HIV-associated rectovaginal fistulae in children: a single-centre retrospective study in the antiretroviral era.

PURPOSE: Acquired rectovaginal fistulae (RVF) are a complication of paediatric HIV infection. We report our experience with the surgical management of this condition. METHODS: We retrospectively reviewed the records of paediatric patients with HIV-associated RVF managed at Chris Hani Baragwanath Academic Hospital (2011-2023). Information about HIV management, surgical history, and long-term outcomes was collected. RESULTS: Ten patients with HIV-associated RVF were identified. Median age of presentation was 2 years (IQR: 1-3 years). Nine patients (9/10) underwent diverting colostomy, while one demised before the stoma was fashioned. Fistula repair was performed a median of 17 months (IQR: 7.5-55 months) after colostomy. An ischiorectal fat pad was interposed in 5/9 patients. Four (4/9) patients had fistula recurrence, 2/9 patients developed anal stenosis, and 3/9 perineal sepsis. Stoma reversal was performed a median of 16 months (IQR: 3-25 months) after repair. Seven patients (7/9) have good outcomes without soiling, while 2/9 have long-term stomas. Failure to maintain viral suppression after repair was significantly associated with fistula recurrence and complications (φ = 0.8, p < 0.05). CONCLUSION: While HIV-associated RVFs remain a challenging condition, successful surgical treatment is possible. Viral suppression is a necessary condition for good outcomes.

Comparative study on the establishment efficacy of four types of animal models of rectovaginal fistula in rabbits.

Various surgical methods have so far been developed for treating rectovaginal fistula (RVF), each with its own advantages and disadvantages. The lack of standardized animal models of RVF is a major reason for the failure to establish a unified and effective surgical method for the treatment of RVF. This study aimed to explore the feasibility of an RVF animal model by magnetic compression and compare it with the traditional modeling method. Thirty-two female Japanese white rabbits were randomly divided into four groups: A, B, C, and D, based on how the rectovaginal septum was treated. The operation time, intraoperative blood loss, and model success rate of each group were determined. The experimental animals were euthanized 2 weeks after the operation. Their rectovaginal septum specimens were obtained. RVF was observed by the naked eye. The fistula size was measured. Histological changes of fistula were observed by hematoxylin and eosin and Masson staining. All rabbits completed the RVF model and survived 2 weeks after the operation. Groups A and B had no bleeding, while groups C and D had < 0.5 mL of bleeding. The magnet detached in 4-6 days in group A, while it remained in place for 2 weeks after surgery in group B. Only one group D rabbit had a plastic hose for 2 weeks after surgery. The RVFs of groups A and C healed by themselves. In group B, the fistula was well formed. In group D, fistula healing was observed in three animals and the diameter of the fistulas was only 2.82-4.64 mm in the other four animals. Groups B and D had a scar on the inner surface of fistulas. Our study shows that the magnetic compression technique based on the T-shaped magnet is a highly useful method to establishing a continuous and stable RVF model in rabbits.

Multidisciplinary approach to evaluation of rectovaginal fistulas.

Thorough evaluation of a rectovaginal fistula is essential to optimize surgical repair. The underlying cause should be addressed and treated, which can affect the timing and the approach to repair. It is imperative to be well prepared because the highest chance of successful closure occurs during the initial repair attempt. Our objective was to demonstrate how multidisciplinary colorectal surgery and urogynecology teams use specific methods during the examination under anesthesia to evaluate a complex rectovaginal fistula and to optimize the surgical approach to repair. Anesthesia may be provided with monitored anesthesia care and a posterior perineal block. This pain control allows for a wide range of techniques to evaluate the fistula using anoscopy, fistula probe, hydrogen peroxide, and sigmoidoscopy. In addition, the teams show how curettage and subsequent seton placement can encourage closure by secondary intention and decrease the risk of abscess formation, respectively.

Measuring the cost-effectiveness of treating rectovaginal and vesicovaginal fistulas: A multicenter global study by the Fistula Foundation.

OBJECTIVE: Surgery for obstetric fistula is a highly effective treatment to restore continence and improve quality of life. However, a lack of data on the cost-effectiveness of this procedure limits prioritization of this essential treatment. This study measures the effectiveness of fistula surgeries using disability-adjusted life years (DALYs) averted. METHODS: In 2021 and 2022, the Fistula Foundation funded 20 179 fistula surgeries and related procedures at 143 hospitals among 27 countries. We calculated DALYs averted specifically for vesicovaginal fistula and rectovaginal fistula procedure types (n = 13 235 surgeries) by using disability weights from the 2019 Global Burden of Disease study. We based cost calculations on direct treatment expenses, including medical supplies, health provider fees, and preoperative and postoperative care. We measured effectiveness using data on the risk of permanent disability, country-specific average life spans, and treatment outcomes. RESULTS: The total treatment cost was $7.6 million, and a total of 131 433 DALYs were averted. Thus, the cost per DALY averted-the cost to restore 1 year of healthy life-was $58. For this analysis, we took a cautious approach and weighted only surgeries that resulted in a closed fistula with restored continence. We calculated DALYs averted by country. Limitations of the study include data entry errors inherent in patient logs and lack of long-term outcomes. CONCLUSION: The current study demonstrates that obstetric fistula surgery, along with having a significant positive impact on maternal health outcomes, is highly cost-effective in comparison with other interventions. The study therefore highlights the benefits of prioritizing fistula treatment as part of the global agenda for maternal health care.

Treatment techniques for rectovaginal fistulas after low rectal resection for deep endometriosis.

Endometriosis is a benign gynecologic affection that may lead to major surgeries, such as colorectal resections. Rectovaginal fistulas (RVF) are among the possible complications. When they occur, it is necessary to adapt the repair surgery as best as possible to limit their functional consequences. This video shows three different techniques for correcting RVF after rectal resection for endometriosis, with a combination of perineal surgery and laparoscopy: a mucosal flap, a transanal transection and single stapled anastomosis (TTSS) and a pull through. Supplementary file1 (MP4 469658 KB).

Rectovaginal Fistula: What Is the Role of Martius Flap and Gracilis Muscle Interposition in the Therapeutic Strategy?

BACKGROUND: Although numerous treatments exist for the management of rectovaginal fistula, none has demonstrated its superiority. The role of diverting stoma remains controversial. A few series include Martius flap in the armamentarium. OBJECTIVE: Determine the role of gracilis muscle interposition and Martius flap in the surgical management of rectovaginal fistula. DESIGN: Retrospective cohort study of a pooled prospectively maintained database from 3 centers. PATIENTS: All consecutive eligible patients with rectovaginal fistula undergoing Martius flap and gracilis muscle interposition were included from 2001 to 2022. MAIN OUTCOME MEASURES: Success was defined by the absence of stoma and rectovaginal fistula. RESULTS: Sixty-two patients were included with 55 Martius flap and 24 gracilis muscle interposition performed after failures of 164 initial procedures. Total length of stay was longer for gracilis muscle interposition by 2 days ( p = 0.01) without a significant difference in severe morbidity (20% vs 12%, p = 0.53). Twenty-seven percent of the Martius flap interpositions were performed without a stoma, which did not have an impact on overall morbidity ( p = 0.763). Per patient immediate success rates were not significantly different between groups (35% vs 31%, p > 0.99). The success of gracilis muscle interposition after the failure of the Martius flap was not significantly different from an initial gracilis muscle interposition ( p > 0.99). After simple perineal procedures, the immediate success rate rose to 49.4% (49% vs 50%, p > 0.99). After a median follow-up of 23 months, no significant difference was detected in success rate between the 2 procedures (69% vs 69%, p > 0.99). Smoking was the only negative predictive factor ( p = 0.02). LIMITATIONS: By its retrospective nature, this study is limited in its comparison. CONCLUSIONS: This novel comparison between Martius flap and gracilis muscle interposition suggests that Martius flap presents several advantages, including shorter length of stay, similar morbidity, and similar success rate. Proximal diversion via a stoma for Martius flap does not appear mandatory. Gracilis muscle interposition could be reserved as a salvage procedure after Martius flap failure. See Video Abstract . FSTULA RECTOVAGINAL CUL ES EL ROL DEL COLGAJO DE MARTIUS Y LA INTERPOSICIN DEL MSCULO GRACILIS EN LA ESTRATEGIA TERAPUTICA: ANTECEDENTES:Si bien existen numerosos tratamientos para el manejo de la fistula rectovaginal, ninguno ha demostrado su superioridad. El papel del estoma de derivación sigue siendo controvertido. Pocas series incluyen colgajo de Martius en el armamento.OBJETIVO:Determinar el rol de la interposición del músculo gracilis y del colgajo de Martius, en el manejo quirúrgico de la fístula rectovaginal.DISEÑO:Estudio de cohorte retrospectivo de una base de datos mantenida prospectivamente en 3 centros.AJUSTES/PACIENTES:Se incluyeron todos los pacientes elegibles consecutivos con fistula rectovaginal sometidos a colgajo de Martius y la interposición del músculo gracilis desde 2001 hasta 2022.RESULTADOS PRINCIPALES:El éxito se definió por la ausencia de estoma y fistula rectovaginal.RESULTADOS:Se incluyeron 62 pacientes con 55 colgajo de Martius y 24 con interposición del músculo gracilis realizados después de fracasos de 164 procedimientos iniciales. La duración total de la estancia hospitalaria fue dos días más larga para la interposición del músculo gracilis ( p = 0,01) sin una diferencia significativa en la morbilidad grave (20% frente a 12%, p = 0,53). El 27% de los colgajos de Martius se realizaron sin estoma, sin impacto en la morbilidad global ( p = 0,763). Las tasas de éxito inmediato por paciente no fueron significativamente diferentes entre los grupos (35% vs. 31%, p = 1,0). El éxito de la interposición del músculo gracilis después del fracaso del colgajo de Martius no fue significativamente diferente de una interposición del músculo gracilis inicial (p = 1,0). La tasa de éxito inmediato aumentó al 49,4% (49% frente a 50%, p = 1,0) después de procedimientos perineales simples. Después de una mediana de seguimiento de 23 meses, no se detectaron diferencias significativas en la tasa de éxito entre los dos procedimientos (69 % frente a 69 %, p = 1,0). El tabaquismo fue el único factor predictivo negativo ( p = 0,02).LIMITACIONES:Por su naturaleza retrospectiva, este estudio tiene limitaciones en su comparación.CONCLUSIÓN:Esta novedosa comparación entre colgajo de Martius y la interposición del músculo gracilis sugiere que el colgajo de Martius presenta varias ventajas, incluida una estancia prolongada más corta, una morbilidad similar y un éxito. La derivación proximal a través de un estoma para el colgajo de Martius no parece obligatoria. La interposición del músculo gracilis podría reservarse como procedimiento de rescate después de una falla de colgajo de Martius. (Traducción-Dr. Aurian Garcia Gonzalez ).

Transanal fistula repair for the treatment of rectovestibular fistula with normal anus in female children: a 5-year single-center experience.

PURPOSE: The purpose of this study was to review a 5-year operative experience of transanal fistula repair for the treatment of rectovestibular fistula with a normal anus in female children. METHODS: In this study, we conducted a retrospective review of children diagnosed with rectovestibular fistula with normal anus who underwent transanal fistula repair in the department of General Surgery, Children's Hospital of Chongqing Medical University. Clinical data were retrospectively analyzed. RESULTS: A total of 56 female children were included in the study. The patients' ages ranged from 1 year 10 months to 15 years 11 months, with an average age of 5 years 1 month. These children had a clear history of gas or loose stool leakage through the vestibular area, with or without a history of vestibular infection. All patients had a normal anus and underwent transanal fistula repair. Follow-up was conducted through telephone or outpatient visits for a duration of 10 months to 5 years (average follow-up duration 19 months). Three patients experienced minimal secretion from the external orifice of the vestibular fistula within two weeks after the operation, but were successfully treated with sitting bath therapy without any relapse. Another three cases had a recurrence of the fistula, and two of them underwent transanal fistula repair at our center again, resulting in a successful cure after reoperation. The remaining case has not yet undergone reoperation. In the long-term follow-up, all the children had satisfactory anal appearance, with no fecal incontinence, anorectal stenosis, or fistula infection. CONCLUSION: Transanal fistula repair is a simple, safe, and effective surgical method to treat female children with rectovestibular fistula with a normal anus.

Modified Internal Pudendal Artery Perforator Flap Interposition for Rectovaginal Fistula.

IMPORTANCE: Rectovaginal fistula (RVF) is a challenging condition associated with recurrences and significant functional impairment. OBJECTIVES: The internal pudendal artery perforator (IPAP) flap has become a viable option for reconstructing the vagina and perineal regions. This study aims to introduce a modified technique of IPAP flap interposition and evaluate its postoperative outcomes in the treatment of low RVF. STUDY DESIGN: Sixteen patients with RVF who underwent modified IPAP flap interposition between 2016 and 2021 were retrospectively enrolled. Recurrence rate, the satisfaction of vulvar appearance (Visual Analog Scale), and quality of sexual life (Female Sexual Function Index score) were followed up and analyzed. RESULTS: All patients presented with low fistula with a mean diameter of 8.3 mm. The mean width and length of the IPAP flaps were 3.8 and 6.2 cm, respectively. The mean follow-up period was 14.1 months. All patients achieved successful healing without recurrence. High satisfaction was reported for the cosmetic effect of the vulva with a mean Visual Analog Scale score of 8.4. The proportion of female sexual disorder exhibited a statistically significant reduction, decreasing from 100% preoperatively to 38% after surgery ( P < 0.05). CONCLUSIONS: The modified IPAP flap interposition is a reliable and safe option for repairing low RVF, with high success rates and minimal donor site morbidity. Moreover, this procedure provides a suitable volume flap and preserves the vaginal physiological environment, which benefits postoperative sexual function.

Obstetric fistula repair failure and its associated factors among women who underwent repair in sub-Saharan Africa. A systematic review and meta-analysis.

BACKGROUND: Obstetric fistula repair failure can result in increased depression, social isolation, financial burden for the woman, and fistula care programs. However, there is limited, comprehensive evidence on obstetric fistula repair failure in Sub-Saharan African countries. This systematic review and meta-analysis aimed to determine the pooled prevalence of obstetric fistula repair failure and associated factors among women who underwent surgical repair in Sub-Saharan African countries. METHODS: To identify potential articles, a systematic search was done utilizing online databases (PubMed, Hinari, and Google Scholar). The Preferred Reporting Items for Systematic Review and Meta-Analysis Statement (PRISMA) guideline was used to report the review's findings. I2 test statistics were employed to examine study heterogeneity. A random-effects model was used to assess the pooled prevalence of obstetric fistula repair failure, and the association was determined using the log odds ratio. Publication bias was investigated using the funnel plot and Egger's statistical test at the 5% level of significance. Meta-regression and subgroup analysis were done to identify potential sources of heterogeneity. The data were analyzed using STATA version 17 statistical software. RESULTS: A total of 24 articles with 9866 study participants from 13 Sub-Saharan African countries were included in this meta-analysis. The pooled prevalence of obstetric fistula repair failure in sub-Saharan Africa was 24.92% [95% CI: 20.34-29.50%]. The sub-group analysis by country revealed that the highest prevalence was in Angola (58%, 95% CI: 53.20-62.80%) and the lowest in Rwanda (13.9, 95% CI: 9.79-18.01%). Total urethral damage [OR = 3.50, 95% CI: 2.09, 4.91], large fistula [OR = 3.09, 95% CI: (2.00, 4.10)], duration of labor [OR = 0.45, 95% CI: 0.27, 0.76], and previous fistula repair [OR = 2.70, 95% CI: 1.94, 3.45] were factors associated with obstetric fistula repair failure. CONCLUSION: Women who received surgical treatment for obstetric fistulas in Sub-Saharan African countries experienced more repair failures than the WHO standards. Obstetric fistula repair failure was affected by urethral damage, fistula size, duration of labor, types of fistula, and history of previous repairs. Therefore, we suggest policy measures specific to each country to provide special attention to the prevention of all risk factors, including poor nutrition, multiparty, obstructed labor, and maternal age, which can result in conditions like large fistulas, urethral damage, and repeat repair, in order to reduce obstetric fistula repair failure.

Stapled transperineal rectovaginal fistula repair for low- and mid-level rectovaginal fistulas: A comparison study with rectal mucosal advancement flap repair.

BACKGROUND: As an innovative treatment, stapled transperineal rectovaginal fistula repair (STR) for rectovaginal fistula (RVF) has demonstrated effectiveness in preliminary reports. This study aims to compare STR with rectal mucosal advancement flap repair (RAF), a widely utilized surgical procedure, for the surgical outcome of the low- and mid-level RVF. METHODS: In this retrospective cohort study, patients with low- and mid-level RVF who underwent STR or RAF were included from both the Sixth Affiliated Hospital of Sun Yat-sen University and Xi'an Daxing Hospital. Among the 99 total patients, 77 underwent STR and 22 underwent RAF. Patient demographics, operative data, and outcomes were collected and analyzed. Recurrence rate and associated risk factors were evaluated. RESULTS: There were no statistically significant differences among patients in terms of clinical characteristics like age, BMI, aetiology, and fistula features. During the follow-up period of 20 months (interquartile range 3.0-41.8 months), a total of 28 patients relapsed, with a significantly lower recurrence rate in the STR group (20.8 %) than in the RAF group (54.6 %) (P = 0.005). In the multivariate Cox analysis, STR was an independent protective factor against recurrence (HR: 0.37, 95%CI: 0.17-0.79, P = 0.01). Logistic regression indicated that there was no statistically significant difference between these two procedures in terms of surgical complications (OR: 0.53, 95%CI: 0.19-1.48, P = 0.23). CONCLUSION: For low- and mid-level RVF, STR may be an alternative option for treatment modality that offers a lower recurrence rate, without observed disadvantage in terms of surgical complication rates.

The prevention of rectovaginal fistula after rectal cancer surgery by packing with laparoscopic dislocated fat flap containing ovarian vascular pedicle anterior to the anastomotic stoma: a parallel group randomized controlled trial protocol.

BACKGROUND: Rectovaginal fistula (RVF) is an abnormal channel formed by epithelial tissue between the anterior wall of the rectum and the posterior wall of the vagina, which manifests as vaginal gassing and defecation. It is one of the common complications of female pelvic surgeries. With the increased number of proctectomies for rectal cancer, the number of postoperative rectovaginal fistulas also increases. Once RVF occurs, the failure rate is still high with various treatments available. RVF causes great suffering to women and is still a major problem in treatment. Therefore, it is significant for female rectal cancer patients to prevent RVF after rectal cancer surgery. In this study, we introduce a new method to prevent RVF during rectal cancer radical operation. METHODS: In this randomized controlled trial (RCT), all operations are performed according to the principle of total mesorectal excision (TME) radical resection in rectal cancer surgery. All eligible participants will be divided into two groups: the experimental group and the control group. Experimental group: the anterior rectal wall of about 1 cm distal to the anastomosis was dislocated. Before the anastomosis of the rectal end, a fat flap (usually left side) containing the ovarian vascular pedicle was dislocated, measured by 10-15 cm in length and 2 cm in width. The fat flap containing the ovarian vascular pedicle was packed and fixed anterior to the anastomotic stoma with fibrin glue. CONTROL GROUP: surgery will be carried out in accordance with the TME principle. Participants will be compared on several variables, including the incidence of RVF after operation (primary outcomes), the occurrence time of postoperative RVF, the occurrence time of RVF after stoma closure, and other postoperative complications, such as anastomotic leakage, chylous leakage, and intestinal obstruction (secondary outcomes). The follow-up data collection will be conducted according to the follow-up time point, and the baseline data will also be collected for follow-up analysis. By comparing the incidence of rectovaginal leakage between the experimental group and the control group, we aim to explore the feasibility of this method for the prevention of postoperative RVF. DISCUSSION: This RCT will explore the feasibility of packing with a laparoscopic dislocated fat flap containing an ovarian vascular pedicle anterior to the anastomotic stoma after rectal cancer surgery to prevent RVF. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR) registration ChiCTR2000031449. Registered on June 26, 2019. All items of the WHO Trial registration data set can be found within the protocol.

Extraperitoneal Cesarean Section after two Medial Laparotomies, Anus Prater, and Surgical Treatment of the Rectovaginal Fistula in a Patient with Crohn's Disease: A Case Report.

The aim of this case report is to show the advantages of the extraperitoneal cesarean section (ECS) approach in a pregnant patient with multiple previous abdominal transperitoneal colon surgeries and Crohn's disease. A pregnant nulliparous woman with Crohn's disease was admitted for delivery. After delivery, a large rupture and lesion of the rectum was observed. Suturing of the vagina, rectum and sphincter was performed by an abdominal surgeon. Because of a very large and irregularly shaped rectum rupture, the patient underwent infraumbilical medial laparotomy and sigmoidostomy. After 18 months, the patient started to experience vaginal discharge and Y-shaped rectovaginal fistula was confirmed. Surgical reconstruction was performed. The patient's second pregnancy began one year later. At 38 weeks of pregnancy, elective extraperitoneal cesarean section was performed. A healthy newborn was delivered. Follow-up showed full and fast recovery after the ECS. In cases of pregnant women who have had multiple colon surgeries, gynecology surgeons can choose to perform an ECS to avoid transperitoneal entrance into the abdomen. ECS avoids lysis of postoperative adhesions after repetitive gastrointestinal surgeries, the formation of new adhesions by lysis of the old adhesions, and most importantly, the possibility of colon or small intestine lesions during lysis of dense or firm adhesions.

Repair of radiation-induced rectovaginal fistula with rectal stricture by a combined Tuttle, Turnbull-Cutait and Singapore flap approach.

Radiation-induced rectovaginal fistula (RI-RVF) with associated rectal stricture represents a challenging problem in management. The aim of the present technical note is to describe a surgical technique aimed at minimizing disease recurrence by avoiding radiated tissue in the reconstruction: 1. Tuttle longitudinal incision of posterior vaginal wall with sharp excision of proximally located fistula; 2. Resection of strictured rectum via a combined transvaginal/laparotomy access, reconstruction with Turnbull-Cutait colon pull-through, and delayed handsewn coloanal anastomosis with loop ileostomy; 3. Bridge closure of the posterior vaginal wall by the interposition of a Singapore flap. This approach resulted in a favorable outcome at the 1-year follow-up in one patient with a medical history of gynecological carcinoma status after hystero-salpingo-oophorectomy followed by adjuvant radiation.

Rectovaginal Fistulas: Comparative Analysis of Laparoscopic Assisted Pullthrough and Posterior Sagittal Anorectoplasty.

AIM: Compare the laparoscopic treatment (LT) and the posterior sagittal anorectoplasty treatment (ST) of the rectovaginal fistulas (RvaF) in a single center. We have previously reported feasibility and results of LT in this rare variety of anorectal malformations (ARM) [1-3]. MATERIAL AND METHODS: 19 patients were treated between February 2000 and November 2020. Nine underwent a LT and 10 a ST. Both surgical techniques were previously described. [2][4][5] The distal posterior wall of the vagina was kept intact in the LT. A technical change was introduced in the ST for that purpose. The fistula was treated from the inside of the rectum, avoiding the opening of the distal vagina as described for the treatment of a urethra rectal bulbar fistula in males. Age at operation, associated anomalies, sacral ratio index (SR), complications, urinary continence, presence of spontaneous intestinal movements, constipation, soiling and requirements of bowel management program (BMP) were analyzed. RESULTS: Associated anomalies occurred in 17 patients (89.5 %), 63 % of which were urological. Five (26 %) had a SR below 0.4; 4 in the LT group and 1 in the ST group. The mean age at the time of operation was 23.2 (8-59) in ST and 17.6 months (4-32) in LT. Average operative time was 190.4 min for ST (120-334) and 195.8 min (90-270) for LT (p 0.13). One patient in the LT group presented a mild rectal prolapse and 2 a partial wound dehiscence after the ST. Only 15 patients were evaluable for functional results (8 in ST and 7 in LT). Mean follow up was 83 months (12-197). All patients are clean with a bowel management program. Five of the 7 patients undergoing a LT had a bad prognosis (SR < 0,4). Three (43 %) are clean with diet or any treatment, 3 (43 %) using laxatives or enemas and 1 (14 %) with a trans anal irrigation system. Only 1 of the 8 patients in the STgroup had a bad prognosis. Six (40 %) needed a diet; 4 (50 %) laxatives or enemas and 1 (10 %) a cecostomy button for antegrade enemas. CONCLUSIONS: Patients with RvaF had a high index of associated anomalies. The difference of operative time was not statistically significative. No differences in functional results between both groups were observed. LT is a valid option to treat RvaF.

A phase IB/IIA study of ex vivo expanded allogeneic bone marrow-derived mesenchymal stem cells for the treatment of rectovaginal fistulizing Crohn's disease.

BACKGROUND: Crohn-related rectovaginal fistulas are notoriously difficult to treat. Studies of mesenchymal stem cells for the treatment of perianal Crohn fistulizing disease have largely excluded rectovaginal fistulas. The aim of this study was to determine the safety and efficacy of mesenchymal stem cells for refractory rectovaginal fistulizing Crohn disease. METHODS: A phase IB/IIA randomized control trial was performed in a 3:1, single-blinded study. Patients included were adult women with an anovaginal/rectovaginal fistula in the setting of Crohn disease. Seventy-five million mesenchymal stem cells were administered with a 22G needle after curettage and primary closure of the fistula tract at day 0 and month 3. Adverse and serious adverse events were recorded at post-procedure day 1, week 2, week 6, month 3, month 6, and month 12, along with clinical healing, magnetic resonance imaging, and patient-reported outcomes. RESULTS: A total of 19 patients were enrolled and treated-15 treatment and 4 control. There were no adverse or serious adverse events related to mesenchymal stem cell therapy. At 6 months, 50% of the treatment group and 0% of the control had complete clinical and radiographic healing; 91.7% of the treatment group had improvement at 6 months with only one patient having a lack of response, whereas only 50% of the control group had improvement at 6 months. CONCLUSION: Bone marrow-derived mesenchymal stem cells offer a safe alternative treatment approach for rectovaginal fistulas in the setting of Crohn disease. Complete healing was achieved in half of the patients.