorrhoidectomy still remains one of the most painful by the patients in particular the first 14 days after surgery. It may arise from the incorporation of sensitive anal mucosa or fibers of the internal anal sphincter into stitches nevertheless it may also due to the timing of wound healing, as reported in several articles [2,3,4]. According to our experience, because of the open wounds most of the patients may have a certain sense of fear in touching the operated area and therefore the wounds are not always well cleaned [5].

The aim of this study is to assess the short – term outcomes of Anonet® Crema in the post – operative management after open diathermy hemorrhoidectomy in terms of wound healing and post – operative pain.

Anonet® Crema (Uniderm S.r.l. Rome, Italy) is a soothing and lubricating cream rich in Almond Oil, Flavonoids and Mallow. These ingredients protect the skin: the first provides lubricating and emollient action, the effects of flavonoids are well known and these active principles originate from Witch Hazel and provide a vasotonic and astringent action. Finally, mallow is rich in flavonoids, mineral salts and vitamins, provides hydrating, emollient and lenitive action. All these oils and fats remove the hydrolipid film containing the excess dirt without using any aggressive component, mostly surfactants. They provide a lubricating, hydrating, lenitive and filmogen action. Affinity cleansing fully respects the skin’s structure and its physiology.

Between January 2022 and December 2022, seventy consecutive patients underwent open diathermy hemorrhoidectomy by the same surgeon (GL) for III- and IV- degree hemorrhoids using Anonet® Crema postoperatively and were evaluated. Inclusion in the study was allowed only if III- and IV- degree hemorrhoidal disease could be verified by proctoscopy [6]. All patients were evaluated and treated by the same surgeon (GL). Patients who met any of the following criteria were excluded from the retrospective study: positive pregnancy test, known allergy to flavonoids, acute perianal thrombosis, fecal incontinence, perianal fistula, anal fissure, proctitis, perianal abscess, known hereditary thrombophilia. Pre- and Post- operative data were recorded anonymously on our prospective database retrospectively evaluated. An informed consent was obtained from all patients.

Preoperative preparation and surgical procedure were conducted with a standardized and well define technique which we previously described, therefore all patient underwent open diathermy excisional hemorrhoidectomy under spinal anaesthesia, with removal of the three classical piles at 3, 7 and 11.00 o’clock [2].

All patients received standard care treatment in the immediate post-operative period, consisting of stool softeners and oral analgesia (1000 mg Paraceramole on demand, never more than three times daily; 10 mg Ketorolac if necessary, never more than twice a day). All patients received Anonet® Crema topically every 12 h (2 mL per dose) for 30 consecutive days.

The pain severity was evaluated using the well-known Visual Analog Scale (VAS), both at the baseline, at 7 days after the procedure, and all patients were outpatient evaluated 2 weeks, and 1 months after the treatment while the symptoms severity was investigated through the Hemorrhoid Severity Score (HSS). As recently proposed by Gallo et al [5], this latter is a widely used test consisting of 5-items based questionnaire assessing the frequency of pain, discomfort, itching, soiling and need for manual reduction of hemorrhoids. Each item was graded on a 3-point scale (never 1⁄4 0; less than once a week 1⁄4 1; 1–6 times weekly 1⁄4 2; every day 1⁄4 3. Minimum score 1⁄4 0, Maximum score 1⁄4 15). From what we know, there are few studies in the literature that compared creams in the hemorrhoidectomy post-operative treatment, therefore we decided to use the same approach in order to better evaluate our results and, if possible, compared them.

All patients were submitted to clinical examination of the perineum, and the rectum; digital exploration; and proctoscopy during the follow-up. At the end of the follow – up complete wound healing was considered the primary end point, secondly the post – operative pain one month after the procedure. Complete wound healing was defined as absence of swelling of the wound moreover a VAS score < 2 was considered satisfying. Any adverse events related to the use of Anonet® crema were recorded. All patients were encouraged to contact the clinic if necessary. The cream is a well-studied and already used product in the anorectal disease so a licensing committee was not necessary. The study is reported in accordance to the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines [7].

A total of 70 patients reported bleeding, itching and discomfort with third- (n = 46, 65%) and fourth- degree (n = 24, 35%) hemorrhoids with a mean age of 47 years old (range, 21–73) were consecutively enrolled and underwent OH. Of these, 40 (58%) patients were male and 30 patients were female (42%). The mean operative time was 21 minutes (range, 17 to 41 min). No intraoperative complications were detected and all patients were discharge the same day of the procedure. Morbidity occurred in 2 patients: 1 urinary retention that required urinary catheter for 1 day and one post – operative bleeding treated with hemostatic sponge (Table 1).

Table 1

**Patient Characteristics.** **PTS** **Patients**, M **Male**, F **Female** HSS and VAS score decreased over the time and all patients achieved complete wound healing at the last follow-up (Fig. 1) despite three of these developed posterior anal fissure, medically treated maybe due to reduced mucosal bridge (Table 2). Nevertheless on the last visit, all patients had returned to normal activities (range, 10 days to 15 days).
	PTS
Sex Ratio (M : F)	40 : 30
Mean (range) Age (years)	47 (21–73)
Hemorrhoid Grade
III	46
IV	24

Table 1

Patient Characteristics. *PTS* Patients, M Male, F Female
	PTS
Sex Ratio (M : F)	40 : 30
Mean (range) Age (years)	47 (21–73)
Hemorrhoid Grade
III	46
IV	24

Table 2

**Operative and Postoperative Outcome, and Complications.** ^* **Values are median (range).** **PTS** **Patients;** H **Hours;** **VAS** **Visual Analog Scale;** **HSS** **Hemorrhoid Severity Score**
	PTS
Length of Surgery (min)^*	21 (17–41)
VAS score^* 7 days 2 weeks 1 months	7 (4–9) 4 (3–7) 2 (1–4)
HSS^* Preoperative 7 days 2 weeks 1 months	11 (8–12) 8 (7–10) 5 (4–9) 2 (2–6)
Wound Healing (days)^*	18.8 (14–28)
Return to work (days)^*	12.5 (10–15)
Complications
Urinary retention	1
Bleeding	1
Incontinence	0
Anal Fissure	3

Post-operative complications following surgical hemorrhoidectomy commonly include pain and delayed wound healing. These issues, affecting the majority of patients, result from a combination of thermal, mechanical, and chemical factors [8]. The genesis of postoperative pain involves various factors such as the surgical incision, spasm of the internal anal sphincter, incarceration of smooth muscle fibers and mucosa in the transfixed vascular pedicles, epithelial denudation of the anal canal, and edema caused by tissue inflammation around the wound [9,10]. Despite efforts to manage post-hemorrhoidectomy pain and expedite wound healing through various pharmacotherapies, the outcomes have been unsatisfactory. While the benefits of using topical agents to aid in the wound healing process have been observed, there is a lack of clinical studies. Presently, most surgeons do not incorporate topical agents to alleviate pain following hemorrhoidectomy [11,12].

In the last few years, variations in the surgical technique of hemorrhoidal dissection have been described with the aim of minimizing pain as well as several medical strategies are increased to avoid delayed wound healing which is recognized as the leading cause of pain after open hemorrhoidectomy [2, 12].

Brusciano L and Colleagues [13] recently proposed laser hemorrhoidoplasty to reduce post-operative pain and complications rate. They retrospectively analyzed fifty patients (28 males and 22 females) underwent laser treatment for II- and III- degree hemorrhoids with a 3-columns treated of 84%. No significant complications were occurred with a mean VAS score of 2 after four post-operative pain. These results are certainly promising, despite the small sample size and the short term follow – up, it deserves consideration and multicenter study. In our case series with showed a comparable VAS at the end of the follow – up, despite diathermy does not allow to reach it after 4 days and it should be also emphasized that we have treated patients with III- and IV- degree hemorrhoids.

In a recent randomized trial Vejdan AK [14] investigated the effects of sucralfate ointment on wound healing (epithelialisation) and postoperative pain after open hemorrhoidectomy. The trial involves two groups of randomly collected forty patients undergone OH and a 10% topical sucralfate ointment was applied to the investigated group's wounds, while the control group patients used Vaseline as a placebo.

At the end of the postoperative phase, the Authors demonstrated that the mean VAS was 3.70 for the investigated group and 6.90 for the control group. On the average, the completion of epithelialisation for the investigated group was on day 13 as opposed to day 20 for the control group. Despite these promising results, the trial has the “age-limitation”, in fact the Authors included patients between 25 and 45 y-o, it is known that the wound healing may be slower in older patients. Despite a slower wound healing in our study group (mean days 18.8), we achieved the same results in terms of VAS and complete wound healing with a bigger sample size and a mean age of 47 y-o (range, 21–73).

In addition, Gallo G and Colleagues enrolled 50 patients and investigated the effectiveness of Polycarbophil and Propionibacterium acnes lysate gel on pain control after OH. The Authors achieved complete wound healing at last follow-up (40 days), compared to only 17 (68%) in the control group (p = 0.004). Again, the patients in the study group had a significantly lower mean VAS score at the 20th post-operative day (1.44 (standard deviation, 1.16), compared to 2.12 (0.93) in the control group; p = 0.045).

In our sample size, we reached comparable results although the topic ointment was used up to thirty days after surgery with a faster return to normal activities, despite we did not achieve the same VAS score at the end of the follow – up (Table 3).

In the last systematic review published by Lohsiriwat V et al [15], a total of 157 RCTs and 15 meta-analyses were analyzed in terms of post operative pain and wound healing after OH. Although the quality and the number of sample size of all the RCTs included were various and it was difficult to compare the treatment effects among type of OH, ointment and other therapies; several topical agents were associated with a significant reduction in post-operative pain and faster wound healing although no evidence among these was pointed out.

Table 3

Summary of recent studies. *Pts* Patients; FU Follow up; *VAS* Visual Analog Scale [at the end of the follow-up
Author [ref]	Pts	FU (days)	VAS (range)	Wound Healing (day)	Overall Complications (%)
Present study	70	30	2 (2–6)	18.8 (14–28)	5 (3.5)
Gallo et al. [9]	25	40	0	-	3 (0.7)
Vejdan et al. [14]	20	-	3.7	13	-

This study has several limitations. Firstly, there is not a control group with no power analysis, but the aim of this study was to focus on technical aspects of the Anonet® Crema after OH, comparing our case series with the international experience. Secondly, it is not a randomized trial and it is an observational design. For a better assessment of the functional outcome, wound healing and pain evaluation, a prospective randomized study with more patients may be required.

Despite those limitations some consideration can be made. In literature there are few studies that investigated on the effectiveness of topic ointments in terms of faster wound healing and lower post-operative pain, and surely the present one analyzed a great number of consecutive patients. In addition, the study was performed in a single center with the same senior surgeon, with no bias regarding the operator and surgical technique. Our results suggest that the use of Anonet® Crema benefited all patients receiving the product in terms of wound healing at 30 days after surgery with better pain control at 30 days after surgery.

The results suggest the effectiveness in terms of post operative pain and wound healing of Anonet® Crema after open diathermy hemorrhoidectomy. Further multicenter study comparing different ointment are needed to confirm this finding.

Acknowledgments: LG designed and wrote the paper, MRM collected data, MC and MB drafted the manuscript. All authors approved the submitted version.

Funding: This research received no external funding.

Data Availability Statement: The authors confirm that the data supporting the findings of this study are available within the article

Conflicts of Interest: All authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Ethical approval: All procedures involving human participants were performed in accordance with the ethical standards of the institutional and/or national research committee and the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. All methods were carried out in accordance with relevant guidelines and the approval deemed unnecessary according to national legislation (Codice AIC: 906607914 - EAN: 8032836150422, DL507/1992, Cir 1/05/2021 n20)

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No competing interests reported.

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Short – Term Outcome After Use of Perianal Cleansing Cream After Open Diathermy Hemorrhoidectomy: a Single Center Retrospective Study on a Consecutive Cohort of Patients

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