Prevesical peritoneum interposition to prevent risk of rectovaginal fistula after en bloc colorectal resection with hysterectomy for endometriosis: Results of a pilot study

IntroductionNipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM (RNSM) has the potential to improve the ergonomic challenges of open NSM. Recent studies in RNSM demonstrate the feasibility and safety of the procedure, but this technique is still novel in the USA.Methods and analysisThis is a single-arm prospective pilot study to determine the safety, efficacy and potential risks of RNSM. Up to 12 RNSM will be performed to assess the safety and feasibility of the procedure. Routine follow-up visits and study assessments will occur at 14 days, 30 days, 6 weeks, 6 months and 12 months. The primary outcome is to assess the feasibility of removing the breast gland en bloc using the RNSM technique. To assess safety, postoperative complication information will be collected. Secondary outcomes include defining benefits and challenges of RNSM for both surgeons and patients using surveys, as well as defining the breast and nipple-areolar complex sensation recovery following RNSM. Mainly, descriptive analysis will be used to report the findings.Ethics and disseminationThe RNSM protocol was reviewed and approved by the US Food and Drug Administration using the Investigational Device Exemption mechanism (reference number G200096). In addition, the protocol was registered with ClinicalTrials.gov (NCT04537312) and approved by The Ohio State University Institutional Review Board, reference number 2020C0094 (18 August 2020). The results of this study will be distributed through peer-reviewed journals and presented at surgical conferences.Trial registration numberNCT04537312.

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Multi-loop traction device facilitates gastric endoscopic submucosal dissection: ex vivo pilot study and an inaugural clinical experience

BMC Gastroenterology ◽

10.1186/s12876-021-02085-w ◽

2022 ◽

Vol 22 (1) ◽

Author(s):

Hiroaki Matsui ◽

Naoto Tamai ◽

Toshiki Futakuchi ◽

Shunsuke Kamba ◽

Akira Dobashi ◽

...

Keyword(s):

Pilot Study ◽

Endoscopic Submucosal Dissection ◽

Clinical Outcomes ◽

Ex Vivo ◽

En Bloc Resection ◽

Bloc Resection ◽

R0 Resection ◽

En Bloc ◽

Submucosal Dissection ◽

Traction Device

Abstract Background Endoscopic submucosal dissection (ESD) is technically difficult and requires considerable training. The authors have developed a multi-loop traction device (MLTD), a new traction device that offers easy attachment and detachment. We aimed to evaluate the utility of MLTD in ESD. Methods This ex vivo pilot study was a prospective, block-randomized, comparative study of a porcine stomach model. Twenty-four lesions were assigned to a group that undertook ESD using the MLTD (M-ESD group) and a group that undertook conventional ESD (C-ESD group) to compare the speed of submucosal dissection. In addition, the data of consecutive 10 patients with eleven gastric lesions was collected using electronic medical records to clarify the inaugural clinical outcomes of gastric ESD using MLTD. Results The median (interquartile range) speed of submucosal dissection in the M-ESD and C-ESD groups were 141.5 (60.9–177.6) mm2/min and 35.5 (20.8–52.3) mm2/min, respectively; submucosal dissection was significantly faster in the M-ESD group (p < 0.05). The rate of en bloc resection and R0 resection was 100% in both groups, and there were no perforation in either group. The MLTD attachment time was 2.5 ± 0.9 min and the MLTD extraction time was 1.0 ± 1.1 min. Clinical outcomes of MLTD in gastric ESD were almost the same as those of ex vivo pilot study. Conclusions MLTD increased the speed of submucosal dissection in ESD and was similarly effective when used by expert and trainee endoscopists without perforation. MLTD can potentially ensure a safer and faster ESD.

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