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Helica.co.ukHELICA* - A RevolutionaryNew Surgical Treatment forEarly Stage Endometriosis North Florida Regional Women’s Centre
PO Box 147600, Gainsville, Florida, FL 32614 – 7006
Helica* - A Revolutionary New Surgical
Treatment For Early Stage Endometriosis
by Richard King, M.D.
Obstetrician/Gynecologist in private practice
Endometriosis can effect up to 10% of women in the reproductive age group and up to 35% of infertilewomen.1, 2 A novel and revolutionary new treatmentnow exists for laparoscopic treatment of early stageendometriosis - the Helica Thermal Coagulator. TheHelica is safer, more thorough, easier to use, and lessexpensive than any current laparoscopic modality INTRODUCTION
Endometriosis has been described since the eighteen hundreds. It may be defined as the condition in which endometrial tissue is found in various extrauterinelocations. The most common locations are the ovaries, uterine ligaments (round,broad, uterosacral and pelvic peritoneum) and bowel.3, 13 Endometriosis atlaparoscopy is found two to three times more often (approximately 35%, more often)in infertility patients than in the normal population.2 Sampson's paper in 1927 "Peritoneal Endometriosis Due to Menstrual Dissemination of Endometrial Tissue Into the Peritoneal Cavity" introduced the termendometriosis. Sampson established the most prevalent theory of development ofendometriosis being retrograde flow of endometrial tissue through the fallopian tubesduring menstruation.1 Endometrial lesions can vary in appearance from "typical" powder bum lesions to very "subtle" lesions such as blebs.5, 14 A significant finding by Dr. Dan Martin wasthat microscopic endometriosis was present in normal appearing peritoneum in ahigh percentage of patients .6, 10, 15 Symptoms of endometriosis are pelvic pain, dysmenorrhea, dyspareunia, dyschezia (pain with defecation) and infertility.5, 6 The pain of endometriosis appearsto be inversely proportional to the amount of disease found by laparoseopy.3 Pre and post surgical treatment of endometriosis has varied from actual pregnancy to pseudopregnancy with continuous hormonal therapy, progestationalagents, birth control pills, danazol and lupron.
Surgical treatment has consisted of excision or ablation with either electrocautery or carbon dioxide laser. These treatments can be very time-consuming, have a high failure rate and can be expensive.
The American Fertility Society Revised Classification of Endometriosis is the currently accepted method for staging endometriosis with stages varying from StageI (minimal) to Stage IV (severe).4 FRONTIERS OF THERAPY
Maurice Howieson, an engineer in Edinburgh, Scotland, developed the Helica Thermal Coagulator with the specific task of solving problems associated with softtissue coagulation.
The Helica works by combining low-pressure helium gas with low AC electrical power (approximately 4-6 watts) which passes along a single insulated probe.12 It isused in a non- touch method approximately 3-5 mm away from the tissue.10Coagulation is activated at this distance and a temperature of 800 degreescentigrade is achieved. Because the coagulation is in a helium environment there isno smoke, no carbonization and decreased scanning. By using low wattage, tissuecoagulation is limited to one millimeter. Depth and width of coagulation in differentpower settings and distances from tissue has been performed.7, 8, 11, 12 All studiesperformed showed a very controlled depth of coagulation with little chance ofdamage to the surrounding tissue.9, 10 As with any laparoscopic technique (coagulation or laser) damage can occur if the beam is held in one area for a longperiod of time. In an in vitro comparison of helium thermal coagulation and argonbeam coagulation the depth of bum with the Helica at 6 watts in liver tissue was0.43mm at 4 seconds and 0.83mm at 10 seconds. With the Helica in muscle tissueat 6 watts and 4 seconds depth of burn was 0.20mm and at 10 seconds 1.03mm.8Since a visual flame is seem through the laparoscope the area to be treated is veryeasily seen and controlled.
The Helica is now in use to treat endometriosis laparoscopically in Scotland in over fifty hospitals.7, 9, 10 There have been no untoward effects to date. The HelicaThermal Coagulator was awarded the John Logie Baird Award for Innovation in1997, awarded a Millennium Product Award in May 1999, and obtained FDA approvalin July 1999.
The Helica was first used in North America at North Florida Regional Medical Center in April of 2000. Since that time eight patients with pain have beensuccessfully treated without side effects. The technique of treatment was learnedfrom Scottish OB-GYNS with five years of Helica experience. The Scottish physicianstreat a large area around any endometriosis that is found, sometimes including theentire cul-de-sac and peritoneum over the bladder. This procedure correlates withthe studies of Dr. David Redwine who theorized the pain of endometriosis originatedfrom the peritoneum and if one removed the entire peritoneum the pain wouldresolve.15 Recent studies using Patient Assisted Laparoscopy has shown that thepain associated with endometriosis extended well beyond the visible lesion.11 INSTRUMENTS
The Helica machine weighs approximately twenty pounds and is smaller than a briefcase. It comes on a self-contained rolling cart. When used it only has to beplugged into AC current, the patient electronically grounded and a physician-activated foot pedal put in place. The machine is already attached to a small tank ofhelium, which should last approximately two hundred cases. A sterile probe ispassed off and is plugged into the machine. The probe is tested against a wet 4x4.
The set up time is less than three minutes. For laparoscopic cases the power is seton low and the rheostat on approximately 4-6 watts.
Preoperatively, the patient is given 200-mg celebrex the morning of surgery with a sip of water and each morning for two mornings after surgery. This procedurehas been found to decrease postoperative pain.
The patient is put to sleep under general anesthesia and placed in Allen stirrups. The bladder is drained and a manipulator is placed on the cervix. A 10-12mm trocar and sleeve is placed in the umbilicus after infiltrating with 3cc 1-%marcaine with epinephrine. Two interdyne 5mm trocars and sleeves are placedunder direct visualization. After infiltration with 2cc 1-% marcaine with epinephrineapproximately four finger- breadths above the symphysis pubis and four-cm lateralto the midline. This is higher than the normal location for second and third problesbut allows the Helica to be kept at right angles to the tissue being treated because itis easier to use at this angle.
The Helica is placed through the second or third 5mm sleeve and all areas of endometriosis and surrounding tissue are treated. If endometriosis is found in thecul-de-sac then the entire cul-de-sac is treated. An area two to four inches is treatedaround the area of endometriosis. Since the beam and the tissue treated can beeasily visualized a circular technique of increasing size or painting technique going upand down or sideways allows the treatment of a large area rapidly. All patients thusfar have been treated in less than twenty minutes.
Once all areas are treated a 20 cc syringe is placed on the veries needle with 0.5% marcaine and the anterior cul-de-sac is sprayed with 10cc and the posteriorcul-de-sac with 10cc. This process is thought to decrease the pain associated withcoagulation of a large area of peritoneum.
The patients go home within one and one-half hours. There have been no adverse side effects and all patients thus far have been pleased with the treatmentand results.
Endometriosis is present in 30%-40% of women with the complaint of pelvic pain. Pelvic pain and infertility are the two most common complaints of patients withendometriosis6 and these two complaints represent a large portion of the indicationfor diagnostic laparoscopy. The aggressive nature of early stage endometriosis hasbeen shown biochemically.5 Wheeler and Malinah found the cumulative three and five-year recurrence rates after surgery to be 13.5% and 40.3% respectively.2 After seven years 56% ofall treated patients had a recurrence.1 In a report by Dr. P. Dewart from Scotland, in twenty-four patients with follow-ups of four to twenty-five months there was a 50% decrease in pain and 80%decrease in dyspareunia.9 In Cummings and Phillips paper from Scotland, it wasreported that 60% of patients had improvement or cure after three months.11Currently no long-term studies of Helica treatment exist to determine recurrence ofendometriosis and or symptoms.
The Helica Thermal Coagulator has been found to be easy to use, very fast because the results are visual and safer than coagulation or laser treatments. Areasof early endometriosis have been treated over bowel, bladder, ureter and majorblood vessels without untoward effects. Since a large area of peritoneum wastreated in all cases it is hoped improvement will occur in results based on patientsperception of pain. A study in this regard is currently underway.
The Helica Thermal Coagulator represents a new frontier in the treatment of early endometriosis. It is easy to use, a large amount of tissue can be treatedrapidly and the chance of injury to surrounding tissue is minimal. Six years ofresults from Scotland show good results both initially and in the short-term. Long-term studies are underway to determine the rate of recurrence of symptoms andwhether a decrease in infertility occurs.
1 Speroff L, Glass R., Kase N. Clinical Gynecologic Endocrinology and lnfertility.
Baltimore, Williams and Wilkins, 853-871, 1994.
2 Nunley W., Mtchin J. "Endometriosis'. Gynecology and Obstetrics. Philadelphia, 3 Novak E., Jones G, Jones H. Novak’s Textbook of Gynecology. Baltimore, Williams 4 The American Fertility Society Revised Classification of Endometriosis. 1985.
5 McCarus S. “Early-Stage Endometriosis and Pelvic Pain". The Female Patient. 6 Scialli,A. “Using GnRH-a Following A Negative Laparoscopy”. OBG Management. 7 Marias J. “Depth of Tonsillar Burns Produced By Helium Thermo-Coagulation.” 8 "In Vitro Comparison Of Helica Thermal Coagulation and Argon Beam Coagulator.
9 Dewart, P. “Helica Thermal Coagulator.” Helica Instruments Ltd.
10 Donaldson K., Hawthorn R. Helica Thermal Coagulator Medical Reports. “Laparoscopic Use of The Helica Thermal Coagulator". 1995.
11 Cumming G., Phillips K. Helica Thermal Coagulator Medical Reports. “Another Wave At An Old Chesnut: The Helium Beam Coagulator In The Treatment of 12 Turvill J.L., Domizio P. Helica Thermal Coagulator Medical Reports, “Assessment Of The Helica T. C. In Vivo: Effect of Duration of Exposure and Power Setting
on Tissue Injury".
13 Weed J, Ray J. Obstetrics and Gynecoloy, “Endometriosis Of The Bowel". 1987.
14 Martin D. The Female Patient. "Endometriosis Subtle Lesion". 48-54, 1994.
15 Demco L. Journal Of The Society Of Laparoendoscopic Surgeons; “Review Of Pain Associated NVith Minimal Endomeuiosis; The Society ofLaparoendoscopic Surgeons, Inc.; 2000* For more information visitwww.Helica.co.uk
CRUCIBLE online If chance favours the prepared mind, what can we do to prepare those minds? ««« By Peter Child, PhD Peter Child has a BSc. in chemistry (McMaster) and a PhD in biochemistry (Toronto). He has been on faculty at the Department of Medical Biophysics at the University of Toronto then moved into the environmental field in the late 1980s. In 1991, he co-founded Investigative S