Sclerotherapy with 3% polidocanol foam for the treatment of mucocutaneous bridges and/or residual piles after open excisional hemorrhoidectomy.

Injection sclerotherapy is an effective and safe treatment in selected cases. It might be used as the first treatment for I-III degree hemorrhoidal disease (HD), but also as a bridge therapy for more severe cases not amenable to invasive treatments. However, concerning the long-term recurrence rate, open excisional hemorrhoidectomy remains the gold standard in cases of III- and IV-degree HD. In this context, it is recommended to perform the excision of no more than three piles and to preserve the muco-cutaneous bridges to avoid post-operative anal stenosis. The aim of this study is to evaluate surgical outcomes and efficacy of the combined treatment of open excisional hemorrhoidectomy and the use of ST on the remnant muco-cutaneous bridges/residual piles. This was a single-center retrospective study and a total of 18 patients with IV-degree HD, aged between 18 and 75 years with symptomatic HD according to the Goligher classification, were enrolled between January 2023 and June 2023 and their follow-up continued until October 2023 after reaching 3 months of follow-up. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey Incontinence Score were used to assess symptoms and their impact on quality of life and continence. A total of 77.8% (14/18) of the patients were symptom-free (hemorrhoidal disease symptom score (HDSS) score = 0) after 3 months. Moreover, a statistically significant decrease in the median HDSS and short health scale for HD (SHS-HD) score was registered from 16 preoperatively (T0) to 2 at 3-month follow-up (T3). Neither post-operative bleeding nor any type of complications occurred. The use of sclerotherapy in combination with the traditional open excisional hemorrhoidectomy has shown promising results. Further structured studies are needed and greater dissemination and education of the general surgeon on the subject is necessary.

Clinical evidence and rationale of mesoglycan to treat chronic venous disease and hemorrhoidal disease: a narrative review.

Chronic venous disease (CVD) and hemorrhoidal disease (HD) are among the most common vascular diseases in the world, with CVD affecting 22-41% of the population in Europe and HD having a point prevalence of 11-39%. The burden is substantial in terms of the effect of symptoms on patients' health-related quality of life (HRQoL) and direct/indirect medical costs. Treatment begins with lifestyle changes, compression in CVD and topical therapies in HD, and escalates as needed through oral therapies first and eventually to surgery for severe disease. CVD and HD share etiological features and pathological changes affecting the structure and function of the tissue extracellular matrix. Mesoglycan, a natural glycosaminoglycan (GAG) preparation composed primarily of heparan sulfate and dermatan sulfate, has been demonstrated to positively impact the underlying causes of CVD and HD, regenerating the glycocalyx and restoring endothelial function, in addition to having antithrombotic, profibrinolytic, anti-inflammatory, antiedema and wound-healing effects. In clinical trials, oral mesoglycan reduced the severity of CVD signs and symptoms, improved HRQoL, and accelerated ulcer healing. In patients with HD, mesoglycan significantly reduced the severity of signs and symptoms and the risk of rectal bleeding. In patients undergoing excisional hemorrhoidectomy, adding mesoglycan to standard postoperative care reduced pain, improved HRQoL, reduced incidence of thrombosis, and facilitated an earlier return to normal activities/work, compared with standard postoperative care alone. The clinical effects of mesoglycan in patients with CVD or HD are consistent with the agent's known mechanisms of action.

Abdominoplasty after massive weight loss. Safety preservation fascia technique and clinical outcomes in a large single series-comparative study.

Introduction: Weight loss after bariatric surgery causes very important modifications to the patient's silhouette. Abdominal fat and skin excess reduction are associated with several complications. The most frequent are seroma and hematoma whereas major complications, such as pulmonary embolism, are less frequent. This study aimed to describe our technical procedure for abdominoplasty in patients with massive weight loss after bariatric surgery. Methods: In total, 196 patients were included. All patients who underwent abdominoplasty classic (group A) and abdominoplasty with the preservation and lift of Scarpa fascia (group B) and with umbilical transposition between May 2018 and May 2021 were included. Patients with concomitant correction of ventral hernia were excluded. Demographic and operative data were analyzed according to comorbidities and postoperative complications. Results: There were 160 (81.6%) women. The mean age was 43.6 years; the mean weight was 86.7 kg; and the mean BMI was 28.6 kg/m2. Five patients (2.5%) presented postoperative seroma. Four patients (2%) presented partial dehiscence/skin necrosis one of them requiring a revision. Finally, 26 patients presented a postoperative complication, with an overall incidence of 12.6%. The average postoperative hospital stay was 3.6. The rates of seroma were significantly higher in men, patients with a BMI > 30 kg/m2, and aged >50 years. Conclusion: Preserving Scarpa Fascia during surgical post-bariatric patient procedures reduces the seroma formation and the scar complication and reduces the tension of the inguinal-pubic region with correction of our deformation after weight loss. Improves reducing the drain and reducing seroma incidence suction and hospital stay.

European Society of Coloproctology: Guidelines for diagnosis and treatment of cryptoglandular anal fistula.

AIM: The primary aim of the European Society of Coloproctology (ESCP) Guideline Development Group (GDG) was to produce high-quality, evidence-based guidelines for the management of cryptoglandular anal fistula with input from a multidisciplinary group and using transparent, reproducible methodology. METHODS: Previously published methodology in guideline development by the ESCP has been replicated in this project. The guideline development process followed the requirements of the AGREE-S tool kit. Six phases can be identified in the methodology. Phase one sets the scope of the guideline, which addresses the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula in adult patients presenting to secondary care. The target population for this guideline are healthcare practitioners in secondary care and patients interested in understanding the clinical evidence available for various surgical interventions for anal fistula. Phase two involved formulation of the GDG. The GDG consisted of 21 coloproctologists, three research fellows, a radiologist and a methodologist. Stakeholders were chosen for their clinical and academic involvement in the management of anal fistula as well as being representative of the geographical variation among the ESCP membership. Five patients were recruited from patient groups to review the draft guideline. These patients attended two virtual meetings to discuss the evidence and suggest amendments. In phase three, patient/population, intervention, comparison and outcomes questions were formulated by the GDG. The GDG ratified 250 questions and chose 45 for inclusion in the guideline. In phase four, critical and important outcomes were confirmed for inclusion. Important outcomes were pain and wound healing. Critical outcomes were fistula healing, fistula recurrence and incontinence. These outcomes formed part of the inclusion criteria for the literature search. In phase five, a literature search was performed of MEDLINE (Ovid), PubMed, Embase (Ovid) and the Cochrane Database of Systematic Reviews by eight teams of the GDG. Data were extracted and submitted for review by the GDG in a draft guideline. The most recent systematic reviews were prioritized for inclusion. Studies published since the most recent systematic review were included in our analysis by conducting a new meta-analysis using Review manager. In phase six, recommendations were formulated, using grading of recommendations, assessment, development, and evaluations, in three virtual meetings of the GDG. RESULTS: In seven sections covering the diagnostic and therapeutic management of perianal abscess and cryptoglandular anal fistula, there are 42 recommendations. CONCLUSION: This is an up-to-date international guideline on the management of cryptoglandular anal fistula using methodology prescribed by the AGREE enterprise.

Sclerobanding in the treatment of second and third degree hemorrhoidal disease in high risk patients on antiplatelet/anticoagulant therapy without suspension: a pilot study.

Introduction: Around 20% of population in western countries is under anticoagulant treatment. However, there is paucity of evidence about the treatment of HD in patients under anticoagulant/antiplatelet therapy, although both suspension and continuation in the perioperative period may increase the risk of severe complications. The aim of this pilot study was to confirm the feasibility and safety of sclerobanding (Combined Rubber Band Ligation with 3% Polidocanol Foam Sclerotherapy), an office-based procedure, for the treatment of second-and third-degree HD in patients under anticoagulant/antiplatelet therapy without suspension. Materials and methods: Patients affected by second-third-degree haemorrhoids unresponsive to conservative treatment and under anticoagulant/antiplatelet were enrolled between November 2019 and October 2021. Postoperative complications, readmission, mortality and reintervention during the follow-up were evaluated. Results: Fifty-one patients were recruited, 23 female (45.1%) and 28 male (54.9%), with an average age of 65 years ± 11.4 SD (range 42-90). Twenty-seven patients (52.9%) had II-degree haemorrhoidal disease, and 24 (47.1%) had grade III-degree. The most frequently taken medications were dual antiplatelet therapy (51%) and new oral anticoagulants (NOACs) (21.6%). The mean follow-up was 23 months. No intraoperative complications were recorded. The rate of complications in the first postoperative month was 13.7%, represented by mild complications: 6 cases of moderate to severe pain and 1 case (2%) of thrombosis of a residual haemorrhoidal nodule, all regressing after conservative therapy. No severe complications were reported. Postoperative complications were not statistically significantly associated with the number of nodules treated (1, 2, or 3), the disease grade (2nd vs. 3rd) or the specific anticoagulant/antiplatelet regimen. During follow-up, 2 patients (4%) required a new procedure for recurrent bleeding: one an infrared photocoagulation as outpatient, and another a haemorrhoidectomy after 3 months. No cases of intraoperative or postoperative mortality occurred. Conclusions: Sclerobanding is a safe and effective technique in treating intermediate-grade haemorrhoidal disease in patients at high risk on anticoagulant/antiplatelet therapy. Sclerobanding is repeatable, usually does not require anaesthesia, and is cost-effective. Observational multicentre studies with a larger number of patients and controlled clinical trials will be needed to confirm these results.

An international survey exploring the management of pilonidal disease.

AIM: Pilonidal disease (PD) is a common debilitating condition frequently seen in surgical practice. Several available treatments carry different benefit/risk balances. The aim of this study was to snapshot the current management of PD across European countries. METHOD: Members affiliated to the European Society of Coloproctology were invited to join the survey. An invitation was extended to others via social media. The predictive power of respondents' and hospitals' demographics on the change of therapeutic approach was explored. RESULTS: Respondents (n = 452) were mostly men (77%), aged 26-60 years, practising in both academic and public hospitals and with fair distribution between colorectal (51%) and general (48%) surgeons. A total of 331 (73%) respondents recommended surgery at first presentation of the disease. Up to 80% of them recommended antibiotic therapy and 95% did not use any classification of PD. A primary closure technique was the preferred procedure (29%), followed by open technique (22%), flap creation (7%), sinusectomy (7%) and marsupialization (7%). Approximately 27% of subjects would choose the same surgical technique even after a failure. Almost half (46%) perform surgery as office based. A conservative approach was negatively associated with acutely presenting PD (p < 0.001). Respondents who were not considering tailored surgery based on patient presentation tended to change their approach in the case of a failed procedure. CONCLUSION: With the caveat of a heterogeneous number of respondents across countries, the results of our snapshot survey may inform the development of future guidelines.

Surgeons' practice and preferences for the anal fissure treatment: results from an international survey.

The best nonoperative or operative anal fissure (AF) treatment is not yet established, and several options have been proposed. Aim is to report the surgeons' practice for the AF treatment. Thirty-four multiple-choice questions were developed. Seven questions were about to participants' demographics and, 27 questions about their clinical practice. Based on the specialty (general surgeon and colorectal surgeon), obtained data were divided and compared between two groups. Five-hundred surgeons were included (321 general and 179 colorectal surgeons). For both groups, duration of symptoms for at least 6 weeks is the most important factor for AF diagnosis (30.6%). Type of AF (acute vs chronic) is the most important factor which guide the therapeutic plan (44.4%). The first treatment of choice for acute AF is ointment application for both groups (59.6%). For the treatment of chronic AF, this data is confirmed by colorectal surgeons (57%), but not by the general surgeons who prefer the lateral internal sphincterotomy (LIS) (31.8%) (p = 0.0001). Botulin toxin injection is most performed by colorectal surgeons (58.7%) in comparison to general surgeons (20.9%) (p = 0.0001). Anal flap is mostly performed by colorectal surgeons (37.4%) in comparison to general surgeons (28.3%) (p = 0.0001). Fissurectomy alone is statistically significantly most performed by general surgeons in comparison to colorectal surgeons (57.9% and 43.6%, respectively) (p = 0.0020). This analysis provides useful information about the clinical practice for the management of a debated topic such as AF treatment. Shared guidelines and consensus especially focused on operative management are required to standardize the treatment and to improve postoperative results.

Long term results of video-assisted anal fistula treatment for complex anal fistula: another shattered dream?

AIM: Complex anal fistula represents a burden for patients, and its management is a challenge for surgeons. Video-assisted anal fistula treatment (VAAFT) is one sphincter-sparing technique. However, data on its long-term effectiveness are scant. We aimed to explore the outcomes of VAAFT in a retrospective cohort of patients referred to a tertiary centre. METHOD: Consecutive adult patients with a minimum of 2 years' follow-up after VAAFT were reviewed. Patients were followed up to 5 years postoperatively. Failure was defined as incomplete healing of the external orifice(s) during the first 6 months. Recurrence was defined as new radiologically and/or clinically confirmed onset of the fistula after primary healing. A generalized linear model was fitted to evaluate the association between failure and sociodemographic characteristics. Predictors of recurrence were determined in a subgroup analysis of patients found to be free from disease at 6 months postoperatively. RESULTS: Overall, 106 patients (70% male; mean age 41 years) were reviewed. Of these 86% had a previous seton placement. Fistulas were either high trans-sphincteric (74%), suprasphincteric (12%) or extrasphincteric (13%). Eight (7%) patients experienced postoperative complications, none of which required reintervention. Mean follow-up was 53 ± 13.2 months. VAAFT failed in 14 (13%) patients. The overall recurrence rate ranged from 29% at 1 year to 63% at 5 years. Multiple external orifices, suprasphincteric fistula, younger age, previous surgery and higher complexity of the fistulous tract were independent risk factors for recurrence. CONCLUSION: VAAFT is a safe sphincter-sparing technique. The initially high success rate decreases over time and relates to a higher degree of complexity.

Complication of Gastric Cancer Surgery: A Single Centre Experience.

BACKGROUND/AIM: Gastric cancer surgery is still characterised by high morbidity and mortality. However, in 2018 an online platform, GASTRODATA has been proposed in Europe to standardize the recording of gastric surgery complications. The aim of the study was to present a single center experience regarding incidence and grading of acute postoperative complications in a population of patients treated surgically for gastric cancer on the basis of the gastrodata online platform. PATIENTS AND METHODS: The present study was a single center, observational, retrospective trial held in the General Surgery Unit of the Sant'Andrea Hospital of Rome. The study included 181 consecutive patients who underwent gastric surgical resection for cancer from May 2004 to December 2020 with curative R0 purpose. RESULTS: Thirty-three percent of patients reported at least one complication, while seventeen percent of the whole population reported a complication classified as at least grade 3 on the Clavien Dindo Classification. The most frequent complications were disorders of the respiratory system (13.3%), followed by bleeding (7.6%) and wound infections (6.2%). Deaths accounted for 3.7% of the population. CONCLUSION: A list of defined complications of gastrectomy, if systematically adopted in the Literature, could lead to a reduction in the wide variation of proposals for treatment and assessment. Objectively evaluating the impact of complications on outcomes can lead to quality improvement project proposals.

A pilot study on staged surgery by delta video-assisted anal fistula treatment (dVAAFT) for complex anal fistula.

Complex anal fistulas (CAF) present a challenge in achieving healing while preserving anal sphincter function. This study aims to introduce a novel staged approach for CAF treatment, combining video-assisted anal fistula treatment (VAAFT), seton placement, and other staged approaches. Consecutive patients with CAF underwent the staged approach involving VAAFT and seton placement. Data on patient demographics, fistula characteristics, and operative findings were collected. Pre-operative work-up included clinical evaluation, endoanal ultrasonography (EAUS), and magnetic resonance imaging (MRI). Surgical techniques and outcomes were evaluated. Eighteen patients (median age 38 years) were included. Misplacement of a previously placed seton was observed in 64% of cases. VAAFT combined with seton placement achieved simplification and healing of secondary tracts in 66% of cases. Operative times significantly decreased across interventions. At a median follow-up of 14 months, complete healing was achieved in 2 patients, with 1 patient demonstrating persistence of the fistula. Post-operative complications were observed in 11% of patients, with no deterioration in continence. The staged approach combining VAAFT, seton placement, and staged procedures offers a potential solution for treating CAF. VAAFT provides diagnostic and therapeutic benefits, simplifying the fistula anatomy and optimizing seton placement. The approach allows subsequent procedures based on individual fistula characteristics.

Preoperative tumor marking with indocyanine green (ICG) prior to minimally invasive colorectal cancer: a systematic review of current literature.

Aim: To describe the currently available evidence regarding the efficacy and safety of preoperative tumor marking using indocyanine green (ICG) prior to laparoscopic or robotic colorectal resections. Methods: A systematic search for relevant studies was conducted using the following databases: Embase (OVID), MEDLINE® (OVID), APA PsycInfo (OVID), Global Health (OVID) and HMIC Health Management Information Consortium (OVID) through June 2022 reported according to PRISMA 2020 guidelines. Primary outcome was the detection rate of the tumor sites preoperatively marked with ICG. Secondary outcomes were timing of ICG injection in days prior to the operation and technique-related complications. Results: Eight single center studies, published between 2008 and 2022, were identified yielding a total of 1,061 patients, of whom 696 were preoperatively tattooed with ICG. Injection dosage of diluted ICG ranged from 0.1-1.5 ml. Four studies used the saline test injection method prior to ICG injection. When the marking was placed within one week, the visualization rate was 650/668 (97%), whereas when it was longer than one week, the detection rate was 8/56 (14%). No severe complications were reported. Conclusion: Preoperative tumor marking using ICG prior to minimally invasive colorectal resections is safe and effective, allowing intraoperative tumor site location when performed up to a week prior to surgery without disturbing the surgical view in potential mild complications.

Comparison of laparoscopic partial nephrectomy performed with AirSeal® system vs. standard insufflator: results from a referral center.

Objective: To compare perioperative and oncologic surgical outcomes during laparoscopic partial nephrectomy (LPN) performed by standard carbon dioxide insufflation, with those from surgeries in which the AirSeal® intelligent insufflation system was used for renal tumors. Materials and methods: A total of 27 patients with renal tumor were identified, 14 underwent LPN with AirSeal® (group A) and 13 LPN with standard insufflator (group B), respectively. Demographic baseline characteristics were similar in the two groups. Results: The size of the tumor was largest in group B (29.64 vs. 32.1 mm). The mean operative time was shorter in the AirSeal® group [group A: mean 109.0 min, median 107.5 min, interquartile range (IQR) 85; group B: mean 121.0 min, median 120.0 min, IQR 50.0]. Positive margin rates were absent in the two groups. Estimated blood loss presented a difference in the perioperative period (group A: mean 1.5 g/dL, median 1.45 g/dL; group B: mean 2.15 g/dL, median 2.2 g/dL). Time to ischemia was found to be shorter in group A with a median of 18 min compared to a median of 20 min in group B. No subcutaneous emphysema, pneumothorax, and pneumomediastinum cases occurred in either group. A postoperative complication developed in one patient requiring superselective embolization. Conclusion: In selected patients, our preliminary surgical experience has shown that the LPN procedure performed with the aid of the AirSeal® intelligent insufflation system can be used to treat even medium-/high-complexity kidney lesions, with a reduction in operating times, lower rates of complications, and perioperative blood loss. Clinical trial registration: AirSealV1.

The Role of Donor Gamma-Glutamyl Transferase as a Risk Factor for Early Graft Function after Liver Transplantation.

BACKGROUND: Growing interest has been recently reported in the potential detrimental role of donor gamma-glutamyl transferase (GGT) peak at the time of organ procurement regarding the risk of poor outcomes after liver transplantation (LT). However, the literature on this topic is scarce and controversial data exist on the mechanisms justifying such a correlation. This study aims to demonstrate the adverse effect of donor GGT in a large European LT cohort regarding 90-day post-transplant graft loss. METHODS: This is a retrospective international study investigating 1335 adult patients receiving a first LT from January 2004 to September 2018 in four collaborative European centers. RESULTS: Two different multivariable logistic regression models were constructed to evaluate the risk factors for 90-day post-transplant graft loss, introducing donor GGT as a continuous or dichotomous variable. In both models, donor GGT showed an independent role as a predictor of graft loss. In detail, the log-transformed continuous donor GGT value showed an odds ratio of 1.46 (95% CI = 1.03-2.07; p = 0.03). When the donor GGT peak value was dichotomized using a cut-off of 160 IU/L, the odds ratio was 1.90 (95% CI = 1.20-3.02; p = 0.006). When the graft-loss rates were investigated, significantly higher rates were reported in LT cases with donor GGT ≥160 IU/L. In detail, 90-day graft-loss rates were 23.2% vs. 13.9% in patients with high vs. low donor GGT, respectively (log-rank p = 0.004). Donor GGT was also added to scores conventionally used to predict outcomes (i.e., MELD, D-MELD, DRI, and BAR scores). In all cases, when the score was combined with the donor GGT, an improvement in the model accuracy was observed. CONCLUSIONS: Donor GGT could represent a valuable marker for evaluating graft quality at transplantation. Donor GGT should be implemented in scores aimed at predicting post-transplant clinical outcomes. The exact mechanisms correlating GGT and poor LT outcomes should be better clarified and need prospective studies focused on this topic.

A Fecal MicroRNA Signature by Small RNA Sequencing Accurately Distinguishes Colorectal Cancers: Results From a Multicenter Study.

BACKGROUND & AIMS: Fecal tests currently used for colorectal cancer (CRC) screening show limited accuracy in detecting early tumors or precancerous lesions. In this respect, we comprehensively evaluated stool microRNA (miRNA) profiles as biomarkers for noninvasive CRC diagnosis. METHODS: A total of 1273 small RNA sequencing experiments were performed in multiple biospecimens. In a cross-sectional study, miRNA profiles were investigated in fecal samples from an Italian and a Czech cohort (155 CRCs, 87 adenomas, 96 other intestinal diseases, 141 colonoscopy-negative controls). A predictive miRNA signature for cancer detection was defined by a machine learning strategy and tested in additional fecal samples from 141 CRC patients and 80 healthy volunteers. miRNA profiles were compared with those of 132 tumors/adenomas paired with adjacent mucosa, 210 plasma extracellular vesicle samples, and 185 fecal immunochemical test leftover samples. RESULTS: Twenty-five miRNAs showed altered levels in the stool of CRC patients in both cohorts (adjusted P < .05). A 5-miRNA signature, including miR-149-3p, miR-607-5p, miR-1246, miR-4488, and miR-6777-5p, distinguished patients from control individuals (area under the curve [AUC], 0.86; 95% confidence interval [CI], 0.79-0.94) and was validated in an independent cohort (AUC, 0.96; 95% CI, 0.92-1.00). The signature classified control individuals from patients with low-/high-stage tumors and advanced adenomas (AUC, 0.82; 95% CI, 0.71-0.97). Tissue miRNA profiles mirrored those of stool samples, and fecal profiles of different gastrointestinal diseases highlighted miRNAs specifically dysregulated in CRC. miRNA profiles in fecal immunochemical test leftover samples showed good correlation with those of stool collected in preservative buffer, and their alterations could be detected in adenoma or CRC patients. CONCLUSIONS: Our comprehensive fecal miRNome analysis identified a signature accurately discriminating cancer aimed at improving noninvasive diagnosis and screening strategies.

Practice of proctology among general surgery residents and young specialists in Italy: a snapshot survey.

Anal diseases are very common and, in most of the cases, require surgery of minor or medium complexity, and, therefore, are among the most accessible diseases for surgeons in training. Aim of this study is to investigate the status of the training in proctology in Italy. A 31-items questionnaire was administered to residents and young specialists (≤ 2 years) in general surgery, using mailing lists, and the social media accounts of the Italian Society of Colorectal Surgery. Answers from 338 respondents (53.8% males) were included in the final analysis. Overall, 252 respondents (74.5%) were residents and 86 (25.5%) young specialists. Two hundred and fifty-five (75.4%) respondents practiced proctology for the first time early on during their postgraduate training, but only 19.5% did it continuously for ≥ 24 months. Almost all respondents (334; 98.8%) had the chance to participate in proctological procedures, 205 (60.5%) as first surgeon. This percentage decreases according to the complexity of the surgery. In fact, only 11 (3.3%) and 24 (7.1%) of the respondents were allowed to be the first surgeon in more complex proctological diseases such as surgery for rectal prolapse and fecal incontinence. The present survey suggests that, in Italy, most surgeons in training deal with anal diseases. However, only few of them could achieve sufficient professional skills in the management of proctological diseases to be able to practice autonomously as young specialists.

Efficacy and safety of Propionibacterium extract gel versus glyceryl trinitrate ointment in the treatment of chronic anal fissure: a randomized controlled trial.

AIM: Chronic anal fissure (CAF) is an extremely frequent finding in clinical practice. Several topical agents have been proposed for its treatment with the common goal of increasing anodermal blood flow to promote healing. The aim of this study was to compare the efficacy and safety of a Propionibacterium extract gel (PeG) and 0.4% glyceryl trinitrate ointment (GTN) in patients with CAF. METHOD: Patients were randomly allocated to a PeG or GTN group and medication was administered every 12 h for 40 days. The primary outcome was the success rate, as measured by a decrease in the REALISE scoring system for anal fissure at 10, 20 and 40 days after initiating either treatment. The secondary outcomes recorded at the same time points were healing rate, visual analogue scales for itching and burning, rate of complications and adverse events, patient quality of life and satisfaction, and cost analysis. RESULTS: A total of 120 patients were enrolled, and 96 patients (PeG, n = 53; GTN, n = 43) completed the primary outcomes. A significant decrease over time in the REALISE score was observed in both groups. Adverse events occurred more frequently in the GTN group than in the PeG group, peaking at visit 1 [37 (63.8%) vs. 2 (3.4%), respectively], with headache being the most prevalent. The between-treatment cumulative average costs per patient were significantly higher for GTN than that for PeG at each follow-up visit. There were no other significant differences between the two groups for any of the other outcomes. CONCLUSION: While there was no difference in healing rates between the two treatments, PeG was more cost-effective and associated with fewer adverse events.