Efficacy of Micronized Purified Flavonoid Fraction in the Posthemorrhoidectomy Period Trial: Open-Label Randomized Controlled Trial.

BACKGROUND: Frequent early postoperative complications of hemorrhoidectomy are thrombosis and edema of mucocutaneous "bridges." OBJECTIVE: This study aimed to investigate the efficacy of micronized purified flavonoid fraction in preventing complications after elective hemorrhoidectomy. DESIGN: Prospective unicentral open-label randomized controlled trial. SETTINGS: 2021-2022 at the Clinic of Colorectal and Minimally Invasive Surgery at Sechenov University (Moscow, Russia). PATIENTS: Patients who underwent hemorrhoidectomy for grade III and IV hemorrhoids. INTERVENTIONS: After hemorrhoidectomy, patients were randomly assigned either to standard treatment (peroral nonsteroid anti-inflammatory drugs and local anesthetics, topical steroids, psyllium, warm sitz baths, and nifedipine gel), referred to as the control group, or to standard treatment with micronized purified flavonoid fraction, referred to as the study group, and followed up for 60 days. MAIN OUTCOME MEASURES: Thrombosis or edema of mucocutaneous bridges and pain intensity on a visual analog scale оn postoperative days 1-7, 14, 21, and 30; quality of life and patient-assessed treatment effect оn postoperative days 1, 3, 7, 21, and 30; and perianal skin tags оn postoperative day 60. RESULTS: The data from 50 patients were analyzed (25 in each group). The visual analog scale demonstrated no differences between groups in each follow-up point. Compared to the control group, the patients in the study group had a significantly higher patient-assessed treatment effect оn postoperative days 1, 3, 7, 21, and 30 and a significantly lower rate of thrombosis or edema of mucocutaneous bridges оn postoperative days 1-7 and 14. Patients in the study group had significantly lower rates of perianal skin tags. LIMITATIONS: Unicenter open-label design. CONCLUSIONS: Micronized purified flavonoid fraction in the posthemorrhoidectomy period is an effective adjunct to standard treatment that helps reduce the rate of thrombosis and edema of mucocutaneous bridges, improves patient-assessed treatment effect, and prevents postoperative perianal skin tags formation. Micronized purified flavonoid fraction in the posthemorrhoidectomy period is not associated with additional pain relief in comparison with nonmicronized purified flavonoid fraction standard treatment. See Video Abstract . EFICACIA DE LA FRACCIN DE FLAVONOIDES PURIFICADA MICRONIZADA EN EL PERODO POSTERIOR A LA HEMORROIDECTOMA ENSAYO MOST ENSAYO CONTROLADO, ALEATORIZADO, ABIERTO: ANTECEDENTES:Una complicación postoperatoria temprana frecuente de la hemorroidectomía es la trombosis y el edema de los "puentes" mucocutáneos.OBJETIVO:Investigamos la eficacia de la fracción de flavonoides purificada micronizada en la prevención de complicaciones después de una hemorroidectomía electiva.DISEÑO:Ensayo controlado aleatorio, prospectivo, unicentral, abierto.AJUSTES:2021-2022 Clínica de Cirugía Colorrectal y Mínimamente Invasiva Universidad Sechenov (Moscú, Rusia).PACIENTES:Pacientes después de hemorroidectomía, que se realizó para hemorroides de grado III-IV.INTERVENCIONES:Después de la hemorroidectomía, los pacientes fueron asignados aleatoriamente al tratamiento estándar (antiinflamatorios no esteroides perorales y anestésicos locales, esteroides tópicos, psyllium, baños de asiento tibios, gel de nifedipina) - grupo de control, o al tratamiento estándar con flavonoide purificado micronizado. fracción (grupo de estudio) y seguido durante 60 días.RESULTADOS DE MEDIDAS PRINCIPALES:Trombosis o edema de puentes mucocutáneos e intensidad del dolor en una escala analógica visual entre el 1.º, 7.º, 14.º, 21.º y 30.º día postoperatorio; calidad de vida y efecto del tratamiento evaluado por el paciente el día 1, 3, 7, 21 y 30 del postoperatorio; Marcas cutáneas perianales en el día 60 del postoperatorio.RESULTADOS:Se analizaron los datos de 50 pacientes (25 en cada grupo). La escala analógica visual no demostró diferencias entre grupos en cada punto de seguimiento. En comparación con el grupo de control, los pacientes en el grupo de estudio tuvieron un efecto del tratamiento evaluado por el paciente significativamente mayor en los días 1, 3, 7, 21 y 30 después de la operación, una tasa significativamente menor de trombosis o edema de los puentes mucocutáneos en los días 1, 7 y 14.. Los pacientes del grupo de estudio tuvieron tasas significativamente más bajas de marcas en la piel perianal.LIMITACIONES:Diseño Unicenter de etiqueta abierta.CONCLUSIONES:La fracción de flavonoides purificada micronizada en el período posterior a la hemorroidectomía es un complemento eficaz del tratamiento estándar que ayuda a reducir la tasa de trombosis y edema de los puentes mucocutáneos, mejora el efecto del tratamiento evaluado por el paciente y previene la formación de marcas cutáneas perianales posoperatorias. La fracción de flavonoides purificados micronizados en el período posterior a la hemorroidectomía no se asocia con un alivio adicional del dolor en comparación con el tratamiento estándar con la fracción de flavonoides purificados no micronizados. (Traducción-Yesenia Rojas-Khalil ).

Garg incontinence scores: New scoring system on the horizon to evaluate fecal incontinence. Will it make a difference?

The main aim of this opinion review is to comment on the recent article published by Garg et al in the World Journal of Gastroenterology 2023; 29: 4593-4603. The authors in the published article developed a new scoring system, Garg incontinence scores (GIS), for fecal incontinence (FI). FI is a chronic debilitating disease that has a severe negative impact on the quality of life of the patients. Rome IV criteria define FI as multiple episodes of solid or liquid stool passed into the clothes at least twice a month. The associated social stigmatization often leads to significant under-reporting of the condition, which further impairs management. An important point is that the complexity and vagueness of the disease make it difficult for the patients to properly define and report the magnitude of the problem to their physicians. Due to this, the management becomes even more difficult. This issue is resolved up to a considerable extent by a scoring questionnaire. There were several scoring systems in use for the last three decades. The prominent of them were the Cleveland Clinic scoring system or the Wexner scoring system, St. Marks Hospital or Vaizey's scores, and the FI severity index. However, there were several shortcomings in these scoring systems. In the opinion review, we tried to analyze the strength of GIS and compare it to the existing scoring systems. The main pitfalls in the existing scoring systems were that most of them gave equal weightage to different types of FI (solid, liquid, flatus, etc.), were not comprehensive, and took only the surgeon's perception of FI into view. In GIS, almost all shortcomings of previous scoring systems had been addressed: different weights were assigned to different types of FI by a robust statistical methodology; the scoring system was made comprehensive by including all types of FI that were previously omitted (urge, stress and mucus FI) and gave priority to patients' rather than the physicians' perceptions while developing the scoring system. Due to this, GIS indeed looked like a paradigm shift in the evaluation of FI. However, it is too early to conclude this, as GIS needs to be validated for accuracy and simplicity in future studies.

Thrombosed external hemorrhoids during pregnancy: surgery versus conservative treatment.

The management of thrombosed external hemorrhoids (TEH) during pregnancy is still under debate because of the fear of potential adverse effects on the fetus. This study aims to compare efficacy and safety of conservative versus surgical treatment of acute TEH in pregnant women. Furthermore, the outcome of two different surgical approaches was evaluated. This is a prospective observational study including a sub-analysis on two randomized groups of pregnant women affected by TEH. The primary outcome measured was the impact of conservative and surgical treatment defined in terms of VAS, clinical patient grading assessment scale (CPGAS) and the SF-12 questionnaire. In a randomized sub-analysis of the surgical treatment, the outcome of local excision (LE) versus thrombectomy (TE) was compared. Fifty-three patients entered the study. Twenty-six patients had conservative treatment and 22 underwent surgery. Within the surgical group, 8 were randomized for TE and 14 for LE. VAS, SF-12 and CPGAS improved in both groups after 3 and 10 days from the treatment. However, physical (PCS) and mental health (MCS) domains of the SF-12 and CPGAS showed a significant difference in favor of surgery on the 10th day (PCS: p < 0.002 and MCS: p = 0.03; CPGAS: p = 0.002). The surgical group showed an earlier significant reduction of pain on the 3rd day (p = 0.0004). In the surgical group, randomization was halted due to ethical concerns arising from a notable difference in the primary end point between subgroups during interim analysis. Specifically, the re-thrombosis rate was 38% (3/8) after TE and 7% (1/14) after LE. No complications occurred for either mothers or fetuses. Both surgical and conservative treatments are safe and effective. However, surgery allows a faster relief of anal pain. Thrombectomy is associated with higher risk of re-thrombosis when compared to local excision (clinicaltrials.gov ID number NCT04588467).

Risk factors that impact long-term outcomes in sigmoid colon cancer with urinary bladder involvement.

PURPOSE: This study aimed to identify the risk factors impacting long-term outcomes in patients diagnosed with sigmoid colon cancer with urinary bladder involvement. METHODS: A comprehensive analysis was conducted on a retrospective cohort of 118 patients who underwent multivisceral resection for sigmoid colon cancer with urinary bladder involvement between June 2002 and May 2017. Univariate and multivariate analyses were employed to identify risk factors associated with long-term outcomes. RESULTS: Among the included patients, 10 (8.5%) experienced grade III-IV complications according to Clavien-Dindo classification, with 4 (3.4%) presenting anastomotic leaks. The postoperative mortality was 0.8%. R0 resection was achieved in 108 (91.6%) patients. Adjuvant chemotherapy was administrated to only 31 patient (26.3%). Local recurrence was observed in 8 (6.8%) cases. Risk factors for local recurrence-free survival and disease-free survival were CCI>3, grade III-IV postoperative complications according to Clavien-Dindo classification, positive resection margins, stage III of the disease, additional resected organs (excluding colon and bladder) and the absence of adjuvant chemotherapy. The same risk factors, with the exception of CCI, were associated with overall survival. CONCLUSION: This study highlights that negative resection margins, a postoperative period without grade III-IV complications, and the implementation of adjuvant chemotherapy are crucial factors contributing to improve overall, disease-free and local recurrence-free survival in patients with sigmoid colon cancer with urinary bladder involvement.

International standardization and optimization group for intersphincteric resection (ISOG-ISR): modified Delphi consensus on anatomy, definition, indication, surgical technique, specimen description and functional outcome.

AIM: Intersphincteric resection (ISR) is an oncologically complex operation for very low-lying rectal cancers. Yet, definition, anatomical description, operative indications and operative approaches to ISR are not standardized. The aim of this study was to standardize the definition of ISR by reaching international consensus from the experts in the field. This standardization will allow meaningful comparison in the literature in the future. METHOD: A modified Delphi approach with three rounds of questionnaire was adopted. A total of 29 international experts from 11 countries were recruited for this study. Six domains with a total of 37 statements were examined, including anatomical definition; definition of intersphincteric dissection, intersphincteric resection (ISR) and ultra-low anterior resection (uLAR); indication for ISR; surgical technique of ISR; specimen description of ISR; and functional outcome assessment protocol. RESULTS: Three rounds of questionnaire were performed (response rate 100%, 89.6%, 89.6%). Agreement (≥80%) reached standardization on 36 statements. CONCLUSION: This study provides an international expert consensus-based definition and standardization of ISR. This is the first study standardizing terminology and definition of deep pelvis/anal canal anatomy from a surgical point of view. Intersphincteric dissection, ISR and uLAR were specifically defined for precise surgical description. Indication for ISR was determined by the rectal tumour's maximal radial infiltration (T stage) below the levator ani. A new surgical definition of T3isp was reached by consensus to define T3 low rectal tumours infiltrating the intersphincteric plane. A practical flowchart for surgical indication for uLAR/ISR/abdominoperineal resection was developed. A standardized ISR surgical technique and functional outcome assessment protocol was defined.

Autological platelet-rich fibrin sealant for anterior horseshoe anal fistula in female patient: A video vignette.

INTRODUCTION: Nowadays many techniques have been developed for the treatment of complex anorectal fistulas. Biological substances are used for minimally invasive treatment of anorectal fistulas, especially for complex anal fistulas. Insertion of autological fibrin substance into the fistula tract is one of the types of such procedures. CLINICAL CASE: Here, we present a case of insertion of platelet-rich fibrin sealant into a horseshoe fistula in a female patient. The follow-up period was 10 months with no signs of clinical or MRI recurrence.

Preemptive analgesia for hemorrhoidectomy: study protocol for a prospective, randomized, double-blind trial.

BACKGROUND: Hemorrhoidectomy is associated with intense postoperative pain that requires multimodal analgesia. It includes nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen, and local anesthetics to reach adequate pain control. There are data in literature preemptive analgesia could decrease postoperative pain after hemorrhoidectomy. The aim of this study is to assess the efficacy of preemptive analgesia with ketoprofen 100 mg 2 h before procedure per os with spinal anesthesia to decrease postoperative pain according to visual analog scale and to reduce the opioids and other analgesics consumption. METHODS: Patients of our clinic who meet the following inclusion criteria are included: hemorrhoids grade III-IV and the planned Milligan-Morgan hemorrhoidectomy. After signing the consent all participants are randomly divided into 2 groups: the first one gets a tablet with 100 mg ketoprofen, the second one gets a tablet containing starch per os 2 h before surgery (72 participants per arm). Patients of both arms receive spinal anesthesia and undergo open hemorrhoidectomy. Following the procedure the primary and secondary outcomes are evaluated: opioid administration intake, the pain at rest and during defecation, duration, and frequency of other analgesics intake, readmission rate, overall quality of life, time from the procedure to returning to work, and the complications rate. DISCUSSION: Multimodality pain management has been shown to improve pain control and decrease opioid intake in patients after hemorrhoidectomy in several studies. Gabapentin can be considered as an alternative approach to pain control as NSAIDs have limitative adverse effects. Systemic admission of ketorolac with local anesthetics also showed significant efficacy in patients undergoing anorectal surgery. We hope to prove the efficacy of multimodal analgesia including preemptive one for patients undergoing excisional hemorrhoidectomy that will help to hold postoperative pain levels no more than 3-4 points on VAS with minimal consumption of opioid analgesics. TRIAL REGISTRATION: ClinicalTrial.gov NCT04361695 . Registered on April 24, 2020, version 1.0.

Selective approach to arterial ligation in radical sigmoid colon cancer surgery with D3 lymph node dissection: A multicenter comparative study.

Objectives: Radical surgery for sigmoid colon cancer is commonly performed with complete mesocolic excision (CME) and apical lymph node dissection, reached by central vascular ligation (CVL) of the inferior mesenteric artery (IMA) and associated extended left colon resection. However, IMA branches can be ligated selectively according to tumor location with D3 lymph node dissection (LND), economic segmental colon resection and tumorspecific mesocolon excision (TSME) if IMA is skeletonized. This study aimed to compare left hemicolectomy with CME and CVL and segmental colon resection with selective vascular ligation (SVL) and D3 LND. Material and Methods: Patients (n= 217) treated with D3 LND for adenocarcinoma of the sigmoid colon between January 2013 and January 2020 were included in the study. The approach to vessel ligation, colon resection and mesocolon excision was based on tumor location in the study group, while in the comparison group, left hemicolectomy with routine CVL was performed. Survival rates were estimated as the primary endpoints of the study. Long- and short-term surgery-related outcomes were evaluated as the secondary endpoints of the study. Results: The studied approach to the IMA branch ligation was associated with a statistically significant decrease in intraoperative complication rates (2 vs 4, p= 0.024), operative procedure length (225.56 ± 80.356 vs 330.69 ± 175.488, p <0.001), and severe postoperative morbidity (6.2% vs 19.1%, p= 0.017). Meanwhile, the number of examined lymph nodes significantly increased (35.67 vs 26.69 per specimen, p <0.001). There were no statistically significant differences in survival rates. Conclusion: Selective IMA branch ligation and TSME resulted in better intraoperative and postoperative outcomes with no difference in survival rates.