Auricular point acupressure for managing postoperative pain and reducing anxiety in patients with perianal abscesses.

OBJECTIVE: The objective of this study is to assess the efficacy of auricular point acupressure in relieving postoperative pain and reducing anxiety among patients with perianal abscesses. METHODS: We included 61 patients with perianal abscesses who were admitted to the Nantong First People's Hospital between July 2019 and June 2020 and were scheduled to undergo one-stage radical surgery. We divided them into the treatment group (n = 31), where patients were administered preoperative auricular acupressure targeting the bilateral Shenmen, subcortical, and other points. They were instructed to apply pressure five to six times per day, each time for about 3-5 min. Patients in the control group (n = 30) received routine preoperative preparation. The treatment duration for both groups was one week. We compared the two groups using the pain visual analog scale (VAS) scores, the use of additional postoperative analgesics, and scores on the Hamilton anxiety and depression scales pre- and post-surgery at 6 h, 24 h, 48 h, 72 h, and 1 week after surgery, as well as at the time of the first bowel movement. RESULTS: Patients in the treatment group reported lower VAS scores than those of the control group at 48 h, 72 h, 1 week, and at the first defecation post-surgery, and the differences were statistically significant (all P < 0.05). Additional postoperative analgesics were used in seven patients in the treatment group (22.58 %) and in 10 patients in the control group (33.33 %). The difference between the two groups was not statistically significant (χ2 = 0.88, P = 0.35). Postoperative scores for the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale (HAM-D) in the treatment group were significantly lower than those in the control group (P < 0.05). CONCLUSION: The results of this study demonstrated that auricular point acupressure was effective in alleviating postoperative pain in patients with perianal abscesses and simultaneously reduced their postoperative psychological stress reactions. This dual effect provided both pain relief and a reduction of anxiety with fewer adverse reactions, making it a safe and effective treatment option.

A Rare Case of a Pedunculated Lipoma in the Perianal Region: A 20-Year Journey.

Lipomas are common benign soft tissue tumors, typically presenting as painless, slow-growing masses of mature adipose tissue. However, their occurrence as pedunculated lesions in the perianal region is rare. We present a case of a 70-year-old male with a 20-year history of a painless, cosmetically concerning mass in the perianal region. Clinical examination and ultrasonographic findings were consistent with a pedunculated lipoma. Surgical excision was performed successfully, and histopathological examination confirmed the diagnosis of lipofibroma. This case highlights the importance of considering unusual presentations of lipomas in the differential diagnosis of perianal masses. It emphasizes the role of surgical excision for symptomatic or cosmetically concerning lesions. Long-term follow-up is essential to monitor for recurrence and ensure optimal patient outcomes.

Shining Light on a Dark Corner: A Case Report on Perianal Basal Cell Carcinoma.

Perianal basal cell carcinoma (BCC) is a rare occurrence, with limited documented cases in the existing literature. The precise etiology contributing to its onset remains inadequately elucidated. Macroscopically, perianal BCC often exhibits atypical features, potentially leading to diagnostic challenges. Histopathological examination plays a crucial role in distinguishing BCC from other cutaneous lesions in this region. Despite its localized nature, perianal BCC generally carries a favorable prognosis characterized by a gradual progression. However, diligent follow-up is essential to mitigate the risk of recurrence. Our clinical observation highlights a noteworthy yet uncommon manifestation. The patient, a 64-year-old male, presented with a persistent perianal lesion evolving over a three-month period. Symptoms included intermittent bleeding and purulent discharge, exacerbating the clinical picture. A biopsy was subsequently performed, confirming the diagnosis of basal cell carcinoma. Following this, the patient underwent external beam radiation therapy as part of the treatment regimen.

Pelvic floor imaging in women with hemorrhoidal disease: An anatomical feasibility study.

OBJECTIVE: To compare pelvic floor muscle and organ structures in women with and without hemorrhoidal disease (HD) using magnetic resonance imaging (MRI). MATERIAL AND METHODS: Pelvic MRI measurements and computer-based medical records of women diagnosed with HD between January 2018 and March 2021 were analyzed. Parameters including pubococcygeal distance, puborectal distance, posterior anorectal angle, obturator internus muscle area, presence of levator ani muscle defect, genital hiatus length, vaginal length, uterocervical angle, cervix-upper vagina angle, and cervix-middle vagina angle were evaluated. The control group consisted of women without HD, matched for age and body mass index. RESULTS: Puborectal hiatus distance was higher in the HD group (59.2 â€‹± â€‹8.7 â€‹mm vs. 55.5 â€‹± â€‹7.1 â€‹mm, p â€‹= â€‹0.03). Similarly, the distance to the M line was greater in the HD group (18.3 â€‹± â€‹4.8 â€‹mm vs. 16 â€‹± â€‹4.6 â€‹mm, p â€‹= â€‹0.04). Obturator internus muscle area was found to be lower in the HD group compared to the non-HD group (1721 â€‹± â€‹291.4 â€‹mm2 vs. 1897.5 â€‹± â€‹352.5 â€‹mm2, p â€‹= â€‹0.02). Additionally, the presence of unilateral levator ani muscle defect was higher in HD patients (p â€‹= â€‹0.03). There was a negative correlation between birthweight and obturator internus muscle area (r â€‹= â€‹-0.388, p â€‹= â€‹0.02), and a positive correlation with M line distance (r â€‹= â€‹0.344, p â€‹= â€‹0.04). CONCLUSION: Levator ani muscle defects and obturator internus muscle area, indicators of pelvic floor dysfunction, are more common in patients with hemorrhoidal disease.

A case report of genital Crohn's disease with a brief review of Indian cases reported.

Crohn's disease (CD) is a type of inflammatory bowel disease, which presents with extraintestinal manifestations in some cases, skin being one of the organs involved. Vulvar and perianal involvement leads to significant morbidity and has an adverse effect on the quality of life. We report a case of genital CD affecting the vulva, perianal region, and oral cavity, due to its rarity and diagnostic difficulty.

A Case of Perianal Annular Rash: Atypical Presentation of Recurrent Secondary Syphilis.

Syphilis is a complex, systemic infectious disease caused by Treponema pallidum subspecies pallidum. Secondary syphilitic lesions typically manifest within 3 months following initial exposure to T. pallidum. The predominant cutaneous manifestations of secondary syphilis are macula and papule. Certain individuals with syphilis may present with an atypical rash during the secondary stage owing to immunosuppression and other factors. Herein, we report a rare case of atypical recurrent secondary syphilis around the anus in a 65-year-old woman. Based on cerebrospinal fluid findings and skin biopsy results, the patient was ultimately diagnosed as neurosyphilis and recurrent secondary syphilis. Following intravenous antibiotic therapy, the patient's rash improved significantly. This case underscores the importance for physicians to remain vigilant regarding the possibility of syphilis when encountering cases exhibiting unusual clinical manifestations, as a definitive diagnosis necessitates a comprehensive evaluation.

Fournier's gangrene originating from the perianal region or the urogenital area: does it make a difference?

OBJECTIVE: Fournier's gangrene (FG) is a rare and serious disorder which is associated with high mortality. In the literature, there is no study evaluating clinician-, patient- and disease-related factors affecting disease outcomes according to aetiological variation in FG. In our study, laboratory results and Uludag Fournier's Gangrene Severity Index (UFGSI) score, clinical characteristics and mortality rates were compared between FG originating from perianal or from urogenital regions. METHOD: Platelet-to-lymphocyte ratio, neutrophil-to-lymphocyte ratio, Laboratory Risk Indicator for Necrotizing Fasciitis (LRINEC) and UFGSI risk scores were calculated in patients with FG at presentation to the emergency department. The patients were assigned to two groups according to FG aetiology. RESULTS: It was observed that the number of debridement interventions and the need for colostomy were significantly greater in the perianal FG group, while the need for flap or reconstruction was significantly (p=0.002) higher in the genitourinary FG group. No significant difference was detected in mortality between groups and the difference in aetiology had no significant effect on the results of the neutrophil-to-lymphocyte ratio, LRINEC or UFGSI scores. CONCLUSION: Laboratory results and UFGSI score were helpful in assessing disease severity independently from aetiology. The higher number of debridement interventions to protect anal function in the perianal group and the greater need for reconstructive surgery in the urogenital group were identified as factors that prolonged length of hospital stay.

Anal Mucinous Adenocarcinoma Presenting as a Superficial Lesion Without Luminal Involvement.

Anal mucinous adenocarcinoma arises from mucin-secreting columnar epithelium within anal glands and is extremely rare, comprising 2%-3% of all gastrointestinal malignancies. We present a unique case of 65-year-old developmentally disabled man with complaint of rectal pain. Examination showed an excoriated erythematous perianal region with mucinous film and subdermal nodularity. Surgical pathology of the lesion revealed poorly differentiated mucinous adenocarcinoma of intestinal type. Subsequent colonoscopy was without findings of intraluminal lesions. He established with oncology and later underwent a positron emission tomography scan that showed extensive metastasis. This case highlights a unique presentation of de novo mucinous adenocarcinoma with luminal sparing.

Endometriosis presenting as a perianal abscess: case report.

Endometriosis is common benign disorder characterized by the presence of endometrial glands and stroma outside the uterine cavity. Endometriosis of perianal region is a rare condition. We report a case of perianal endometriosis presenting initially as a perianal abscess. Transperineal ultrasound showed a 1.5 cm size irregular mixed echogenicity lesion without involving anal sphincters. Complete surgical excision was performed. The histopathological examination confirmed as endometriosis.

Mesenchymal stem cell therapy for therapy refractory complex Crohn's perianal fistulas: a case series.

BACKGROUND: Mesenchymal stem cell treatment (MST) has emerged as a new therapeutic strategy for Crohn's perianal fistulas. It has been demonstrated that a fibrotic tract on MRI with a MAGNIFI-CD score ≤ 6 is the best predictor for long-term clinical closure. Therefore, the aim of the current study was to analyse the effectiveness of MST for complex Crohn's perianal fistulas based on MRI. METHODS: Consecutive patients with complex Crohn's perianal fistulas, previously failing both anti-TNF treatment and surgical closure, who had surgical closure of the internal opening with MST were included. The primary endpoint was radiological remission of the fistula(s) defined as a MAGNIFI-CD ≤ 6 on MRI, read by an experienced radiologist. RESULTS: Between December 2019 and March 2023, 30 patients (15 males) with 48 fistula tracts were included with a median follow-up of 16.5 months. Radiological remission was achieved in thirteen patients (43.3%) after a median follow-up of 5.0 months (IQR 3.0-6.0). The median MAGNIFI-CD at baseline was 15.0 (IQR 7.0-20.0) which significantly decreased to 8.0 (IQR 3.0-15.0) after treatment (p = 0.001). Clinical closure was achieved in 21 patients (70.0%). Three patients (14.3%) developed a recurrence during long-term FU, all with clinically closed fistula(s), but no radiological remission. The median PDAI decreased significantly from 10.5 (IQR 7.0-14.0) to 4.0 (IQR 0.0-7.3) (p = 0.001). CONCLUSION: MST is a promising treatment strategy for therapy refractory Crohn's perianal fistulas, resulting in > 40% radiological remission, clinical closure in 70% and a significant improvement in quality of life. No recurrences were seen in patients with radiological remission.

Perianal Angioleiomyoma: A Case Report and Review of the Literature.

Angioleiomyomas are rare benign tumors, which take origin from smooth muscle fibers of the tunica media of veins. Even though angioleiomyomas can appear anywhere in the body, these masses are rarely occurred in the gastrointestinal system. This is the first reported case of perianal angioleiomyomas, where the tumor in close relation with the anal canal was investigated with endoanal ultrasonography. Local excision of such lesion is generally curative.

Persistence, effectiveness and safety of ustekinumab and vedolizumab therapy for complex perianal fistula in Crohn's disease: The HEAL study from GETECCU.

BACKGROUND: The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety of these drugs in this context. METHODS: Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians' assessment. RESULTS: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab. CONCLUSION: Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles.

Safety and Effectiveness of Ustekinumab for Crohn's Disease With Perianal Manifestations: Ad hoc Analysis Data From 1-Year Post-Marketing Surveillance Study in Japan.

Background: Crohn's disease (CD) is an immune-mediated inflammatory disorder of the gastrointestinal tract with perianal disease being one of the challenging possible manifestations. Here, we report, an ad hoc analysis of the safety and effectiveness of 1-year use of ustekinumab (UST) for CD in patients with perianal manifestations using post-marketing surveillance (PMS) data in Japan. Methods: Among 341 patients enrolled in the PMS, 229 and 224 patients who had baseline Crohn's Disease Activity Index (CDAI) data used for evaluating perianal manifestations were included in the safety and efficacy analysis sets, respectively. Incidence of adverse drug reactions, clinical remission, the mean or its change in CDAI scores, and CDAI items were evaluated through week 52 in the presence or absence of perianal manifestations at baseline. The prevalence of perianal manifestations was also described. Results: Comparing patients with and without baseline perianal manifestations at week 52, there was no difference in ADR incidence (9.1% [n = 66] vs. 15.3% [n = 163]), no difference in clinical remission (68.3% vs. 59.9%; P = 0.269), and decreased mean change of CDAI score (-82.9 [n = 60] vs. -68.8 [n = 137]). The proportion of patients with perianal manifestations decreased after UST treatment in both biologics-naïve patients (23.5% [n = 4/17]) and patients who had received biologics (35.0% [n = 14/40]) at week 52. Conclusions: In Japanese clinical practice, UST is safe and effective in CD patients with and without perianal manifestations. The therapy might be also beneficial in those with manifestations regardless of prior use of other biologics.

Myrrh sitz bath for wound healing after hemorrhoidectomy: A retrospective study of adverse effects and treatment outcomes.

Background and Aim: Hemorrhoids affect 75% of people worldwide. surgical hemorrhoidectomy remains the definitive intervention for severe cases. Postoperative wound care is critical, and alternative treatments, like Myrrh, are of growing interest due to their potential wound-healing properties. This study aimed to compare the safety, efficacy, and treatment outcomes of Myrrh sitz baths with standard clinical care in promoting wound healing after hemorrhoidectomy. Methods: A retrospective cohort study was carried out using medical records from Abha Private Hospital for the period of January-December 2022. The data of patients who underwent hemorrhoidectomy were collected and categorized based on postoperative wound care into two groups: Group A for Myrrh-based wound care as a self-medication and Group B for standard wound care. Results: The study included 67 patients who underwent hemorrhoidectomy. Out of these patients, 52 had standard wound care, while 15 used Myrrh-based wound care as self-treatment without medical advice. The Myrrh group patients were significantly older with more comorbidities. The Myrrh group had significant Grade III wound healing outcomes 9/15 (60%) compared to the standard care group 2/52 (3.8%) (p < 0.001). However, despite the better healing outcomes, the Myrrh group had a significantly higher complication rate 7/15(46.7%) than the standard care group 1/52 (1.9%) (p < 0.001). These results indicate that despite the good healing capacity of Myrrh, cautious usage must be considered. Conclusion: Myrrh sitz baths appear more effective than standard wound care in enhancing healing after hemorrhoidectomy. However, increased complications suggest the necessity for comprehensive evaluation and research on its safety profile. These findings can guide future research and clinical practices related to postoperative wound care.

Perianal Fistulizing Crohn's Disease-Associated Anorectal and Fistula Cancers: Systematic Review and Expert Consensus.

BACKGROUND & AIMS: Perianal fistulizing Crohn's disease (PFCD)-associated anorectal and fistula cancers are rare but often devastating diagnoses. However, given the low incidence and consequent lack of data and clinical trials in the field, there is little to no guidance on screening and management of these cancers. To inform clinical practice, we developed consensus guidelines on PFCD-associated anorectal and fistula cancers by multidisciplinary experts from the international TOpClass consortium. METHODS: We conducted a systematic review by standard methodology, using the Newcastle-Ottawa Scale quality assessment tool. We subsequently developed consensus statements using a Delphi consensus approach. RESULTS: Of 561 articles identified, 110 were eligible, and 76 articles were included. The overall quality of evidence was low. The TOpClass consortium reached consensus on 6 structured statements addressing screening, risk assessment, and management of PFCD-associated anorectal and fistula cancers. Patients with long-standing (>10 years) PFCD should be considered at small but increased risk of developing perianal cancer, including squamous cell carcinoma of the anus and anorectal carcinoma. Risk factors for squamous cell carcinoma of the anus, notably human papilloma virus, should be considered. New, refractory, or progressive perianal symptoms should prompt evaluation for fistula cancer. There was no consensus on timing or frequency of screening in patients with asymptomatic perianal fistula. Multiple modalities may be required for diagnosis, including an examination under anesthesia with biopsy. Multidisciplinary team efforts were deemed central to the management of fistula cancers. CONCLUSIONS: Inflammatory bowel disease clinicians should be aware of the risk of PFCD-associated anorectal and fistula cancers in all patients with PFCD. The TOpClass consortium consensus statements outlined herein offer guidance in managing this challenging scenario.

Acquired Thrombotic Thrombocytopenic Thrombocytopenia Presenting As Urinary Tract Infection and Perianal Abscess: A Case Review.

Thrombotic thrombocytopenic purpura (TTP) is a rare but potentially life-threatening hematologic disorder characterized by hemolytic anemia, thrombocytopenia, renal failure, fever, and neurologic dysfunction. While cases often do not present with all five characteristics (<5%), TTP can be hereditary or acquired, often due to a deficiency or dysfunction of the ADAMST13 enzyme. Here, we describe a case of infection-induced acquired TTP in a middle-aged male with urinary tract infection (UTI) and perianal abscess. Suspicion arose from hematologic abnormalities, fever, thrombocytopenia, acute renal failure, and the presence of an underlying infection. A PLASMIC score of 6 (indicating a 72% probability of ADAMTS13 deficiency) prompted ADAMTS13 level testing, revealing levels <5% with the presence of an inhibitor, confirming TTP diagnosis. Treatment with high-dose steroids and daily plasma exchange yielded a swift platelet response, necessitating only two to three days of plasma exchange. In addition, incision and drainage of the perianal abscess were performed. The patient was discharged on daily prednisone and initiated on four doses of weekly Rituximab to mitigate recurrence risk. This case underscores the importance of early suspicion and treatment in infectious triggers such as UTI/perianal abscess, offering crucial diagnostic and prognostic insights.

Activated HLA-DR+CD38+ Effector Th1/17 Cells Distinguish Crohn's Disease-associated Perianal Fistulas from Cryptoglandular Fistulas.

BACKGROUND: Perianal fistulas are a debilitating complication of Crohn's disease (CD). Due to unknown reasons, CD-associated fistulas are in general more difficult to treat than cryptoglandular fistulas (non-CD-associated). Understanding the immune cell landscape is a first step towards the development of more effective therapies for CD-associated fistulas. In this work, we characterized the composition and spatial localization of disease-associated immune cells in both types of perianal fistulas by high-dimensional analyses. METHODS: We applied single-cell mass cytometry (scMC), spectral flow cytometry (SFC), and imaging mass cytometry (IMC) to profile the immune compartment in CD-associated perianal fistulas and cryptoglandular fistulas. An exploratory cohort (CD fistula, n = 10; non-CD fistula, n = 5) was analyzed by scMC to unravel disease-associated immune cell types. SFC was performed on a second fistula cohort (CD, n = 10; non-CD, n = 11) to comprehensively phenotype disease-associated T helper (Th) cells. IMC was used on a third cohort (CD, n = 5) to investigate the spatial distribution/interaction of relevant immune cell subsets. RESULTS: Our analyses revealed that activated HLA-DR+CD38+ effector CD4+ T cells with a Th1/17 phenotype were significantly enriched in CD-associated compared with cryptoglandular fistulas. These cells, displaying features of proliferation, regulation, and differentiation, were also present in blood, and colocalized with other CD4+ T cells, CCR6+ B cells, and macrophages in the fistula tracts. CONCLUSIONS: Overall, proliferating activated HLA-DR+CD38+ effector Th1/17 cells distinguish CD-associated from cryptoglandular perianal fistulas and are a promising biomarker in blood to discriminate between these 2 fistula types. Targeting HLA-DR and CD38-expressing CD4+ T cells may offer a potential new therapeutic strategy for CD-related fistulas.

We applied high-dimensional analyses to profile the immune compartment in CD-associated and cryptoglandular perianal fistulas. Data analysis revealed activated HLA-DR+CD38+ effector Th1/17 cells as distinctly increased in CD-associated fistulas, suggesting a potential novel therapeutic target.

Perianal Mucinous Adenocarcinoma: A Case of Recurrent Anal Fistula.

An anal fistula is a fairly common clinical condition, with a very low incidence of malignant transformation. Mucinous adenocarcinoma is a subtype of adenocarcinoma, and its occurrence within perianal fistula tracts is quite rare. This case report describes a 54-year-old male patient with recurrent anal fistula, initially suspected of Crohn's disease (CD), and ultimately diagnosed with perianal mucinous adenocarcinoma. After our joint internal medicine, surgery, and imaging reassessment, the diagnosis was confirmed. Anal fistula is usually considered a benign lesion, but it may also be associated with other diseases. Due to overlapping symptoms of related diseases, the investigation of malignant lesions is often overlooked. This case report emphasizes the importance of timely referral and multidisciplinary management for disease diagnosis and early treatment.

Validation of a 3D-printed model of cryptoglandular perianal fistulas.

INTRODUCTION: Visualising the course of a complex perianal fistula on imaging can be difficult. It has been postulated that three-dimensional (3D) models of perianal fistulas improve understanding of the perianal pathology, contribute to surgical decision-making and might even improve future outcomes of surgical treatment. The aim of the current study is to investigate the accuracy of 3D-printed models of perianal fistulas compared with magnetic resonance imaging (MRI). METHODS: MRI scans of 15 patients with transsphincteric and intersphincteric fistulas were selected and then assessed by an experienced abdominal and colorectal radiologist. A standardised method of creating a 3D-printed anatomical model of cryptoglandular perianal fistula was developed by a technical medical physicist and a surgeon in training with special interest in 3D printing. Manual segmentation of the fistula and external sphincter was performed by a trained technical medical physicist. The anatomical models were 3D printed in a 1:1 ratio and assessed by two colorectal surgeons. The 3D-printed models were then scanned with a 3D scanner. Volume of the 3D-printed model was compared with manual segmentation. Inter-rater reliability statistics were calculated for consistency between the radiologist who assessed the MRI scans and the surgeons who assessed the 3D-printed models. The assessment of the MRI was considered the 'gold standard'. Agreement between the two surgeons who assessed the 3D printed models was also determined. RESULTS: Consistency between the radiologist and the surgeons was almost perfect for classification (κ = 0.87, κ = 0.87), substantial for complexity (κ = 0.73, κ = 0.74) and location of the internal orifice (κ = 0.73, κ = 0.73) and moderate for the percentage of involved external anal sphincter in transsphincteric fistulas (ICC 0.63, ICC 0.52). Agreement between the two surgeons was substantial for classification (κ = 0.73), complexity (κ = 0.74), location of the internal orifice (κ = 0.75) and percentage of involved external anal sphincter in transsphincteric fistulas (ICC 0.77). CONCLUSIONS: Our 3D-printed anatomical models of perianal fistulas are an accurate reflection of the MRI. Further research is needed to determine the added value of 3D-printed anatomical models in preoperative planning and education.

A phase I/II clinical trial of ex-vivo expanded human bone marrow derived allogeneic mesenchymal stromal cells in adult patients with perianal fistulizing Crohn's Disease.

BACKGROUND: Perianal fistulas (PF) affect one-third patients with Crohn's disease (CD) with limited therapeutic options. There is dearth of literature on safety and efficacy of bone marrow-derived mesenchymal stromal cells (BMSCs) in this population. METHODS: An open-label, phase I/II, single-arm study was conducted involving local administration of human allogeneic bone marrow-derived mesenchymal stromal cells in perianal fistula of patients with Crohn's disease refractory to standard therapies. Clinical severity and biomarkers were assessed at baseline and periodically until week 104 , and MRI at week 24 and 104. Primary and secondary objectives were to assess safety and efficacy respectively. Fistula remission was complete closure of fistula openings with < 2 cm perianal collection on MRI, and fistula response was decrease in drainage by ≥ 50%. Change in perianal disease activity index, quality-of-life and Van Assche index on MRI over time was assessed using mixed-effect linear regression model. RESULTS: Ten patients (male:8, mean age:27.4 ± 12.0years) were recruited. Self-resolving procedure-related adverse events occurred in three patients, with no follow-up adverse events. In intention to treat analysis at week 24, two patients (20%) achieved fistula remission and seven (70%) had fistula response. At week 52, two (20%) patients were in remission and seven (70%) maintained response. At 104 weeks, two (20%) patients maintained response and one (10%) was in remission. Statistically significant decrease in perianal disease activity index (P = 0.008), Van Assche Index (P = 0.008) and improvement in quality-of-life (P = 0.001) were observed over time. CONCLUSIONS: Allogeneic BMSCs are safe and effective for the treatment of perianal fistulizing CD with significant improvement in clinical severity and radiological healing. TRIAL REGISTRATION: The study was prospectively registered on Clinical trials registry - India (CTRI), CTRI/2020/01/022743 on 14 January 2020, http://ctri.nic.in .