Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasms

Hemorrhage

Intestinal Diseases

Inflammatory Bowel Diseases

Colonic Neoplasms

Prolapse

Rectal Neoplasms

Diverticulitis

Constriction, Pathologic

Rectal Prolapse

Anastomotic Leak

Gastrointestinal Diseases

Gastroenteritis

Pathological Conditions, Anatomical

Diverticulum

Diverticular Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Rectal Diseases

Colonic Diseases

Pelvic Organ Prolapse

Restoring intestinal continuity using the NITI CAR27 device

Compression Anastomosis Device

endoscopic exploration of anastomosis after complete healing

follow-up colonoscopy

Friedrich Herbst, MD, FRCS

After resection of diseased segments of the large intestine, the continuity of the intestine has to be restored. This can be done by suturing or with so called stapling devices. In addition since 2 centuries compression rings are used to connect the intestine after resection. The NITICAR27 device is a novel compression anastomosis device. The investigators want to prove if this novel device can be compared to commonly used stapling devices concerning anastomotic leakage, bleeding and stenosis.

NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery

Compression Anastomosis: Initial Clinical Experience With the ColonRingTM

St John of God Hospital, Vienna

Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device

follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing

NITI CAR27 (ColonRing)

Age, Continuous

Sex: Female, Male

Bernhard Dauser (MD)

Anastomotic Leakage

Clinical Relevant Stenosis

Overall Study

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Daniel C Steinemann, MD

Sebastian Lamm, MD

Andreas Zerz, MD

Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.

Primary endpoint:

To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.

Secondary endpoints:

* quality of life 6 months after surgery
* continence 6 months after surgery
* pain postoperative
* complication rate
* duration of procedure
* lengh of stay

Hypothesis:

The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).

study design: This is an open cohort study on 60 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.

Inclusion criteria:

- benign indication for left sided colectomy.

exclusion criteria:

* age \<18 years
* patient unable to understand informed consent or missing informed consent
* emergency surgery

power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.

Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection

Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.

Postoperative complications are recorded and graded according to Clavien-Dindo classification. Complication rates and especially occurence of anastomotic leakage and pelvic sepsis will be compared to the literature of current techniques.

Cantonal Hosptal, Baselland

Principle Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Blood and Lymph Conditions

Immune System Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Crohn Disease

Colitis

Colitis, Ulcerative

Ulcer

Endometriosis

Lymphoma

Intestinal Volvulus

Intestinal Polyposis

Diverticulum, Colon

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Intestinal Obstruction

Congenital Abnormalities

Lymphosarcoma

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

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")

Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies

Clinical database

Philippe Rouanet, MD

Evaluation of robot Da Vinci Xi by determining its learning curve.The operating time will be defined by patient then the operating average will be calculated.

Since the emergence of minimally invasive technology twenty years ago, as a surgical concept and surgical technique for colorectal cancer surgery, its obvious advantages have been recognized.

Laparoscopic technology, as one of the most important technology platform, has got a lot of evidence-based support for the oncological safety and effectiveness in colorectal cancer surgery Laparoscopic technique has advantages in terms of identification of anatomic plane and autonomic nerve, protection of pelvic structure, and fine dissection of vessels.

But because of the limitation of laparoscopic technology there are still some deficiencies and shortcomings, including lack of touch and lack of stereo vision problems, in addition to the low rectal cancer, especially male, obese, narrow pelvis, larger tumors, it is difficult to get better view and manipulating triangle in laparoscopy. However, the emergence of a series of new minimally invasive technology platform is to make up for the defects and deficiencies. The robotic surgical system possesses advantages, such as stereo vision, higher magnification, manipulator wrist with high freedom degree, filtering of tremor and higher stability, but still has disadvantages, such as lack of haptic feedback, longer operation time, high operation cost and expensive price.

3D system of laparoscopic surgery has similar visual experience and feelings as robotic surgery in the 3D view, the same operating skills as 2D laparoscopy and a short learning curve. Transanal total mesorectal excision (taTME) by changing the traditional laparoscopic pelvic surgery approach, may have certain advantages for male cases with narrow pelvic and patients with large tumor.

No prospective study has compared these four surgical techniques. Furthermore, the learning curve still remains a crucial problem in term of data interpretation.

We will collect synchronized videos and data on surgeon performance during colorectal surgeries using the Vinci Logger (dVLogger, Intuitive Surgical, Inc.), it is a personalized recording tool that captures synchronized video in the form of endoscope view at 30 frames per second. Kinematic data included characteristics of movement such as instrument travel time, path length and velocity. Events included frequency of master controller clutch use, camera movements, third arm swap and energy use.

We will explore and validate objective surgeon performance metrics using novel recorder ("dVLogger") to directly capture surgeon manipulations on the daVinci Surgical System.

Clinical Database of Colorectal Robotic Surgery

French Prospective Clinical Database of Colorectal Robotic Surgery

This questionnaire assessed the bowel function of patient. The range is from 8 (low function) to 35 (high function)

The range is from 1 (low erectile function) to 27 (high erectile function)

The range is from 3 (low sexual function) to 55 (high sexual function).

The range is from 0 (low urinary function) to 40 (high urinary function).

The quality of the mesorectum resection is determined by the pathologist according to the aspect of mesorectum, the circumferential resection margin, cone effect .

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
NITI CAR27 (ColonRing) Compression Anastomosis in Colorectal Surgery	NCT01056913	Colonic Neoplas... Rectal Neoplasm... Diverticulitis Inflammatory Bo... Rectal Prolapse	Compression Ana... follow-up colon...	18 Years - 90 Years	St John of God Hospital, Vienna
Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection	NCT01992406	Sigmoid Diverti... Sigmoid Diverti... Colon Adenoma Rectal Prolapse		18 Years -	Cantonal Hosptal, Baselland
Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection	NCT01992406	Sigmoid Diverti... Sigmoid Diverti... Colon Adenoma Rectal Prolapse		18 Years -	Cantonal Hosptal, Baselland
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
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
Clinical Database of Colorectal Robotic Surgery	NCT04013152	Crohn Disease Polyposis Ulcerative Coli... Diverticulitis Colorectal Tumo... Rectal Prolapse Benign Colorect...	Clinical databa...	18 Years -	Institut du Cancer de Montpellier - Val d'Aurelle

Spots Global Cancer Trial Database for rectal prolapse