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SEALING OF CYSTIC DUCT USING ULTRASONIC GENERATOR AND ITS COMPARISON WITH THE APPLICATION OF CLIPS - A REVIEW Dr. Sudhanshu SINGH M.B.B.S, M.S. (GEN. SURG.)
PROJECT TO BE SUBMITTED IN PARTIAL FULFILLMENT OF DIPLOMA IN MINIMAL ACESS SURGERY ABSTRACT Ever since the beginning of laparoscopic Cholecystectomy, in 1985 by Erich Mühe in Germany followed by Harry Reich and Eddie Joe Reddick an American in 1989, the technique has seen many areas of refinements. Initially popularized techniques were turned down by the pioneers on the account of incredible and awful complications substantiated by controlled trials. The dissection of the cystic pedicle (which entails cystic duct division and the sealing of cystic artery), a crucial step in Gall Bladder surgery, has undergone revolutionary change since the introduction of harmonic Scalpel. The issue with clipping (absorbable & nonabsorbable) is that there is the complication of clips being dislodged. With the advent and use of ultrasonically activated scalpel a new chapter is re-written for tissue cutting and co-agulation with potential replacement of electrosurgery by virtue of its complications. The safety profile of Harmonic Scalpel (HS) in other surgeries has been already demonstrated and documented. It’s use in Gall Bladder surgery in particular cholecystectomy needs more to be emphasized over the application of clips on cystic duct and the artery which underlines the aim of this study. KEYWORDS Laparoscopic cholecystectomy (LC), Ultrasonic Generator (UG), Clipless cholecystectomy, Sealing of Cystic Duct and artery. INTRODUCTION Laparoscopic Cholecystectomy is the “Gold Standard “for the treatment of cholelithiasis and acute cholecystitis. But, still the problem of cystic duct leak leading to biloma, an infrequent but one of the most dreaded complications mandates the need to review the efficacy of the use of Clips comparing with the Harmonic Scalpel in sealing of Cystic Duct and artery. Technological advances have set new standards for different indications keeping in view the patient’s comfort at its utmost. This document reviews the issue of harmonic scalpel as a new technique applicable to laparoscopic cholecystectomy, examines the causes, indications, complications with proper use and rewrites the literature, refuting the use of clips and advocating the use of harmonic scalpel on the cystic duct and the artery. AIM
MATERIALS AND METHODS A thorough search of literatures which included controlled trials, original articles and reviews was conducted using Google, Highwire, Springerlink as the respective search engines. Articles of different surgical disciplines, giving vivid details of the effect of Harmonic Scalpel and clipping were also incorporated. Research materials conducted on animals in various Labs across the Globe were used for reference. The following key words were used: “laparoscopic Cholecystectomy”, “Clips”, “Harmonic Scalpel”, and “Ultrasonic dissection”. More than 500 citations were found in total. Following protocol was fixed for the selection of literature.
Erich Mühe (1985) of Germany first performed Laparoscopic Cholecystectomy and today it is the “Gold standard” for almost all the Gallbladder diseases. Apart from all the steps of surgery it is the Dissection of cystic pedicle (clipping or sealing of cystic duct and artery) which is the most crucial. Most of the complications directly or indirectly are pertaining to this crucial step of surgery. Dissection of Cystic Pedicle [1] The correct size of clip for the vessel needs to be selected. The distance between first two clips should not exceed 3mm and those between second and third should be 6mm.The risk of slippage is high if the clip. • Is selected too small for the vessel The correctly applied clips generally offer a pressure between 450 and 700 mbar. Clips with pressure less than 100 mbar are never tight and inadvertently fall off. [3] A Retrospective Comparative Evaluation of Titanium versus Absorbable Clips was conducted by Lapo Bencini et.al[12] Their aim was to determine any differences in outcome and costs of the clips. From January 1999 to February 2002, 690 patients were selected who had successfully undergone a laparoscopic cholecystectomy and were reviewed. According to the type (absorbable and nonabsorbable) of clip, they retrospectively identified two groups of patients: 199 of those in which the surgeons had used absorbable clips (absorbable clip group, ACG) and 491 of those in which the surgeons had used titanium nonabsorbable clips (titanium clip group, TCG). Data about demographics, operation, results, complications, and follow-up were collected and matched in between the two groups. The difficulty score of the operation was lower (6.3 vs. 7.0, P = .03) and the operative time was shorter (44 vs. 61 minutes, P < .0001) in the ACG than in the TCG. The complications, hospital stay, and long-term results were satisfactory and comparable between the two groups. Correlation was not found between clip type and the incidence of biliary tree injuries, bleeding, wound infection, or readmission. There was slight variation as far as respective price was concerned (90 euros for each procedure). Inspite of the fact mentioned that the absorbable clips are theoretically less likely to cause complications than metallic ones; the study did not demonstrate any clinical advantage during laparoscopic cholecystectomy [12]. Complications: 1. Duct leakage Inspite of the best applications, clipping suffers a huge drawback, somewhat more in the hands of surgeon-in-training. Several studies have been conducted to prove the superiority of non absorbable clips over and above the absorbable ones but went futile. A. Rohatgi and A.L. Widdison had reviewed the cholecystectomies performed at the Royal Cornwall Hospital on the patients over a 5-year period and reported similar results when the two varieties of clips were compared [11].
A case presented with recurrence of common bile duct stones 2 years post laparoscopic cholecystectomy in whom laparoscopic common bile duct exploration. Was performed at a later date [15]. Tsumura H et al reported an extremely rare complication, migration of an endoclip into the common bile duct, following few months after laparoscopic cholecystectomy, in a 57-year-old man. He underwent laparoscopic cholecystectomy, but was confronted by postoperative bile leakage that occurred from the cystic duct stump and was treated by conservative drainage for 1 month. It was that again after Five years, he came with the complain of vomiting and pain in the right hypochondrium, and was admitted for investigations of jaundice and liver dysfunction. Computerized tomography scanning of the abdomen and endoscopic retrograde cholangiography revealed the fact that several calculi, formed around six endo-clips acting as the nidus, had migrated into the biliary tract. Many other reports have substantiated the migration of clips in the hepatic duct after laparoscopic cholecystectomy, as cause of late recurrent gallstones. Choledochal stenosis and lithiasis caused by penetration and migration of surgical metal clips has also been documented. The translocation of surgical pins to distant sites may be a sign of impending doom if not rectified. Wasserberg N et al describes two cases in which there was an incorporated surgical clip into a duodenal ulcer post laparoscopic cholecystectomy. The patients presented with were acute gastrointestinal bleeding. Both were treated endoscopically, and the bleeding stopped after the removal of the clip from the ulcer base. [19]
Eighteen months after cholecystectomy a patient complained of dyspnea. Plain radiograph and computed tomography of the thorax was advised which showed a metallic clip in the branch of the left pulmonary artery supplying the posterior basal segment of the left inferior lobe. This is a case of Embolism of a metallic clip following laparoscopic cholecystectomy reported by Ammann K et al from Austria. The clip was applied to control bleeding from the Gall Bladder bed which was the cause of disaster. Hence, the use of clips on Gall Bladder bed should be strictly condemned. There are studies which have shown migration of clips to distant locations like intervertebral discs and other awfully incredible sites. Hence, most of the researchers have condemned their use though it is rampantly used by the developing world. Ultrasonic Generators The dissection of the cystic pedicle in Gall Bladder surgery has undergone revolutionary change since the introduction of harmonic Scalpel. The ultrasonically activated (Harmonic) scalpel has proved its efficacy and is, efficient, and safe instrument for dissection and hemostasis in both open and laparoscopic surgical procedures.
Mechanism of action: The Ultrasonic Generator system consists of different parts which comprise of: a current generator, a hand piece that houses an ultrasonic transducer, an instrument which has end effector (specific types include blade or shears) used to cut tissue, a foot pedal, and a hand switching adaptor. Advantages: The Ultrasonic generator provides complete hemobiliary stasis for most of the patients and is often a safe alternative to Monopolar current, standard clip or ligature closure of the cystic duct. [21] Tebala GD[23] Performed three-port laparoscopic cholecystectomy by harmonic dissection without using the standard clips for sealing cystic duct and artery on 100 patients and documented that the risk of tissue injury caused by repeatedly blind extraction and insertion maneuvers of various instruments in the abdomen was decreased by the use of the multipurpose ultrasonic dissector. Safe in less experienced hands A randomized clinical trial of ultrasonic versus electrocautery dissection of the gallbladder in laparoscopic cholecystectomy was conducted by I. M. C. Janssen et al [24]on 200 patients. He reported that with the use of ultrasonic generators in laparoscopic cholecystectomy the incidence of gallbladder perforation dropped down drastically and the operation progressed more smoothly. The surgeons with less experience benefited the most from ultrasonic dissection, particularly in daunting and complicated Intraoperative circumstances. Effect on Post operative immunity A study on the Intraoperative and post operative immune status of the patient was conducted using Ultrasonic Generators for surgery and it was proved that the devices using Ultrasonic technology and those with Monopolar electrosurgery are equally traumatic in terms of activation of mediators for the systemic immune response [25].
Effect on post operative pain. Retrieval of data on post operative pain after LC was not possible due to insufficient literatures available but its effect on those undergoing hemorrhoidectomy was recorded. There was significantly reduced postoperative pain with U.G. hemorrhoidectomy compared with those of electrocautery controls. The diminished pain in the postoperative period using ultrasonic generator most likely resulted from the avoidance of lateral thermal injury. [26] Effect on wound healing Histological examination of the tissues revealed that segments divided with the ultrasonic techniques retained more or near normal tissue architecture at the site of anastomosis two weeks after the surgery. There results show that with use of ultrasonic generators, the wound healing was rapid and complete than with electrocautery [27]
Surgical Smoke Ultrasonic scalpel generated plume contained Large quantities of cellular debris (>1x107particles/ml) almost approximated to be one-quarter the amount of particle concentration when compared with the plume generated by dissection of a similar amount of tissue with electrocautery.[28] The liquid (blood or serum) aerosol concentration
Disadvantage of HS The only Great disadvantage with Harmonic Scalpel is that it is very costly. Conclusion Harmonic scalpel has a definite edge over clips used for laparoscopic cholecystectomy. 1. Alfred Cuschieri ,Department of Surgery, Ninewells Hospital and Medical School, University of Dundee, Dundee, Scotland, U.K. 5. Huang X, Feng Y, Huang Z (1997) Complications of laparoscopic cholecystectomy in China: an analysis of 39,238 cases. Chinese 7. McMahon AJ, Fullarton G, Baxter JN, O_Dwyer PJ (1995) Bile duct injury and bile leakage in laparoscopic cholecystectomy. Br JSurg 82: 307–313 8. Miroshnik M, Saafan A, Koh S, Farlow J, Neophyton J, Lizzio J,Yee F, Ethell T, Bean A, Fenton-Lee D (2002) Biliary tract injury in laparoscopic cholecystectomy: results of a single unit. ANZ J Surg 72: 867–870. 9. Muhe E (1986) Die erste Cholecystektomie durch das Laparoskop:English summary. Langenbecks Arch Klin Chir 369: 80411. Nathanson LK, Easter DW, Cuschieri A (1991) Ligation of the structures of the cystic pedicle during laparoscopic cholecystectomy. Am J Surg 161: 350–354. 12. Laparoscopic Cholecystectomy: Retrospective Comparative Evaluation of Titanium versus Absorbable ClipsLapo Bencini, Bernardo Boffi, Marco Farsi, Luis Jose Sanchez, Marco Scatizzi, Renato Moretti. Journal of Laparoendoscopic & Advanced Surgical Techniques. April 1, 2003, 13(2): 93-98. Doi: 10.1089/109264203764654713. 13. Shea JA, Healey MJ, Berlin JA, Clarke JR, Malet PF, StarocikRN, Schwartz JS, Williams SV (1996) Mortality and complications associated with laparoscopic cholecystectomy. Ann Surg 224: 609–620. 14. Wise US, Glick GL, Landeros M (1996) Cystic duct leak after laparoscopic cholecystectomy: a multiinstitutional study. Surg Endosc10: 1189–1193 15. J Laparoendosc Adv Surg Tech A. 1999 Oct;9(5):441-4. Alberts MS, Fenoglio M, Ratzer E.Department of Surgery, Exempla Saint Joseph Hospital, Denver, Colorado 80218, USA. 16. Med Sci Monit. 2005 Mar; 11(3):CS16-8. Mouzas IA, Petrakis I, Vardas E, Kogerakis N, Skordilis P, Prassopoulos P.Gastroenterology Department, University Hospital, Heraklion, Greece. mouzas@med.uoc.gr. 17. World J Gastroenterol. 2007 Dec 21;13(47):6446-8Dolay K, Alis H, Soylu A, Altaca G, Aygun E.Bakirkoy Egitim ve Arastirma Hastanesi Genel Cerrahi Klinigi Endoskopi Unitesi Istanbul, Turkey. dolayk@yahoo.com 18. J Hepatobiliary Pancreat Surg. 2002; 9(2):274-7. Tsumura H, Ichikawa T, Kagawa T, Nishihara M, Yoshikawa K, Yamamoto G.Department of Surgery, Funairi Hospital, 14-11 Funairisaiwai-cho, Naka-ku, Hiroshima 730-0844, Japan. 19. Am Surg. 2001 Sep; 67(9):901-6. Wasserberg N, Gal E, Fuko Z, Niv Y, Lelcuk S, Rubin M.Department of Surgery B, Rabin Medical Center, Beilinson Campus, Petah Tiqva, Israel. nirwg5@012.net.il 20. Ammann K, Kiesenebner J, Gadenstätter M, Mathis G, Stoss F.Department of General Surgery, University Hospital, Innsbruck, Austria.N Z Med J. 2005 Feb 25; 118(1210):U1318 21. Clipless Cholecystectomy: Broadening the Role of the Harmonic Scalpel Westervelt, James1Source: JSLS, Journal of the Society of Laparoendoscopic Surgeons, Volume 8, Number 3, July - September 2004 , pp. 283-285(3) 24. I. M. C. Janssen , D. J. Swank , O. Boonstra , B. C. Knipscheer , J. H. G. Klinkenbijl ,Department of Surgery, Rijnstate Hospital Arnhem, The Netherlands 26. David N. Armstrong1 Wayne L. Ambroze1, Marion E. Schertzer1 and Guy R. Orangio. 28. Ott D E, Moss E and Martinez K, “Aerosol exposure from an ultrasonically activated (harmonic) device”, J. Am. Assoc.Gyn. Laparoscopists, 5(1) (1998), pp. 29–32. 29. Amaral J F, “The experimantal development of an ultrasonically activated scalpel for laparoscopic use”, Surg. Laparosc.Endosc, 4 (1994), pp. 92–99. 30. Johnson G K and Robinson W S, “Human Immunodeficiency virus – 1 (HIV – 1) in the vapors of surgical power instruments”, J. Med. Virology, 33 (1991), pp.47–50. |
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