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 ).

Three-plane Model to Standardize Laparoscopic Right Hemicolectomy with Extended D3 Lymph Node Dissection.

AIM: The purposes of this study were to create a "three-plane model" for laparoscopic right hemicolectomy and to compare short-term outcomes of anterior medial-to-lateral (aM-to-L) and caudal-to-cranial access by retroperitoneal tunneling (Ca-to-Cr), as described based on the three-plane model. METHODS: A three-plane model was developed to clarify the steps of an operation. Consecutive cases of right colon cancer were operated upon with an aM-to-L approach in the earlier period and then with a Ca-to-Cr approach, and postoperative outcomes were evaluated. Short-term results were compared. RESULTS: Sixty-two patients were divided into aM-to-L (n=29) and Ca-to-Cr (n=33) groups. The two groups did not differ in terms of the patients' baseline characteristics. Median operative time was 220 min (IQR 190-260) for the aM-to-L group and 222.5 min (IQR 180-255) for the Ca-to-Cr group (p=0.73). Estimated blood loss was similar in both groups (p=0.13). Median length of hospital stay was 6 days (IQR 5-8) in the aM-to-L group and 7 days (IQR 6-9) in the Ca-to-Cr group (p=0.17). Median number of harvested lymph nodes was 45.5 (IQR 25-44.9) in the aM-to-L group and 30 (IQR 18-48.5) in the Ca-to-Cr group (p=0.34). CONCLUSION: The approach used to reach the superior mesenteric vessels for laparoscopic right hemicolectomy with D3 lymph node dissection does not affect the short-term outcome of the operation. The present three-plane model gives surgeons additional insight to perform this operation.

A Multicenter Study Evaluating Natural Orifice Specimen Extraction Surgery for Rectal Cancer.

BACKGROUND: Low anterior resections are increasingly performed laparoscopically for rectal cancer. Recently, natural orifice specimen extraction surgery (NOSES) has been reported as an alternative approach without additional incisions or extensions. In this study, we aimed to evaluate the safety and feasibility of NOSES by comparing the short-term outcomes with those of conventional laparoscopic resection (CLR) in a multicenter retrospective study from China and Russia. METHODS: The retrospective multicenter study was conducted at three centers between January 2015 and December 2017. Relevant collected data included patient demographics, operative parameters, and postoperative complications. All procedures were performed using either a NOSES or a CLR approach. RESULTS: The data of a total of 768 consecutive patients with rectal cancer were retrospectively analyzed, including 412 CLR and 356 NOSES cases. The two groups were comparable for all demographics and characteristics except for the median tumor size (P = 0.038). No difference was found in the operative time and number of retrieved lymph nodes. Intraoperative complications and positive resection margins were nil in both groups. No difference was found in the time to first flatus (P = 0.150), time to first defecation (P = 0.084), length of postoperative hospital stay (P = 0.152), anastomotic leakage (P = 0.377), and intra-abdominal abscess (P = NA). The CLR group but not the NOSES group had incisional hernia or wound infection events, although the difference between groups was not significant (P = 0.253). CONCLUSIONS: The NOSES procedure is a well-established strategy and may be considered as an alternative procedure to CLR for rectal cancer. However, the long-term benefits of this approach require further evaluation.

Transperineal Excision of Rectal Gastrointestinal Stromal Tumor.

Gastrointestinal stromal tumors (GIST) of the rectum occur in approximately 4% of patients with rectal malignancies. Herein, we demonstrate a transperineal approach as a safe surgical technique for GISTs located anterior to the rectum. The proposed technique allows safe and effective excision of a tumor without disturbing the rectal anterior wall. Unlike previous techniques, this method stresses the importance of accurate preoperative assessment and use of the surgeon's finger in the rectum to facilitate rectal wall preservation.

Double-barreled Wet Colostomy Versus Separate Urinary and Fecal Diversion in Patients Undergoing Total Pelvic Exenteration: A Cohort Meta-analysis.

BACKGROUND: The aim of this meta-analysis was to determine whether double-barreled wet colostomy (DBWC) provides similar urinary tract infection rates as separate urinary and fecal diversion (SUFD) in patients undergoing pelvic exenteration. METHODS: The MEDLINE, PubMed, Cochrane Library, and Scopus databases were systematically searched by two independent researchers. The primary endpoint was the urinary tract infection rate. The Mantel-Haenszel method with odds ratios with 95% confidence intervals (OR (95%CI)) was used as an effect measure for dichotomous variables. A random-effects model was used for the meta-analysis. Statistical heterogeneity among effect estimates was evaluated using I2 and Tau2. RESULTS: Three observational studies that included a total of 257 patients (159 DBWC; 98 SUFD) were included after 14 potentially eligible records were screened. Pooled urinary tract infection rates were 1.9% (3/159) in DBWC and 6.1% (6/98) in SUFD. This difference was not statistically significant [OR (95%CI) = 0.27 (0.06, 1.19); p=0.08] with low among-study heterogeneity (I2=0%). CONCLUSIONS: This meta-analysis did not find a significant difference in urinary tract infection rates between DBWC and SUFD in patients undergoing total pelvic exenteration. Further clinical studies will be required to further understand the pros and cons of these procedures.

Biomarker-Based Scoring System for Prediction of Tumor Response After Preoperative Chemoradiotherapy in Rectal Cancer by Reverse Transcriptase Polymerase Chain Reaction Analysis.

BACKGROUND: Numerous molecular markers have been investigated to predict tumor response after preoperative chemoradiotherapy for rectal cancer. OBJECTIVE: This study aimed to evaluate the predictive value of biomarkers for the prediction of tumor response after preoperative chemoradiotherapy. DESIGN & SETTING: Tumor specimens have been collected prospectively from 80 patients with rectal cancer who underwent curative resection at 8 weeks after completing preoperative chemoradiotherapy. MAIN OUTCOME MEASURES: With the use of reverse transcriptase polymerase chain reaction analysis, mRNA expression levels of 7 candidate biomarkers (p53, p21, Ki-67, VEGF, CD133, CD24, and CD44) were evaluated from fresh tumor samples collected before preoperative chemoradiotherapy. The correlation between biomarker expression levels and the pathologic response was assessed based on histopathological staging (pTNM) and tumor regression grade. RESULTS: The mRNA expression levels of 4 biomarkers (p53, p21, Ki67, and CD133) significantly correlated with tumor regression grade response and pathologic complete response. Patients showing low expression of p53 and/or high expression of p21, Ki67, and CD133 exhibited a significantly greater tumor regression grade response and pathologic complete response rate. A scoring system devised so that 1 point was given for each biomarker whose expression level correlated with pathologic complete response (score range: 0-4) showed that 9 of 62 patients with scores of 0 to 2 achieved pathologic complete response, whereas 15 of 18 patients with scores of 3 to 4 achieved pathologic complete response (14.5% vs 83.3%, p < 0.001). For prediction of pathologic complete response, the scoring system showed 62.5% sensitivity, 94.6% specificity, an 83.3% positive predictive value, and an 85.5% negative predictive value. LIMITATIONS: Small patient numbers have limitations related to the reproducibility and ability to provide quantitative information. In addition, this study lacks test and validation sets. CONCLUSIONS: The pretreatment mRNA expression levels of 4 biomarkers correlated with pathologic tumor response after intraoperative chemoradiotherapy in rectal cancer. Furthermore, the scoring system combining values of biomarker expression might have predictive power with high positive and negative predictive values.

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).

Combination of conservative and surgical methods in the treatment of giant lymphedema of the scrotum: A case report.

Objective: Genital lymphedema is a severe, disabling condition associated with a malfunction of the lymphatic system. Primary lymphedema of the scrotum is a variant of congenital dysplasia of lymphatic vessels. Secondary genital lymphedema is much more common and can be caused by parasitic invasion (filariasis) or damage to the lymphatic system during the treatment of cancer (radiation therapy, lymphadenectomy). Healthcare providers are frequently unable to detect and treat this illness successfully in ordinary clinical practice. This paper uses the case of a patient with stage 3 secondary lymphedema (unknown genesis) of both lower extremities and lymphedema of the scrotum, complicated by recurrent erysipelas, a history of lymphorrhoea, impaired skin trophic and multiple papillomatosis, to demonstrate the efficacy of a combination of conservative and surgical methods in the treatment of giant lymphedema of the scrotum. Methods: In the treatment, the combination of decongestant physical therapy (CDPT, CDT) according to M. Földi was used at pre-surgery and post-surgery stages, combined with a reconstructive operation, including the removal of the affected tissues of the urogenital region, phalloplasty, and scrotoplasty with rotational skin flaps. Results: A decrease in the circumference of the lowest extremities in the lower leg area by 68 cm on the right and by 69 cm on the left was achieved by conservative treatment. Due to the combination of conservative and surgical treatment, the patient's body weight decreased by 69.4 kg, and the scrotum decreased by 63 cm. Subsequently, the patient fully recovered his sexual function. Conclusion: A combination of complex decongestive physical therapy and surgery is necessary for patients with advanced genital edema. The isolated use of surgical or conservative treatment does not provide a sufficient improvement in the patient's quality of life. Modern plastic surgery technologies enable patients to achieve complete functional and cosmetic recovery, while proper selection and usage of compression hosiery help preserve and improve the outcomes acquired following treatment.

Classifications and Clinical Assessment of Haemorrhoids: The Proctologist's Corner.

BACKGROUND: Haemorrhoidal disease (HD) is a benign condition affecting a considerable part of adult population. HD can be considered a social and economic burden with high impact on patients' lifestyle. Several new techniques and devices have been proposed for HD treatment; however, preoperative assessment is essential and the use of classification system is recommended. METHODS: In the last two decades many studies described the preoperative assessment and several attempts of classification for HD. This review focuses on the most relevant studies found in literature where classification systems and clinical evaluation with differential diagnosis have been evaluated. RESULTS: The knowledge of classification systems and differential diagnosis for HD has been shown to play a central role in the clinical assessment and the best treatment choice. Although there are new challenging techniques and devices for HD treatment, a preoperative assessment is always mandatory. CONCLUSION: Preoperative clinical evaluation is essential for HD patient treatment and outcome. Classification systems are useful for the therapeutic choice and researches on new medical or surgical treatments. In fact, the international guidelines advise several therapeutic options depending on the severity of the HD.

Hemorrhoidal artery ligation with Doppler guidance vs digital guidance for grade II-III hemorrhoidal disease treatment: Study protocol clinical trial (SPIRIT Compliant).

INTRODUCTION: Hemorrhoidal artery ligation (HAL) with Doppler guidance and suture fixation of hemorrhoidal nodes (RAR) is a popular minimally invasive technique for hemorrhoidal disease (HD) treatment which uses an ultrasound probe to detect hemorrhoidal arteries for further ligation. We hypothesized that ultrasound guidance has no advantages over manual hemorrhoidal arteries detection for HD treatment.The aim is to compare the results of HAL-RAR procedure in patients with stage II-III HD with Doppler and manual HA detection.In this ongoing randomized, controlled, single center clinical study 204 patients randomly divides into group A (HAL-RAR with Doppler US navigation) and group B (HAL with manual HA detection and mucopexy) are planned to be included. The primary endpoint was recurrence of any symptoms of HD; secondary endpoints were pain syndrome severity, treatment satisfaction (1 to 5 points), and need for the drug therapy in 30 days and 8 weeks after surgery. CONCLUSION: Ultrasound guidance technology of HAL with mucopexy could have the same efficacy the manual HA detection regarding the HD treatment effectiveness and patient satisfaction.

Does an Ileostomy Rod Prevent Stoma Retraction? A Meta-analysis of Randomized Controlled Trials.

A rod passed through the mesenteric window is commonly used during maturation of ileostomies, but evidence for the effectiveness of this procedure is limited. PURPOSE: The aim of this meta-analysis was to determine whether ileostomy rods decrease stoma retraction rates in patients undergoing loop ileostomy (LI). METHODS: The PubMed, EMBASE, Cochrane Library, MEDLINE via Ovid, Cumulative Index of Nursing and Allied Health Literature, and Web of Science databases were systematically searched for randomized controlled trials (RCT) published in English from 1990 to the present date using the MeSH terms ostomy, rod, and bridge to compare ileostomies with a rod to those without a rod. Study information, patient demographics, characteristics, and stoma retraction rates were abstracted. The primary endpoint, stoma retraction, was defined as the disappearance of normal stomal protrusion to at, or below, skin level. The Mantel-Haenszel method of meta-analysis with odds ratio and 95% confidence interval (OR [95% CI]) was used. Among-study statistical heterogeneity was assessed using Cochrane chi-squared and I² tests. Tau² analysis to assess between-study variance was employed when I² was greater than 50%. The number needed to treat/harm (NNT) was calculated to assess clinical relevance of any statistical difference. Visual assessment of funnel plots and Egger's test were used to assess for publication bias. RESULTS: Of the 228 publications identified, 3 RCTs totaling 392 patients (194 LI with rod and 198 LI without rod) met the inclusion criteria for analysis. Overall bias risk was low. The stoma retraction rate was 3.1% (6/194) in patients with a rod versus 4.5% (9/198) in patients with LI without a rod at a mean follow-up of 3 months. This difference was not statistically or clinically significant (OR [95% CI] = 0.60 (0.21-1.72); P = .34; NNT = 69), with low statistical heterogeneity noted among the studies (I² = 0%). CONCLUSION: This meta-analysis found that ileostomy rods do not decrease stoma retraction rates at 3-month follow-up. Studies examining the rate of all potential complications in patients who do and do not receive rod placement following IL are needed to help surgeons make evidence-based decisions.