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Adult Patients who underwent a laparoscopic or open colorectal resection with the creation of an anastomosis using the ColonRing™ in routine clinical practice

Creation of a circular Compression Anastomosis

ColonRing™

Eran Choman, Msc

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing™ device in routine clinical practice at a single center. The data will assist in further evaluating the performance of the ColonRing™ device in regards to the creation of a colorectal anastomosis.

Hypothesis:The performance of the ColonRing™, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.

Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis

a RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing ™

The primary study outcome is the rate of anastomotic leakage. Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.

The following complications will be examined for relation to the device:

Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess).

Readmission, re-operation, death within two months of the procedure. Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)

novoGI

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Gastrointestinal Agents

Herbal and Botanical

Ethanol

Anesthetics

Anti-Bacterial Agents

Laxatives

Cathartics

Cola

Patients undergoing elective colorectal surgical resection for benign/malignant disease.

A multidisciplinary validated approach based on 24 items including Preadmission information, education and counselling Preoperative optimization (increasing exercise, stop smoking and alcohol consumption should 4 weeks before surgery) No preoperative bowel preparation Use of preoperative carbohydrate drinks Pre-anesthetic medication Prophylaxis against thromboembolism Antimicrobial prophylaxis and skin preparation Standard anesthetic protocol for rapid awakening PONV Mini-invasive surgery No nasogastric dreinage Prevention of intraoperative hypothermia Perioperative fluid management No drains in the peritoneal cavity after colonic anastomosis Early remouval of urinary drainage (24-48 hrs) Prevention of postoperative ileus (including use of postoperative laxatives) Postoperative analgesia Perioperative nutritional care Postoperative control of glucose Early mobilization Auditing

Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number of items which have been demonstrated to reduce morbidity rates, hospital stay and to implement functional recovery comparing standard approach. Accordingly, ERAS society developed a Guidelines for a number of procedures, including colorectal.

The aim of this study is to evaluate the adherence over the last years to these protocols in eight Department of Surgery in Rome in a series of colorectal cancer patients.

Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.

Background. The acronym ERAS (Enhanced Recovery After Surgery) refers to a patient-centered, evidence-based multi-disciplinary protocol designed to implement perioperative operation, reduce surgical trauma, and facilitate recovery of physiological functions aiming to an early hospital discharge.

Usually ERAS protocols give a continuum of care starting at home (pre-hospital/pre-admission phase) to continue in followed by the pre-/ intra-/ and post-operative phases.

ERAS includes a wide range of disciplines and specialists, which focus on the needs of the patient in order to improve support by facilitating his return home.

The first author to introduce the fast-track term in rectal surgery was Prof. Henrik Kehlet in the mid-1990s, proposing a multi-modal rehabilitation program aimed to reduce post-surgical stress response, morbidity, mortality and postoperative hospitalization. Since then, a number of studies were conducted leading to the first ERAS protocol; since then, these protocols were reviewed on a regular basis, the last time in 2017 and included in the guidelines by the ERAS society (http://www.erassociety.org).

Currently, it is widely demonstrated that, comparing to a traditional approach, ERAS is associated with a significant reduction in morbidity, days of hospitalization, mortality, implementing early postoperative recovery with a consequent reduction of the costs, without compromising patient safety.

In particular, ERAS for colorectal surgery, includes 24 demonstrated multi-disciplinary.

Aims. the investigators aim to evaluate the adherence to the individual items and the short-term outcomes (postoperative hospitalization, complication rates within 30 days of intervention, re-intervention) in a consecutive series of patients undergoing colorectal resection, in eight centers in the Lazio region, treated according to the ERAS protocol.

Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.

Design. This is a no-profit, spontaneous, observational, non-intervention Audit collecting data in eight surgical Departments based in Lazio region, since September 2014 to October 2017. Each participating center will be depositary of its own data.

Participating Centers.

1. UOC General Surgery 1, Fondazione Policlinico Universitario "A. Gemelli ", Rome (Coordinator) -
2. Department of Surgery, S. Eugenio Hospital, Rome
3. UOD Week-Day Surgery, St. Andrea Hospital, Rome
4. UOC General Surgery, Polyclinic University Bio-Medical Campus, Rome
5. UO General and Urgent Surgery, Policlinico Casilino Hospital, Rome
6. UOC Surgery, San Paolo Hospital, Civitavechia (RM)
7. UOC General Surgery, Cristo Re Hospital, Rome
8. UOSD Robotic Surgery for General Surgery, San Giovanni-Addolorata Hospital, Rome

Data Collection. Each center will collect the data in a homogeneous Database. The data will be collected in anonymous form and will be aimed at the definition of:

1. Duration of postoperative stay
2. Short-term morbidity rate (within 30 days) according to Clavien-Dindo classification
3. Re-intervention rate (within 30 days)
4. Hospital readmission (within 30 days)

f. Adherence rate to items of the series All data will be treated sensibly; each patient will be recorded with a sequential center-specific code. For all new patients and for patients seen in follow-up visits, the specific informed consent of the study will be compiled.

Statistical analysis. Categorical variables will be presented as rate and percentages, the continuous variables as mean, median, and standard deviation.

A logistic regression will also be performed, computing items as co-variates, with the end-point of post-operative morbidity and hospital stay.

Sample Size Calculation: 1000 patients, calculated on the basis of the annual case of each participating center.

For the conduct and management of this observational study no additional cost will be charged on NHS funds.

ERAS Lazio Network Clinical Registry

No individual participant data will be shared

Number of items included in the ERAS protocols that were applied in each centre

Multivariate analysis to relate ERAS items to morbidity or a longer hospital stay (\>mean values)

Azienda Ospedaliera "Sant'Andrea"

Policlinico Casilino ASL RMB

San Giovanni Addolorata Hospital

Campus Bio-Medico University

Ospedale San Paolo Civitavecchia

Ospedale Cristo Re - Roma

S.Eugenio Hospital

Roberto Persiani

Principal Investigator

The ColonRing device is intended to be used for the creation of intestinal anastomoses in colorectal surgery in both open and laparoscopic surgeries. This indication is within the currently cleared indication of the ColonRing device, which has been cleared by the US FDA and carries the CE Mark for use throughout the alimentary trct for the creation of circular end-to-end, side-to-end or side-to-side anastomosis.

Dr. Matthew Albert, MD

Leslee Cunnion

Dr. Domingo E. Galliano Jr., MD

Kathleen Lueck

Dr. Domingo E. Galiano Jr., MD

Dr. Jose Dominguez, MD

Kami Oster

The proposed study is a post marketing, observational, retrospective data collection intended to gather and record data on patients treated with the ColonRing device in routine clinical practice at 4-6 centers. The data will assist in future evaluating the performance of the ColonRing device in regards to the creation of a colorectal anastomosis in Low Anterior Resection procedures.

Hypothesis: The performance of the ColonRing, determined by the rate of complications, will be within the acceptable range reported in the literature for alternative treatment modalities.

A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing

Multi Center, Observational, Retrospective Data Collection of Patients Treated With the ColonRing in Routine Clinical Practice. This Study to Continue RETROPRESS Study ID NCT01301417

Anastomotic leakage is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to a communication between the intra and extra luminal compartments.

The Following complications will be examined:

Bleeding. Stricture (either clinical evidence of a stricture or the inability to pass a 12 mm sigmoidoscope through the anastomosis in a procedure that does not include a diversion). Septic complication (including wound infection, pelvic infection, peritonitis, abscess) Readmission, re-operation, death within two months of the procedure Extra colonic complications (including urinary infection, urinary retention, DVT, pneumonitis, pulmonary embolism, cardiac, injury to other organs - e.g. spleen, ureter)

The following post operative measures will be reported:

Hospitalization duration (two dates will be recorded: ready for discharge and discharge). The latter noting where the patient was discharged to - e.g. nursing home or home. First day to first postoperative flatus. First day to first postoperative bowel movements. First day of first postoperative toleration of liquids and solids (time to "keeping them down")

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis	NCT01301417	Diverticulum, C... Colorectal Neop... Crohn Disease Colitis, Ulcera... Colostomy Ileostomy - Sto... Rectal Prolapse Intestinal Poly... Lymphoma Endometriosis Intestinal Volv...	ColonRing™	18 Years -	novoGI
ERAS Lazio Network Clinical Registry	NCT03353311	Colon Cancer Diverticulum, C...		-	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
ERAS Lazio Network Clinical Registry	NCT03353311	Colon Cancer Diverticulum, C...		-	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Data Collection of Patients Treated With the ColonRing™ for the Creation of Circular Compression Anastomosis	NCT01301417	Diverticulum, C... Colorectal Neop... Crohn Disease Colitis, Ulcera... Colostomy Ileostomy - Sto... Rectal Prolapse Intestinal Poly... Lymphoma Endometriosis Intestinal Volv...	ColonRing™	18 Years -	novoGI
A RETROspective Data Collection of comPRESSion Anastomosis Using the ColonRing	NCT01880918	Diverticulum, C... Colorectal Neop... Crohn Disease Colitis, Ulcera... Colostomy Ileostomy - Sto... Rectal Prolapse Intestinal Poly... Lymphoma Endometriosis Intestinal Volv...		18 Years -	novoGI

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