Digestive System Diseases

All Conditions

Symptoms and General Pathology

Diverticulitis

Diverticulum

Diverticular Diseases

Gastroenteritis

Gastrointestinal Diseases

Pathological Conditions, Anatomical

Herbal and Botanical

All Drugs and Chemicals

Cola

During left-sided colonic resections, anastomosis perfusion will be estimated by the visual appreciation of the surgeon and the ICG fluorescence-based enhanced reality. These two approaches will be compared.

During interventions, anastomosis perfusion will be estimated (outcomes: visual appreciation of the surgeon, ICG fluorescence-based enhanced reality and series of peri-operative samplings) in order to validate the accuracy of ICG fluorescence-based enhanced reality technique.

In any case, the resection will be performed according to the surgeon's appreciation.

Left-sided colonic resection

Didier Mutter, MD, PhD

Michele Diana, MD

The aim of this study is to evaluate the ability of a ICG-fluorescence guidance complemented with enhanced reality to correctly document intestinal pre-anastomotic perfusion and to validate the accuracy of this technique with metabolic intestinal cells changes.

Accurate intraoperative evaluation of peri-anastomotic gastrointestinal tract perfusion is essential to reduce the risk of anastomotic complications such as leakage or strictures. Anastomotic leakage is the most dreadful complication of colorectal resections.

Intestinal microcirculation and viability is usually estimated from the color of the serosal surface, presence of peristalsis, pulsation and bleeding from the marginal arteries. This is subjective and based on the experience of the surgeon.

Fluorescence videography integrates a near-infrared endoscope able to detect the signal emitted by a fluorescent dye, Indocyanine Green (ICG), which is administered by intravenous injection. Fluorescence intensity is proportional to the amount of fluorescent dye diffused in the tissue and it consequently is a surrogate marker of tissue perfusion.

The hypothesis is that ICG-fluorescence guidance coupled with enhanced reality would allow a precise and rapid localization of the future anastomotic site in terms of optimal perfusion in laparoscopic colorectal resections.

In patients undergoing elective left-sided colonic resection by laparoscopic approach, resection site and anastomosis perfusion will be evaluated by :

* the visual appreciation of the surgeon
* the fluorescence-based enhanced reality, after injection of ICG and digital process.

A series of peri-operative samplings will also be carried out. In any case, the resection will be performed according to the surgeon's appreciation.

Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis

The perfusion evaluated by the ICG fluorescence-based enhanced reality, obtained by the digital process of the fluorescence dynamic signal, will be correlated to the metabolic state of the intestine, assessed by the measure of biological markers on several points of the intestine.

The intraoperative intestinal perfusion on the anastomosis site, measured by fluorescence videography, will be correlated to the rate of anastomosis leakage.

The distance between the resection site based on the surgeon's clinic appreciation and the resection site based on the digital analysis and the level of capillary lactates and mitochondria respiratory rate on different sites will be measured.

IHU Strasbourg

Neoplasms

Prolapse

Adenoma

Rectal Prolapse

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Rectal Diseases

Intestinal Diseases

Pelvic Organ Prolapse

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Perfusion Evaluation by Real-time Fluorescence-based Enhanced Reality of Anastomosis	NCT02626091	Sigmoid Diverti... Sigmoid Diverti... Colorectal Mali...	Left-sided colo...	18 Years -	IHU Strasbourg
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

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