AIM: the purpose of this study is figure out around "pouch failure" including time of its onset, identify risk factors of "pouch failure", as well as evaluation of the effectiveness of treatment of complications that led to "pouch failure" in patients with ulcerative colitis.
PATIENTS AND METHODS: the retrospective single-center study included 144 patients from 2011 to 2018, who had J-pouch surgery at the Ryzhikh National Medical Research Center of Coloproctology Median time of follow-up of patients with J-pouch - 32 (20; 43) months.
RESULTS: the definition of «pouch failure» was phrased as the condition, which develops when J-pouch associated complications are being shown and requires switch off J-pouch by removing of pouch or ileostomy or ileostomy won’t being able to closed during 12 months or more.
The multivariate analysis has shown that hypoalbuminemia was independent risk factor of «pouch failure» OR = 5,74, 95% CI 1,83 – 18,01, p=0,003. Also multivariate analysis of pouch associated complications impact to risk of «pouch failure» was performed and those have statistically significant higher risk of «pouch failure»: pouch associated fistula – OR = 127,93, 95% CI19,86 -824,07, p=0,0000003, ileal-pouch anastomosis leakage - OR = 5,55, 95% CI1,06 -29,14, p=0,043, and ileus - OR = 13,72, 95% CI2,86 -65,87, p=0,001.
Among 30 patients with «pouch failure»: 11(36,7%) cases ileostomy wasn’t closed, but pouch was saved, in 8 (26,6%) cases pouch was removed. In 5(16,7%) J-pouch was removed due to refusing of «pouch salvage surgery».
CONCLUSION: identification of risk factors of «pouch failure» is still actual problem. Our study has identified definition of «pouch failure» and time of its onset, also risk factors of «pouch failure» was found out and results of the treatment of pouch complications was got. That would be really helpful to continue this study with more patients and longer time of follow-up for getting more evidences.
ORIGINAL ARTICLES
AIM: to assess results of pouch surgery for ulcerative colitis (UC).
PATIENTS AND METHODS: the retrospective single-center study included 144 patients who underwent J-pouch surgery in 2011–2018 (4 patients refused ileostomy closure due to nonmedical reasons and were excluded from analysis). Median follow-up was 32 (20; 43) months. The definition of «pouch failure» (PF) was clarified as a condition, when J-pouch associated complications do not permit ileostomy closure ≥ 12 months or more after pouch surgery.
RESULTS: PF was detected in 30/140 (21.4%) cases and only in 8/140 (5,7%) patients pouch was removed. The most common complication identified by PF was pouch fistula, which was detected in 16/30 (53.3%) patients. Of the 30 patients with PF, 22 (73.3%) managed to “save” the pouch, of which — in 11/30 (36.7%) cases, anal defecation was restored, and in other cases — 11 (36. 7%) the ileostomy was not closed, but the pouch was preserved and is being treated conservatively. In 9/30 (30%) patients, the identified complications were performed by transanal removal of the remaining part of the rectum with the formation of a pouch-anal anastomosis, followed by closure of the ileostomy. In 8/30 (26.6%) cases pouch was removed. The multivariant analysis revealed hypoalbuminemia at the time of pouch surgery (OR = 5.74; 95% CI = 1.83–18.01; p = 0.003) as independent risk factors for PF.
CONCLUSION: the only independent risk factor for complications which lead to PF was hypoalbuminemia. Multi-stage surgical treatment of complications associated with the pouch made it possible to “save” the ileal pouch in 22/30 (73.3%) cases, and completely overcome PF and restore anal defecation in 11/30 (36.7%) cases. In 8/140 (5.7%) patients, the pouch had to be removed and a permanent ileostomy was done.
AIM: to analyze the quality of primary colonoscopy protocols in patients included in the colorectal cancer screening program.
PATIENTS AND METHODS: out of the 86 patients admitted for the removal of colon polyps detected during primary screening of colorectal cancer at medical institutions of various levels, 67 (77.9%) had colonoscopy protocols, which were analyzed in accordance with the study objectives.
RESULTS: the informative value of colonoscopy protocols at the endoscopic stage of colorectal cancer screening in clinic institution of the 3rd level was significantly higher than in the 2nd and 1st levels (5 criteria out of 8).
Comparison of protocols quality of two last medical institutions showed no significant differences. The optimal and acceptable quality of colonoscopy protocols, studied in accordance with the same criteria, was achieved by 3 (37.5%) at clinics of the 3rd level and by 1 (12.5%) at medical institutions of the 2nd and 1st levels.
CONCLUSION: the quality of colonoscopy protocols at clinics of the 3rd level is significantly higher than at hospitals of the 1st and 2nd levels of medical care delivery. The audit of the diagnostic colonoscopy protocols for colorectal cancer screening of the entire cohort showed the loss of information compared to the standard protocol and in most of them there is a low quality of content.
AIM: to evaluate effectiveness of laser technologies for pilonidal disease in comparison with the traditional excisional method.
PATIENTS AND METHODS: a prospective randomized single-center study included 84 patients (first main group 44 patients, control one — 40 patients). The groups were homogeneous in age, gender, BMI. The inclusion criterion was the pilonidal disease with straight fistulas without additional fistula tracks. The exclusion criterion was the impossibility to perform laser procedure.
RESULTS: no intraoperative morbidity occurred in both groups. The operative time was significantly shorter in the main group (12.0 ± 5.0 min vs 18.5 ± 6.5; p = 0.049). The hospital stay was significantly lower in the main group as well (8.5 days vs 11.2; p < 0.001). The time of wound healing was significantly lower in the main group (12.0 ± 2.0 vs 25.0 ± 3.0 days; p < 0.001).
CONCLUSION: the laser technique is significantly more effective than traditional approach in operative time, hospital stay and wound healing and can be used for outpatient management.
AIM: to estimate the outcomes after fistula laser coagulation for transsphincteric anal fistulas.
PATIENTS AND METHODS: a prospective randomized single-center study included 42 patients with transsphincteric anal fistulas, 36 (85.7%) of them had a follow-up > 3 months. Nineteen patients were randomized to the group of laser thermocoagulation of the fistula track (diode laser 1560 nm) combined with ligation of intersphincteric fistula track (LC + LIFT). Seventeen patients were randomized to the group of laser thermocoagulation of the fistula combined with closure of internal fistula opening by advancement flap (LC + AF). Mean follow-up period was 6.5 months. Perioperatively (before surgery, 1 and 2 months after surgery), patients underwent ultrasound to assess fistula healing and early detection of recurrence.
RESULTS: no intraoperative and early postoperative complications occurred. In the LC + LIFT group, healing rate was 89,5% (17/19 patients), in the LC + AF group — 64.7% (11/17patients). Endorectal ultrasound confirmed healing or early recurrence. No significant factors affecting recurrence rate were identified in both groups.
CONCLUSION: treatment of transsphincteric anal fistulas by LC + LIFT showed better results compared with LC + AF technique. However, further recruitment of patients into study groups is required with evaluation of late results.
AIM: to assess results of balloon dilatation (BD) and electric destruction (ED) for strictures of colorectal anastomoses.
PATIENTS AND METHODS: the prospective cohort study included 69 patients with colorectal anastomotic strictures. Thirty-two of them underwent endoscopic balloon dilatation, 37 — electric destruction of scar tissue using a spherical monopolar electrode.
RESULTS: the recurrence rate of the anastomotic stricture in the BD group was 3 times higher than after ED (OR = 2.9; 95% CI: 0.7–11.1; p = 0.04). The independent factor of stricture recurrence was the extent of stricture > 11 mm (OR = 11.8; 95% CI: 1,57–123,5; p = 0.02).
CONCLUSION: electric destruction and balloon dilatation are effective and safe methods for strictures of colorectal anastomoses. The independent factor recurrence risk of the stricture was the extent of the scar narrowing more than 11 mm long.
AIM: to assess late results of surgery for incomplete internal anal fistulas.
PATIENTS AND METHODS: the prospective cohort study included 156 patients with in complete internal anal fistulas in 2014-2017.
RESULTS: complete efficacy of the treatment was obtained in 132/147 (89.8%) patients, 106/117 (90.6%) revealed no anal incontinence (AI). Recurrence developed in 15/147 (10.2%) cases and 11/147 (7.5%) — anal incontinence. Newly developed incontinence was revealed in 7/117 (6.0%) patients: 6/117 (5.1%) had mild AI and 1/117 (0.9%) — moderate. The increase of AI degree showed 4/30 (13.3%) patients.
CONCLUSION: a differentiated approach to anal fistulas surgery made it possible to minimize risk of incontinence and recurrence.
AIM: to assess the learning curve of implementation of laser vaporization for hemorrhoids.
PATIENTS AND METHODS: laser vaporization was performed by one surgeon for 378 patients, which had no personal experience of implementation of this technique before. CUSUM method was used to analyze the duration of the training period.
RESULTS: the two-fold decrease of negative results percentage was obtained after 40 procedures. During the training period, 7 (17.5%) unfavorable outcomes were revealed and 17 (5.0%) — during consolidation of experience (p = 0.008). Difference in outcomes between vaporizations only and combined interventions was not significant.
CONCLUSION: the learning curve for implementation of laser vaporization for hemorrhoids determined by the СUSUM analysis method is 40 cases. The risk of unfavorable results is not associated with the volume of procedure, but with the training period.
AIM: to evaluate the cost-effectiveness of the enhanced recovery program (ERP).
PATIENTS AND METHODS: a randomized clinical trial was carried out. A total of 152 patients were divided into ERP (n = 77) and conventional (n = 75) groups. To study the cost-effectiveness of ERP, direct medical costs were assessed at all stages of treatment (outpatient, inpatient, and also within 30 days after discharge from the hospital). Cost minimization analysis (CMA) was used.
RESULTS: the median total costs at the stage of outpatient check-up ERP and conventional groups where comparable (33115-35146 rubles; p = 0.1). The total cost of inpatient treatment in the main group was 175,535 rubles, in the control group — 199,055 rubles (p < 0.0001). The costs of outpatient follow-up in ERP group were significantly higher compared to the conventional group (p = 0.0005). The difference, according to Hodges-Lehmann estimation, was 940.7 rubles. The cost of the entire cycle of treatment in the ERP group was 214805 rubles, in the conventional — 237890 rubles (p < 0.0001). Thus, the total reduction in treatment costs associated with ERP amounted to 23,085 rubles (9.7% expenditures)
CONCLUSION: a cost-effectiveness analysis of the implementation of the Enhanced Recovery Program showed an overall cost reduction of 9.7% due to a reduction in costs at the inpatient stage.
AIM: assess tolerability and safety of total neoadjuvant therapy (TNT) with three consolidation courses of XELOX for patients with rectal carcinoma.
PATIENTS AND METHODS: patients with histologically proven rectal carcinoma were randomly assigned in two groups: in the TNT group after the neoadjuvant CRT 50–54 Gy with capecitabine 3 consolidation courses of XELOX were done, in the CTR group — conventional neoadjuvant CRT 50–54 Gy with capecitabine. The RTOG scale was used to assessed radial reactions, and the NCI-CTC v5.0 scale was used to evaluate toxicity. For selected patients with a complete clinical response «watch and wait» approach was used. Postoperative complications were graded according with the Clavien-Dindo scale. The primary endpoint of study was the complete response rate (clinical and pathomorphological). Secondary endpoints of study: frequency and structure of intraoperative and postoperative complications, the rate of grade 3–4 toxicity of radiotherapy and chemotherapy, R0-resection rates. The study was registered on the ClinicalTrials.gov (NCT04747951).
RESULTS: between October 2020 and March 2022, 145 patients were enrolled in the randomized study: 72 patients in the TNT group and 73 patients in the CRT group. The full course of neoadjuvant treatment was completed in 90% patients in the TNT group, comparing with 96% in the CRT group (p = 0.65). The total rate of severe adverse effects of radiation therapy was 59% in the TNT group, comparing with 67% in the CRT group (p = 0.48), with 3–4 grade by RTOG scale were observed only in two cases in the CRT group. During chemotherapy severe adverse effects were observed in 54% in the TNT group comparing with 19% in the CRT group (p < 0.001). Grade 3–4 toxicity was 3% in the TNT group comparing with 2% in the CRT group. The rate of intra- and postoperative complications did not differ between two groups.
CONCLUSION: TNT is a safe alternative to conventional CRT.
AIM: to work out the program for psychological support for patients with colorectal cancer and to evaluate its efficiency.
PATIENTS AND METHODS: the prospective clinical psychological pilot study involved 26 patients who underwent surgery for colorectal cancer (after 6–12 months), aged 64.6 ± 7.1 year. The patients were divided into two groups: the main group included 12 patients who underwent psychotherapy and the control group with single consulting by the psychologist in order to fulfill the questionnaire (without psychotherapy). The psychological adjustment included cognitive behavioral psychotherapy and methods of neurofeedback. The efficiency assessment of the program for psychological adjustment was performed using the Hospital Anxiety and Depression Scale (HADS) before the rehabilitation and after its completion.
RESULTS: the primary diagnostics showed that the anxiety of all patients in both groups was increased up to the subclinical level (8.6 ± 0.5 and 8.7 ± 0.2 points). Most patients of both groups initially demonstrated depressive symptoms of various severity degrees (83.3% and 85.7%). After the psychological adjustment, the anxiety level of the patient of the main group was reduced from 8.6 ± 0.5 to 7.5 ± 0.3 points (p = 0.052). In the control group, the anxiety level practically did not change (8.7 ± 0.2 and 8.2 ± 0.6 points) (p = 0.436). The quantitative analysis of the testing results showed that after the adjustment course including psychotherapeutic measures the number of patients who did not have depression in the main group definitely increased (41.7%). In the control group, the number of patients with depression was reduced less significantly from 85.7% to 71.4%.
CONCLUSION: the anxiety-depressive condition is peculiar for patients with colorectal cancer 1 year after surgery and requires psychological support. The combination of cognitive behavioral psychotherapy and methods based on neurofeedback are effective psychological methods for these patients.
AIM: to estimate results of minimally invasive laser procedures for pilonidal disease.
PATIENTS AND METHODS: the prospective randomized multicenter study included 154 patients with chronic and 76 patients with acute inflammation of pilonidal sinus. Patients were blindly divided into equal groups by simple randomization. Patients of group A underwent laser coagulation and curettage of the pilonidal sinus, in group B — sinus excision, in group C — laser coagulation through a wound, in group D — simple abscess opening. Laser radiation of a diode device with a wavelength of 1.56 microns with a power of 10–15 W was used.
RESULTS: the recurrence rate 1 year after laser coagulation and curettage of the pilonidal sinus was 5.2%. Significant advantages (lower pain level, wound infection rate, treatment duration, time of wound healing) of the sinus excision were revealed (p < 0.05 for all). Ultrasound control a year after procedure showed that the infiltrative changes of tissues in the postoperative area were significantly less common, as well as scar deformities of the intergluteal area (p < 0.0001; p = 0.006).No significant differences in wound healing time were revealed between groups C and D (p = 0.8). In group D, a secondary fistula was detected in 10.5% after a month of follow-up and required a sinus excision later. The disease remission rate was lowest in group C after 1 year of follow-up (p = 0.01). Morphometry and ultrasound after a year showed infiltration without fluid structures and inflammation in surgical site in group C in 7.9% of patients, in group D — in 23.7%.
СONCLUSION: the laser coagulation with curettage and laser coagulation through a wound has a number of advantages over the traditional procedures. These methods can become alternative options for chronic and acute pilonidal disease in regimen of “one-day surgery”.
REVIEW
AIM: to determine if there is an improvement in overall survival of palliative primary tumor resection (PTR) followed by chemotherapy in minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases compared to those of upfront chemotherapy/radiotherapy (chemo/RT) alone.
MATERIALS AND METHODS: a systematic review based on Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines were done on PubMed and Cochrane database.
RESULTS: eighteen non-randomized studies were identified, including a total of 2995 patients (1734 PTR and 1261 chemo/RT). Age, gender, American Society of Anesthesiologists (ASA) staging of patients in the two groups were comparable in 12 studies and had significant differences in 4 studies. Median survival in the two groups was comparable in 13 studies (1460 patients: 787 PTR и 673 chemo/RT) and was significantly higher in PTR group in 5 studies (1535 patients: 947 PTR и588 chemo/RT). The rate of surgical intervention due to complications was 0-5.1% in PTR group and 4.4-48.1% in chemo/RT group in 17 studies. Thirty-day mortality was 0-4.8% in PTR group and 0-14% in chemo/RT group in 17 studies. One study had a high 30-day mortality rate in both groups (29.4% PTR и 19.3% chemo/RT, P < 0.05).
CONCLUSIONS: the question remains whether palliative primary tumor resection could improve overall survival of minimally symptomatic patients with colorectal cancer and synchronous unresectable metastases. However, the recent data showed that patients who underwent PTR could gain a cancer-specific survival benefit. This conclusion based on the results of nonrandomized comparative studies and data from early terminated RCTs. Further well-designed RCTs are required to reach definitive conclusions.
Reversal after Hartmann’s procedures is technically challenging and followed by high morbidity rate.
One the main risk factors of complications is need to dissect peritoneal adhesions for optimal access to large bowel, which leads to bowel deserosing, intestine lumen opening and late perforation. Meanwhile, the question remains unresolved: is there a need for total adhesiolysis during operations for end colostomy takedown, or is it more appropriate to minimize its volume? Recent literature data are presented by narrative reviews, single observational and experimental studies. Options for decision making are based on experts’ opinion. There is a strong need to test hypotheses by prospective randomized study.
Ulcerative colitis is a chronic autoimmune bowel disease that currently has no complete cure other than surgery. The use of various agents in a number of patients is ineffective or leads to certain adverse events that require a change in therapy. There is an unmet need for new agents that are fundamentally different in mechanism of action, but show high efficacy and safety. Ozanimod, being a sphingosine-1-phosphate receptor modulator, prevents lymphocyte entry, thereby reducing inflammation in the gut. This article presents a review of data on the mechanism of action of this drug, its efficacy and safety in the treatment of ulcerative colitis, both in bionaive patients and those who have not responded to treatment with other biological drugs.
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