Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

* Patients older than 18 years
* Diagnosis of rectal cancer
* Inferior edge of the tumour not further than 2 cm above the anorectal ring
* Clinical TNM staging T1N0M0

Transanal local excision

Rodrigo Tovar Perez, MD

Carlos Cerdán Santacruz, PhD

Óscar Cano Valderrama, PhD

Francisco Jiménez Escovar, PhD

Blas Flor Lorente, PhD

Javier García Septiem, PhD

Rodrigo Oliva Pérez, PhD

Rectal cancer is one of the most frequent malignant tumors nowadays. There are several possible treatment options including chemotherapy, radiotherapy and surgery. Surgery for early stage rectal cancer can be either a radical surgery (RS) or a local excision (LE).

A radical surgery removes the rectum including the tumor and the lymph nodes through which it spreads, improving survival but with a possible impact in the patients quality of life (QoL). A local excision only removes the tumor and a safety margin of healthy rectum. This has the potential to avoid the possible complications and QoL decrease. However there are some complications after a LE and also poor prognostic factors inherent to the tumor biology that can lead the surgical team to perform a RS after LE with worse outcomes. These are impossible to know before the procedure.

The goal of this registry is to determine the frequency of these poor prognostic biological factors and complications in patients undergoing LE for early rectal cancer.

The main question it aims to answer are:

• How frequently does LE allow for rectum preservation?

Participants will undergo LE for early rectal cancer when it is considered the best treatment by their surgeons according to their expertise and protocols. Patients will follow the standard treatment that would be given to them, and the biological prognostic factors and the appearance of complications will be recorded.

Registry´s main hypothesis:

Exclusive LE is insufficient for in situ rectum preservation in cT1N0M0 extraperitoneal rectal adenocarcinoma in ≥20% of the patients treated with this approach in real everyday´s clinical practice.

A database will be design recording demographics, tumor details, type of intervention, complications, histological details and further necessity of treatments and rectal preservation along time. It will be hosted online through the REDCap system.

Data entry will be done baseline, after surgical procedure, and at different follow-up periods, at 30 postoperative day and at 6, 12, 18, 24 and 36 months after surgical intervention.

Sample size calculation:

Previous evidence states that most patients would be willing to assume a recurrence risk of 20% (IQR 10-35%) in locally advanced rectal cancer after chemo-radiotherapy in order to join the watch and wait strategy for organ preservation. In the project the investigators propose a salvage TME rate of less than 20% at three years to be acceptable. With this approach, accepting a risk α of 0.05 and a risk β of 0.2, a two-tailed test would require a total of 145 patients to identify a difference of 0.1 units. A proportion in the reference group of 0.2 and a loss rate of 5% has been estimated.

Clinical variables

Clinical and demographic data will be collected from each patient, using their computerised clinical history, and a data collection notebook will be prepared.

* Centre code: Each participating centre will receive a unique code that will be the first variable in the database in order to identify the participation of each centre in the study.
* Patient code: Each patient included in each centre will receive a consecutive numerical code to identify the different cases registered in the study.
* Demographic variables: Sex, date of birth, weight (kg), height (cm).
* Comorbidities and cardiovascular risk factors: ASA classification, diabetes mellitus, hypertension, dyslipidaemia, smoking, heart disease, immunosuppression.
* Preoperative laboratory values: haemoglobin (mg/dl), albumin (mg/dl), carcinoembryonic antigen (mg/dl).
* Preoperative clinical staging: Tests performed (MRI, endoanal ultrasound, endoscopic techniques), distance of the tumour to the ano-rectal ridge, distance of the tumour to the external anal margin, tumour size (cranial-caudal axis), percentage of rectal circumference occupation (\<25%, 25-50%, \>50%).
* Operative data: Date of resection, resection approach (endoscopic vs. surgical), transanal resection devices (TEM, TEO, TAMIS, Robot-TAMIS), technique used (local full-wall resection vs. submucosal dissection), intraoperative complications (bleeding, vaginal perforation, tumour perforation/rupture), medical complications).
* Postoperative complications: Clavien-Dindo classification, wound dehiscence, surgical site infection, bleeding.
* Pathological data: pT classification, histological grade, circumferential margins, vascular, lymphatic and perineural infiltration, micron infiltration of submucosa and tumour budding.
* Need to complete treatment: Reason (local resection complication, high risk factors, inadequate surgical margins, piecemeal resection, local recurrence, final pathological staging greater than pT1), radical surgery (dichotomous), technique used (total mesorectal excision, abdominoperineal amputation of rectum), time from local excision to radical surgery (date), stoma preparation (dichotomous), type of stoma (ileostomy vs. Colostomy, temporary vs. definitive), transit reconstruction within the study period (in temporary stomas), adjuvant radiotherapy, adjuvant radio-chemotherapy,
* Follow-up: complications recorded prospectively at 60 days by means of periodic visits to the coloproctology clinic, with the end of follow-up for the patient within the study being the annual check-up. The number of consultations during the first year, recurrence (indicating date and management) and death will be assessed. Oncological follow-up will be carried out with control of tumour markers (CEA), control imaging tests (CAT scan associated with PET/CT in the case of recurrence), and selected biopsies according to the results.

Statistical method:

The data obtained from each patient will be entered into a database and the analysis will be performed with a statistical programme Stata 13.1 (StataCorp, Texas, USA).

A descriptive analysis of demographic and clinical variables will be performed. Categorical variables will be presented as percentages and frequencies. Qualitative variables will be presented as percentages and frequencies. Quantitative variables will be described as mean and standard deviation (SD) if they follow a normal distribution or as median and interquartile range (IQR), in case of skewness.

The association between the variables collected and the target variables of the study will be performed by Pearson's Chi-square test or Fisher's exact test, as appropriate, in the case of categorical variables and, for continuous variables, by Student's t-test for independent samples or Mann-Whitney U-test, respectively, depending on whether or not their distribution conforms to the normal distribution.

Overall survival, disease-free survival, local recurrence-free survival and overall mesorectal resection-free survival will be estimated using the Kaplan-Meier method and the Cox proportional hazards model. Patients lost to follow-up will be censored.

Chronogram and study´s stages:

* March - September, 2023: Study´s protocol design and approval by the promoter center´s local ethics committee. Recruitment period for other participant centers.
* October,- December 2023: Unique registry database design in the REDCap platform.
* January 2024 - December 2024: Recruitment of the necessary cases according to the sample size calculation.
* January - December 2025: 1-year follow-up of patients included in the study.
* January - April 2026: Interim analysis after the first year of oncologic follow-up for assessment of the primary endpoint of the study (organ preservation with exclusive local resection) as well as some of the secondary endpoints.
* December 2027: Follow-up period to complete the study at 3 years.

Ethical and legal aspects:

The investigation will be conducted according to the 2013 Fortaleza´s update of the the Helsinki Declaration, and to each participant´s country law.

Rectal cancer transanal local excision specimen

Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment

Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment (LORENA Trial).

Rate of patients with no need of Total Mesorectal Excision after follow-up

Postoperative complication rate, description, and severity according to Clavien Dindo classification

Describe the rate of margin tumor infiltration

Describe the rate of lymphatic, vascular and perineural invasion, histological grade, mean submucosal invasion depth

Describe the quality of Total Mesorectal Excision specimen in terms of mesorectal fascia integrity

Hospital Alemão Oswaldo Cruz

Hospital Universitario La Fe

Complejo Hospitalario Universitario de Vigo

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

Symptoms and General Pathology

Polyps

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

400 patients with a known rectal tumour that has not demonstrated evidence of cancer to date - may be benign or indeterminate on biopsy or without biopsy performed to date.

Patients in this cohort will undergo examination under anaesthesia as is standard of care. During this examination the pattern of fluorescence seen in NIR camera within the tumour will be observed following administration of ICG (dose 0.25mg/kg) and recorded. Following this, patients will continue with standard of care at the discretion of their surgeon.

The operative video will be uploaded to a secure cloud based system and annotated by the surgeon where further mathematical analysis will be carried out for the purposes of tissue classification.

200 patients with a rectal tumour that has proven previously to contain cancer. Both patients who have and have not undergone neoadjuvant therapy are suitable for inclusion in this group.

Patients in this group will undergo the same processes as the patients in cohort 1.

Alice Moynihan

Ronan Cahill

Cancer of the lowermost part of the intestine (the rectum) is a common disease and both this disease and its treatment can have major impact on patients. Unless treated early, the disease can progress, spread to other parts of the body and ultimately cause death. Treatment often involves radical surgery, but this too has consequences and risks major complications. Best outcomes regarding cure with least impact depend on the disease being detected at an early stage as rectal cancer tends to start first as a non-cancerous polyp.

The smallest of these precursor polyps can be easily removed during a routine colonoscopy but once the polyp grows over 2cm in size it is much harder to categorise correctly as the risk of it containing cancer somewhere in it increases markedly. If there is definitely cancer present in such a polyp it is best treated from the outset as a cancer with major surgery, but if there is definitely not a cancer in it then it can be removed from inside the bowel with minimally invasive techniques. Unfortunately, despite our current very best methods, up to 20% of tumours initially thought to be benign are found to be malignant only after they are excised

We have previously shown that cancerous and non-cancerous tissues can be visually differentiated by analysis of their perfusion during the examination. For this we use a specific approved fluorescent dye, indocyanine green (ICG). ICG is commonly used in bowel surgery anyway to assess the blood supply to the bowel and has a very good safety profile. ICG is injected into the bloodstream during surgery and the rate at which it is taken up by various tissue types is detected by specific and approved cameras which can reveal fluorescence in tissue. We have previously found that the rate of uptake of this dye is different in cancer tissue compared to non-cancer tissue and have used artificial intelligence algorithms to measure this difference. However, we now need to ensure that this method can work also in other patients, in other centres and indeed in other countries to ensure it is indeed a valid and useful way of assessing rectal polyps.

The goal of this observational study is to validate the use of fluorescence pattern analysis in the classification of rectal tumours. Patients enrolled in the study will attend for a visual examination of the rectal tumour in theatre as is standard practice. During this examination a video recording of the fluorescence perfusion will be taken following ICG administration. Patients will then have the tumour excised or treated as is standard of care by their surgeon. The video will later be analysed to determine the pattern of fluorescence perfusion within the tumour, and a classification will be assigned based on the pattern seen. All tumours that are excised are examined under the microscope by a pathologist to determine the final diagnosis. The fluorescence based classification will be compared to this pathological diagnosis to determine the accuracy of the method. So, patients will still have the exact same standard of care as currently happens, the hope is that in future this method can be developed to the point where it could be useful by means of a useable, accurate automated software process. If so, that will form the basis of another study in the future to look to see if it can guide or even replace biopsies and help with ensuring complete removal ('clear margins') after excision.

Rectal polyps \>2cm in size (affecting c. 10,000 patients a year in Europe alone) represent a considerable clinical challenge. While smaller polyps can be addressed by routine endoscopic polypectomy and frank clinical cancer will advance through a traditional cancer surgery paradigm, polyps of this size have the option of being locally excised, intact by transanal endoscopic resection (also referred to as Transanal Minimally Invasive Surgery, TAMIS). This is the treatment of choice in this site due to its ability to provide a single complete unfragmented specimen versus other modalities (e.g. endoscopic submucosal resection). While the technology and training to enable transanal resection has become much more available over the past decade (especially TAMIS) meaning more patients can have large benign lesions and even some early rectal cancers excised in their local specialist centres, the major brake now on such care is patient selection: i.e. how to tell if a given patient has a benign polyp or a cancer in advance of its resection.

Endoscopic biopsies are notoriously inaccurate in up to 20% of such lesions (rectal cancers commence most often as adenomatous lesions and so superficial biopsies may miss a malignant focus). Mistakenly identifying a cancer as a benign lesion and treating it by local excision significantly worsens prognosis and compromises subsequent cancer surgery - including potentially converting a reconstructable site of resection (i.e. a lesion suitable for anterior resection) to an unreconstructable one (i.e. needing an abdominoperineal resection with permanent colostomy) and by seeding cancer cells into a deep margin or different plane, particularly as in the case for anteriorly positioned lesions. Additionally, transanal excision techniques continue to have relatively high rates of positive margins; this risks regrowth in benign lesions and limits effective local therapy for earliest stage cancers due to the presence of inapparent disease close to the main tumour bulk.

We have previously demonstrated, through the use of fluorescent indocyanine green (ICG), that perfusion is visibly different, between tumour and healthy tissue. This difference can be captured via infrared video and mathematical analysis can differentiate the perfusion pattern of malignant areas from any benign/normal tissue also visible in the same endoscopic view. In brief, the saturation of fluorescence in each region of interest (ie tumour or area of normal mucosa), can be measured from the recorded video using existing software developed by IBM. The change in fluorescence over time can be plotted on a curve, demonstrating the inflow, peak and outflow of ICG, which is depending on the perfusion patters within the region of interest. These curves differ depending on the tissue being examined and so can be used to classify benign from malignant tumours through calculating the slope of the uptake and area under the curve to measure outflow. Therefore, in a location (such as the rectum) where a cancer is suspected, analysis of the video can be used to differentiate between healthy and cancerous tissues. This discovery can be made exploited for clinical use by the application of AI methods including computer vision and machine learning. In essence, the fluorescence intensity of pixels displaying tissues of interest varies with blood flow (perfusion), when the blood is dyed with ICG and lit by near-infra-red (NIR) light. The intensity is captured over time, from multiple video frames, and this intensity is plotted as a curve. The intensity curves of tumour tissue are different from those of healthy tissue, and those of benign tumours are different from malignant tumours. Analysis of the curve features for each pixel in a region of interest can thus lead to a classification.

Such an AI system has been prototyped and trained in the Mater Hospital previously with videos from a population of Irish cancer patients from two regional centres, so that it can automatically identify malignant tumours and benign lesions from healthy tissue by their perfusion patterns. This prototype has previously demonstrated accuracy of \>80%.

In this study, we clinically validate the basic concept or method of classifying tissue by its fluorescence signal characteristics while also seeing if a device can be built on the basis of this that can extrapolate the data being generated from the videos by UCD staff. We also address the question of generalisability - can other surgeons use the system and get similar results from their specific patient cohorts? This will pave the way for future studies which are planned to determine the roles of biopsy (can the system enable optimal choice of biopsied tissue, and thus reduce biopsy error?); and tumour resection (can the system increase the completeness and accuracy of tumour resection?).

CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery Study 1

Given the sensitive nature of the data being collected (health data) individual participant data will not be shared, in line with GDPR and as described in the patient information leaflet. However metadata will be made publicly available at the end of the project. A decision regarding the degree of pooled participant data that will be made available to other researchers will be made towards the conclusion of the project.

The primary objective of CLASSICA Study 1 is to validate the concept of tissue characterisation by ICG signal perfusion patterns in a large series of data across multiple centres using mathematical models. Accuracy of this measurement will be determined through calculation of sensitivity and specificity rates of the classification system.

CLASSICA-Web and CLASSICA-OR platforms will be deployed across all five clinical sites. Accessability and usablity of these systems will be assessed through user surveys and analysis of video quality measures.

Institut de recherche Contre Les Cancers de L'appareil Digestif

Stitchting EAES

Pintail LTD

Kobenhavns Universitet

Universita Degli Studi di Torino

Ziekenhuis Oost-Limburg Autonome Verzorginginstelling

Arctur Racunalniski Inzeniring Doo

Stitchting VUMC

Penn State University

Krankenhaus der Barmherzigen Bruder Graz

Horizon Europe

Mater Misericordiae University Hospital

Professor of Surgery

Gland and Hormone Related Diseases

Rare Diseases

Esophageal Neoplasms

Adenocarcinoma

Pancreatic Neoplasms

Colonic Neoplasms

Anastomotic Leak

Colonic Diseases

Head and Neck Neoplasms

Esophageal Diseases

Postoperative Complications

Esophageal Cancer

Pancreatic Cancer

Melissa NN Arron, MD

Richard PG ten Broek, MD PhD

Stefan AW Bouwense, MD PhD

Martijn WJ Stommel, MD PhD

Harry van Goor, MD PhD

The MA-PPING is a multicenter prospective observational study that includes patients undergoing surgery for gastrointestinal cancer.

The study aims to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer during their surgical patient journey from the moment of diagnosis until full recovery (three months after surgery).

Rationale: The gut microbiome is the composition of micro-organisms that reside in the gastrointestinal tract. Under normal circumstances, the microbiome is balanced and has a beneficial effect on gut function. However, when the microbiome is stressed i.e. by an operation, patients' health or medication, the composition of the microbiome may change rapidly and the virulence of its micro-organisms can increase fast. Surgery, in particular gastrointestinal surgery, has a disruptive effect on the mucosal gut barrier and may lead to shifts in microbial composition. Also, the underlying surgical disease itself can be characterized by changes in the microbiome. Gastrointestinal cancer is associated with specified alterations of the microbiome, and the presence of certain microbiota is related with carcinogenesis and lymph node involvement.

Anastomotic leakage is a severe complication after gastrointestinal surgery and several animal studies linked microbial shifts to the development of anastomotic leakage. Only a few, small and explorative, human studies investigated the microbiome during surgery and correlated their findings with the development of postoperative complications. However, the majority of these studies only sampled the microbiome intraoperatively. Surgery-related microbial shifts manifest also in the pre- and postoperative phase, therefore, sampling in these phases is crucial. To further understand the changes of the microbiome composition due to gastrointestinal surgery and the relation with postoperative infectious complications, samples should be collected on several time points; before, during, and after surgery. With this study we aim to map the oral and gut microbiome of patients diagnosed with pancreatic, esophageal or colorectal cancer in a time frame ranging from the work-up for an operation until the postoperative phase to assess the changing composition of the microbiome during a surgical patient journey.

Four types of samples will be collected for microbiome analysis: saliva, feces, intraoperative mucosal swabs and drain fluid.

Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery

Changes of the microbiome composition during the surgical treatment quantified as alpha-diversity by 16S rRNA sequencing. Samples will be collected on 7 moments, starting one month before surgery until three months after surgery.

The effect of neo-adjuvant therapy on microbiome composition quantified as beta-diversity by 16S rRNA sequencing

The effect of (preoperative) antibiotic prophylaxis on microbiome composition quantified as beta-diversity by 16S rRNA sequencing

The effect of preoperative bowel preparation on microbiome composition quantified as beta-diversity by 16S rRNA sequencing

The effect of selective decontamination of the digestive tract (SDD) on microbiome composition quantified as beta-diversity by 16S rRNA sequencing

The effect of infectious complications (such as anastomotic leakage, sepsis, wound infection, pneumonia and urinary tract infection) on microbiome composition quantified as beta-diversity by 16S rRNA sequencing

Radboud University Medical Center

Gastrointestinal Agents

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

Infections

Wounds and Injuries

Carcinoma

Communicable Diseases

Surgical Wound Infection

Surgical Wound

Wound Infection

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Anti-Infective Agents

Anti-Bacterial Agents

Metronidazole

Antibiotics, Antitubercular

Neomycin

Mechanical Bowel Preparation and Oral Antibiotics

Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)

Oral Antibiotics

Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)

Placebo

Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)

Mechanical Bowel Preparation

Laura Koskenvuo, MD, PhD

Anna Lepistö, MD, PhD

Ville Sallinen, MD, PhD

MOBILE2 is a randomized controlled trial comparing mechanical and oral antibiotic bowel preparation to mechanical bowel preparation only in patients undergoing anterior rectal resection with primary anastomosis. Primary endpoint is Comprehensive Complication Index within 30 days from surgery.

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery

Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery - a Prospective, Randomized Controlled Trial

Individual deidentified participant data will not be available for sharing. Study protocol will be available.

Difference in quality of life between baseline and 1 year measured using SF-36

Difference in quality of life between baseline and 1 year measured using QLQ-C30

Difference in quality of life between baseline and 1 year measured using QLQ-CR29

Difference in quality of life between baseline and 1 year measured using LARS

Surgical site infection as defined by CDC

Patients receiving adjuvant therapy divided by patients needing adjuvant therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Local Excision for Organ Preservation in Early REctal Cancer With No Adjuvant Treatment	NCT05927584	Rectal Cancer Rectum Neoplasm	Transanal local...	18 Years -	Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
CLASSICA: Validating AI in Classifying Cancer in Real-Time Surgery Study 1	NCT05793554	Rectum Neoplasm Rectum Polyp Rectal Cancer		18 Years -	Mater Misericordiae University Hospital
Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery	NCT04189393	Gastrointestina... Colorectal Canc... Pancreatic Canc... Esophageal Canc... Rectum Neoplasm Esophageal Neop... Pancreatic Duct... Colonic Neoplas... Gastrointestina... Microbiota Anastomotic Lea...		18 Years -	Radboud University Medical Center
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
Microbiome Analysis in esoPhageal, PancreatIc and Colorectal CaNcer Patients Undergoing Gastrointestinal Surgery	NCT04189393	Gastrointestina... Colorectal Canc... Pancreatic Canc... Esophageal Canc... Rectum Neoplasm Esophageal Neop... Pancreatic Duct... Colonic Neoplas... Gastrointestina... Microbiota Anastomotic Lea...		18 Years -	Radboud University Medical Center
Mechanical Bowel Preparation and Oral Antibiotics Versus Mechanical Bowel Preparation Only Prior Rectal Surgery	NCT04281667	Rectal Adenocar... Rectum Neoplasm Rectum Carcinom... Colorectal Canc... Colorectal Neop... Colorectal Carc... Surgical Site I... Surgery--Compli...	Oral Antibiotic... Placebo Mechanical Bowe...	18 Years -	Helsinki University Central Hospital

Spots Global Cancer Trial Database for rectum neoplasm