Is Transvaginal Natural Orice Translumenal Endoscopic Surgery thefuture of CholecystectomySailee Sansgiri, [email protected]
nlMahdieh Shojaei Baghini, [email protected]
nlAbstract — A systematic study on cholecystectomy performedthrough Vaginal Natural Orice Transluminal EndoscopicSurgery (vaginal NOTES) and its feasibilty as a future pro-cedure for scarless surgery.I. INTRODUCTIONThe Natural Orice Surgery Consortium for Assessmentand Research (NOSCAR) was founded in 2005, consistingof members from The Society of American Gastrointesti-nal Endoscopic Surgeons (SAGES) and American Societyof Gastrointestinal Endoscopy (ASGE) 1.
They proposedthe term NOTES (natural orice transluminal endoscopicsurgery) for “surgery performed using instruments whichgain access through a natural orice” 2.NOTES is performed by introducing instruments in thebody cavity (usually the peritoneal cavity) by gaining accessthrough a natural orice such as the mouth,urethra, vagina oranus, as opposed to percutaneous access 2.This is in contrastto traditional laparotomy, where one large incision is made inthe abdominal wall, or laparoscopic surgery, where a smallincision is made in the abdominal wall to allow a laparoscopeto enter 3. Hybrid NOTES combine NOTES with directtranscutaneous access to the abdominal cavity, usually incombination with laparoscopic instrumentation 2. NOTES isknown to improve the cosmetic outcome, and also reducesurgical injury.
This, in turn decreases the inammatoryand neuroendocrine response resulting in less post-operativepain and quicker recovery 4. incorporating the applicablecriteria that follow. In 2007 Zorron et.
al. performed the rsttransvaginal NOTES for cholecystectomy on a 43 year oldpatient who was discharged within 48 hours of surgery. Theoperative procedure is close to that of the Hasson techniqueRegarding NOTES access to the peritoneum, the posteriorfornix of the vagina is described to have the lowest riskof infections post-operatively, but the long-term risks tofertility and dyspareunia remains unclear 5. However, followup studies have occured in the case wherein 68 patients(meanage 50 years) were interviewed 3-10 months post-surgery andnone reported any discomfort during sexual intercourse 6According to a study by Yoshiki(2017), The vagina canbe easily decontaminated and provides direct access to theperitoneum as it has no interposed organ or anatomicalstructure. Trans-vaginal procedures mandate an incision inthe vaginal wall, which has been approved as safe and easyto close.
With regard to closure of the perforation site withinthe natural orices, an acceptable closure method is notyet present in any other access site except the vagina. He concludes that the transvaginal port is the most reliable forNOTES in humans.7II. METHODSA. Search Methodolgy Google Scholar, PubMed, and Cochrane databases wereused for collection of relevant articles and studies (includingrandomized control trials).
A smart search was performedusing the keywords: “cholecystectomy” AND/OR “vaginal”AND “NOTES” . Searches were limited to English. Sevenrandomised trials were found out of which two were ex-cluded since the procedure adopted was Hybrid NOTES. Allyears of publication were included in the search.B. Types of articles included Articles were either systematic reviews, clinical trials,established medical articles, surveys, perception studies, casecontrol studies, and case series.
The participants were chosenby random allocation. Obese patients and patients withprevious gall bladder surgeries were excluded from the study.One porcine model study was included as well.C. Types of data collected The quantitative parameters that were included were lengthof operation (LOS), postoperative pain (measured on a VisualAnalogue Scale, or VAS), length of stay (non Intensive Care),number of cases with intra and post-operative complications,number of patients opting for analgesics post discharge,and conversion to open surgery or standard laparoscopy.The qualitative parameters that were included were scarring,sexual function, fertility, and dietary change(s).
D. Quality Analysis The quality of the articles was assessed and implementedin a PRISMA (Preferred Reporting Items for SystematicReviews and Meta-Analyses) ow diagram. A total of 12articles were left after screening which we have furtherutilized to discuss the effect of transvaginal NOTES oncholecystectomy. The papers ranged from 2005-2018.The criteria for inclusion were: patients with no surgicalcomorbidities, non-obese patients (Body Mass Index(BMI)¿=30 kg/m2), patients with no multiple procedures(only cholecystectomy), middle-aged (to reduce risksof infertility), patients with a vagina, and articles andstudies in English.
For better clarity we have includedstudies with control trials (Vaginal NOTES vs ConventionalLaparoscopy).Fig. 1.
PRISMA Flow DiagramIII. RESULTSA. Surgical Process To describe the surgical instruments used in puretransvaginal NOTES, we have isolated 2 reports, which werereportedly one of the rst few surgeries for cholecystectomy.Gumbs et al(2009) performed the surgery on one patient,with colpotomy and subsequent introduction of a trocar underdirect vision into the abdominal cavity. A 15-mm port wasestablished through the colpotomy, which was used to createthe pneumoperitoneum.
A double channel gastroscope wasthen introduced. An extra 5-mm port was placed beside the15-mm port to allow placement of a curved retractor. Thecystic duct and artery were clipped using endoscopicallyplaced clips and the gallbladder was removed through thevagina. The colpotomy was then closed with absorbablesutures. The duration for the entire procedure was 185minutes.9 The authors reported that the main problem wasto get a real safe view as the gastroscope is inserted frombehind and there some risk of biliary duct lesions.10 Thepatient was discharged within 23 hours post surgery, and had 2 follow-ups, one after 2 weeks of the surgery and one after4 weeks.
In both the follow-ups, the patient reported no pain,no post-operative complications, followed a regular diet anddid not need any pain medication. However, it is importantto note that the patient reported pain of around 7(out of 10)on the Universal pain assessment tool immediately after thesurgery.9De Sousa et al11 published 4 pure NOTES transvaginalcholecystectomies in 2004. Transvaginal NOTES access wasobtained by direct vaginal incision, and two endoscopeswere simultaneously introduced in the abdominal cavity.The pneumoperitoneum was established connecting a exibletube to a standard gastroscope that was inserted througha 2.5 cm posterior colpotomy. A second colonoscope withtwo operative channels was inserted using the same access.Dissection was accomplished with available endoscopic in-struments.
Ligation of cystic duct and artery was performedusing endoscopic clips. Vaginal closure was achieved usingthe direct-vision sutured technique.The authors consideredthe view and the spatial resolution to be of good quality.The main problem was represented by the introduction ofworking tools through a small access (the vagina) and thelack of triangulation.10B. Operative outcomes First and foremost, NOTES is consideredto be more cosmetic than Laparoscopy,simply because it involves no external inci-sion.https://www.sciencedirect.
com/science/article/pii/S2213179512000041The primary advantage of this route is that it reducesthe risk associated with standard laparoscopy (bileleakage, infections, and post operative pain due toresidual effects of CO2). According to an article abouta multicenter clinical trial comparing transvaginal andoral NOTES, the principal investigator stated that”Post-operatively, many patients experience pain whilewalking or coughing due to contraction of the abdominalmuscles. This discomfort is absent following the naturalorice approach” with regards to gallbladder removalsurgeries.https://health.ucsd.edu/news/2010/Pages/7-7-oral-gallbladder-surgery.
aspx The transvaginal routehas been proven to be the most effective route in acholecystectomy. According to Michelle et. al. a naturalorice entry reduces risks of infection, intraoperativehernias with a complication of just 1.5According toAndol et al, in 714 NOTES surgeries, the averagelength of stay in the hospital was 1.
9 days Marerscauxet. al. performed a TVC on one female patient afterwhich the patient had no scarring and was dischargedon the day of the surgery (https://www-tandfonline-com.tudelft.idm.oclc.
org/doi/pdf/10.1080/08941930902866287?needAccess=true).A one month follow up detected no complications.According to Hensel et.al. (https://www.thieme-connect.
com/DOI/DOI?10.1055/s-0030-1247332) therewas a signicant reduction in consumption of opiates(p¡0.001) and peripheral analgesics (p ¡0.001).However, due to its steep learning curve andavailability of instruments, along with sociological barriers(https://www.sciencedirect.
com/science/article/pii/S2213179513000060),transvaginal NOTES is yet to be accepted as a standardprocedure for gall bladder removal surgery. Gumbs etal have reported that one of the greatest disadvantagesof this technique is ” difculty in obtaining the “criticalview of safety,”” and lack of triangulation of instrumentsduring the surgical procedure. Most surgeons currentlydo not possess the knowledge and skill to perform toperform NOTES14 Similarly, exible laparoscopes arenot familiar to most surgeons, and surgical techniques andprocedures are not familiar to most gastroenterologists,more specically for the transvaginal approach14. Ina study conducted by Adler et al(2017) that comparedtransvaginal cholecystectomies to traditional laparoscopicsurgery( 226 laparoscopic cholecystectomies vs 90 NOTEStransvagnal cholecystectomies, all done by the samesurgeon), no intraoperative complications were observed inlaparoscopy, whereas there were 3 instances of complications(bleeding in 2, gallbladder rupture in 1)during the NOTESprocedures.15 According to Freeman et al(2011), It hasbeen concluded in this study that NOTES procedures resultin longer operative times in the early part of the learningcurve and require considerable experience before reachingprociency16IV. DISCUSSIONA. Morbdities Fertility and dyspareunia: Although there is nosupporting literature to prove that transvaginal NOTEShas indeed had an adverse effect on the fertilityof a patient, in a study conducted by Thele etal(https://www.
thieme-connect.com/DOI/DOI?10.1055/s-2008-1077379), a questionnaire was presented toheads of gynaecological departments in 181 hospitals,and 44.
2Furthermore, according to Targarona etalhttps://www.ncbi.nlm.
nih.gov/pmc/articles/PMC2999235/the complications of transvaginal cholestectomy shouldlogically resemble those of transvaginal hysterectomy andfertiloscopy. In the same article, a study by Nasif et al isreferenced, wherein dyspareunia is reported in 2-Risk of biliary duct lesions: Gums et al reported thatthere was a risk of binary duct lesions during surgery whileplacing a transvaginal retractor during transvaginal cholecys-tectomy(here) -Internal abdominal injuries during surgery: -Operative errors: -conversion to open surgery: conversion to4-port surgery(3.
7B. Perception in patients Regarding perception of NOTES in patients, A studyconducted by Verlaan et al(2011) gauged the perceptionof patients with regards to bariatric surgery. This studynoted that low complication risk was the most importantcriteria for patients, followed by quick recovery , intensityof postoperative pain, the duration of pain , length ofhospital stay and nally, post-operative scars. Most of thepatients preferred a laparoscopic procedure above NOTES. Patients with high education chose a NOTES proceduremore often than patients with low education. Zorniget alhttps://www.ncbi.nlm.
nih.gov/pubmed/21181204reported that 10% of patients were not satised with theirscars after laparoscopic cholecystectomy, but no similarcomplaints occurred in the TVC group. According toVaradarajulu et al (2008), patient preference for NOTEScholecystectomy was 100% if overall complications were¡3%. However, they preferred the oral route most (81% ofthe women in the survey), as opposed to the transvaginalroute. The same can be echoed by a study by Chiu et al,that stated that due to cultural variances, the acceptanceof transvaginal procedures is much lower in Asiancountries17. In Asian countries, despite the extensiveresearch and progress in TVC, there is a cultural biaswhich makes the vaginal route the least preferred route forTVChttps://www.
sciencedirect.com/science/article/pii/S2213179513000060.Furthermore, gynaecologists believe that patients over theage of 50 are most suitable for this approach, whichdecreases our sample size even further.V. CONCLUSIONS AND RECOMMENDATIONSOur Recommendation Category for pure NOTES (basedon the scale used by U.
S. Preventive Services Task Force) iscurrently at Level C (At least fair scientic evidence suggeststhat there are benets provided by the clinical service, but thebalance between benets and risks are too close for makinggeneral recommendations)APPENDIXAppendixes should appear before the acknowledgment.ACKNOWLEDGMENTThe preferred spelling of the word Oacknowledgment ´O inAmerica is without an Oe ´O after the Og ´O.
Avoid the stiltedexpression, OOne of us (R. B. G.
) thanks . . . ´O Instead, tryOR. B. G. thanks ´O. Put sponsor acknowledgments in theunnumbered footnote on the rst page.
References are important to the reader; therefore, eachcitation must be complete and correct. If at all possible,references should be commonly available publications.RE F E R E N C E S1 G. O.
Young, OSynthetic structure of industrial plastics (Book stylewith paper title and editor), ´O in Plastics, 2nd ed. vol. 3, J. Peters, Ed.
New York: McGraw-Hill, 1964, pp. 1564.2 W.-K.
Chen, Linear Networks and Systems (Book style). Belmont, CA: Wadsworth, 1993, pp. 123135.3 H.
Poor, An Introduction to Signal Detection and Estimation. New York: Springer-Verlag, 1985, ch. 4.4 B. Smith, OAn approach to graphs of linear forms (Unpublished workstyle), ´O unpublished.5 E. H. Miller, OA note on reector arrays (Periodical style ˜NAcceptedfor publication), ´O IEEE Trans.
Antennas Propagat., to be publised.6 J.
Wang, OFundamentals of erbium-doped ber ampliers arrays (Peri-odical style ˜NSubmitted for publication), ´O IEEE J. Quantum Electron.,submitted for publication.
7 C. J. Kaufman, Rocky Mountain Research Lab., Boulder, CO, private communication, May 1995.
8 Y. Yorozu, M. Hirano, K. Oka, and Y. Tagawa,OElectron spec-troscopy studies on magneto-optical media and plastic substrate in-terfaces(Translation Journals style), ´O IEEE Transl.
J. Magn.Jpn., vol.2, Aug.
1987, pp. 740741 Dig. 9th Annu.
Conf. Magnetics Japan,1982, p. 301.9 M. Young, The Techincal Writers Handbook. Mill Valley, CA: Uni- versity Science, 1989.
10 J. U. Duncombe, OInfrared navigation ˜NPart I: An assessment offeasibility (Periodical style), ´O IEEE Trans. Electron Devices, vol. ED-11, pp.
3439, Jan. 1959.11 S.
Chen, B. Mulgrew, and P. M. Grant, OA clustering techniquefor digital communications channel equalization using radial basisfunction networks, ´O IEEE Trans. Neural Networks, vol. 4, pp. 570578,July 1993.12 R.
W. Lucky, OAutomatic equalization for digital communication, ´OBell Syst. Tech. J., vol.
44, no. 4, pp. 547588, Apr. 1965.13 S. P.
Bingulac, OOn the compatibility of adaptive controllers (Pub-lished Conference Proceedings style), ´O in Proc. 4th Annu. AllertonConf. Circuits and Systems Theory, New York, 1994, pp.
816.14 G. R. Faulhaber, ODesign of service systems with priority reserva-tion, ´O in Conf.
Rec. 1995 IEEE Int. Conf. Communications, pp. 38.15 W.
D. Doyle, OMagnetization reversal in lms with biaxialanisotropy, ´O in 1987 Proc. INTERMAG Conf., pp. 2.2-12.
2-6.16 G. W. Juette and L. E. Zeffanella, ORadio noise currents n shortsections on bundle conductors (Presented Conference Paper style), ´Opresented at the IEEE Summer power Meeting, Dallas, TX, June 2227,1990, Paper 90 SM 690-0 PWRS.
17 J. G. Kreifeldt, OAn analysis of surface-detected EMG as anamplitude-modulated noise, ´O presented at the 1989 Int. Conf.Medicine and Biological Engineering, Chicago, IL.18 J. Williams, ONarrow-band analyzer (Thesis or Dissertation style), ´OPh.
D. dissertation, Dept. Elect. Eng.
, Harvard Univ., Cambridge, MA,1993.19 N. Kawasaki, OParametric study of thermal and chemical nonequilib-rium nozzle ow, ´O M.S.
thesis, Dept. Electron. Eng., Osaka Univ.,Osaka, Japan, 1993. 20 J. P.
Wilkinson,ONonlinear resonant circuit devices (Patent style), ´OU.S. Patent 3 624 12, July 16, 1990.
