Symptoms and General Pathology

All Conditions

Anastomotic Leak

Postoperative Complications

Herbal and Botanical

All Drugs and Chemicals

Cola

Patients who can be treated with either PME or TME and receive a primary anastomosis during surgery.

Quantitative analyse of ICG around the proximal/oral part of the anastomosis pre-formation of the primary anasomosis

Quantitative Indocyanine Green Fluorescence Angiography

Carolin Oppermann, MD

Niclas Dohrn, MD

Ismail Gögenur, DMSc, MD

Mads Falk Klein, PhD, MD

Fluorescence angiography with indocyanine green (ICG-FA) has gained increased popularity in colorectal surgery to check perfusion to the newly-formed anastomotic area and decrease the rate of postoperative anastomotic leakage.

While qualitative ICG assessment has the advantage to be used instantly during the operative procedure, it does bear drawbacks (subjective assessment, dependent on factors like camera distance, ICG dose and white-light contamination).

The alternative is quantitative ICG assessment, which is performed by evaluating the time-intensity curve of the ICG-FA with an external analyzing software. The procedure is showing promising results, but the methodology is still reported very heterogeneously.

This study is a multi-center, prospective, standardized, surgeon-blinded observational trial. The key aspect of this study is the non-interventional design with blinding of both the qualitative and quantitative results from the ICG perfusion measurement, providing no chance of influencing the course of the operation. Assessment of perfusion will be performed postoperatively blinded to the outcome. Assessment of the pre-anastomotic area is intraoperatively performed by an image analysis software that then calculates a perfusion score based on an algorithm integrating relevant perfusion metrics. The primary outcome is the combined rate of early and late anastomotic complications within 90 days postoperatively.

Quantitative ICG Fluorescence Angiography in Colorectal Surgery

Quantitative ICG Fluorescence Angiography in Colorectal Surgery (QUANTICO): A Protocol for a Prospective, Standardized, Observational, Surgeon-blinded Multi-center Trial

combined rate of all anastomotic complications

obstipation and intolerance of oral intake due to nonmechanical factors that disrupt the normal coordinated propulsive motor activity of the gastrointestinal tract following abdominal surgery

surgical complication in which a wound ruptures along a surgical incision

Number of patients had have to be readmitted to the hospital due to postoperative complications

Continuous ECG-monitoring intraoperatively and postoperatively

Perfusion Tech Aps

Zealand University Hospital

Medical Doctor, PhD student

Digestive System Diseases

Emergencies

Diverticulitis

Intestinal Perforation

Diverticulum

Diverticular Diseases

Gastroenteritis

Gastrointestinal Diseases

Primary anastomosis refers to a colonic resection with primary anastomosis and covering ileostomy, followed by a stoma reversal operation.

Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation.

Hartmann's operation

Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.

Primary anastomosis

Stefan Breitenstein, MD

The purpose of this multi-center randomized trial is to identify any differences in the complication rates of patients undergoing Hartmann's (end colostomy) versus Primary Anastomosis (with defunctioning ileostomy) for left-sided colonic performation (including the stoma reversal operation).

Hartmann's operation: the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy.

End colostomy: A stoma is created from one end of the bowel while the other portion of the bowel is either removed or sewn shut (Hartmann's pouch).

The second operation (reversal) requires a colo-rectal anastomosis.

Primary anastomosis: colonic resection with primary anastomosis and defunctioning ileostomy. The second operation (stoma reversal) requires an entero-enteral anastomosis.

Anastomosis: is to join together two bowel ends to restore continuity after resection or stoma formation.

Colostomy: is a reversible surgical procedure in which a stoma is formed by drawing the healthy end of the colon through an incision in the anterior abdominal wall and suturing it into place. This opening, in conjunction with the attached stoma appliance, provides an alternative channel for feces to leave the body.

Ileostomy is a surgical opening constructed by bringing the loop of small intestine (the ileum) out onto the surface of the skin.

Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation

Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation - A Prospective Randomized Multicenter Trial

The Clavien-Dindo Classification of Surgical Complications:

Grade I: Any deviation from the normal postoperative course without the need for treatment. Grade II: Requiring pharmacological treatment with drugs. Grade III: Requiring surgical, endoscopic or radiological intervention. Grade IV: Life-threatening complication requiring IC/ICU-management. Grade V: Death of a patient

Primary operation: the one the patients were randomized to, either Hartmann's or Primary anastomosis

Reversal operation is the one of either the colostomy (Hartmann's) or the ileostomy (Primary anastomosis)

Sum of the number of different complications

Primary operation is the one patients were randomized into.

Reversal rate is the proportion of patients having their stoma reversed (second operation)

Duration of the primary procedure, the reversal procedure, and overall (minutes)

Cost of the primary operation, the reversal, and combined, in US dollars.

Kantonsspital Winterthur KSW

University of Lausanne

Kantonsspital Graubünden

University of Zurich

Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Colonic Diseases

Intestinal Diseases

primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure")

staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS)

primary tumor resection

Alessio Giordano

Sfogli Anna

CROSCO-1 study is a national, multi-center, prospective observational study presenting patients to the emergency departments of the participating centers with obstructive left colon cancer (in the absence of metastases and peritoneal carcinomatosis) undergoing primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or without a primary anastomosis ("Hartmann's procedure") or staged resection after endoscopic stenting with Self-expandable Metallic Stent (SEMS).

The main questions it aims to answer are:

* the Stoma rate at 1 year after tumor resection
* the 30-day and 90-day major morbidity and mortality
* 1-year quality of life (EQ-5D-5L test)
* Timing of chemotherapy initiation and type of chemotherapy regimen. Participants will have an obstructive left colon cancer localized (no peritoneal carcinosis or distant metastasis).

Researchers will compare: primary surgical tumor resection with a primary colorectal anastomosis (associated or not with a diverting loop ileostomy) or an "Hartmann's procedure" with a staged resection after endoscopic stenting with SEMS.

Since surgical and oncological outcomes of the different treatment strategies for obstructing left colon cancers have not been studied on a large scale globally, we launched the CROSCO-1 study intending to compare the clinical results of all these therapeutic regimens in a cohort of patients treated for obstructive left-sided colorectal cancer (CRC).

The primary aim of the CROSCO-1 (Colonic Resection, stOma or self-expanding metal Stents for obstruCtive left cOlon cancer) study is to describe the outcomes of the management of emergency presentations of obstructive left CRC with colorectal resection with or without primary anastomosis versus the staged approach with SEMS insertion and subsequent colorectal resection. The primary aim of the CROSCO-1 study will be the 1-year stoma rate of patients undergoing primary emergency surgical resection (Hartmann procedure or primary resection and anastomosis) compared with patients undergoing staged resection (emergency endoscopic treatment with SEMS followed by elective resection). Other outcomes will be 30-day and 90-day major morbidity and mortality, 1-year quality of life, and the timing and type of chemotherapy initiation in the two groups.

Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer

Colonic Resection, stOma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer. The CROSCO-1 Multicenter, Prospective Cohort Study

all individual participant data (IPD) that underlie results in a publication

the number of stomas after 1 year of primary surgery with tumor resection

mortality (Overall survival) after 30 and 90-days

The EQ-5D-5L is an instrument to describe the quality of life with a state system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. In this first part, the patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions with graduate answers from 1 (no problem) to 5 (extreme limitations). The aggregation of the responses forms a five-digit number representing the patient's health status. in the second part, the patient is asked to indicate an assessment using a visual analog (VAS) graphically represented by a graduated scale ranging from 0 (the worst possible state of health) to 100 (the best possible state of health) on which the interviewee indicates his or her perceived level of health.

data for chemotherapy initiation in both groups of study

type of drugs regimen in both groups of study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quantitative ICG Fluorescence Angiography in Colorectal Surgery	NCT05153954	Colorectal Canc... Anastomotic Lea...	Quantitative In...	18 Years -	Zealand University Hospital
Hartmann's Versus Primary Anastomosis in Left-sided Colon Perforation	NCT01233713	Surgery Diverticulitis Neoplasms Postoperative C...	Hartmann's oper... Primary anastom...	18 Years - 95 Years	University of Zurich
Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer	NCT05801211	Colon Cancer	primary tumor r...	18 Years -	Azienda Sanitaria di Firenze
Colonic Resection or Stoma, or Self-expandable Metallic Stent for obstruCtive Left cOlon Cancer	NCT05801211	Colon Cancer	primary tumor r...	18 Years -	Azienda Sanitaria di Firenze

Spots Global Cancer Trial Database for primary anastomosis