Sintilimab plus bevacizumab, oxaliplatin and capecitabine as first-line therapy in RAS-mutant, microsatellite stable, unresectable metastatic colorectal cancer: an open-label, single-arm, phase II trial.

Background: Microsatellite stable (MSS) and RAS-mutant metastatic colorectal cancer (mCRC) patients are characterized by an immunosuppressive microenvironment and a low response rate to immunotherapy. Chemotherapy and anti-angiogenesis therapy have been reported to potentially promote immunotherapy response. This study aims to assess the preliminary anti-tumor activity and safety of sintilimab plus bevacizumab, oxaliplatin and capecitabine as a treatment option for patients with RAS-mutant MSS mCRC. Methods: This study was an open-label, single-arm, phase II trial in China. Patients with unresectable, RAS-mutant and MSS metastatic colorectal adenocarcinoma received treatment by intravenous sintilimab (200 mg, day 1) plus bevacizumab (7.5 mg/kg, day 1), oxaliplatin (135 mg/m2, day 1) and oral capecitabine (1 g/m2, day 1-14) in each 21-day cycle. The primary endpoints included objective response rate (ORR) and adverse events. Biomarker analysis was performed to identify potential predictors of good response to treatment. This study is registered with ClinicalTrials.gov, number NCT04194359. Findings: Between April 2021 and December 2021, 25 patients were enrolled. Two (8%) patients showed complete response (CR), 19 (76%) had partial response (PR) and 4 (16%) presented with stable disease. ORR reached 84% (95% CI, 63.9-95.5) and the disease control rate was 100% (95% CI, 86.3-100). The median progression-free survival (PFS) was 18.2 months for the full analysis set. The most common treatment-related adverse events (TRAEs) in all grades were anemia (21/25, 84%), neutropenia (20/25, 80%), and hand-foot syndrome (14/25, 56%). The most frequent grade 3 or 4 TRAEs were neutropenia (3/25, 12%) and increased alanine transaminase (2/25, 8%). No grade 5 adverse events occurred. In the exploration of biomarkers, 5 patients could be characterized as TTN/OBSCN "double-hit" after treatment, and the copy number variants burden was significantly decreased in tumor tissues after treatment compared with the baseline. Nanostring panel RNA sequencing analysis indicated a better tumor immune microenvironment cell infiltration in CR/PR patients compared with non-CR/PR patients as well as the PFS-long (≥12.5 months) group compared with the PFS-short group. Interpretation: Combination treatment with sintilimab plus bevacizumab, oxaliplatin and capecitabine as first-line treatment demonstrated a promising antitumor activity and a manageable safety profile in RAS-mutant, MSS and unresectable mCRC. Exploratory biomarker assessment analysis showed that some RAS-mutant and MSS patients changed into "immune-hot" subtype after the treatment. Funding: This study was supported by the Key R&D Program of Zhejiang Province (2021C03125 to Ying Yuan), the National Natural Science Foundation of China (81872481 to Ying Yuan, 82072624 to Kefeng Ding), the Fundamental Research Funds for the Central Universities (No. 226-2022-00009 to Kefeng Ding), and the Zhejiang Provincial Natural Science Foundation of China (No. LY22H160024 to Hanguang Hu).

Sintilimab plus bevacizumab and CapeOx (BBCAPX) on first-line treatment in patients with RAS mutant, microsatellite stable, metastatic colorectal cancer: study protocol of a randomized, open-label, multicentric study.

BACKGROUND: Rat sarcoma viral oncogene homolog (RAS) gene mutation is a common molecular event in colorectal cancer (CRC). The prognosis of mCRC (metastatic colorectal cancer) patients with RAS mutation is poor and capecitabine and oxaliplatin (CapeOx) plus bevacizumab has shown to be one of the standard therapeutic regimens as first line for these patients with objective response rate (ORR) of ~ 50% and median progression-free survival (mPFS) of 8-9 months. Immunotherapy, especially anti-programmed death 1 (PD-1) monoclonal antibody has demonstrated ground-breaking results in deficient mismatch repair (dMMR) / microsatellite instability-high (MSI-H) mCRC patients. However, the response rate of in microsatellite stable (MSS) patients is extremely low. In addition, preclinical studies have demonstrated that anti-Vascular endothelial growth factor (VEGF) agents, such as bevacizumab, can induce tumor vascular normalization and enhance antitumor immunity. Previous study indicated the combination of chemotherapy, anti-VEGF agents (bevacizumab) with immune checkpoint inhibitors may have promising clinical activity in RAS mutant, MSS refractory mCRC patients. Based on these evidences, we will explore the combination of CapeOx with bevacizumab and sintilimab (anti-PD-1 monoclonal antibody) in RAS mutant, MSS mCRC patients as first-line therapy. METHODS: This is a randomized, open-label, multicentric clinical trial. In the sintilimab arm, patients will receive sintilimab in combination with CapeOx and bevacizumab. In the control arm, patients will receive CapeOx and bevacizumab. This trial will recruit 494 patients from 20 centers and randomly (1:1) disseminated into two groups. The primary endpoint is the PFS. The secondary endpoints include overall survival, safety, ORR, and disease control rate. DISCUSSION: This study may provide new ideas for optimizing oncology treatment planning for RAS mutant, MSS mCRC patients in the first-line set. TRIAL REGISTRATION: This study is short for BBCAPX and has been registered at clinicaltrials.gov registry with identifier NCT05171660.

Phase II study of anlotinib in combination with oxaliplatin and capecitabine for patients with RAS/BRAF wild-type metastatic colorectal adenocarcinoma as the first-line therapy.

BACKGROUND: Anlotinib, an oral small molecule tyrosine kinase inhibitor targeting VEGFR 1/2/3, FGFR 1-4, PDGFR a/ß, and c-kit, had demonstrated prolonged progression-free survival (PFS) in refractory metastatic colorectal cancer (mCRC). This multicenter, single-arm, phase II, exploratory study was conducted to evaluate the efficacy and safety of anlotinib combined with capecitabine and oxaliplatin as first-line treatment for unresectable RAS/BRAF wild-type mCRC. METHODS: Patients aged 18-75 with RAS/BRAF wild-type unresectable mCRC, without prior systemic treatment, and ECOG performance status ≤1 were enrolled. Eligible patients received capecitabine (850 mg/m2, p.o., bid, on day 1-14 every 21 days), oxaliplatin (130 mg/m2, i.v., on day 1 every 21 days), and anlotinib (12 mg, p.o., qd, on days 1-14 every 21 days) as induction therapy. Following 6 cycles of therapy, patients who achieved response or stable disease received capecitabine and anlotinib as maintenance therapy until tumor progression. The primary endpoint was objective response rate (ORR) according to RECIST (version: 1.1), and the secondary endpoints were PFS, disease control rate (DCR), duration of response (DOR), and safety. RESULTS: Between November 2019 and February 2021, 31 patients were enrolled. One patient was excluded for refusing treatment. The primary endpoint of ORR was 76.7% (95% CI, 57.7-90.1) with 1 patient achieving a complete response and 22 patients partial response. DCR was 93.3% (95% CI, 77.9-99.2). At a median follow-up of 14.1 months (95% CI, 9.9-18.3), median PFS was 11.3 months (95% CI, 7.1-14.1), and DOR was 7.9 months (95% CI, 5.5-12.7). Twenty-five (83.3%) patients experienced grade 3 or 4 treatment-emergent adverse events (TEAEs). No grade 5 TEAE was reported. The most common grade 3 or 4 TEAEs (>10%) were hypertension (15/30; 50%), neutrophil count decreased (8/30; 26.7%), and diarrhea (4/30; 13.3%). A total of 18 (60%) patients had TEAEs that resulted in dose reduction, interruptions, or delays. CONCLUSIONS: Anlotinib combined with capecitabine and oxaliplatin showed considerable ORR, DCR, PFS, and DOR in the first-line therapy of mCRC with manageable toxicity profiles. TRIAL REGISTRATION: ClinicalTrials.gov : NCT04080843.

Integrin αvß6 contributes to the development of intestinal fibrosis via the FAK/AKT signaling pathway.

Intestinal fibrosis is one of the most severe complications of inflammatory bowel disease (IBD) and frequently requires surgery due to intestinal obstruction. Integrin αvß6, which is mainly regulated by the integrin ß6 subunit gene (ITGB6), is a special integrin subtype expressed only in epithelial cells. In our previous study, we found integrin αvß6 can promote the development of IBD, but the role of integrin αvß6 in intestinal fibrosis remains unclear. In this study, we observed a gradual increase of ITGB6 mRNA expression from normal region to stenotic region of IBD patients' intestinal specimens. Next, we established a dextran sulfate sodium (DSS)-induced intestinal fibrosis model and a heterotopic intestinal transplant model, and found intestinal fibrosis was decreased in ITGB6-deficient mice compared to wild-type (WT) mice. Furthermore, we performed RNA-sequencing and KEGG pathway analysis on intestinal tissues from ITGB6-overexpressing transgenic mice and WT mice, and found multiple pathways containing ITGB6, are related to the activation of focal adhesion kinase (FAK); finding was confirmed by Western blot. At last, we generated a heterotopic intestinal transplant model found the FAK/AKT pathway was inhibited in ITGB6-deficient mice. In conclusion, our data demonstrate that integrin αvß6 promotes the pathogenesis of intestinal fibrosis by FAK/AKT pathway, making integrin αvß6 a potential therapeutic target to prevent this condition.

Comparative evaluation of colonoscopy-assisted transanal minimally invasive surgery via glove port and endoscopic submucosal dissection for early rectal tumor.

BACKGROUND: Early rectal tumor is usually managed by local excision. A novel method-colonoscopy-assisted transanal minimally invasive surgery via glove port (CA-TAMIS-GP)-for resecting early rectal tumor was developed and compared with endoscopic submucosal dissection (ESD). MATERIALS AND METHODS: We performed CA-TAMIS-GP surgery on 26 patients from January 2014 to February 2016. For better analysis, we retrospectively collected data from 31 patients who underwent ESD between October 2012 and December 2013; overall, 57 patients diagnosed with early rectal tumor were included in this study. Perioperative conditions and long-term outcomes of both groups were compared. RESULTS: All lesions were dissected completely and successfully without conversion to open surgery or major complications. On histopathologic examination, all specimens in this study had negative margins. All patients had uneventful postoperative recoveries, except 3 patients of CA-TAMIS-GP with minor hematochezia, which resolved spontaneously; 7 ESD patients had late-onset bleeding and 3 needed colonoscopic hemostasis; 2 patients in each group had mild fever. The CA-TAMIS-GP group had a shorter operation time, less hemorrhage, and a lower average consumable cost than the ESD group (P < 0.05); moreover, the CA-TAMIS-GP group had no recurrence or long-term complications during a follow-up of 10-32 months, whereas3 patients in the ESD group developed local recurrence during a follow-up of 24-36 months. CONCLUSIONS: The CA-TAMIS-GP is a new method that is safe and effective in patients with early rectal tumor and appears to have a shorter operation time and less blood loss as compared with ESD.

[Expression of prostaglandin transporter in colorectal cancer tissues and its relationship with clinicopathological features].

OBJECTIVE: To investigate the expression of prostaglandin transporter (PGT) in colorectal cancer (CRC) tissues and its relationship with clinicopathological features. METHODS: The mRNA and protein levels of PGT were determined by real-time PCR, Western blot and immunohistochemical methods in cancer tissues and adjacent normal tissue from 80 patients with colorectal cancer and their relationship with clinicopathological features was analyzed. RESULTS: Compared with the adjacent normal tissue of colorectal cancer, the PGT mRNA relative expression (0.57 ± 0.33 vs. 2.33 ± 1.20) and the PGT protein expression in cancer tissues decreased significantly [PGT/GAPDH 0.45 ± 0.16 vs. 0.78 ± 0.23, integral A 718.7 ± 359.4 vs. 10412.0 ± 6423.3, average A 0.03 ± 0.01 vs. 0.12 ± 0.09, all P<0.01]. Lower mRNA and protein expressions of PGT in colorectal cancer were associated with depth of invasion T3 to T4 and TNM stage III( to IIII( (P<0.01), while not associated with gender, age, tumor location and differentiation degree (all P>0.05). CONCLUSION: Expression levels of PGT mRNA and protein in colorectal cancer tissue are significantly down-regulation. PGT expression is associated with invasion depth and late stages.

[Modified ligation of the intersphincteric fistula tract in the treatment of simple transsphincteric perianal fistula].

OBJECTIVE: To assess the efficacy and safety of modified ligation of the intersphincteric fistula tract for simple transsphincteric perianal fistula. METHODS: Seventy patients with simple transsphincteric perianal fistula between October 2012 and January 2014 in our department were prospectively enrolled. According to the random number table, patients were divided into two groups: modified-LIFT group (37 cases, from the external opening close to the fistula, dissect the external sphincter fistula to the intersphincteric groove by tunneling technique, resect the lateral free fistula) and LIFT group (33 cases). Clinical parametres before and after operation were compared, and results of pelvic electromyogram (EMG) and anorectal manometry three months after operation were analyzed to evaluated anal function. RESULTS: The operative time, pain score, hospital stay, and healing time were not significantly different between the two groups (all P>0.05). During the median follow-up of 12 months (3-20 months), the healing rate in modified-LIFT group was 83.8% (31/37), which was significantly higher than 60% (20/33) in LIFT group (P=0.029). After operation, 4 patients had persistent unhealed wound, 2 recurred in modified-LIFT group, while 8 patients had persistent unhealed wound, and 5 recurred in LIFT group. No patients developed anal incontinence. By the pelvic EMG and anorectal manometry 3 months after operation, the duration of motor unit potential, occurrence of simple phase, mean resting pressure and maximun squeeze pressure were not significantly different. CONCLUSION: Modified-LIFT procedure for the management of simple transsphincteric perianal fistulas is a simple and effective operation with higher healing rate and similar anal function as LIFT.

[Clinical significance of the detection of serum neutrophil gelatinase-associated lipocalin in human colorectal cancer].

OBJECTIVE: To explore the feasibility and clinical significance of the detection of serum neutrophil gelatinase-associated lipocalin (NGAL) in human colorectal cancer. METHODS: Levels of NGAL in serum samples from 133 healthy people, 125 colorectal polyps patients and 100 colorectal cancer patients respectively were determined by sandwich ELISA assay. Relationship of NGAL level with clinicopathological features of colorectal cancer patients was analyzed. The optimal cut-off value of serum NGAL for diagnosing colorectal cancer was determined by ROC curve and compared with CEA and CA19-9. Univariate and multivariate analyses were performed to examine the relationship of NGAL level with the prognosis of patients with colorectal cancer. RESULTS: The median serum NGAL protein level in 100 colorectal cancer cases was 67.96 (53.30-79.86) µg/L, significantly higher than that in healthy people and colorectal polyps patients. The differences were statistically significant (all P<0.01). Serum NGAL protein level was significantly associated with tumor diameter, TNM stage, lymph node metastasis and vascular involvement (P<0.05). The optimal cut-off point of serum NGAL protein level for diagnosing colorectal cancer was 49.78 µg/L, and the sensitivity and specificity were 88% and 81% respectively. As for colorectal cancer patients with stage I, the sensitivity of serum NGAL (78.9%) was significantly higher as compared to CA19-9 (31.6%) and CEA (36.8%); as for those with stage II, the sensitivity of serum NGAL(88.0%) was also significantly higher compared to CA19-9 (48.0%) and CEA (52.0%). Kaplan-Meier analysis showed that patients with positive NGAL (≥49.78 µg/L) had worse survival than those with negative NGAL (P=0.002). Multivariate analysis showed that NGAL was an independent prognostic factor (HR=2.060, 95%CI:1.023-4.150, P=0.043). CONCLUSIONS: NGAL can be served as the novel malignant biological phenotype marker for human colorectal cancer and can be used for the risk stratification. NGAL may be an independent prognostic factor in colorectal cancer.

Perianal Paget's Disease Co-Associated with Anorectal Adenocarcinoma: Primary or Secondary Disease?

Perianal Paget's disease (PPD) represents a skin neoplasm which can be either primary or secondary to carcinoma from an adjacent internal organ. PPD with underlying colorectal adenocarcinoma is usually looked upon as a secondary disease. We report a rare case of co-associated PPD and anorectal adenocarcinoma. The PPD was found to be located near the anorectal adenocarcinoma with normal tissues between them. Immunohistochemical stains demonstrated that the Paget's cells were CK7+/GCDFP-15-/CK20-/MUC2-/CDX2-, whereas the anorectal adenocarcinoma was shown to be CK7+/GCDFP-15-/CK20+/MUC2+/CDX2+. This immunological phenotypic profile supported the notion that PPD and anorectal adenocarcinoma were of different origins, but could not define the exact origins of PPD. In our determination, this case was a primary PPD with anorectal adenocarcinoma. PPD remains a heterogeneous and complex pathology, and additional studies are required to differentiate between the various possible origins.

[Transanal endoscopic microsurgery by transanal glove port combined with colonoscopy for excision of rectal tumors].

OBJECTIVE: To evaluate the feasibility and efficacy of transanal endoscopic microsurgery (TEM) by transanal glove port combined with colonoscopy for excision of rectal tumors. METHODS: Eight patients with rectal cancer eligible for local resection were chosen to receive a procedure performed via a "glove TEM port" from October 2012 to March 2013. This device was constructed on-table using a circular anal dilator (CAD), standard surgical glove, colonoscopy instruments and straight laparoscopic instruments. RESULTS: Procedures of all the patients were completed successfully by glove TEM. The median (range) diameter of tumor was 2.6(1.5-3.5) cm, the median (range) operative time was 55.6(30-110) min. Postoperative pathology included villous adenomas (n=3), tubular adenomas (n=2), tubulovillous adenomas (n=2), serrated adenoma (n=1), low-grade intraepithelial neoplasia (n=2), and high-grade intraepithelial neoplasia (n=1). All resection margins were negative. Two patients presented with postoperative minor bleeding. There were no serious intraoperative complications. No cancer recurrence was found during a follow-up of 1-5 (median 3.1) months. CONCLUSION: Transanal endoscopic microsurgery by transanal glove port combined with colonoscopy in the treatment of early rectal cancer is easy and safe.

An experimental research into endostatin microbubble combined with focused ultrasound for anti-tumor angiogenesis in colon cancer.

OBJECTIVE: to evaluate the therapeutic effect of targeted endostatin-loaded microbubbles, combined with improved, focused, directional ultrasound radiation for inhibition of subcutaneous translocation in situ colon tumor angiogenesis in colon cancer. METHODS: 65 BALB/c nude mice with subcutaneous translocation in situ colon tumors were randomly divided into five groups. Group A was the control group, without any treatments. In Group B, the mouse was treated with ultrasonic radiation. In Group C, the mouse was treated with ultrasonic radiation combined with empty SonoVue microbubbles. In Group D, the mouse was treated with ultrasonic radiation combined with empty Targestar-SA microbubbles. In Group E, the mouse was treated with ultrasonic radiation combined with endostatin microbubbles. The tumor size was measured before and 1, 14, and 28 days after irradiation. The peak intensity (PI), regional blood volume (RBV) and regional blood flow (RBF) were recorded using contrast-enhanced ultrasound. The tumor tissue was removed for pathological examination; the tumor necrosis area and microvascular density (MVD) were evaluated by immunohistochemistry. RESULTS: Tumors in Groups C, D and E were significantly smaller than in Groups A and B at 28 days after irradiation, with Group E the smallest. PI, RBF and RBV of Groups C, D, and E were significantly decreased 28 days after radiation with Group E the lowest, and significantly lower than Groups A and B (all P < 0.05). The tumor tissue necrosis area of Group E was clearly greater while MVD was obviously lower than the other groups (all P < 0.01) at 28 days after treatment. CONCLUSION: The targeted endostatin microbubbles, combined with focused, directional ultrasound radiation can damage tumor microvasculature of subcutaneous colon translocation in situ colon cancer, as well as inhibit the tumor angiogenesis.

[Multi-gene methylation detection increases positive methylation rate in colorectal cancer].

OBJECTIVE: To study whether combined detection of the methylation status of vimentin, sFRP1, and HPP1 gene can increase the positive methylation rate in colorectal cancer. METHODS: Tissue samples were collected from 90 patients with colorectal cancer, 60 patients with adenomatous polyp, and 20 healthy controls. DNA was extracted and the methylation status of vimentin, sFRP1, and HPP1 gene was detected by Methylation-specific PCR (MSP). The relationship between clinicopathologic features of colorectal cancer and gene methylation was analyzed. RESULTS: The methylation rates of vimentin, sFRP1, and HPP1 were 66.7%, 68.9%, and 72.2% in colorectal cancer, 53.3%, 55.0%, and 50.0% in colorectal adenomas, and 0, 0, and 5.0% in healthy controls, respectively. The methylation of each of the three genes in colorectal cancer tissues was higher than colorectal adenomas and healthy controls(P<0.05). The diagnostic sensitivity by combining three methylation markers was 93.3% in colorectal cancer, 76.7% in colorectal adenomas, which was higher than the sensitivity using single gene testing(P<0.05). No significant associations existed between the methylation status of the three genes and clinical characteristics including sex, age, tumor location, lymph node metastases, distant metastasis, and TNM stage(P>0.05). CONCLUSIONS: DNA methylation levels of vimentin, sFRP1 and HPP1 are significantly higher in colorectal cancer tissue. Combined detection significantly improves the positive rate of methylation, and may be used as early diagnosis method for colorectal cancer.

[Transsacral resection for presacral tumors].

OBJECTIVE: To explore the operation indication and safety of presacral tumor. METHODS: Clinical data of 36 patients with presacral tumor from November 1990 to May 2006 treated in our hospital, in whom 23 patients underwent trans-sacral operation, were analyzed retrospectively. RESULTS: The operation time was from 43 to 210 min (average 94 min). The volume of blood loss was from 30 to 2000 ml (average 350 ml). Hospital stay was from 8 to 16 days (average 10.7 days). There were 13 different pathology types of tumors in the 36 patients including 26.4% of malignancy. Complications of trans-sacral operation included 1 case of ureteral damage, 1 case of sacral wound hernia, 1 case of presacral abscess who was healed by sigmoid stoma and wound drainage. CONCLUSION: Trans-sacral resection of low presacral tumor is safe and effective with less trauma, less bleeding and quick recovery.

[Bowel preparation with sodium phosphate versus polyethylene glycol: a prospective, randomized, controlled clinical trial].

OBJECTIVE: To compare the efficacy, tolerance and safety between oral sodium phosphate(NaP) and polyethylene glycol(PEG) on bowel preparation. METHODS: One hundred and fifteen inpatients were randomly divided into NaP group and PEG group. The questionnaire was designed for scoring by patients and doctors regarding to tolerance, taste, side effects and cleaning degree etc. RESULTS: Compared with PEG group, NaP presented better tolerance, lower side effects and higher rate of adequate cleaning quality(P<0.05). NaP could cause electrolytic alterations, such as hyperphosphatemia, hypernatremia, hypocalcemia and hypopotassemia, but these changes were transient and without clinical significance. CONCLUSION: Sodium phosphate is safe and effective for bowel preparation, and is better than polyethylene glycol in tolerance.

[Efficacy of the procedure for prolapse and hemorrhoids combined with external hemorrhoids excision in the treatment of III or IV mixed hemorrhoids].

OBJECTIVE: To investigate the efficacy of the procedure for prolapse and hemorrhoids (PPH) combined with external hemorrhoids excision in the treatment of III or IV mixed hemorrhoids. METHODS: One hundred and twelve patients with III or IV mixed hemorrhoids admitted for surgical treatment were randomly divided into three groups: PPH 1 group (34 cases), PPH2 group (36 cases), and Milligan-Morgan group (42 cases). PPH1 group received the standard PPH operation, PPH2 received PPH and external hemorrhoids excision, and Milligan-Morgan group received Milligan-Morgan hemorrhoidectomy. Postoperative 24 h-pain index, pain index when defecating, bleeding, anal discomfort feeling , wound edema, the ability of controlling feces, operating time, hospitalization time and charges were recorded. The change of anal dynamics was detected by anorectal manometry. All the patients were followed-up for 0.5-1 year. RESULTS: There were no significant differences among the three groups in bleeding, anal discomfort feeling, the ability of controlling feces (P>0.05). The postoperative 24 h-pain index of PPH1 group was lower than those of the other two groups (P<0.05). PPH1 group and PPH2 group were better than Milligan-Morgan group in pain index when defecating, wound edema, operating time, and hospitalization time (P<0.05). Milligan-Morgan group was better than the other two groups in postoperative urinary retention and hospital charges (P<0.05). The change of anal duct pressure of Milligan-Morgan group was less than those of the other two groups (P<0.05). Within 0.5-1.0 year follow-up, 3 patients got thrombosed external hemorrhoid in PPH1 group, 2 patients recurred and 1 patient got thrombosed external hemorrhoid in Milligan-Morgan group, no recurred patients in PPH2 group. CONCLUSION: PPH combined with external hemorrhoid excision is a safe and effective treatment for mixed hemorrhoids, which is suitable for mixed hemorrhoids with severe external hemorrhoids.

[Prophylactic use of antibiotics in selective colorectal operation: a randomized controlled trial].

OBJECTIVE: To investigate the reasonable proposal of prophylactic antibiotics use in selective colorectal operation. METHODS: One hundred and sixty-five patients underwent colorectal surgery were randomized to Treatment 1 (55 cases), Treatment 2 (50 cases) and Control (60 cases) group. The Treatment 1 group was given oral MgSO4 solution at the night before operation, and Cefradine 2.0 g (I.V.) during the induction of anesthesia, continued with tow times of intravenous Cefradine 2.0 g and 0.5% Metronidazole 100 ml at an interval of 12 hours in 24 hours after the operation. The Treatment 2 group was given the same treatment as Treatment 1, but the antibiotics would not be withdrawn until 3-5 d after operation. On the basis of the treatment of Treatment 2 group, the Control group was given oral antibiotics 2-3 days before operation. Postoperative complications including surgical site infection, stoma leakage, dysbacteriosis, and WBC, body temperature, days of hospitalization and antibiotic expenses in the three groups were observed and compared. RESULTS: There was no significant differences in surgical site infection, stoma leakage, WBC counting and its change, body temperature and hospital stay among the three groups (P > 0.05). The incidence rate of dysbacteriosis in Control group was significantly higher than that in Treatment 1 group (P < 0.05). The antibiotic expenses in the Treatment 1 group was significantly lower than those of the other two groups (P < 0.05). CONCLUSIONS: Prophylactic antibiotic use during the induction of anesthesia and 24 hours after operation was reasonable in selective colorectal operation, it can prevent the surgical site infection effectively with good social-economic effects and fewer side effects.