Symptoms and General Pathology

All Conditions

Neoplasms

Digestive System Diseases

Anastomotic Leak

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Postoperative Complications

a machine learning based anastomotic leakage prediction model

Prediction model evaluation

Anastomotic leakage is one of the most serious postoperative complications of low rectal cancer, with an incidence of 3%-21%. The occurrence of anastomotic leakage is related to many factors, and the occurrence of anastomotic leakage can be predicted by building a prediction model. Most of the anastomotic leakage prediction models constructed in the past are nomograms, which have limitations in the fitting of model creation. In the previous study, the center took the lead in building a random forest anastomotic leakage prediction model based on machine learning. This study intends to prospectively enroll patients with rectal cancer undergoing anterior abdominal resection and use their clinical data to prospectively verify the efficacy of the anastomotic leakage prediction model, and further improve and promote the prediction model.

Evaluation of AL Prediction for Rectal Cancer

Evaluation of a Machine Learning Based Anastomotic Leakage Prediction Model After Anterior Resection for Rectal cancer-a Multicenter, Prospective, Randomized Controlled Study

Accuracy of stoma implementation: the number of anastomotic leakage patients with stoma and none anastomotic leakage patients without stoma to the number of total patients.

Changhai Hospital

professor

Colonic Neoplasms

Colonic Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

The IMV will be tie under the pancreas as the usual procedure in left hemicolectomy and ARR

The IMV will be tie under the left colic vein

Low tie of IMV

Giovanni G Laracca, MD

Luigi Masoni, MD

Francesca Foglio, MD

Giorgio Pedretti, MD

This study aim to determine if a different surgical technique could result in a lower anastomotic leak rate. The two techniques are equally used around the world and well described by the international literature but this is the first study that compare the two techniques.

Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. It is the second most common cancer diagnosed in women and third most in men. In women, incidence and mortality are approximately 25% lower than in men. These rates also vary geographically, with the highest rates seen in the most developed countries. With continuing progress in developing countries, the incidence of colorectal cancer worldwide is predicted to increase to 2·5 million new cases in 2035. Stabilising and decreasing trends tend to be seen in highly developed countries only. These have been primarily attributed to nationwide screening programmes and increased uptake of colonoscopy in general, although lifestyle and dietary changes might also contribute. In contrast, a worrying rise in patients presenting with colorectal cancer younger than 50 years has been observed, especially rectal cancer and left-sided colon cancer. Although genetic, lifestyle, obesity, and environmental factors might have some association, the exact reasons for this increase are not completely understood.

The safety of colorectal surgery for oncological disease has dramatically improved over the last 50 years due to a better preoperative preparation, antibiotic prophylaxis, surgical technique, and postoperative management. Since abdomino-perineal resection, new and less aggressive procedures have been developed (e.g., laparoscopic and robotic approach, endoluminal resection), always respecting the concepts of oncologically free margins (R0) and of avoiding the dissemination of cancer cells during surgery. Several years ago, a further step forward in the field of colorectal surgery was the introduction of surgical stapler, which allowed surgeons to perform safer and quicker anastomoses especially during minimally invasive surgery. Moreover, in the last decades there has been a spread of minimal invasive procedures such as the total trans-anal mesorectal excision with an even better clinical outcome for the patients. There has also been the development and spread of robotic devices to aid surgical procedures.

However, complications after colorectal surgery are still inevitable. Their severity is variable ranging from mild with a minimal impact on the patient, to severe and potentially fatal, in case of anastomotic leak (AL). AL is one of the most severe complications for colorectal surgery owing to its negative impact on both short- and long-term outcomes. The incidence reported in the literature has not significantly changed in recent decades despite constant improvements in both stapled and manual sutures, in the pre-operative assessment of the patient, as well as in the surgical technique. The reported incidence is about 2.8-30% as all, of which 75% occurs in rectal anastomosis resulting in a mortality rate of 2-16.4% and in a morbidity rate of 20-35%. Many risk factors have been identified in association with AL, such as low-level anastomosis, male gender, and smoking; however, these factors are all patient-related and not modifiable. Among the other important elements more directly related to the surgeon's experience that can impair anastomotic healing, the most important are undue tension at the level of the anastomosis; technical failure of the stapler; insufficient blood perfusion. It is generally accepted that adequate perfusion is required for anastomotic healing and surgeons usually perform different checks before and after the completion of anastomosis. In fact, poor arterial vascularity is an independent predictor of anastomotic failure after rectal resection with colorectal anastomosis. Currently, there are no data about the role of the venous ischemia in AL. The tie of the inferior mesenteric vein (IMV) under the pancreas, is considered the standard, and it permits to reduce the tension on the anastomosis lengthening the colon segment. Some authors arguing that the high tie of the IMV is responsible for the venous stasis and the venous ischemia responsible for the AL. At present time doesn't exist any study that compare different level of IMV tie and the correlation with AL.

Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial

Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial. LOTHVEIN Study

Anastomotic leak clinically or radiologically evident

San Carlo di Nancy Hospital

patients undergoing ARR with primary anastomosis between November 2016 and December 2020 after centralization of rectal cancer cases

patients undergoing ARR with primary anastomosis between January 2006 and October 2016

In November 2016, the decision to centralize rectal cancer patients to only one surgical unit was taken, with only two surgeons performing the procedures. Furthermore, a close collaboration with local Gastroenterology Units and General Practiotioners was started in order to increase colorectal cancer case referral to our unit. At the same time, we decided to promote the use of laparoscopy and to implement ERAS protocol in our colorectal surgery practice.

Rectal cancer case centralization

Hospital centralization effect is reported to lower complications and mortality especially for high risk and complex general surgery operations, including colorectal surgery. However, no linear relation between volume and outcome has been demonstrated. Aim of the study was to evaluate the increased surgical volume effect on early outcomes of patient undergoing restorative anterior rectal resection (ARR).

Volume-outcome Relationship in Rectal Cancer Surgery

rate of any postoperative leakage of colo-rectal anastomosis clinically, radiologically or endoscopically demonstrated

rate of any surgical site infection clinically demonstrated

Rate of any complication after rectal resection

rate of radiologically demonstrated pneumonia

rate of any ileus clinically demonstrated

Rate of any clinically radiologically or endoscopically demonstrated bleeding after rectal resection

Rate of any unplanned readmission after discharge

number of days between primary rectal resection and discharge

rate of minimally invasive rectal ARR performed

rate of conversion form laparoscopy to one surgery

University of Rome Tor Vergata

MD, PhD, Associate Professor

Investigated interventions comprise conservative, radiological, endoscopic and surgical (including stoma formation) interventions

The efficacy of various interventions for anastomotic leakage after rectal cancer resection are investigated

Frans van Workum, MD

Pieter Tanis, MD, PhD

Hans de Wilt, MD, PhD

The TENTACLE: Rectum study is a multinational retrospective cohort study that includes patients with anastomotic leakage after rectal cancer resection.

The study aims to develop an anastomotic leakage severity score and to evaluate the efficacy of different treatments of anastomotic leakage.

Rationale:

Anastomotic leakage occurs in up to 20% after low anterior resection for rectal cancer. It is a severe complication with high associated morbidity, ICU admission, prolonged hospital stay and need for reinterventions and readmissions. Anastomotic leakage is independently associated with the risk of local recurrence and reduced long term survival. Most literature focusses on incidence and predictive factors. Remarkably, there is almost no data on the efficiency of different treatments of anastomotic leakage after low anterior resection.

Anastomotic leakage after rectal cancer resection is generally underreported, mainly due to subclinical leaks below a diverting stoma. However, up to 50% of the leaks do not heal with fecal diversion alone, especially not in an irradiated field, related to a competent sphincter which hampers adequate drainage of the presacral abscess. Late diagnosis of 'reactivated' leaks after stoma reversal is not an infrequent phenomenon. Chronic sinus, gluteal abscess, and fistula formation have been reported in up to 10%, and permanent stoma rates around 20%, both having significant impact on quality of life.

Examples of factors that may influence the severity and chance of healing of the anastomotic leakage are: timing of diagnosis, degree of systemic inflammatory response, etiology (e.g. ischemia of the afferent loop), degree of dehiscence and retraction, location of the leak (e.g. circular staple line, blind loop), whether or not a diverting stoma is in place, and extent of abdominal contamination. However, little is known about to what extent these and other factors contribute to anastomotic leakage severity and chance of healing. In addition, it is not known which anastomoses are likely to be preserved by which type of treatment, and which anastomotic failures require redo surgery at a certain time frame.

Primary study objectives

1. To investigate which factors contribute to anastomotic leakage severity and to compose an evidence based anastomotic leakage severity score, in which clinically relevant subgroups will be explored (e.g. diversion or not), as well as different clinical settings (e.g. leak diagnosis within or beyond 90 days postoperatively).
2. To evaluate the effects of different treatment approaches on all different pre-specified outcome parameters, stratified for severity score, anatomical characteristics of leakages and timing of diagnosis of leakage.

Study design:

International multicenter retrospective cohort study.

Study population:

Adult patients with anastomotic leakage after low anterior resection for rectal cancer.

Primary outcome parameter:

1-year stoma-free survival.

Secondary outcome parameters:

ICU length of stay, mortality, comprehensive complications index, total number of reinterventions (surgical, radiological, endoscopic) within one year, total number of unplanned readmissions within one year, total hospital stay during one year, total time of having a stoma until one year, stoma present at one year, type of stoma present at one year (diverting, permanent), secondary leakage related complications (extrapelvic abscess, cutaneous fistula, vaginal fistula, bladder fistula, small bowel, ureteric fibrosis with hydronephrosis), hospital related costs.

Sample size calculation:

Inclusion of 980 patients will be sufficient to analyze primary study objective 1 and this is 1246 patients for primary study objective 2. Therefore, the aim is to include at least 1246 patients.

Treatment of Anastomotic Leakage After Rectal Cancer Resection

Treatment of AnastomotiC Leakage After Rectal Cancer Resection. TENTACLE Rectum Study

Planning to share IPD with collaborators if interesting research questions are submitted to the study steering committee.

Specifics will be determined in study meetings in the nearby future.

Readmission to the hospital after discharge

Total number of reinterventions (radiological, surgical, endoscopic)

extrapelvic abscess, cutaneous fistula, vaginal fistula, bladder fistula, small bowel fistula, ureteric fibrosis with hydronefrosis

Costs of hospital/ICU stay and interventions/diagnostics

Survival of the patient and absence of a stoma

Length of stay in the intensive care unit

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of AL Prediction for Rectal Cancer	NCT05610904	Anastomotic Lea...	Prediction mode...	18 Years - 75 Years	Changhai Hospital
Evaluation of AL Prediction for Rectal Cancer	NCT05610904	Anastomotic Lea...	Prediction mode...	18 Years - 75 Years	Changhai Hospital
Evaluation of AL Prediction for Rectal Cancer	NCT05610904	Anastomotic Lea...	Prediction mode...	18 Years - 75 Years	Changhai Hospital
Low Tie Versus High Tie of the Inferior Mesenteric Vein During Colorectal Cancer Surgery: A Randomized Clinical Trial	NCT05411783	Anastomotic Lea... Anastomotic Lea... Anastomotic Lea... Colon Cancer Colon Neoplasm Rectum Cancer Rectum Neoplasm Colorectal Canc...	Low tie of IMV	-	San Carlo di Nancy Hospital
Evaluation of AL Prediction for Rectal Cancer	NCT05610904	Anastomotic Lea...	Prediction mode...	18 Years - 75 Years	Changhai Hospital
Volume-outcome Relationship in Rectal Cancer Surgery	NCT04761536	Rectal Cancer Anastomotic Lea...	Rectal cancer c...	18 Years -	University of Rome Tor Vergata
Volume-outcome Relationship in Rectal Cancer Surgery	NCT04761536	Rectal Cancer Anastomotic Lea...	Rectal cancer c...	18 Years -	University of Rome Tor Vergata
Treatment of Anastomotic Leakage After Rectal Cancer Resection	NCT04127734	Anastomotic Lea... Rectal Cancer	The efficacy of...	18 Years -	Radboud University Medical Center

Spots Global Cancer Trial Database for anastomotic leak rectum