Clinical Research Directory

Leakage Rate of Ileo-COlic Sutured Anastomosis After Right Hemicolectomy

The primary aim of the study is to show that the ileo-colic anastomosis leakage rate until the first 30 days after surgery using MonoPlus® suture material for anastomosis construction after right hemicolectomy is not inferior to the anastomosis leakage rate published in the literature for totally handsewn or stapled-handsewn ileo-colic anastomosis.

Surgical Outcomes in Splenic Flexure Cancers: A Multicenter Comparison of Segmental vs. Extended Hemicolectomy (SPARROW Study)

SPARROW Study: Surgical Outcomes in Splenic Flexure Cancer Colonic cancers located at the splenic flexure where the transverse colon turns into the descending colon are uncommon and represent less than 10% of all colorectal cancers. Because of their unique location between the blood supply of the right and left colon, there is no clear agreement on which surgical method provides the best results. Two main procedures are used: Segmental hemicolectomy, which removes only the part of the colon containing the tumor, and Extended hemicolectomy, which removes a larger section of the colon and more lymph nodes. The SPARROW Study is a prospective, multicenter observational study designed to compare these two surgical approaches in patients with splenic flexure cancer. The study will include about 140 patients (70 in each group) from multiple tertiary colorectal centers in Turkey and Europe. Researchers will collect information about each patient's surgery, recovery, and follow-up outcomes. The main outcomes include postoperative ileus, leakage at the surgical connection (anastomosis), wound infection, and total postoperative complications. Other outcomes include number of lymph nodes removed, complete tumor resection (R0), hospital stay, recovery time, reoperation, and 3-year overall and disease-free survival. By analyzing both short- and long-term results, the SPARROW Study aims to provide high-quality evidence to guide surgeons in choosing the best and safest operation for patients with splenic flexure cancers. All participants will provide written informed consent before joining the study. The study has received ethical approval from the Koç University Ethics Committee and will be conducted in accordance with the Declaration of Helsinki.

The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy

Experimental design: This study is a multicenter, prospective, randomized, controlled phase III clinical trial that identifies, classifies, defines, and quantitatively analyzes technical errors between robotic and laparoscopic radical right hemicolectomy (D3 lymph node dissection), identifies surgical risk areas, compares intraoperative performance, and patient short-term and long-term clinical outcomes. This experimental design was based on a 1:1 effective target case ratio between the experimental group and the control group for enrollment. The experimental group underwent robotic radical right hemicolectomy (D3 lymph node dissection), while the control group underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection). The unedited surgical videos of patients were analyzed, and relevant indicators and adverse events were recorded. Patients were followed up in the outpatient department after discharge until 3 years after surgery or until death or recurrence. Sample size calculation: In this study, the calculation of sample size was based on pre experiments and hypotheses, and a goodness test was conducted by selecting the means of two independent samples. Referring to the results of the pilot study, based on a 1:1 random (random number table method) ratio, assuming a significance level of unilateral α=0.025, a test power of 1- β=80%, and a superiority margin of 20% in reducing the number of errors, and considering the maximum dropout rate of 0.1 in this clinical study, the total sample size for this study was determined to be 368 patients (184 in the RRC group and 184 in the LRC group). Primary endpoint: incidence of technical errors during right hemicolectomy. Secondary endpoint: incidence of intraoperative complications; The incidence of complications within 30 days after surgery; Total surgical time, robot/laparoscope time; Estimate the amount of blood loss; Conversion to open surgery rate; Postoperative hospitalization time; Total number of lymph nodes cleared and positive rate of lymph nodes; Early postoperative recovery process (time of first defecation and defecation); 30 day readmission rate and unplanned reoperation rate after surgery; Postoperative nutritional status, inflammation, and immune response; 3-year disease-free survival rate DFS; 3-year overall survival rate (OS). Inclusion criteria: 1) 18 years old\<age\<80 years old, regardless of gender; 2) The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology; 3) The preoperative clinical staging was cStage I-III (cT1-4a, N0/+, M0) (according to UICC/AJCC-8thTNM tumor staging); 4) The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers); 5) Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs; 6) Preoperative ECOG physical status score ≤ 2; 7) Preoperative ASA scores I-III; 8) Patient informed consent. Exclusion criteria: 1) History of colon surgery (excluding ESD/EMR for colon cancer); 2) History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy); 3) Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment; 4) Pregnant or lactating women; 5) Suffering from severe mental illness; 6) Multiple primary cancers; 7) History of other malignant diseases within 5 years; 8) Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented; 9) History of unstable angina or myocardial infarction within 6 months; 10) Heart, lung, liver, kidney dysfunction or history of cerebral infarction; 11) Simultaneous surgical treatment is required for other diseases; 12) Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.

Fluorescence Lymph Node Mapping for Colon Cancer Surgery

Fluorescence-guided surgery using indocyanine green can visualize the complex and diverse lymph node drainage structures for each patient and help determine the extent of dissection of the D3 lymph node tailored to the patient. However, since fluorescence lymph node mapping (FLNM) is still being conducted only at some institutions for research purposes and is limited to reporting the results of small-scale studies of patients, a large-scale multi-center study was conducted to verify the clinical-oncological effects of FLNM. Research is needed. Therefore, this study used real-time fluorescence lymph node mapping (FLNM) to determine the extent of D3 lymph node dissection when performing right hemicolectomy and D3 lymph node dissection in patients with locally advanced right-sided colon cancer and to safely remove extensive lymph nodes. We aim to evaluate whether the dissection procedure is safe and beneficial in terms of clinical oncology.