Vacuum inversion and securing of distal colonic pseudodiverticula with novel spiked O-rings.

BACKGROUND: Diverticular disease is increasingly prevalent in Western societies and is associated with significant morbidity. OBJECTIVE: Two-stage endoscopic device development for inversion and secured ligation of colonic diverticula; first, human cadaver studies were performed to measure forces required for diverticular inversion; second, a novel set of devices (elastic spiked O-ring with delivery system) was tested in animals. DESIGN: Prospective, observational study of human cadavers and prospective, interventional study of a porcine model. SETTING: University hospital pathology laboratory and animal facility. INTERVENTION: Full-thickness inversion of the colonic wall with a pipelike delivery instrument to produce an inverted pseudodiverticulum that was secured with a spiked O-ring. MAIN OUTCOME MEASUREMENTS: The forces required for diverticular inversion, the secured closure of inverted pseudodiverticula, and the time until necrotic tissue falls off. RESULTS: A total of 248 of 248 of cadaveric sigmoid diverticula could be inverted by means of vacuum or forceps. The forces required for inversion ranged from 0.28 to 0.47 N (median, 0.37 N). Twenty-four spiked O-rings were delivered in 6 living pigs to produce 24 inverted pseudodiverticula. One animal died the day after the procedure of a pulmonary thromboembolism. In the remaining 5 pigs, all delivered spiked O-rings remained in place for 7 to 22 days. At necropsy, none of the inverted sites showed signs of perforation but rather full-thickness reparative scarring with ingrowth of connective tissue. LIMITATIONS: Animal model, stiff pipelike delivery instrument, variations in diverticular location, diameter, and size. CONCLUSIONS: Endoluminal inversion and securing of colonic diverticula induces tissue necrosis, diverticular sloughing, and full-thickness scarring.

A novel endoscopic device for repeated right-side colonic access during colonoscopy (with video).

BACKGROUND: Megachannel is a newly developed colonic access system allowing rapid and multiple passes of the colonoscope to the right side of the colon. OBJECTIVE: The aim of this study was to evaluate the safety and clinical feasibility of placing a 100 cm Megachannel prototype in the right side of the colon. SETTING: Six centers, international, both surgeons and gastroenterologists performing endoscopy. DESIGN AND INTERVENTION: Patients scheduled for colonoscopy with suspected right-side colonic polypoid lesions were included. The prototype was loaded onto a 160 cm lower GI endoscope and introduced via colonoscopic guidance. MAIN OUTCOME MEASUREMENT: The ability to place this device in the right side of the colon. RESULTS: The Megachannel prototype was introduced in 41 patients (19 female, mean age 54 years) undergoing colonoscopy. The cecum was reached in 27 cases (66%) within 18 minutes (range, 3-35 minutes) and with 73 cm (range, 40-100 cm) of the device being inserted into the colon. Mild tissue bruises and mild pain were observed in 5 and 3 patients, respectively. In 14 patients, the device assisted the removal of multiple polyps (2-12) as tissue was repeatedly retrieved through the channel. The device also allowed delivery of an endoscopic US scope or suction caps to the right side of the colon. LIMITATIONS: Prototype performance may differ from the actual product (80 cm in length, redesigned introducer plugs). Small number of patients, difficult in diverticular disease. CONCLUSIONS: This newly developed colonic access system can be safely placed in the right side of the colon and is useful for a variety of advanced procedures that require repeated insertion of the colonoscope or delivery of bulky instruments. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT00987896.).

Design and instrumentation of new devices for performing appendectomy at colonoscopy (with video).

BACKGROUND: There is increasing interest in natural orifice surgery (NOS). Because the lumen of the appendix is connected to the cecum, a minimally invasive method for removing the appendix by colonoscopy may be feasible. OBJECTIVES: Our purpose was to design, develop, and test new devices for inverting and removing the appendix by colonoscopy. DESIGN: Prospective prototype development program. SETTING: University-based study in 25 colons from adult human cadavers. INTERVENTIONS AND METHODS: Various prototypes were evaluated by inserting them into the appendiceal orifice to its luminal tip, with the intent to invert the appendix in a controlled fashion into the lumen of the cecum. The advantage of using a tubular structure as a counterforce to aid inversion of the appendix was evaluated. When inversion was incomplete, the growing tissue strain was relieved by endoluminal incision of the mesenteric side of the appendix. Closure methods with endoloops or ligating loops were studied. Appendiceal resection was completed by snare diathermy, leaving an inverted intraluminal stump. MAIN OUTCOME MEASUREMENT: Ability to invert the appendix into the cecum. RESULTS: The mean appendix length and luminal diameter were 84 +/- 23 mm and 4.9 +/- 1.2 mm, respectively. It was possible to advance various types of inversion devices to the tip of the appendiceal lumen. Partial inversion of the appendix was successful in 22 of 25 tests. Mesenteric tissue tension, tissue volume, and device slippage were the main reasons for incomplete inversion. The complete inversion was achieved with a combination of vacuum, tip grip, counterforce at the appendix base, and eventually endoluminal incision. CONCLUSIONS: The inversion of the human appendix by colonoscopy seems feasible and may be an alternative approach to conventional appendectomy.