New detachable occlusion balloon unit for transrectal natural orifice translumenal endoscopic surgery

Xu, Hao; Ohdaira, Takeshi; Nagao, Yuhei; Tsutsumi, Norifumi; Mori, Megumu; Uemura, Munenori; Toyoda, Kazutaka; Ieiri, Satoshi; Hashizume, Makoto

doi:10.3109/13645706.2012.732080

Cited by 2 publications

(3 citation statements)

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“…Previously a single balloon catheter for colon occlusion in a porcine model for transrectal peritoneoscopy has been proposed [27]. Furthermore, the use of a detachable occlusion balloon was demonstrated in a porcine model [29]. In the latter experiment balloon dislocation of around 2 cm was described.…”

Section: Discussionmentioning

confidence: 99%

Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout

et al. 2020

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Background Transrectal Natural Orifice Transluminal Endoscopic Surgery is currently limited by the inherent risk of surgical site infection due to peritoneal contamination after rectotomy. Coloshield has been developed as a temporary colon occlusion device to facilitate rectal washout. However, effectiveness and safety has not been evaluated in humans. Methods Twenty-two patients have been randomly assigned to undergo proctological intervention with a rectal washout with and without the use of Coloshield. Patients and assessors were blinded. Boston Bowel Preparation Scale (BBPS) has been determined 30 min as well as immediately after rectal washout. Feasibility, pain, intra- and postoperative morbidity as well as bowel function and continence 6 weeks after surgery were assessed. Results BBPS 30 min after rectal washout with and without Coloshield was in mean 2.42 ± 1.02 and 2.12 ± 0.89 (p = 0.042). Mean BBPS immediately after rectal washout was 2.39 ± 1.02 and 2.24 ± 0.66 (p = 0.269). Mean BBPS immediately after rectal washout and 30 min thereafter did not differ (p = 0.711). Coloshield application was feasible without any complications. The median (interquartile range) numeric rating scale for pain 4 h after surgery was 1 (0–1) and 3 (0–4) (p = 0.212). Six weeks after surgery 0/11 and 1/11 patients suffered from evacuation difficulties (p = 1.0) and the median Vaizey–Wexner score was 1 (0–3) and 1 (0–2) (p = 0.360). Conclusions Coloshield application in humans is feasible and safe. Slight benefits in rectal preparation by washout are found when Coloshield is used. Colon occlusion by Coloshield for transrectal NOTES should be evaluated within clinical studies. Trial registration Clinicaltrials.gov NCT02579330

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Section: Discussionmentioning

confidence: 99%

Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout

et al. 2020

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“…Xu et al had applied a detachable oval occlusion balloon unit for transrectal NOTES, which achieved good results in preventing fluid leakage. However, localized damage to the mucosa was observed where the balloon was located …”

Section: Discussionmentioning

confidence: 99%

“…18 where the balloon was located. 21 In general, a spherical or oval balloon is prone to shifting due to intermittent bowel peristalsis. Moreover, high local pressure is harmful to the pressed colonic wall.…”

Section: Senft Et Al Used a Spherical Balloon For Transrectal Notes Omentioning

confidence: 99%

A reliable detachable balloon that prevents abdominal cavity contamination during transrectal natural orifice transluminal endoscopic surgery

Fan

Zhao

et al. 2019

J of Digest Diseases

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Objective To evaluate the efficacy and safety of a detachable endoluminal balloon in the prevention of abdominal cavity contamination during transrectal natural orifice transluminal endoscopic surgery (NOTES). Methods The efficacy and safety of a detachable endoluminal balloon to maintain disinfection in the distal colon of the pigs were evaluated. The bacterial loads and colonic cleanliness were monitored. Additionally, the device was applied to another nine pigs that underwent a cholecystotomy by transrectal NOTES. Necropsy and pathological examination were performed after 28‐day follow‐up. Results All animals exposed to the device and one of the seven pigs not exposed to the device scored three points on the bowel cleanliness scale (P < 0.001). After 30 min bacterial loads of the test (with balloon occlusion) and control (without balloon occlusion) groups showed a significant difference (0.8 × 103 CFU/mL vs 186.8 × 103 CFU/mL, P < 0.01). Cholecystotomy by transrectal NOTES with the device was successfully performed. The mean intraperitoneal procedure time was 102.9 ± 37.7 min. There were no procedure‐related adverse events. During the follow‐up, all animals presented normal behavior and appetite. No peritoneal infection or adhesion was detected at autopsy. Cholecystotomy and rectal incision were histologically healed and no histological abnormalities were detected in the colon related to balloon placement. Conclusions The detachable balloon provides a reliable solution for preventing peritoneal contamination during transluminal operations. The technique may assist in future transrectal NOTES.

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New detachable occlusion balloon unit for transrectal natural orifice translumenal endoscopic surgery

Abstract: This newly-developed occlusion balloon unit helps to establish good visibility and adequate bacterial clearance for endoluminal surgical procedures.

Cited by 2 publications

References 32 publications

Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout

Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout

A reliable detachable balloon that prevents abdominal cavity contamination during transrectal natural orifice transluminal endoscopic surgery

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