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This trial evaluated the superiority of intraoperative wound irrigation (IOWI) with aqueous povidone-iodine (PVP-I) compared to that with saline for reducing the incidence of surgical site infection (SSI).IOWI with aqueous PVP-I is recommended for the prevention of SSI by the World Health Organization and Centers for Disease Control and Prevention, although the evidence level is low.This single-institute in Japan, prospective, randomized, blinded-endpoint trial was conducted to assess the superiority of IOWI with aqueous PVP-I in comparison to IOWI with saline for reducing the incidence of SSI in clean-contaminated wounds after gastroenterological surgery. Patients ≥20 years old were assessed for eligibility, and eligible participants were randomized at a 1:1 ratio using a computer-generated block randomization. In the study group, IOWI was performed for one minute with 40 mL of aqueous 10% PVP-I before skin closure. In the control group, the procedure was performed with 100 mL of saline. Participants, assessors, and analysts were masked to the treatment allocation. The primary outcome was the incidence of incisional SSI in the intention-to-treat set.Between June 2019 and March 2022, 941 patients were randomized to the study group (473 patients) or the control group (468 patients). The incidence of incisional SSI was 7.6% in the study group and 5.1% in the control group (risk difference 0.025, 95% CI -0.006 to 0.056; risk ratio 1.484, 95% CI 0.9 to 2.448; P=0.154).The current recommendation of IOWI with aqueous PVP-I should be reconsidered.

The study aimed to evaluate the impact of sarcopenia on short- and long-term outcomes for laparoscopic colorectal cancer surgery.Study participants were 209 patients who underwent laparoscopic surgery for any stage of colorectal cancer between 2016 and 2017. Skeletal muscle indices were calculated with preoperative computed tomography. Patients were divided into sarcopenic and non-sarcopenic groups based on index cut-off values and variables were compared.The prevalence of sarcopenia was 41.1%. Sarcopenic patients experienced shorter operative times and a lower incidence of surgical site infections; however, the incidence of severe postoperative complications and readmission were increased for this group. Although the 3-year disease-free survival rate was not statistically different between groups, sarcopenic patients had a significantly worse 3-year overall survival rate compared with than the non-sarcopenic group.Sarcopenia has both favorable and unfavorable effects on patients who underwent laparoscopic colorectal cancer surgery.

Complex interactions among endogenous and exogenous factors influence the incidence of colorectal cancer (CRC). Germline mutations in mismatch repair (MMR) genes causing Lynch syndrome (LS) are major endogenous factors. The exogenous factor, alcohol consumption, is potentially associated with CRC incidence among patients with LS. However, insufficient data are available to determine whether alcohol consumption influences the time of the first onset of CRC associated with sex, MMR gene mutations, and anatomical tumor site.Among 316 patients with LS identified in a Japanese LS cohort, we included 288 with data on age, sex, proband status, alcohol status, smoking status, tumor location, and MMR gene mutations. Multivariable analysis assessed the association of alcohol consumption with earlier onset of the first CRC.Ever drinkers were associated with higher risk of the first onset of CRC than never drinkers (HR 1.54, 95%CI 1.14-2.07, P = 0.004). The association of the first onset of CRC with alcohol consumption was stronger in men, carriers of pathogenic MLH1 and MSH2 mutations (vs those with pathogenic MSH6, PMS2 and EPCAM mutations), and tumors in the proximal colon cancer (vs distal colon and rectal cancer).Alcohol consumption was associated with earlier onset of the first CRC in Japanese LS cohort. The association was stronger in men, carriers of pathogenic MLH1 and MSH2 mutations, and tumors located in the proximal colon. Our findings illuminate the mechanism of LS-associated carcinogenesis and serve as a recommendation for discontinuing or ceasing alcohol consumption.

PDF - 59K, SN-38 IC50 in the presence or absence of 10 nM olaparib in colon cancer cell lines.

PDF - 156K, Mismatch repair, TP53, MRE11 and RAD50 gene status of colon cancer cell lines.

PDF - 949K, Fig. S1: Cell counts with cell diameters in colon cancer cells. Fig. S2: Clonogenic assay. Fig. S3: Immnofluorescence double staining for BrdU and 53BP1. Fig. S4: Western blot analysis. Fig. S5: Cell counts with cell diameters in SW1116 transfected with siRNA. Fig. S6: Cell counts with cell diameters in HCT116 transfected with siRNA.

PDF - 83K, Table S3-S5: Data of cell diameters measured using the Scepter 2.0 cell counter in each treatment as shown in Supplementary Fig. S1, Fig. 5 and Supplementary Fig. S6. Table S6: Data of blood samples of SW1116 xenografted mice.

Potent application of topoisomerase I inhibitor plus PARP inhibitor has been suggested to be an effective strategy for cancer therapy. Reportedly, mismatch repair (MMR)–deficient colon cancer cells are sensitive to topoisomerase I inhibitor, presumably due to microsatellite instability (MSI) of the MRE11 locus. We examined the synergy of SN-38, an active metabolite of irinotecan, in combination with the PARP inhibitor olaparib in colon cancer cells showing different MMR status, such as MSI or microsatellite stable (MSS) phenotype. Treatment with SN-38 and olaparib in combination almost halved the IC50 of SN-38 for a broad spectrum of colon cancer cells independent of the MMR status. Furthermore, olaparib potentiated S-phase–specific double-strand DNA breaks (DSB) induced by SN-38, which is followed by Rad51 recruitment. siRNA-mediated knockdown of Rad51, but not Mre11 or Rad50, increased the sensitivity to olaparib and/or SN-38 treatment in colon cancer cells. In vivo study using mouse xenograft demonstrated that olaparib was effective to potentiate the antitumor effect of irinotecan. In conclusion, olaparib shows a synergistic effect in colon cancer cells in combination with SN-38 or irinotecan, potentiated by the Rad51-mediated HR pathway, irrespective of the Mre11-mediated failure of the MRN complex. These results may contribute to future clinical trials using PARP inhibitor plus topoisomerase I inhibitor in combination. Furthermore, the synergistic effect comprising topoisomerase I-mediated DNA breakage–reunion reaction, PARP and Rad51-mediated HR pathway suggests the triple synthetic lethal pathways contribute to this event and are applicable as a potential target for future chemotherapy. Mol Cancer Ther; 13(5); 1170–80. ©2014 AACR.

PDF - 70K, Supplementary Materials and Methods, legends for Supplementary Figures 1 through 6, and legends for Supplementary Tables 1 through 6.

Stomal prolapse (SP) is characterized by full-thickness protrusion of the bowel through the stoma site. The surgical procedures for SP include local repair, abdominal wall fixation, and stoma relocation. However, previous reports were mostly case reports or case series with a small number of patients and lacked long-term results. A modified Altemeier technique (MAT) has been used for the local repair of SP in our institution, and this study aimed to evaluate its mid-term efficacy. We reviewed patients who underwent MAT for SP between August 2013 and December 2020. The variables included patient characteristics, type of stoma, indications of stoma creation, the time interval from stoma creation to prolapse, site of prolapse, reasons for SP surgery, perioperative variables, complications during SP surgery, and length of follow-up. Recurrence of SP was defined as the need for change in stoma care or re-protrusion of the stoma by more than 5 cm in length. Ten patients were included in this study. The median age at the time of SP surgery was 71.5 years. The indications of stoma creation included unresectable or recurrent intra-abdominal malignancies in four patients, diverting ileostomy with rectal cancer surgery in two, transverse colon cancer in one, gastric and rectal cancer in one, rectovaginal fistula in one, and non-occlusive mesenteric ischemia in one. The median interval from stoma creation to prolapse was 2.5 months. Six patients underwent elective SP surgery, and four patients underwent emergency surgery for incarcerated prolapse. The median operative time was 75.5 min. Postoperative complications that included transient mucosal ischemia and subcutaneous abscess occurred in one patient. There were four recurrences (40%), and the median time interval from surgery to recurrence was 4.5 months. Two patients underwent repeated MAT, one of whom underwent stomal reversal with laparotomy for re-recurrence. The median follow-up duration was 19 months. MAT for SP is associated with a high recurrence rate in mid-term follow-up.

Combined treatment with bevacizumab and trifluridine/tipiracil (TAS-102) leads to an increased chance of survival in patients with refractory metastatic colorectal cancer (mCRC); however, this treatment is associated with an increased frequency of severe neutropenia (number of neutrophils1,000), which should ideally be managed without dose delays. The present study provided a retrospective review of 35 patients with mCRC, and aimed to elucidate the benefits of prophylactic pegfilgrastim for the treatment of severe neutropenia. Patients received TAS-102 (35 mg/m

There is a paucity of evidence pertaining to long-term survival outcomes of laparoscopic versus open surgery for locally advanced rectal cancer.This study aimed to evaluate the long-term survival outcomes of laparoscopic surgery for locally advanced rectal cancer and to investigate the recurrence pattern.This was a prospective analysis of a registered cohort.This study was conducted at 69 institutions across Japan.A total of 1500 patients with clinical stage II-III rectal cancer located below the peritoneal reflection between January 2010 and December 2011 were included. After propensity score matching, all eligible patients, including the matched patients registered in 2014, were prospectively followed up.Five-year relapse-free survival was the primary outcome.The median follow-up period was 5.6 years. Among the 964 matched patients, the 5-year relapse-free survival was 65.1% in the open group versus 63.5% in the laparoscopic group (HR 1.04; p = 0.71). Distant recurrences at rare sites, which were more frequently observed in the laparoscopic group, were significantly less salvaged (adjusted OR 0.74; p = 0.045). Postrecurrence 5-year overall survival was significantly better for patients who underwent salvage surgery than for those who did not; 55.3% vs 29.5% for patients with initial local recurrence ( p = 0.03) and 64.4% vs 30.7% for patients with distant recurrence alone ( p0.001).Potential heterogeneity and influence of unknown confounding.Five-year follow-up data demonstrated that laparoscopic surgery for locally advanced rectal cancer was safely performed in terms of long-term prognosis. In addition, salvage surgery for recurrent lesions was associated with prolonged postrecurrence survival, both in patients with local and distant recurrence. However, recurrence at rare sites may require further investigation. See Video Abstract at http://links.lww.com/DCR/B793 .ANTECEDENTES:Existe una escasez de pruebas relacionadas con los resultados de supervivencia a largo plazo de la cirugía laparoscópica versus abierta para el cáncer de recto localmente avanzado.OBJETIVO:Este estudio tuvo como objetivo evaluar los resultados de supervivencia a largo plazo de la cirugía laparoscópica para el cáncer de recto localmente avanzado e investigar el patrón de recurrencia.DISEÑO:Fue un análisis prospectivo de una cohorte registrada.ENTORNO CLÍNICO:El estudio se llevó a cabo en 69 instituciones en todo Japón.PACIENTES:Se incluyó un total de 1500 pacientes con cáncer de recto en estadio clínico II-III ubicados por debajo de la reflección peritoneal, entre enero del 2010 y diciembre del 2011. Después del pareamiento por puntaje de propensión, se realizó un seguimiento prospectivo de todos los pacientes elegibles, incluidos los pacientes emparejados registrados en 2014.PRINCIPALES MEDIDAS DE VALORACIÓN:La supervivencia sin recaídas a cinco años fue el resultado primario.RESULTADOS:El período de seguimiento medio fue de 5,6 años. Entre los 964 pacientes emparejados, la supervivencia libre de recaída a 5 años fue del 65,1% en el grupo abierto frente al 63,5% en el grupo laparoscópico (cociente de riesgo 1,04; p = 0,71). Las recurrencias a distancia en sitios raros, que se observaron con mayor frecuencia en el grupo laparoscópico, tuvieron menor sobrevida (razón de posibilidades ajustada 0,74; p = 0,045). La supervivencia general a los 5 años después de la recidiva fue significativamente menor en los pacientes sometidos a una cirugía de rescate; 55,3% frente al 29,5% para los pacientes con recidiva local inicial ( p = 0,03) y 64,4% frente al 30,7% para los pacientes con recidiva a distancia sola ( p0,001).LIMITACIONES:Potencial heterogeneidad e influencia de factores de confusión desconocidos.CONCLUSIONES:El seguimiento a cinco años demostró que la cirugía laparoscópica para el cáncer de recto localmente avanzado es segura en términos de pronóstico a largo plazo. Además, la cirugía de rescate de las lesiones recurrentes se asoció con una mayor supervivencia posrecurrencia, tanto en pacientes con recurrencia local como a distancia. Sin embargo, la recurrencia en sitios raros puede requerir una mayor investigación. Consulte Video Resumen en http://links.lww.com/DCR/B793 . (Traducción- Dr. Ingrid Melo ).

Background/aim The impact of diverting ileostomy on the feasibility of adjuvant chemotherapy (ACT) remains unclear. We retrospectively investigated the tolerability and adverse events of ACT for rectal cancer in patients with diverting ileostomy. Patients and methods Thirty-three patients who received ACT after curative resection with ileostomy construction for rectal cancer were analyzed. We assessed completion rate, the mean relative dose intensities, and the factors affecting the tolerability of ACT. Results The completion rate of each chemotherapy regimen was 10 out of 16 patients in oral uracil-tegafur plus leucovorin (UFT/LV), 1 out of 3 patients in oral capecitabine (Capecitabine) and 2 out of 14 patients in capecitabine plus oxaliplatin (CAPOX). The mean relative dose intensities were 77% in UFT/LV, 48% in Capecitabine, and 57% of capecitabine and 42% of oxaliplatin in CAPOX. In multivariate analysis, laparoscopic surgery (Odds ratio=11.6, p=0.021) and receiving preoperative chemoradiotherapy (Odds ratio=32.4, p=0.021) were associated with treatment completion. Conclusion Completion rate of ACT in patients with diverting ileostomy was lower than that of colorectal cancer patients in the previous studies. UFT/LV may be a more tolerable regimen than Capecitabine or CAPOX in colorectal cancer patients with diverting ileostomy.

Desmoid tumors are monoclonal fibroblastic proliferations arising from soft tissue classified as intra-abdominal, extra-abdominal and abdominal wall types. We present a patient with an intra-abdominal desmoid tumor diagnosed 20 months after laparoscopic resection of rectal cancer. A 70-year-old woman with hematochezia was diagnosed with advanced rectal cancer. Preoperative chemoradiotherapy followed by laparoscopic low anterior resection was performed. During follow-up, a nodular soft-tissue density measuring 28 mm was detected in the presacral region. Metastasis from rectal cancer was diagnosed and four courses of chemotherapy were given, including capecitabine, oxaliplatin and bevacizumab. Computed tomography scan showed that the mass slightly decreased in size and surgical resection was performed. Histopathological examination revealed a proliferation of spindle-shaped cells and collagenous stroma diagnosed as a desmoid tumor. This report highlights the possibility of a desmoid tumor in the differential diagnosis of an intra-abdominal mass found during follow-up after resection of colorectal cancer including following laparoscopic resection.

IntroductionSurgical site infection (SSI) is one of the most common complications after gastrointestinal surgery, with a reported incidence of approximately 10%–25%, which is higher than the rates after other types of surgery. Intraoperative wound irrigation (IOWI) is a simple intervention for SSI prevention, and recent studies have reported that IOWI with aqueous povidone–iodine (PVP-I) is significantly more effective at reducing the incidence of SSI than saline. However, the evidence level of previous trials evaluating the efficacy of aqueous PVP-I solution for preventing SSI has been low.Methods and analysesWe propose a single-institute, prospective, randomised, blinded-endpoint trial to assess the superiority of IOWI with aqueous 10% PVP-I solution compared with normal saline for reducing SSI in clean-contaminated wounds after elective gastrointestinal surgery. In the study group, IOWI with 40 mL of aqueous 10% PVP-I solution is performed for 1 min before skin suture, and in the control group, IOWI with 100 mL of saline is performed for 1 min before skin suture. We hypothesise that IOWI with aqueous 10% PVP-I solution will achieve a 50% reduction in the incidence of SSIs. The target number of cases is set at 950. The primary outcome is the incidence of incisional SSI up to postoperative day 30 and will be analysed in the modified intention-to-treat set.Ethics and disseminationThis trial was designed and is being conducted by Saitama Medical Center, Jichi Medical University, with approval from the Bioethics Committee for Clinical Research, Saitama Medical Center, Jichi Medical University. Participant recruitment began in June 2019. The final results will be reported in international peer-reviewed journals immediately after trial completion.Trial registration numberUMIN000036889.

Introduction Surgery for patients taking antithrombotic drugs for the prevention and treatment of cardiovascular disease, including anticoagulants and antiplatelet drugs, is increasing because of the aging society. In patients with moderate to high risk for cardiovascular events, receiving antiplatelet therapy, and requiring noncardiac surgery continuing antiplatelet drugs perioperatively is recommended. To date, there have been limited reports on the risk of secondary bleeding after proctological surgery in patients who are administered antithrombotic drugs. The purpose of this study was to identify the incidence and severity of secondary bleeding after proctological surgery for patients with or without antithrombotic therapy. Methods We retrospectively identified 113 patients who underwent proctological surgery in our hospital from March 2009 to February 2019. In general, antiplatelet drugs were continued and anticoagulant drugs were either substituted or withdrawn prior to surgery. The severity of secondary bleeding was classified as mild, moderate, or severe. Results Eighteen patients underwent antithrombotic therapy (A group) and 95 patients did not undergo antithrombotic therapy (N group). Secondary bleeding was observed in nine patients (8.0%) and patients in the A group exhibited a significantly higher rate of secondary bleeding than those in the N group (39% vs. 2.4%, P < 0.01). The median interval from surgery to the onset of secondary bleeding was five days (range: 0-11). The severity of bleeding was the highest in patients administered direct oral anticoagulants (DOAC) and was the lowest in those administered aspirin. There was no mortality or cardiovascular event. Conclusion Antithrombotic therapy carries a high risk of secondary bleeding after proctological surgery. Delaying the postoperative resumption of anticoagulants is considered while balancing the risk of postoperative thromboembolic complications against secondary bleeding.

Hereditary colorectal cancer (HCRC) accounts for

IntroductionTrocar site hernia (TSH) is an uncommon complication after laparoscopic surgery, but may potentially require surgical intervention. The available data have shown the importance of prediction and prevention, and the optimal surgical approach for TSH remains unclear and its long-term outcome is scarcely available. Here, we present a case of a lateral TSH after laparoscopic incisional hernia repair, which was successfully repaired using the onlay technique with a self-gripping mesh.Case PresentationA 74-year-old woman presented with an abdominal incisional hernia at the midline after an open cholecystectomy. She underwent laparoscopic surgery for incisional hernia with intraperitoneal onlay mesh repair. Fascial closure was performed for trocar sites. After 12 months, she noticed a painful bulge in the left upper quadrant suggestive of TSH. At the time of diagnosis, her body mass index was 32 kg/m2. TSH repair was performed under general anesthesia. A 3 × 3 cm defect was identified, and the hernial content was found to be the omentum. Defect closure was performed using interrupted sutures followed by placement of a self-gripping mesh (11 × 11 cm in size, obtaining a 4 cm overlap for the defect). The operative time was 80 min. The postoperative course was uneventful except for a spontaneously resolved seroma. CT scan at the 1-year follow-up and physical examination at the 2-year visit showed no recurrence.ConclusionOur proposed onlay repair using self-gripping mesh may be considered as the treatment of choice for cases of lateral TSH after laparoscopic incisional hernia repair.

// Yuji Takayama 1 , Koichi Suzuki 1 , Yuta Muto 1 , Kosuke Ichida 1 , Taro Fukui 1 , Nao Kakizawa 1 , Hideki Ishikawa 1 , Fumiaki Watanabe 1 , Fumi Hasegawa 1 , Masaaki Saito 1 , Shingo Tsujinaka 1 , Kazushige Futsuhara 1 , Yasuyuki Miyakura 1 , Hiroshi Noda 1 , Fumio Konishi 2 and Toshiki Rikiyama 1 1 Department of Surgery, Saitama Medical Center, Jichi Medical University, Omiya-ku, Saitama 330-8503, Japan 2 Department of Surgery, Nerima-Hikarigaoka Hospital, Nerima-ku, Tokyo 179-0072, Japan Correspondence to: Koichi Suzuki, email: ksuzbnhm@yahoo.co.jp Keywords: liquid biopsy; circulating tumor DNA; colorectal cancer; KRAS; droplet digital PCR Received: December 27, 2017 Accepted: April 13, 2018 Published: May 11, 2018 ABSTRACT KRAS mutated circulating tumor DNA (MctDNA) can be monitored in the blood of patients with metastatic colorectal cancer (mCRC), but dynamic changes have not been determined. Four hundred and fifty-seven plasma samples were collected prospectively from 85 mCRC patients who underwent chemotherapy. MctDNA in plasma was detected by droplet digital PCR, and the percentage of MctDNA in total circulating cell-free DNA was calculated. KRAS assessment in tumor tissues showed 29 patients with the mutant-type (MT) and 56 patients with the wild-type (WT). Twenty-three of 29 MT patients (79.3%) and 28 of 56 WT patients (50.0%) showed MctDNA. Emergence of MctDNA was recognized during treatments with various drugs. Regardless of KRAS status in tumor tissues, patients with MctDNA in blood showed poor progression-free survival with first-line treatment. Median percentage of MctDNA accounted for 10.10% in MT patients and 0.22% in WT patients. These differences between MT and WT likely affected patterns of changes in MctDNA. KRAS monitoring identified dynamic changes in MctDNA, such as continuous, intermittent, and transient changes (quick elevation and disappearance). Emergence of MctDNA involved drug resistance, except for transient changes, which were seen in WT patients and likely corresponded with the drug response. Transient changes could be involved in recovery of sensitivity to anti-EGFR antibody in WT patients. Monitoring MctDNA during various treatments showed dynamic changes in KRAS status and could provide useful information for determining treatments for patients with mCRC.

Sequential administration of the chemotherapy regimes capecitabine and oxaliplatin (XELOX) and capecitabine and irinotecan (XELIRI) in the first- to second-line treatment setting would allow patients to be managed more easily in an outpatient unit. However, a small number of studies have raised concerns of cumulative adverse events as a consequence of the continuous use of capecitabine. To investigate this, the present study conducted a retrospective review of 81 consecutive metastatic colorectal cancer (mCRC) patients treated with the oxaliplatin, fluorouracil and leucovorin-irinotecan, fluorouracil and leucovorin (FOLFOX-FOFIRI/F-F) regimen (n=40) or the XELOX-XELIRI (X-X) regimen (n=41) in first- to second-line chemotherapy in Saitama Medical Center between 2006 and 2012. The disease control rate (DCR), the progression free survival (PFS), the overall survival (OS) and the time to failure of strategy (TFS) from first to second-line chemotherapy, as well as adverse events, were assessed and compared between patients receiving X-X or F-F. A total of 10 and 20 patients were additionally treated with bevacizumab in the F-F and X-X regimens, respectively, during first or second-line chemotherapy. There was no significant difference in DCR and the median PFS between the two regimens for first or second-line chemotherapy. There was no significant difference in the median OS and TFS between the two regimens (OS=24.5 and TFS=14 months in the F-F vs. 23.2 and 12.0 months in the X-X). Regarding adverse events, 45.0% of patients (18/40) exhibited grade 3-4 neutropenia throughout treatment with F-F. Whilst, 15.0% of patients (6/41) exhibited grade 3 hypertension throughout treatment with X-X, which was effectively controlled by a single antihypertensive drug. The results show that sequential administration of X-X is as effective and feasible as F-F treatment, while additionally reducing the frequency of infusion visits and eliminating the need for a central venous access device or home infusion pump, thereby offering a more convenient treatment option to patients with mCRC.

Inappropriate stoma site, improper management of stoma, and stoma complications lead to diminished quality of life of ostomates. Healthcare professionals involved in stoma creation and/or care should have the fundamental and updated knowledge of the management of stomas and their complications. This review article consists of the following major sections: principles of perioperative patient management, early complications, and late complications. In the “principles of perioperative patient management” section, the current concepts and trends in preoperative education, stoma site marking, postoperative education, and patient educational resources are discussed. In the “early complications” section, we have focused on the etiology and current management of ischemia/necrosis, fluid and electrolyte imbalances, mucocutaneous separation, and retraction. In the “late complications” section, we have focused on the etiology and current management of parastomal hernia, stoma prolapse, parastomal varices, and pyoderma gangrenosum. Pre- and postoperative patient education facilitates the patient's independence in stoma care and resumption of normal activities. Healthcare providers should have basic skills and updated knowledge on the management of stomas and complications of stomas, to act as the first crisis manager for ostomates.

Background and study aims Delayed bleeding is believed to occur less frequently after cold snare polypectomy (CSP), but this has not been validated in clinical trials. This study aimed to compare rates of delayed bleeding after CSP and hot snare polypectomy (HSP). Patients and methods We conducted a multicenter, randomized controlled trial. Participants scheduled to undergo endoscopic resection of colorectal polyps ≤ 10 mm were enrolled and randomly assigned to CSP or HSP. Prophylactic clipping was performed at the endoscopists’ discretion. The primary outcome was delayed bleeding rate. Secondary outcomes included immediate bleeding rate and clipping rate. Sample size calculation showed that 451 patients were required in each arm. Results At the end of the study period decided in advance, 308 participants were recruited and an interim analysis was performed. A total of 273 patients (mean age 62.2 ± 8.8 years; 188 males) were analyzed, with 139 patients allocated to CSP and 134 to HSP. In total, 367 polyps were resected with CSP and 360 polyps with HSP. There were no significant differences in patient demographics or polyp characteristics. In per-patient-based analysis, delayed bleeding rates were 0.7 % after CSP and 0.7 % after HSP. Per-polyp analysis showed similar results (CSP: 0.3 % vs. HSP: 0.6 %). The immediate bleeding rate was significantly higher with CSP vs. HSP (54 % vs.14 %, P Conclusion This interim analysis did not demonstrate that delayed bleeding after CSP is less frequent than after HSP. The delayed bleeding rate after HSP was lower than expected.Meeting presentations: Digestive Disease Week 2017