Analysis Of The Clinical Safety Of Transrectal Pure NOTES

BackgroundNatural orifice transluminal endoscopic surgery(NOTES)is a newly developed ultra-minimally invasive technique that uses soft or rigid endoscopes pass through the natural cavity,such as mouth,esophagus,colorectal,vagina,and even the umbilical area to reach thoracic and abdominal cavity.The more common accesses,such as the transgastric approach and transvaginal approach NOTES,have been quickly applied to the clinic after a large number of feasible animal experiments,which fully meet the increasing requirements for minimally invasive diagnosis and treatment.The development of NOTES via rectal approach is relatively late,mainly because the intestinal tract is a polluted environment for storing feces,which causes a higher risk of abdominal infection.However,the transrectal approach has its own unique advantages.It can provide a good viewing angle of the upper abdominal organs,and the operation can be performed directly without reversing the endoscope.Compared with the transvaginal approach,there is no gender restriction,and the operation space of the surgical approach is larger,which is convenient for the removal of surgical resection tissue.Our team designed a detachable intestinal surgical field protection balloon device(Patent number:ZL 201410276499.9).In the previous basic experiments,we used this device on pig models to seal half of the intestine,and measured the bacterial load before and after sealing.The results are believed to be able to effectively prevent the upstream feces and intestinal juice from contaminating the operation area.At the same time,the balloon combined with povidone-iodine solution disinfection can preliminarily ensure the clean state of the operation area.AimIn this study,we collected clinical data of pure NOTES transrectal surgery using this detachable balloon device.Through intestinal fluid bacteriological detection and perioperative related results,a comprehensive analysis of pure NOTES transrectal surgery has been done for its safety and feasibility.Objectives and methodsThe clinical information of pure NOTES transrectal surgery performed in the First Affiliated Hospital of Zhengzhou University from January 2018 to June 2020 has been collected.In 10 patients who underwent pure NOTES transrectal gallbladder preserving surgery,the intestinal liquids at different operation periods(before balloon placement,after balloon placement,postoperative and after balloon removal)have been collected and been sent for bacterial testing.Record the results of bacterial counts and bacterial cultures from all the intestinal liquids.Record all included patients’ age,gender,chief complaint,preoperative examination results,hospital stay and other basic clinical data,as well as operation time,postoperative inflammation indicators,adverse reactions and other surgical related data.Results1.Patient clinical data analysisA total of 41 patients were enrolled in this study.There are 16 males and 25 females,with the age of 42.00±12.09 years old.2.Bacteriological examinationIn 10 patients undergoing TRGPC/TRGPP surgery,intestinal liquid was collected from different periods of operation and bacteriological testing was performed.No bacteria were detected in 8 patients after the balloon was placed;No bacteria were detected in 9 patients after the surgical incision was closed.3.Operation related information3.1 Operation results:All 41 patients were successfully performed the pure NOTES transrectal operation.After the balloon was withdrawn,the mucosa around the intestinal wall was examined with no hyperemia,pallor,ulcer or perforation.The operation time of the TRGPC/TRGPP group was 140.61±61.26min,the hospital stay was 10.36±3.86 days,the postoperative hospital stay was 4.82±2.69 days,and the postoperative fasting time was 1.78±1.46 days.3.2 Inflammatory marker results:The preoperative white blood count(WBC)was(5.83± 1.53)×109/L,the preoperative neutrophil percentage(NEU%)was(51.63±11.77)%;the WBC on the first day after surgery was(10.08±3.59)×109/L,the NEU%on the first postoperative day was(83.81±10.20)%;the WBC was(6.91±2.40)×109/L on the third postoperative day,and the NEU%on the third postoperative day was(67.39±12.53)%.The CRP on the first postoperative day was 27.92±35.34 mg/L;the CRP on the third postoperative day was 39.40±38.06 mg/L.3.3 Adverse events:The adverse effects of 41 patients were abdominal pain(10/41),fever(4/41),biliary peritonitis(4/41),nausea and vomiting(4/41),and abdominal distension(1/41).Symptoms such as nausea and abdominal distension were considered as side effects of anesthesia.No special treatment was given but just close observation,and the conditions got better afterwards.3.4 Follow up:As of December 2020,41 patients had been followed up for 21.34±8.27 months,and all patients had no symptoms of dyspepsia.A total of 26 patients(26/39)underwent a foll-ow-up of gallbladder ultrasound examination,and 2 patients were found to have recurrences of gallbladder stones at the 12-month followup and 14-month follow-up respectively.Conclusion1.The detachable balloon device can effectively prevent the proximal intestinal liquids from contaminating the surgery area,and the application of the balloon combined with iodophor solution can effectively prevent bacterial infection in the clinical surgical area.2.It is clinically safe and feasible to use this device for pure NOTES transrectal operation.