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Intestinal Diseases

Rectal Diseases

All patients admitted with colorectal cancer were subjected to various types of colorectal resections

Colorectal resections

Nisar A Chowdri

Due to COVID 19 (Corona virus disease)pandemic, majority of surgeries, including surgery for cancer patients got delayed across the globe. Surgeries were limited to emergency set up only. At our institute we tried to perform colorectal cancer surgeries through out the pandemic, albeit in less numbers, as we thought cancer in itself is an emergency setting. we are planning to analyse the prospectively managed database of this particular group of patients over a period of last six 6 months and look out at 30 day post operative morbidity and mortality. Besides we will try to analyse the implications of our decision to carry on with cancer surgeries in terms of number of health care workers who got infected while being involved in primary care of these patients.

INTRODUCTION Health systems all across the globe have been under tremendous stress due to COVID 19 pandemic. Based on information suggesting that India was faring better compared to the west \[1\] and that oncology patients were likely to get deferred care with significant implications \[2\], the department of general surgery (colorectal division) took a conscious decision to continue offering elective cancer surgeries albeit in less numbers.in this study we will try to collect 30 day post operative outcome data of elective colorectal cancer resections at our department and discuss the implications of our decision.

Such reports are still sparsely reported from Covid hotspots around the world.

Methods:

We will analyze the prospective database of the department of colorectal surgery at Sheri Kashmir Institute of Medical Sciences, Srinagar, a tertiary referral centre and a high volume centre for colorectal cancer surgeries ( with more than 300 colorectal cancer surgeries performed every year) in North India wef 23rd March to 22nd September 2020 (6 months).and report outcomes of all elective colorectal cancer surgeries. Each patient will be followed up for 30 days, thereby last follow up will end on 22nd October 2020.

All colorectal cancer patients subjected to elective and emergency surgeries during COVID 19 pandemic will be included. Patients who were positive for SARS CoV2 (Severe acute respiratory syndrome coronavirus 2) infection and underwent surgery for colorectal cancer will be excluded.

The data will be statistically analysed using Statistical Product and Statistical Solutions(SPSS) sotware v 23. All categorical variables will be shown in the form of frequency and percentage. Continuous variables will further be analysed by independent t test and using multivariate analysis.

Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy

patients who died within 30 days following their surgery

post operative complications will be graded as per clavien dindo grading system

determine whether any health care worker involved with the care of this cohort of patients got infected with SARS CoV 2.

Determine whether any patient from the cohort got infected with SARS CoV 2 during their hospital stay or immediately after discharge

Sheri Kashmir Institute of Medical Sciences

Senior Resident

Anastomotic Leak

Postoperative Complications

Marco Catarci, MD FACS

Augusto Verzelli, MD

Nancy Cianforlini, MD

Roberto Campagnacci, MD

Angela Maurizi, MD

Paolo Millo, MD

Elisa Ponte, MD

Gianluca Guercioni, MD

Paolo Ciano, MD

Walter Siquini, MD

Francesco Luparini, MD

Stefano Guadagni, MD

Marco Clementi, MD

Francesco Crafa, MD

Adele Noviello, MD

Gian Luca Baiocchi, MD

Sarah Molfino, MD

Nereo Vettoretto, MD

Emanuele Botteri, MD

FELICE BORGHI

DESIREE' CIANFLOCCA, MD

Gabriele Anania, MD

Serena Rubino, MD

Matteo Scaramuzzi, MD

Matteo Tardio, MD

Marco Scatizzi, MD

Alessandro Falsetto, MD

Lorenzo Pandolfini, MD

STEFANO SCABINI, MD

ANTONIO MARTINO

Giuseppe Brisinda, MD

Maria M Chiarello, MD

Massimo G Viola, MD

Amedeo Altamura, MD

Gianandrea Baldazzi, MD

Diletta Cassini, MD

Lucio Taglietti, MD

Silvia Ruggiero, MD

Massimo Basti, MD

Valerio Caracino, MD

Graziano Ceccarelli, MD

Walter Bugiantella, MD

Alberto Patriti, MD

Valerio Sisti, MD

Gianluca Di Mauro, MD

Agata Ardizzone, MD

Andrea Liverani, MD

Tatiana Di Cesare, MD

Graziano Longo, MD

Federico Tomassini, MD

Pierluigi Marini, MD

Graziella Attinà, MD

Stefano Mancini, MD

Carla Di Cosimo, MD

Marco Caricato, MD

Gabriella T Capolupo, MD

Giuseppe S Sica, MD

Claudio Arcudi, MD

Andrea Lucchi, MD

Giacomo Martorelli, MD

Gianluca Garulli, MD

Basilio Pirrera, MD

Stefano Berti, MD

Andrea Gennai, MD

Alessandro Carrara, MD

Michele Motter, MD

Giuseppe Tirone, MD

Alberto Di Leo, MD

Jacopo Adreucetti, MD

Andrea Muratore, MD

Patrizia Marsanic, MD

Maurizio Pavanello, MD

Carlo Di Marco, MD

GIACOMO RUFFO, MD

ELISA BERTOCCHI, MD

Daniele Zigiotto, MD

Corrado Pedrazzani, MD

Giulia Turri, MD

Raffaele Macarone Palmieri, MD

Pietro Amodio, MD

PAOLO DEL RIO, MD

UGO PACE, MD

Felice Pirozzi, MD

Antonio Sciuto, MD

Prospective observational multicenter study on the influence of adherence to enhanced recovery pathways on early outcomes (anastomotic leakage, morbidity, mortality, readmission, reoperation rates and length of postoperative stay) after elective colorectal surgery in Italy.

BACKGROUND

Anastomotic leakage (AL) is a dreaded major complication after colorectal surgery. The overall incidence of anastomotic dehiscence and subsequent leaks is 2 to 7 percent when performed by experienced surgeons. The lowest leak rates are found with ileocolic anastomoses (1 to 3 percent) and the highest occur with coloanal anastomosis (10 to 20 percent). Leaks usually become apparent between five and seven days postoperatively. Almost half of all leaks occur after the patient has been discharged, and up to 12 percent occur after postoperative day (POD) 30. Late leaks often present insidiously with low-grade fever, prolonged ileus, and nonspecific symptoms attributable to other postoperative infectious complications. Small, contained leaks present later in the clinical course and may be difficult to distinguish from postoperative abscesses by radiologic imaging, making the diagnosis uncertain and underreported.

There is no uniform definition of an anastomotic dehiscence and leak. In a review of 97 studies, as an example, 56 different definitions of an anastomotic leak were used. The majority of reports define an anastomotic leak using clinical signs, radiographic findings, and intraoperative findings. The clinical signs include: Pain, Fever, Tachycardia, Peritonitis, Feculent drainage, Purulent drainage. The radiographic signs include: Fluid collections, Gas containing collections. The intraoperative findings include: Gross enteric spillage, Anastomotic disruption.

Risk factors for a dehiscence and leak are classified according to the site of the anastomosis (extraperitoneal or intraperitoneal). A prospective review of 1598 patients undergoing 1639 anastomotic procedures for benign or malignant colorectal disease found a significantly increased risk of anastomotic leak with extraperitoneal compared with intraperitoneal anastomoses (6.6 versus 1.5 percent; 2.4 percent overall).

Major risk factors for an extraperitoneal AL include: The distance of the anastomosis from the anal verge (Patients with a low anterior resection and an anastomosis within 5 cm from the anal verge are the highest risk group for an anastomotic leak), Anastomotic ischemia, Male gender, Obesity.

Major risk factors for an intraperitoneal AL include: American Society of Anesthesiologists (ASA) score Grade III to V, Emergent surgery, Prolonged operative time, Hand-sewn ileocolic anastomosis.

Controversial, inconclusive, or pertinent negative associations between the following variables and AL have been reported: Neoadjuvant radiation therapy, Drains, Protective stoma, Hand-sewn colorectal anastomosis, Laparoscopic procedure, Mechanical bowel preparation, Nutritional status, Perioperative corticosteroids.

Enhanced Recovery After Surgery (ERAS) programs for colorectal surgery have been extensively studied during the last 20 years. It is now clear that they offer a consistent reduction of overall morbidity rates, postoperative length of stay and costs, and that there is a clear dose-effect relation between adherence to at least 60-70% of the program items and these outcomes. On the other hand, little is known concerning the potential benefit of ERAS programs over AL rates or if adherence to specific items of the program may reduce AL rates.

Therefore, the investigators planned this study to prospectively evaluate AL rates after colorectal resections and their interaction with known risk factors and ERAS program items.

METHODS

Prospective enrollment from January to December 2019 in 41 Italian surgical centers. All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after having provided a written informed consent. A total of 1,750 patients is expected based on a mean of 43 cases/year per center.

Outcome measures

1. Preoperative risk factors of anastomotic leakage (age, gender, obesity, nutritional status, diabetes, cardiovascular disease, chronic liver disease, renal failure, inflammatory bowel disease, perioperative steroid therapy, ASA class I-II vs III)
2. Operative parameters (approach, procedure, anastomotic technique, length of operation, disease stage)
3. ERAS program items (prehabilitation, counseling, nutritional evaluation, immuno-nutrition, deep venous thrombosis prophylaxis, antibiotic prophylaxis, bowel preparation, preoperative carbohydrates load, standardized anesthesia protocol, restrictive i.v. fluid administration, control of body temperature, nausea and vomit prophylaxis, multimodal approach to opioid-sparing pain control, restrictive use of surgical drains, laparoscopic surgery, removal of nasogastric tubes before reversal of anesthesia, early removal of urinary catheter, early mobilization, early oral intake of fluids and solids, use of chewing gums and laxatives, intake of protein-rich nutritional supplements, prepare for early discharge, audit).

Endpoints

1. Anastomotic leakage rate
2. Minor and major complications
3. Length of postoperative hospital stay
4. Readmission and reoperation rates Recorded data and follow-up Potential patient-specific and intraoperative risk factors will be recorded: gender, body mass index, nutritional status according to the Mini Nutritional Assessment short-form, surgical indication (cancer, polyps, chronic inflammatory bowel disease, diverticular disease), preoperative albuminemia, use of steroids, renal failure and dialysis, cardiovascular or respiratory disease, American Society of Anesthesia class, bowel preparation (decision made by operating surgeon), laparoscopy or laparotomy, level of anastomosis and technique (mechanical or hand-sewn, intra- or extra-corporeal), operative time, presence of drainage, and perioperative blood transfusion(s). During the postoperative period, patients will be examined by the attending surgeon daily. Fever (central temperature \> 38 °C), pulse, abdominal signs, bowel movements, volume and aspect of drainage (if present) will be recorded daily. The attending surgeon will make any decision for complementary exams and imaging according to his own criteria. The rate of any complication will be calculated and graded including all leaks (independently of clinical significance), wound infection (according to the definitions of the Centers for Disease Control and Prevention and wound culture), pneumonia (clinical symptoms, and physical and radiological examinations), central line infection (positive blood culture), urinary tract infection (positive urine culture with bacterial count ). Patients will be followed-up in the outpatient clinic up to 6 weeks after discharge from the hospital.

Main endpoint is anastomotic dehiscence (intended as any deviation from the planned postoperative course related to the anastomosis, or presence of pus or enteric contents within the drains, presence of abdominal or pelvic collection in the area of the anastomosis on postoperative CT scan, performed at the discretion of the attending surgeon, leakage of contrast through the anastomosis during enema or evident anastomotic dehiscence at reoperation for postoperative peritonitis). Thus, all detected leaks will be considered independently of clinical significance. No imaging will be performed routinely in order to search for leakage.

Secondary endpoints are morbidity and mortality rates, postoperative length of stay, readmission and reoperation rates.

After anonymization, all data of each single case will be prospectively uploaded by every local investigator on a protected web-based database. Thereafter, all data will be incorporated into a spreadsheet (MS Excel) for data analysis, checking for any discrepancy, that will be addressed and solved through strict cooperation between chief investigator, data manager and participating center.

Statistical Analysis Quantitative values will be expressed as mean ± standard deviation, median and range; categorical data with percentage frequencies. Mean values of duration of stay will be compared according to the presence or absence of fistulas using Student's two-sided t test (allowing for heterogeneity of variances) or with a non-parametric Mann-Whitney test. Both univariate analysis and multivariate analysis will be performed to assess risk factors for leakage and overall complications. The odds ratio (OR) will be presented followed by its 95% confidence interval (95% CI). For all statistical tests the significant level is fixed at p \< .05.

Statistical analyses will be carried out using STATA software (Stata Corp. College Station, Texas, USA).

Sample size Considering that adherence to 70% of the items of an ERAS program determines a significant reduction in surgical complications after colorectal surgery, an estimation of the OR for AL and ERAS program adherence at 70% of the items is equal to 0.55 (95% c.i. 0.36-0.87); assuming a maximum error equal to 0.04, the required sample size is n=1,748 (about 874 cases per arm expected in low vs high adherence to ERAS programs).

Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery

Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery: the Italian ColoRectal Anastomotic Leakage Study Group (iCral 2)

Rate of any complication related to the anastomosis after colorectal resection

Rate of any complication after colorectal resection

Rate of any death after colorectal resection

Rate of any unplanned readmission after discharge

number of days between primary colorectal resection and discharge

Ospedale C & G Mazzoni

Director, General Surgery Unit

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Diverticulitis

Colonic Polyps

Polyps

Inflammatory Bowel Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid

Hextend

Lactated Ringers

Anthony Senagore, MD

The purpose of this study is to find out if guided fluid administration with the esophageal monitor is superior to standard fluid administration and whether use of the hetastarch or lactated ringers offers different benefits with respect to length of stay in the hospital after hand-assisted colorectal surgery.

An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy

A Randomized Prospective Double Blind Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care Versus Either Colloid and Crystalloid

Deltex Medical, Inc.

Spectrum Health Hospitals

Dr. Anthony Senagore

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Outcomes of Elective Colorectal Cancer Surgery During COVID 19 Pandemic: Implications for Cancer Care Policy	NCT04588909	Colo-rectal Can...	Colorectal rese...	-	Sheri Kashmir Institute of Medical Sciences
Anastomotic Leakage and Enhanced Recovery Pathways After Colorectal Surgery	NCT03771456	Colorectal Neop... Anastomotic Lea... Surgery--Compli...	Colorectal rese...	-	Ospedale C & G Mazzoni
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy	NCT00467922	Crohn's Disease Ulcerative Coli... Rectal Cancer Colon Cancer Colon Polyps Rectal Polyps Diverticulitis	Hextend Lactated Ringer...	18 Years - 80 Years	Spectrum Health Hospitals
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy	NCT00467922	Crohn's Disease Ulcerative Coli... Rectal Cancer Colon Cancer Colon Polyps Rectal Polyps Diverticulitis	Hextend Lactated Ringer...	18 Years - 80 Years	Spectrum Health Hospitals

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