Short- and long-term outcome differences between patients undergoing left and right colon cancer surgery: cohort study.

PURPOSE: Since the literature currently provides controversial data on the postoperative outcomes following right and left hemicolectomies, we carried out this study to examine the short- and long-term treatment outcomes. METHODS: This study included consecutive patients who underwent right or left-sided colonic resections from year 2014 to 2018 and then they were followed up. The short-term outcomes such as postoperative morbidity and mortality according to Clavien-Dindo score, duration of hospital stay, and 90-day readmission rate were evaluated as well as long-term outcomes of overall survival and disease-free survival. Multivariable Cox regression analysis was performed of overall and progression-free survival. RESULTS: In total, 1107 patients with colon tumors were included in the study, 525 patients with right-sided tumors (RCC) and 582 cases with tumors in the left part of the colon (LCC). RCC group patients were older (P < 0.001), with a higher ASA score (P < 0.001), and with more cardiovascular comorbidities (P < 0.001). No differences were observed between groups in terms of postoperative outcomes such as morbidity and mortality, except 90-day readmission which was more frequent in the RCC group. Upon histopathological analysis, the RCC group's patients had more removed lymph nodes (29 ± 14 vs 20 ± 11, P = 0.001) and more locally progressed (pT3-4) tumors (85.4% versus 73.4%, P = 0.001). Significantly greater 5-year overall survival and disease-free survival (P = 0.001) were observed for patients in the LCC group, according to univariate Kaplan-Meier analysis. CONCLUSIONS: Patients with right-sided colon cancer were older and had more advanced disease. Short-term surgical outcomes were similar, but patients in the LCC group resulted in better long-term outcomes.

Achieving Textbook Outcomes in Colorectal Cancer Surgery Is Associated with Improved Long-Term Survival: Results of the Multicenter Prospective Cohort Study.

Background: The outcomes of patients with colorectal cancer greatly depend on the quality of their surgical care. However, relying solely on a single quality indicator does not adequately capture the multifaceted nature of modern perioperative care. A new tool-"Textbook Outcome" (TO)-has been suggested to provide a comprehensive evaluation of surgical quality. This study aims to examine how TO affects the long-term outcomes of colorectal cancer patients who are scheduled for surgery. Methods: The data of all patients undergoing elective colorectal cancer resection with primary anastomosis at two major cancer treatment centers in Lithuania-Vilnius University Hospital Santaros Klinikos and National Cancer Institute-between 2014 and 2018 were entered into the prospectively maintained database. The study defined TO as a composite quality indicator that incorporated seven parameters: R0 resection, retrieval of ≥12 lymph nodes, absence of postoperative complications during the intrahospital period, hospital stay duration of fewer than 14 days, no readmission within 90 days after surgery, no reinterventions within 30 days after surgery, and no 30-day mortality. Long-term outcomes between patients who achieved TO and those who did not were compared. Factors associated with failure to achieve TO were identified. Results: Of the 1524 patients included in the study, TO was achieved by 795 (52.2%). Patients with a higher ASA score (III-IV) were identified to have higher odds of failure to achieve TO (OR 1.497, 95% CI 1.203-1.863), while those who underwent minimally invasive surgery had lower odds for similar failure (OR 0.570, 95% CI 0.460-0.706). TO resulted in improved 5-year overall-(80.2% vs. 65.5%, p = 0.001) and disease-free survival (76.6% vs. 62.6%; p = 0.001) rates. Conclusions: Elective colorectal resections result in successful TO for 52.5% of patients. The likelihood of failure to achieve TO is increased in patients with a high ASA score, while minimally invasive surgery is associated with higher TO rates. Patients who fail to achieve successful surgical outcomes experience reduced long-term outcomes.

Neoadjuvant Chemotherapy Followed by Gastrectomy for Cytology-Positive Gastric Cancer without Any Other Non-Curative Factors in a Western Setting: An International Eastern European Cohort Study.

The optimal approach for treating cytology-positive (Cy1) gastric cancer (GC) patients without additional non-curative factors remains uncertain. While neoadjuvant chemotherapy followed by gastrectomy shows promise, its suitability for Western patients is not well supported by existing data. To address this knowledge gap, a cohort study was conducted across four major GC treatment centers in Lithuania, Estonia, and Ukraine. Forty-three consecutive Cy1 GC patients who underwent neoadjuvant chemotherapy between 2016 and 2020 were enrolled. The study evaluated overall survival (OS), progression-free survival (PFS), cytology status conversion, and major pathological response rates, along with the factors influencing these outcomes. All patients underwent surgery post-neoadjuvant chemotherapy, with 53.5% experiencing cytological status conversion and 23.3% achieving a major pathological response. The median OS and PFS were 20 (95% CI: 16-25) and 19 (95% CI: 11-20) months, respectively. Conversion to negative cytology significantly reduced the relative risk of peritoneal progression (RR: 0.11; 95% CI: 0.03-0.47, p = 0.002). The study suggests that neoadjuvant chemotherapy followed by gastrectomy holds promise as a treatment option for Cy1 GC without additional non-curative factors, associating cytology status conversion with improved long-term outcomes and reduced peritoneal relapse risk.

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) with cisplatin and doxorubicin in combination with FOLFOX chemotherapy as a first-line treatment for gastric cancer patients with peritoneal metastases: single-arm phase II study.

BACKGROUND: Gastric cancer (GC) remains among the most common and most lethal cancers worldwide. Peritoneum is the most common site for distant dissemination. Standard treatment for GC peritoneal metastases (PM) is a systemic therapy, but treatment outcomes remain very poor, with median overall survival ranging between 3-9 months. Thus, novel treatment methods are necessary. Pressurized intraperitoneal aerosol chemotherapy (PIPAC) is the most novel technique for intraperitoneal chemotherapy. Some preliminary data suggest PIPAC can achieve improved long-term outcomes in patients with GC PM, especially when used in combination with systemic chemotherapy. However, there is a lack of data from well-design prospective studies that would confirm the efficacy of PIPAC and systemic therapy combination for first-line treatment. METHODS: This study is an investigator-initiated single-arm, phase II trial to investigate the efficacy of PIPAC combined with systemic FOLFOX (5-fluorouracil, oxaliplatin, leucovorin) as a first-line treatment for GC PM. The study is conducted in 2 specialized GC treatment centers in Lithuania. It enrolls GC patients with histologically confirmed PM without prior treatment. The treatment protocol consists of PIPAC with cisplatin (10.5 mg/m2 body surface in 150 mL NaCl 0.9%) and doxorubicin (2.1 mg/m2 in 50 mL NaCl 0.9%) followed by 2 cycles of FOLFOX every 6-7 weeks. In total 3 PIPACs and 6 cycles of FOLFOX will be utilized. The primary outcome of the study is the objective response rate (ORR) according to RECIST v. 1.1 criteria (Eisenhauer et al., Eur J Cancer 45:228-47) in a CT scan performed 7 days after the 4th cycle of FOLFOX. Secondary outcomes include ORR after all experimental treatment, PIPAC characteristics, postoperative morbidity, histological and biochemical response, ascites volume, quality of life, overall survival, and toxicity. DISCUSSION: This study aims to assess PIPAC and FOLFOX combination efficacy for previously untreated GC patients with PM. TRIAL REGISTRATION: NCT05644249. Registered on December 9, 2022.

Effect of home-based prehabilitation on postoperative complications after surgery for gastric cancer: randomized clinical trial.

BACKGROUND: Recent studies have demonstrated that prehabilitation improves patients' physical fitness but its impact on postoperative morbidity remains unclear. This study aimed to assess the effect of personalized, multimodal, semisupervised, home-based prehabilitation on postoperative complications after surgery for gastric cancer. METHODS: This RCT was conducted at two centres in Lithuania. Patients (aged at least18 years) with gastric cancer scheduled to undergo elective primary surgery or surgery after neoadjuvant chemotherapy for gastric cancer were randomized (1 : 1) to prehabilitation or standard care. Prehabilitation included exercise interventions focused on endurance, respiratory muscle strength, stretching, and resistance training as well as nutritional and psychological support. The primary outcome was the proportion of patients with postoperative complications within 90 days after surgery. Secondary outcomes included 90-day mortality rate, physical condition, fitness level, nutritional status, quality of life, anxiety and depression level, and proportion of patients completing neoadjuvant chemotherapy. RESULTS: Between February 2020 and September 2022, 128 participants were randomized to prehabilitation (64) or standard care (64), and 122 (prehabilitation 61, control 61) were analysed. The prehabilitation group had increased physical capacity before the operation compared with baseline (mean 6-min walk test change +31 (95 per cent c.i. 14 to 48) m; P = 0.001). The prehabilitation group had a decreased rate of non-compliance with neoadjuvant treatment (risk ratio (RR) 0.20, 95 per cent c.i. 0.20 to 0.56), a 60 per cent reduction in the number of patients with postoperative complications at 90 days after surgery (RR 0.40, 0.24 to 0.66), and improved quality of life compared with the control group. CONCLUSION: Prehabilitation reduced morbidity in patients who underwent gastrectomy for gastric cancer. REGISTRATION NUMBER: NCT04223401 (http://www.clinicaltrials.gov).

Prehabilitation in Modern Colorectal Cancer Surgery: A Comprehensive Review.

Colorectal cancer remains the third most prevalent cancer worldwide, exceeding 1.9 million new cases annually. Surgery continues to be the gold standard treatment option. Unfortunately, colorectal cancer surgery carries significant postoperative morbidity and mortality. Moreover, most rectal cancer patients and some patients with locally advanced colon cancer require preoperative neoadjuvant therapy. It improves long-term outcomes but impairs patients' physical fitness and thus further increases surgical risk. Recently, prehabilitation has gained interest as a novel strategy to reduce treatment-related morbidity for patients undergoing colorectal cancer surgery. However, the concept is still in its infancy, and the role of prehabilitation remains controversial. In this comprehensive review, we sum up present evidence on prehabilitation before colorectal cancer surgery. Available studies are very heterogenous in interventions and investigated outcomes. Nonetheless, all trials show at least some positive effects of prehabilitation on patients' physical, nutritional, or psychological status or even reduced postoperative morbidity. Unfortunately, the optimal prehabilitation program remains undetermined; therefore, this concept cannot be widely implemented. Future studies investigating optimal prehabilitation regimens for patients undergoing surgery for colorectal cancer are necessary.

The Role of Prehabilitation in Modern Esophagogastric Cancer Surgery: A Comprehensive Review.

Esophagogastric cancer is among the most common malignancies worldwide. Surgery with or without neoadjuvant therapy is the only potentially curative treatment option. Although esophagogastric resections remain associated with major surgical trauma and significant postoperative morbidity. Prehabilitation has emerged as a novel strategy to improve clinical outcomes by optimizing physical and psychological status before major surgery through exercise and nutritional and psychological interventions. Current prehabilitation programs may be unimodal, including only one intervention, or multimodal, combining the benefits of different types of interventions. However, it still is an investigational treatment option mostly limited to clinical trials. In this comprehensive review, we summarize the current evidence for the role of prehabilitation in modern esophagogastric cancer surgery. The available studies are very heterogeneous in design, type of interventions, and measured outcomes. Yet, all of them confirm at least some positive effects of prehabilitation in terms of improved physical performance, nutritional status, quality of life, or even reduced postoperative morbidity. However, the optimal interventions for prehabilitation remain unclear; thus, they cannot be standardized and widely adopted. Future studies on multimodal prehabilitation are necessary to develop optimal programs for patients with esophagogastric cancer.

Short and long-term outcomes of elderly patients undergoing left-sided colorectal resection with primary anastomosis for cancer.

BACKGROUND: The proportion of elderly colorectal cancer (CRC) patients requiring surgery is increasing. Colorectal resection for left-sided cancers is the most controversial as the primary anastomosis or end-colostomy and open or minimally invasive approaches are available. Therefore, this study was conducted to investigate the short- and long-term outcomes in elderly patients after resection with primary anastomosis for left-sided CRC. METHODS: The cohort study included left-sided colorectal cancer patients who underwent resection with primary anastomosis. The participants were divided into non-elderly (≤75 years) and elderly (> 75 years) groups. Short- and long-term postoperative outcomes were investigated. RESULTS: In total 738 (82%) and 162 (18%) patients were allocated to non-elderly and elderly groups, respectively. Minimally invasive surgery (MIS) was less prevalent in the elderly (42.6% vs 52.7%, p = 0.024) and a higher proportion of these suffered severe or lethal complications (15.4% vs 9.8%, p = 0.040). MIS decreased the odds for postoperative complications (OR: 0.41; 95% CI: 0.19-0.89, p = 0.038). The rate of anastomotic leakage was similar (8.5% vs 11.7%, p = 0.201), although, in the case of leakage 21.1% of elderly patients died within 90-days after surgery. Overall- and disease-free survival was impaired in the elderly. MIS increased the odds for long-term survival. CONCLUSIONS: Elderly patients suffer more severe complications after resection with primary anastomosis for left-sided CRC. The risk of anastomotic leakage in the elderly and non-elderly is similar, although, leakages in the elderly seem to be associated with a higher 90-day mortality rate. Minimally invasive surgery is associated with decreased morbidity in the elderly.

Current treatment strategies for patients with only peritoneal cytology positive stage IV gastric cancer.

Gastric cancer (GC) is one of the most common malignancies worldwide and surgery remains the only potentially curative treatment option for it. Although a significant proportion of GC patients are found with distant metastases already at the initial diagnosis. Peritoneal dissemination is the most common site of metastases. Positive peritoneal cytology (Cy1) is associated with poor long-term outcomes; thus, these patients are considered as stage IV even if macroscopic carcinomatosis is absent. Currently, there is no clear evidence for the most optimal treatment for this distinct subpopulation of the stage IV cohort. Available strategies vary from palliative chemotherapy to upfront gastrectomy. This comprehensive review summarized current evidence of different treatment strategies for Cy1 GC including roles of surgery, systemic and intraperitoneal chemotherapy.

Gastrectomy impact on the gut microbiome in patients with gastric cancer: A comprehensive review.

Gastric cancer is one of the most common malignancies worldwide and gastrectomy remains the only potentially curative treatment option for this disease. However, the surgery leads to significant physiological and anatomical changes in the gastrointestinal (GI) tract including loss of the gastric barrier, an increase in oxygenation levels in the distal gut, and biliary diversion after gastrectomy. These changes in the GI tract influence the composition of the gut microbiome and thus, host health. Gastrectomy-induced dysbiosis is characterized by increased abundance of typical oral cavity bacteria, an increase in aero-tolerant bacteria (aerobes/facultative anaerobes), and increased abundance of bile acid-transforming bacteria. Furthermore, this dysbiosis is linked to intestinal inflammation, small intestinal bacterial overgrowth, various GI symptoms, and an increased risk of colorectal cancer.

Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial.

The aim of this study was to assess quality of life and bowel function in patients undergoing early vs. standard ileostomy closure. We retrospectively assessed patients from our previous randomized controlled trial. Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other. Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared. Thirty-six months (17-97) after stoma closure, we contacted patients by phone and filled in two questionnaires-The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and low anterior resection syndrome (LARS) score. This index trial was not powered to assess the difference in bowel function between the two groups. All the patients in the SC group had anastomosis <6 cm from the anal verge compared to 42 of 43 (97.7%) in the EC group. There were no statistically significant differences between EC (26 patients) and SC (25 patients) groups in the EORTC QLQ-C30 and LARS questionnaires. Global quality of life was 37.2 (0-91.7; ±24.9) in the EC group vs. 34.3 (0-100; ±16.2) in the SC (p = 0.630). Low anterior resection syndrome was present in 46% of patients in the EC and 56% in the SC group (p = 0.858). Major LARS was found more often in younger patients. However, no statistical significance was found (p = 0.364). The same was found with quality of life (p = 0.219). Age, gender, ileostomy closure timing, neoadjuvant treatment, complications had no effect of worse bowel function or quality of life. There was no difference in quality of life or bowel function in the late postoperative period after the early vs. late closure of ileostomy based on two questionnaires and small sample size. None of our assessed risk factors had a negative effect on bowel function o quality of life.

Histologic Lymph Nodes Regression after Preoperative Chemotherapy as Prognostic Factor in Non-metastatic Advanced Gastric Adenocarcinoma.

Background: The study aims to evaluate the lymph node (LN) response to preoperative chemotherapy and its impact on long-term outcomes in advanced gastric cancer (AGC). Methods: Histological specimens retrieved at gastrectomy from patients who received preoperative chemotherapy were evaluated. LN regression was graded by the adapted tumor regression grading system proposed by Becker. Patients were classified as node-negative (lnNEG) in the case of all negative LN without evidence of previous tumor involvement. Patients with LN metastasis were classified as nodal responders (lnR) in case of a regression score 1a-2 was detected in the LN. Nodal non-responders (lnNR) had a regression score of 3 in all of the metastatic nodes. Survival was compared using Kaplan-Meier and Cox regression analysis. Results: Among 87 patients included in the final analysis 29.9 % were lnNEG, 21.8 % were lnR and 48.3 % were lnNR. Kaplan-Meier curves showed a survival benefit for lnR over lnNR (p=0.03), while the survival of lnR and lnNEG patients was similar. Cox regression confirmed nodal response to be associated with decreased odds for death in univariate (HR: 0.33; 95 % CI 0.11-0.96, p=0.04) and multivariable (HR 0.37; 95 CI% 0.14-0.99, p=0.04) analysis. Conclusions: Histologic regression of LN metastasis after preoperative chemotherapy predicts the increased survival of patients with non-metastatic resectable AGC.

Impact of the Interval Between Neoadjuvant Chemotherapy and Gastrectomy on Short- and Long-Term Outcomes for Patients with Advanced Gastric Cancer.

BACKGROUND: The optimal time between neoadjuvant chemotherapy (NAC) and gastrectomy for gastric cancer (GC) remains unknown. This study aimed to investigate the association between the time-to-surgery (TTS) interval and the major pathologic response (mPR). METHODS: In this study, 280 consecutive GC patients who underwent NAC followed by gastrectomy between 2014 and 2018 were retrospectively analyzed by the use of prospectively collected databases from three major GC treatment centers in Lithuania and Estonia. Based on TTS, they were grouped into three interval categories: the early-surgery group (ESG: ≤ 30 days; n = 70), the standard-surgery group (SSG: 31-43 days; n = 138), and the delayed-surgery group (DSG: ≥ 44 days, n = 72). The primary outcome of the study was the mPR rate. The secondary end points were postoperative morbidity, mortality, oncologic safety (measured as the number of resected lymph nodes and radicality), and long-term outcomes. RESULTS: The mPR rate for the ESG group (32.9%) was significantly higher than for the SSG group (20.3%) or the DSG group (16.7%) (p = 0.047). Furthermore, after adjustment for patient, tumor, and treatment characteristics, the odds for achievement of mPR were twofold higher for the patients undergoing early surgery (odds ratio [OR] 2.09; 95% conflidence interval [CI] 1.01-4.34; p = 0.047). Overall morbidity, severe complications, 30-day mortality, R0 resection, and retrieval of at least 15 lymph nodes rates were similar across the study groups. In addition, the long-term outcomes did not differ between the study groups. CONCLUSIONS: This study suggests that an interval of more than 30 days between the end of NAC and gastrectomy is associated with a higher mPR rate, the same oncologic safety of surgery, and similar morbidity and mortality.

Distal Gastrectomy with Billroth II Reconstruction is Associated with Oralization of Gut Microbiome and Intestinal Inflammation: A Proof-of-Concept Study.

BACKGROUND: Subtotal gastrectomy with Billroth II reconstruction (SGB2) results in increased gastric pH and diminished gastric barrier. Increased gastric pH following PPI therapy has an impact on the gut microbiome, intestinal inflammation, and possibly patient health. If similar changes are present after SGB2, these can be relevant for patient health and long-term outcomes after surgery. The aim of the study is to investigate whether SGB2 is associated with specific changes in gut microbiome composition and intestinal inflammation. PATIENTS AND METHODS: This cross-sectional proof-of-concept study includes patients after SGB2 (n = 14) for early gastric cancer and their nongastrectomized in-house relatives as controls (n = 8). Fecal microbiome composition, intestinal inflammation (fecal calprotectin), gut permeability (DAO, LBP, sCD14), systemic inflammation (CRP) markers, and gastrointestinal symptoms are investigated. This study is registered at ClinicalTrials.gov (NCT03418428). RESULTS: Microbiome oralization following SGB2 was defined by an increase in Escherichia-Shigella, Enterococcus, Streptococcus, and other typical oral cavity bacteria (Veillonella, Oribacterium, and Mogibacterium) abundance. The fecal calprotectin was increased in the SGB2 group [100.9 (52.1; 292) vs. 25.8 (17; 66.5); p = 0.014], and calprotectin levels positively correlated with the abundance of Streptococcus (rs = 0.639; padj = 0.023). Gastrointestinal symptoms in SGB2 patients were associated with distinct taxonomic changes of the gut microbiome. CONCLUSIONS: SGB2 is associated with oralization of the gut microbiome; intestinal inflammation and microbiome changes were associated with gastrointestinal symptoms. These novel findings may open gut microbiome as a new target for therapy to improve quality of life and general patient health in long-term survivors after SGB2.

Intraoperative testing of colorectal anastomosis and the incidence of anastomotic leak: A meta-analysis.

BACKGROUND: AL remains one of the most threatening complications in colorectal surgery. Significant efforts are put to understand the pathophysiological mechanisms involved in the development of leakage and to create the strategies to prevent it. We aimed to determine whether intraoperative testing of mechanical integrity and perfusion of colorectal anastomosis could reduce the incidence of AL. METHODS: A systematic review and meta-analysis of papers published before November 2019 on PubMed, Scopus, Web of Science, and Cochrane Library databases and comparing intraoperative testing of the colorectal anastomosis with standard care were conducted. Odds ratios (ORs) and 95% confidence interval (CIs) were used to assess the association between intraoperative testing and AL. RESULTS: A total of 23 studies totaling 7115 patients were included. Pooled analysis revealed intraoperative tests, for integrity (OR 0.52, 95% CI 0.34-0.82, P < .001) and perfusion (OR 0.40, 95% CI 0.22-0.752, P < .001) of the lower gastrointestinal tract anastomoses are associated with significantly lower AL rate. CONCLUSIONS: Intraoperative testing for either integrity or perfusion of anastomoses both reduce the AL rate. Studies looking at the combination of these two testing methods of anastomosis, especially intraoperative endoscopy, and indocyanine green fluorescence angiography may be very promising to further reduction of the AL.

Risk factors for anastomotic leakage and its impact on long-term survival in left-sided colorectal cancer surgery.

BACKGROUND: Anastomotic leakage (AL) significantly impairs short-term outcomes. The impact on the long-term outcomes remains unclear. This study aimed to identify the risk factors for AL and the impact on long-term survival in patients with left-sided colorectal cancer. METHODS: Nine-hundred patients with left-sided colorectal carcinoma who underwent sigmoid or rectal resection were enrolled in the study. Risk factors for AL after sigmoid or rectal resection were identified, and long-term outcomes of patients with and without AL were compared. RESULTS: AL rates following sigmoid and rectal resection were 5.1% and 10.7%, respectively. Higher ASA score (III-IV; OR = 10.54, p = 0.007) was associated with AL in patients undergoing sigmoid surgery on multivariable analysis. Male sex (OR = 2.40, p = 0.004), CCI score > 5 (OR = 1.72, p = 0.025), and T3/T4 stage tumors (OR = 2.25, p = 0.017) were risk factors for AL after rectal resection on multivariable analysis. AL impaired disease-free and overall survival in patients undergoing sigmoid (p = 0.009 and p = 0.001) and rectal (p = 0.003 and p = 0.014) surgery. CONCLUSION: ASA score of III-IV is an independent risk factor for AL after sigmoid surgery, and male sex, higher CCI score, and advanced T stage are risk factors for AL after rectal surgery. AL impairs the long-term survival in patients undergoing left-sided colorectal surgery.

Personalized trimodal prehabilitation for gastrectomy.

BACKGROUND: Surgery is the only potentially curative treatment for gastric cancer, however, it bears a high postoperative morbidity and mortality rate. A recent randomized control trial proposed prehabilitation to reduce the postoperative morbidity in patients undergoing major abdominal surgery. Currently, there is a lack of evidence of using prehabilitation for patients undergoing gastrectomy for gastric cancer. The aim of our study is to demonstrate that home-based prehabilitation can reduce postoperative morbidity after gastrectomy for gastric cancer. METHODS: PREFOG is a multi-center, open-label randomized control trial comparing 90-days postoperative morbidity rate after gastrectomy for gastric cancer between patients with or without prehabilitation. One-hundred twenty-eight patients will be randomized into an intervention or control group. The intervention arm will receive trimodal home-based prehabilitation including nutritional, psychological and exercise interventions. Secondary outcomes of the study will include physical and nutritional status, anxiety and depression level, quality of life, postoperative mortality rates and full completion of the oncological treatment as determined by the multidisciplinary tumor board. DISCUSSION: PREFOG study will show if home-based trimodal prehabilitation is effective to reduce postoperative morbidity after gastrectomy for gastric cancer. Moreover, this study will allow us to determine whether prehabilitation can improve physical fitness and activity levels, nutritional status and quality of life as well as reducing anxiety and depression levels after gastrectomy for gastric cancer. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223401 (First posted: 10 January 2020).

The problem of colorectal anastomosis safety.

INTRODUCTION: Anastomotic leakage (AL) remains one of the most threatening complications in colorectal surgery with the incidence of up to 20%. The aim of the study is to evaluate the safety and feasibility of novel - trimodal intraoperative colorectal anastomosis testing technique. METHODS AND ANALYSIS: This multi-center prospective cohort pilot study will include patients undergoing colorectal anastomosis formation below 15 cm from the anal verge. Trimodal anastomosis testing will include testing for blood supply by ICG fluorescence trans-abdominally and trans-anally, testing of mechanical integrity of anastomosis by air-leak and methylene blue leak tests and testing for tension. The primary outcome of the study will be AL rate at day 60. The secondary outcomes will include: the frequency of changed location of bowel resection; ileostomy rate; the rate of intraoperative AL; time, taken to perform trimodal anastomosis testing; postoperative morbidity and mortality; quality of life. DISCUSSION: Trimodal testing of colorectal anastomosis may be a novel and comprehensive way to investigate colorectal anastomosis and to reveal insufficient blood supply and integrity defects intraoperatively. Thus, prevention of these two most common causes of AL may lead to decreased rate of leakage. STUDY REGISTRATION: Clinicaltrials.gov (https://clinicaltrials.gov/): NCT03958500, May, 2019.

Early versus standard closure of temporary ileostomy in patients with rectal cancer: A randomized controlled trial.

BACKGROUND AND OBJECTIVES: A significant proportion of patients undergoing rectal cancer surgery receive a temporary ileostomy because of its benefits in case of anastomotic dehiscence. However, the best timing for closure remains unclear. METHODS: Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared in a single-center randomized controlled trial conducted at National Cancer Institute (Vilnius, Lithuania). Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other serious complications were randomized to early or standard ileostomy closure groups. Thirty days postoperative morbidity following ileostomy closure was the primary outcome of the study. RESULTS: The trial was prematurely terminated due to the safety reason after 86 patients were randomized to EC (43 patients) and SC (43 patients) groups. The overall 30 days postoperative morbidity rate was dramatically higher in the EC group (27.9% vs 7.9%; P = 0.024). Moreover, severe complications (Clavien-Dindo ≥3) were present only after EC of ileostomy in five (11.6%) patients. CONCULSION: Early closure of ileostomy at 30 days after radical rectal resection is not safe and should not be performed.