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International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 “Internal Haemorrhoids ManageMent: Injection ScleroTherapy, An Introspection.” Prof. Dr. Anil K. Sahni M.S, F.I.C.S, Advanced D.H.A A-1/F-1 Block-A DilShad Garden Delhi-110095 India. Mobile-09873083100 Dr.(Mrs.)Poonam Sahni, M.B.B.S, DGO(Gold-Medalist) A-1/F- 1 Block-A DilShad Garden Delhi-110095 India. ‘ABSTRACT’: The Complications & Resultant Morbidities, Following Conventional Operative ManageMent Of Haemorrhoidal Disease Specifically InterNal Haemorrhoids, Has Been Significantly Reduced By Evident Differentially Comparable Result OutComes Of ‘Less-Invasive Surgical Procedures’, In Recent 2-3 Decades. The Availability Of Gradually Efficient ‘Sclerosing Agents’(SA), Re-Established ‘Sclerotherapy’ As Better AlterNativeTo ‘Classical Haemorrhoidectomy’ & Other Procedures. The Present Study Deals With, ‘InterNal Heamorrhoids’(IH)SuccessFul Management By Injection ScleroTherapy(IS), In Large No. Of Patients By- Discrete ‘Case Selection’ Based Upon Clinical History, Exam., Recurrence, Aetio-Pathogenesis, Associated Co-Morbidities(Local & Or Systemic) Evaluations Etc. After Meticulous ‘Pre-Operative Preparations’, Using Proper Dosage Of Appropriate ScleroScant, Instilled Adopting Described ‘Surgical Technique’, With CareFul Post-Operative Care Compliance, Comprising Supportive Measures, Including Life Style Modifications, Dietary Regime, Sitz’s Bath, Medications & Others. The Innovated Procedural Technique, For ScleroSant Injection Of InterNal Haemorrhoidal Disease, Simple, Safe, EcoNomical, OPD Procedure With Ease Of Performance, & Needs Commonly Available AppliancesAppropriate ScleroSant, 2/5 CC Sterile Syringe, No.21/23 Spinal Needle, Proctoscope & Proper Light Source Etc.Following Discrete Clinical Assessment Of Involved Ano-Rectal Pathology For Susceptible Case Selection Group, Properly Secured ‘Pre-Procedural Preparations’, Utlizing Described ‘Surgical Technique’ Meticulously, With Subsequent Cautious ‘Post- Procedural Care & Follow Up’ Compliances, Upto 90% Sign, Symptom Free Recovery Had Been Observed. With Strict Compliance For Case Selection, Pre & Post Procedual Cares, Methodically Performed ‘Surgical Procedural Technique’, Injection ScleroTherapy Management For InterNal Heamorrhoids Can Be Safely Authenticated As A ‘ManageMent Modality’ With Comparable Result OutComes, Especially In Regions Of Disease Prevalence, Recurrences(With/WithOut Previous Surgery) And Associated Co-Morbidities Of Different Origin & Extent Including Infection Inflammation, Trauma, Malignancy & Others. KEY WORDS1. Ano-Rectal Internal Haemorrhoidal Disease 2. Conventional Surgical TreatMent Complications Morbidities 3. Minimally Invasive/Less Invasive Procedures 4. Clinical AssessMent Based Case Selection 5, Pre-Procedural Pre-Requisites 6. Injection ScleroTherapy Technique Efficay: OverAll Result OutCome ---------------------------------------------------------------------------------------------------------------CORRESPONDING AUTHOR: Mobile-09873083100 R S. Publication, [email protected] Page 85 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 I. INTRODUCTION Recent 2-3 Decades Witnessed Reduction In, Conventional Operative Management Of Haemorrhoidal Disease (Specially For Internal Haemorrhoids) Associated Statistics Of Varying Complications, Resultant Morbidities & Sometimes Fatal Consequences, By Gradually Available Various Less-Invasive Surgical Procedures (Rubber Band Ligation, Procto-Colo-Endoscopic Injections, Diathermy, Bipolar Diathermy, Direct-Current Electrotherapy, Infrared Photocoagulation, Cryotherapy, Laser Ablation, Laser Photocoagulation Etc.), With Comparable Differential Result Outcomes. [1][2] Gradually Efficacious ‘Sclerosing Agents’Availability, Supported By Appropriate Infection Control & Proper Procedural Technique, Established ‘Injection ScleroTherapy’, As Safe & Efficacious AlterNative To Excisional Haemorrhidectomy (First Described By Milligan And Morgan), In Selective Group Of Patients. The Present Study Deals With , InterNal Heamorrhoids SuccessFul Management By Injection ScleroTherapy, In Large No. Of Patients ‘Case Selection Group’, Based Upon-Discrete Clinical AssessMent Of Involved Ano-Rectal Pathologies, Evaluation Of Associated Co-Morbidities (Local & Or Systemic), Aetio-Pathogenesis, Recurrences,Other Involved Factors & Discussed ManageMent Modality. II. HAEMORRHOIDAL DISEASE DEFINITIONHemorrhoids, Also Spelled Haemorrhoids, Are Vascular Structures In The Anal Canal. In Their Normal State, They Are Cushions That Help With Stool Control. They Become A Disease (Swollen Or Inflamed) By Enlargement And Lead To Distal Displacement Of The Normal Arteriovenous Anal Cushions, That May Prolapse Through The Anal Canal. The Unqualified Term "Hemorrhoid" Is Often Used To Mean The Disease [Hem´Ŏ-Roid]: Tortousity Of Rectal Vein Or An Enlarged (Varicose) Vein In The Mucous Membrane Inside Or Just Outside The Rectum; Also Called As Hemorrhoids Or Pile. R S. Publication, [email protected] Page 86 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 Complications Of Haemorrhoids Strangulation And Thrombosis Ulceration Gangrene Portal Pyaemia Fibrosis CLASSIFICATION OF HAEMORRHOIDS Different Texts Use Different Methods Of Classification But Following Is Common Classification: First-Degree Haemorrhoids: Confined To Anal Canal – May Bleed But Do Not Prolapse Second-Degree Haemorrhoids: Prolapse On Defecation, With Spontaneous Reduction Third-Degree Haemorrhoids: May Prolapse Spontaneously Or With Defecation And Remain Persistently Prolapsed Outside The Anal Margin Unless Digitally Reduced Fourth-Degree Haemorrhoids: Irreducible Prolapse Other Classification1. External- Distal To the Pectinate Line. Covered Proximally By AnoDerm & Distally By Skin (Both Sensitive To Pain & Temperature.) 2. InterNal-Originating Above The Pectinate Line & Covered By Mucous Membrane. Covered By Columnar Eithelium That Lacks Pain Receptors. 3. Externo-InterNal 4. Prolapsed Haemorrhoid-An InterNal Hemorrhoid That Has Descended Below The Pectinate Line & Protruded OutSide The Sphincter. 5. Strangulated hemorrhoid- An InterNal Hemorrhoid That Has Prolapsed Sufficiently And For A Long Enough Time For Its Blood Supply To Be Come Occluded By The Constricting Action Of Anal Sphincter. ‘External Haemorrhoids’ Is A Non-Specific Term That Should Not Be Used. It Is Applied To Several Conditions: • Perianal Haematoma Or Thrombosed Perianal Varices: Thrombosis Of The Superficial External Haemorrhoidal Plexus Beneath The Skin Of The Distal Anal Canal Below The Dentate Line. Have Been Called ‘A 5-Day, Painful, Self-Curing Lesion’ (Milligan). • Sentinel Pile: A Tag Of Skin At The Outer Edge Of A Fissure In Ano • Perianal Skin Tags: Usually Formed By Resolved Prolapsed Internal Haemorrhoids • Third- Or Fourth-Degree (Prolapsed) Haemorrhoids. External Haemorrhoids R S. Publication, [email protected] Page 87 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 HAAEMORRHOIDS CLASSIFICATION ( 1985 ) Internal Hemorrhoid Grades Gra de Diagram Picture 1 2 3 4 Four Grades Based On The Degree Of Prolapse: Grade I: No Prolapse, Just Prominent Blood Vessels Grade II: Prolapse Upon Bearing Down, But Spontaneous Reduction Grade III: Prolapse Upon Bearing Down Requiring Manual Reduction Grade IV: Prolapse With Inability To Be Manually Reduced. DIFFERENTIAL DIAGNOSIS *Several Anorectal Problems, Including Fissures, Fistulae, Perianal Haematoma Due To Trauma • Perianal Or Ischiorectal Abscess, Tumour Of The Anal Margin • Prolapsing Rectal Polyp Colorectal Cancer, Rectal Varices, And Pruritis, Have Similar Symptoms And May Be Incorrectly Referred To As Hemorrhoids. *Rectal Bleeding May Also Occur Owing To Colorectal Cancer, Colitis Including Inflammatory Bowel Disease, Diverticular Disease, And Angiodysplasia. *If Anemia Is Present, Other Potential Causes Should Be Considered. *Other Conditions That Produce An Anal Mass Include Skin Tags, Anal Warts, Rectal Prolapse, Polyps, And Enlarged Anal Papillae *Anorectal Varices Due To Increased Portal Hypertension (Blood Pressure In The Portal Venous System) May Present Similar To Hemorrhoids But Are A Different Condition. Portal Hypertension Does Not Increase The Risk Of Hemorrhoids. *Carcinoma Of The Rectum Associated With Haemorrhoids, Remains A Not Infrequent Diagnostic Pitfall. MANAGEMENT Exclusion Of Other Pathology- Rectal Bleeding Or Unexplained Anaemia Should Not Be Always Attributed To Haemorrhoids Unless Other, More Serious Causes Are Excluded. Depending On The Symptoms And Age Of The Patient, Sigmoidoscopy, Colonoscopy, Gastroscopy Or Contrast Studies May Be Appropriate. Predisposing Causes, Such As Pelvic Malignancy Or An Abdominal Mass, Should Also Be Excluded By Careful Examination. [3] R S. Publication, [email protected] Page 88 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 Specific Treatment Is Often Not Needed. Initial Measures Consists Of-Conservative/ Supportive Therapy & Subsequent Procedures-A Number Of Office-Based Procedures May Be Performed. While Generally Safe, Rare Serious Side Effects Such As Perianal Sepsis May Occur. [11] [12] [13] [14] [15] [16] [17] [18] [19] Rubber Band Ligation Cauterization Methods -Using Electrocautery,Infrared Radiation,Laser Surgery, Or Cryosurgery. Infrared Cauterization May Be An Option For Grade 1 Or 2 Disease. In Those With Grade 3 Or 4 Disease, Reoccurrence Rates Are High Electrocoagulation Using Direct Current With Bipolar Probes Decreased The Complications Of Sclerotherapy And Gave Higher Cure Rates. Although More Painful, It May Be Regarded As A Safe, More Effective And A Highly Satisfying Procedure For Treating 1st And 2nd Degree Piles. SCLEROTHERAPY-[26] [27] [28] [29] [30] [31] [32] [33] [34] [35] [36] Scle·Ro·Sant (Sklē-Rō'sănt)An Injectable Irritant Used To Treat Varices By Producing Thrombi In Them. ( Farlex Partner Medical Dictionary © Farlex 2012), Sclerotherapy Is Time Honored, Simple, Safe And Cost Effective , Out Patient Procedure That Is Widely Practiced Globally To Treat Hemorrhoids. It Started About One And A Half Century Ago And Was First Advocated In US By Blackwood In 1866. Sclerotherapy Involves The Injection Of A Sclerosing Agent, Such As (Phenol, Hypertonic Saline And Absolute Alcohol) Into The Hemorrhoid. This Causes The Vein Walls To Collapse And The Hemorrhoids To Shrivel Up. Sclerotherapy Treatment Of Blood Vessels Or Blood Vessel Malformations (Vascular Malformations) And Also Those Of The Lymphatic System., Spider Veins(Telangiectasiae), Smaller Varicose Veins, And Hemorrhoids, Is In Common Practice. Many Sclerosants Are Being Used With Variable Efficacies. Further Work On Improving The Technique And Development Of Safer More Effective Sclerosants Continued Through The 1940s And 1950s. Of Particular Importance Was The Development Of Sodium Tetradecyl Sulfate (STS) In 1946. Availability Of Newer And Safer Sclerosants, Such As 5% Phenol In Almond Oil,Phenol In Arachus Oil, Sodium Tetradecyl Sulphate, Polidocanol, Quinine, Urethane, Ethanolamine Oleate, Aetoxisclerol Xiao Zhi Lign (XZL-Consisting Of Chinese Nutgalls And Aluminium Potassium Sulphate), And Most Recently OC-108, 50% Dextrose, Hypertonic Saline And Absolute Alcohol Have Been Used In Clinical Trials Previously . However The Long Term Results And Efficacies Are Yet To Be Established. Flexible Video-Endoscopic Newer Technique Methodology. Assisted Injection Sclerotherapy- Foam Sclerotherapy Is A Technique That Involves Injecting “Foamed Sclerosant Drugs” Within A Blood Vessel Using A Pair Of Syringes – One With Sclerosant In It And One With Gas (Originally Air). The Original Tessari Method Now Modified By The Whiteley-Patel Modification, Uses 3 Syringes(All Silicone Free). The Sclerosant Drugs (Sodium Tetradecyl Sulfate Or Polidocanol) Are Mixed With Air Or A Physiological Gas (Carbon Dioxide) In A Syringe Or By Using Mechanical Pumps, Increasing The Surface Area Of The Drug. The Foam Sclerosant Drug Is More Efficacious Than The Liquid One In Causing Sclerosis. R S. Publication, [email protected] Page 89 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 Complications Due To An Intense Inflammatory Reaction To The ScleroSant ,While Rare, Can Be Serious Sometimes, IncludeVenous Thromboembolism, Visual Disturbances, Allergic Reaction,Thrombophlebitis, Skin Necrosis, And Hyperpigmentation Or A Red Treatment Area. Reported Rare Complications - Liver Absces, Life Threatening Retropenitoneal Sepsis And Nectrotizing Fascitis Of The Perineal Region, Phenol Induced Chemical Hepatitis. Majority Of Complications Associated With Inj. ScleroTherapy Are Urological. Despite All These Associated Complications, Injection Sclerotherapy, Because Of Its Ease Of Use And Effectiveness, Is The Widely Used Nonsurgical Method Of Haemorrhoids Tt. [37] [38] [39] [40] [41] SURGERY A Number Of Surgical Techniques May Be Used If Conservative Management And Simple Procedures Fail. [4] [5] [6] [7] [8] [9] [10] Excisional Hemorrhoidectomy Is A Surgical Excision Of The Hemorrhoid Used Primarily Only In Severe Cases. It Can Be Performed Using An Open (Milligan–Morgan Operation) Or A Closed Technique. Pedicle Ligation /Suture TransFixation Of Haemorrhoid, Lord’s procedure(Anal Dilatation), Complications Of Haemorrhoidectomy Early- Pain-Severe Post Op Pain( Incorporating The Sphincter Into The Transfixion Ligature Causes Severe Postop Pain) Acute Retention Of Urine, Constipation: Avoided By Postop Analgesia And Laxatives, Reactionary Haemorrhage Late-Secondary Haemorrhage, Anal Stricture / Stenosis- Due To Failure To Leave A Bridge Of Epithelium Between Each Excised Haemorrhoid, Anal Fissure- Due To Poor Healing,Submucous Abscesses Anal Ectropion-Submucosal Prolapse- The Anal Mucosa Becomes Everted From The Anus, Similar To A Very Mild Form Of Rectal Prolapse. Incontinence- Damage To The Anal Sphincter Other Postoperative Complications Doppler-Guided, TransAnal Hemorrhoidal DearterializationA Minimally Invasive Treatment Using An Ultrasound Doppler To Accurately Locate The Arterial Blood Inflow. Stapled Hemorrhoidectomy, Also Known As Stapled Hemorrhoidopexy, Involves The Removal Of Much Of The Abnormally Enlarged Hemorrhoidal Tissue, Followed By A Repositioning Of The Remaining Hemorrhoidal Tissue Back To Its Normal Anatomical Position. x 73.11 III. INJECTION SCLEROTHERAPY: MANAGEMENT METHODOLOGY The Present Study Deals With Comprehensive “Management Methodology” For Internal Haemorrhoids Tt. By Injection Sclero-Therapy, Rendered Maximally SuccessFul By, Meticulous ‘Case Selection’ & ‘Pre-Procdural Preparations’, Using Proper ‘Procedural Technique’, With CareFul Post-Operative Care & Evaluation Compliance, For Subsequent NeedFuls. R S. Publication, [email protected] Page 90 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 The ‘Case Study Group’, Included Several Cases Of Bleeding P/R Caused By Different Clinical Entities Like Ano-Rectal Ulcerative Disease?Trauma, Haemorrhoids With Malignancy, Coagulopathies Induced Bleeding P/R From Haemorrhiodal Disease Or Redudant Anal Mucosal Prolapse In Patients With Chr. Debilitating Diseases Like Diabetes, Hepato-Renal DysFunction, Hypertension, HyperLipidaemia, Ischaemic Heart Dis. On Aspirin Therapy & Diabetes Etc., As Palliative Or SomeTimes Only AvailAble Tt., In Limited Resources Circumstances. The Innovated Procedural Technique For ScleroSant Injection Of InterNal Haemorrhoidal Disease, Is Simple, Safe, EcoNomical, OPD Procedure With Ease Of Performance, & Needs Commonly Available Appliances- 2/5 CC Sterile Syringe, No.21/23 Spinal Needle, Proctoscope & Proper Light Source Etc. The OverAll Success Of The Discussed ManageMent Methodolgy Is Based UponI. Proper Case Selection II. Pre- Procedural Pre-Requisites Compliance III. Proper Procedural Technique IV. Post- Procedural Care, Follow-Up & Required NeedFul. I. PROPER CASE SELECTION- Case Selection Group Was Determined By Ano-Rectal Pathologies Evaluation, Based Upon1. Clinical Assessment Clinical History- Age, Sex, Occupation, Residence, Obstetrical History Bleeding, Pain, Bowel Habits, Total Duration Of Illness, Recurrence, Previous Treatment; Conservative, Surgical Intervention H/oWorm Infestation, Irritable Bowel Disease, Crohn’s Dis., Ulcerative Colitis Etc. Clinical Exam-Relevant General & Systemic Exam. In Regards To Portal HyperTension & Varicose Disease DRE-Digital Rectal Exam(Per-Rectal Exam.) ProctoScopy For- ExterNal/InterNal/ Externo-Internal Haemorrhoids ( Grades), Ano-Rectal Mucosa Status & Co-Existing Lesions. The Position And Size Of The Haemorrhoids Is Noted As Clock-Face Numbers, As If The Patient Were In Lithotomy (ie Anterior Is 12-O’clock Lithotomy, Posterior Is 6-O’clock Lithotomy, Right Lateral Is 9-O’clock Lithotomy, Left Lateral Is 3-O’clock Lithotomy). Further Bi-Manual, InterNal- Per-Vaginal(PV) Exam. Gynae. Check Up, May Be Needed In Adjacent Pelvic Organs- Urinary Bladder, Rectum, Uterine Pathologies e.g Tumours ? Malignant Origin, Prolapse, Uterine Decent Of Various Grades, Cysto-Rectocele & Others. Recurrent Disease Cases- Need Complete Evaluation In Regards Too Previous ManageMent (Medical Treatment, Non-Invasive Procedures, Surgical Interventions). o Assessment In Consideration Of Aetio-Pathogenesis Causative, Precipating Factors For Increased Inta-Abdominal Pressures Like Chronic Cogh, Constipation, Obstructive UroPathies, Pregnancies, GeoLogical Prevalence Including Gravitational Force Factor & Others. R S. Publication, [email protected] Page 91 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 Co-Morbidities AssessMent – In Consideration Of Other Medical Illnesses, Porto-Systemic Circulatory DisOrders , Age Related Debilitating Diseases. Generalized Varicose Disease- Suggestive Consideration, Necessarily IncludesHistory Pertaining To Portal HyperTension , Oesophageal Varices, , Varicocele, Inferior Extremities Varicose Veins, Venous Ulcers & Varicosities Any Where Else In The Body. 2. Investigatiory Evaluation- Clinico-Patho-RadioDignostic Evidence Support ForProctitis(Specific, Non Specific), Helminthiasis, Irritable Bowel Disease(IBS), Crohn’s Dis. Ulcerative Colitis, Malignancy, Ano-Rectal Ulcers & Involved Systemic CoMorbidities Essentially Includes- 1.Stool-Routine , MicroScopic , C&S With Rectal Swab For: • Protozoa And Bacteria, Cryptosporidium Spp. And Atypical Mycobacteria • Viruses (Eg Herpes Simplex) • Cytomegalovirus (CMV) And Kaposi’s Sarcoma 2.Needed ColonoScopy & Biopsy 3. & Others. II. PRE-PROCEDURAL PREPARATION- Of Selected Patients, Comprise Following ‘Essentials’ Control Of Bleeding-Per-Rectal Bleeding;HaematoChaezia Proper Assessment ForTotal Duration, Recurrent Episodes, Associated Pain- Severity, Bleeding - Type, Colour & Amount, Causative AnoRectal Pathology,Other Chronic Debilitating Diseases,CoaguloPathies Etc. Traenaxamic Acid (Oral & Injectible)-Recently AvailAble HaemostatIn Dosage Of 500MgmTDS/QID, To Maximum, As Needed , 4-6 Gms/Day, Have Proven SuccessFul Efficay. Anal Packing Soaked With Adrenaline Or Other Local HaemoStats Have Encouraging Results, Especially In Post-Traumatic Cases Of Different Origin. Infestations (HelMinthiasis Etc.) Control – Needed Doses Titration Albendazole(4ooMgm) HS Once/Twice A Week For 1-2 Weeks, Usually Suffices. HowEver, Resistant Cases May Need,Use Of Pyrantel Palmoate, Secnidazole & Others. Control Of Infection-Inflammation –H/o Irregular Bowel Habits Due To Enteritis Of Amoebic, Bacillary, Mixed Origin, Specific/Non-Specific Proctitis & Others Usually Respond To A Course Of Broad Spectrum AntiBiotic (? Stool C&S), An-Aerob, Analgesic Anti-Inflammatory, Antacid, B-Complex Nutrient Supplement, In Appropriate Dosage & Duration. But Chronic GIT Disorders- Irritable Bowel Disease(IBS), Crohn’s Dis., Ulcerative Colitis, Ano-Rectal Ulcers Of Varying Origin, Malignancy & Involved Systemic Co-Morbidities, Need Proper (Curetive & Or Palliative) ManageMent. Needed Bowel Preparation- Using Cremaffin 3-4 TSF H.S X 1-2 Days, Prior To Procedure, Has Rewarding OutComes. Hygeine Maintainence – Of PeriNeal, Peri-Anal, Gluteal, Natal Cleft, InguinoGenital Region, By Soap & Water Washes, With Needed Shaving. History Suggestive Of Drug Allergy- Is Of Special Significance, In Context Of ScleroSant Of Use e.g H/o Allergy To Nuts In Almond Oil Usage. 2% Xylocaine Senstivity R S. Publication, [email protected] Page 92 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 Sclerotherapy Is Not Performed In Patients Having o History Of Intolerance To Other Sclerosants, o Bleeding Diathesis, o Pregnancy (First And Last Trimester), ? Breast Feeding, o Acute Severe Cardiac Disease, And History Of Recent Thrombosis. o Patients Having Acute Prolapsed And Thrombosed Hemorrhoids, And Inflammatory Anorectal Conditions Like Fissures, Fistula, And Ulcerative Colitis Are Not Included In The Study. 3.PROCEDURAL TECHNIQUE Materials Required- SclerosSant, 2% Lignocaine Solution, Spinal Needle (21,23/24 Guaze), 2/5cc Syringe, Anoscope With Illumination(Torch), Lignocaine Jelly, BetaDine And Sterile Gauze Pieces, Gloves. Patient Position – Left Lateral (Sims') Position- Asking Patient To Lie In Left Lateral Position & Bend Both Knees , So As To Touch Chest/Abdomen, Ensures Ease Of Better Compliance. Bi-Lateral Gluteal Manual Retraction / Adhesive Strapping Per-Rectal Exam. – o 2% Xylocaine Jelly 10-15 Ml Liberal Application & Spreading In Anal Canal With Relevant DRE Is Done. o ProctoScopy – Is Done, With The Obturator Above The Dentate Line. Proper Delineation Of Lesion To Be Sclerosed Is Secured. o Pre- Prepared, 2-5 cc Syringe With Spinal Needle No.21/23 Loaded With ScleroScant(1-2 Ml.) [+ - ] 2% Xylocaine (1-2 Ml.) Is Inserted. Through ProctoScope. o Single Prick, Injection Of Medication , To Lesion At Appropriate Site & Depth, WithOut Spillage, Is The Most Important Result OutCome Determinant. Reported Blanchard Method -Sub Mucosal Injection(Around Pedicle) Of Pre Defined Sclerosant(1cc) Is Given, Bleb Is Raised. Identified Hemorrhoid Mucosa Turns Pale In Contrast To Pink Surrounding Mucosa, Is Comparatively Difficult To Practice In Sessile Lesions, While Has Better Results In Pedunculated/Large Lesions. Needle Withdrawl Slowly After 10 To 15 Seconds, Avoids Bleeding And Leakage Of ScleroSant. Injection Should Be Given Above Dentate Line Where Little Or No Pain Should Be Felt. Safety Profile Of (2) To A Maximum Of Three Injections Per Session, In Selected Few Cases Has Been Observed. For ScleroTherapy, At (2) Or More Different Sites, Proctoscope Re-Insertion, Between The Applications, Ensures Lesion Visualization & Proper Sclerosis, Avoiding Intra-Lesional Mucosal Adherence. If The Patient Feels Sharp Pain On Insertion Of The Needle. The Proctoscope Should Be Repositioned Before The Sclerosant Is Injected. o Gauze Soaked With Xylocaine Jelly & Betadine Solution Is Intoduced Through ProctoSope & Left In Situ Over Injected Pile Mass, While ProctoScope Is Brought Out. Finger Compression For Some Time May Be Done. Control Of Slight Bleeding After The Injection, By Topical Application 1:10000 Adrenaline Solution And A Gauze Piece Left In Place For A While, Has Been Observed. o Patient Were Kept In Supine Position For A Few Minutes And Observed For Any Side Effects, Before Leaving. o Sclerotherapy, Can Be Given Every 3-6 Weeks For A Maximum Of 4-6 Sessions. R S. Publication, [email protected] Page 93 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 o Intra-Procedural Hazards Not Injecting The Sclerosant High Enough: Often Haemorrhoids Prolapse Below The Dentate Line Into The Perianal Sensate Area And So The Procedure Should Be Performed Above The Engorged, Haemorrhoidal Tissue Into Fairly Normal-Looking Mucosa. Injecting Sclerosant Too Deeply: If The Thin-Walled Mucosa Does Not Immediately Balloon Out While Injecting, Pull Back The Needle. Deep Injections Anteriorly Affect The Adjacent Prostate, Urethra Or Vagina. Deep Injections Of Sclerosant: Can Cause Perirectal Fibrosis, Urethritis, Vaginal Or Rectal Oleogranulomas, Pain, Ulcers, Haematospermia Or Impotence. Spilling Sclerosant: Phenol Is Highly Irritant And, If It Is Spilled Or Injected Into The Anal Canal And Runs Out Onto The Perianal Skin,It Will Cause Pruritus And Ulceration. Types Of Procto-Scopes (AnoScopes ) ProctoScopic View: Haemorrhoid 3O Clock Position (a) Steel Made Conventional Gabriel Syringe Has Been Replaced By (b) Disposable Syringe NOTE-Simple Commonly Available 2/5 cc Sterile Disposable Syringe & 21/23 No. Sterile Pack Spinal Needle Have Been Used, During Present Study. R S. Publication, [email protected] Page 94 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 4..POST-PROCEDURAL EVALUATION & CAREImmediate & Long Term Supportive Measures Include Postoperative Management Medications o Local Applications- Different Topical Agents And Suppositories Are Available. Most Preparations Include A Combination Of Active Ingredients. These May Include A Barrier Cream Such As Petroleum Jelly Or Zinc Oxide, An Analgesic Agent Such As Lidocaine, Vasoconstrictor Such As Epinephrine, Glyceryl Trinitrate. Some Contain Balsam Of Peru To Which Certain People May Be Allergic. Steroid-Containing Agents Should Not Be Used For More Than 14 Days, As They May Cause Thinning Of The Skin. o Medications; Symptomatic- Appropriate AntiMicrobials + An-Aerob Combination, Anti-Inflammatory Analgesics, AntAcid, B-Complex Course, In Adequate Dosage & Duration. o Medications; Specific-Calcium Dobesilate In Dosage Of 250/500 Mgm TDS/QID X 3-6 Weeks, Have Documented Beneficial Effects. o Laxatives: Cremaffin White 3-4 Table Spoon Ful H.S, Supported By High Intake Of Fruits,Green Leafy Vegetables, With Needed Dose Titration Demonstrates, Very Good Constipation Control & Normal Bowels Regularization In Vast Majority Of Cases. o Flavonoids Are Of Questionable Benefit, With Potential Side Effects. Pregnancy Induced Haemorrhoidal Symptoms Usually Resolve Following Delivery Thus Active Treatment Is Often Delayed Until. Diet Regulation Constipation Avoidance Achieved By Increasing Fiber Intake By Dietary Alterations Or The Fiber Supplements Consumption, Drinking Fluids To Maintain Hydration Etc. Life Style Modifications (Regular Exercises,Obesity Avoidance Etc.) Sitz’s Bath- To Sit In, Luke Warm Water Tub With 1-2 TSF Betadine Solution For 10-15 Minutes After Stools For 1-2 Times In A Day. Regular Follow Up Of Case- Review In Outpatients In 6 Weeks. Repeat Treatment (Properly Programmed) May Be Needed For Same Or Other Site. If Haemorrhoids Do Not Regress And Or Are Still Symptomatic, Other AvailAble Surgical Options Can Be Considered. TreatMent Result OutCome Evaluatory Determinants Following Result OutComes Are Suggestive Of TreatMent Success Extent1. No Effect: No Effect Or Slight Decrease (0- 25%) In Bleeding Per Rectum. No Shrinkage Of Pile Cores On Proctoscopy. 2. Reduced Bleeding: Noticeable Reduction In Bleeding Per Rectum And The Pile Cores Were Shrunken On Proctoscopy. 3. Fully Cured: Bleeding Per Rectum Was Fully Or Nearly Fully Stopped And The Pile Cores Were Sclerosed On Proctoscopy (>90% Reduction). R S. Publication, [email protected] Page 95 International Journal of Pharmaceutical Science and Health Care Available online on http://www.rspublication.com/ijphc/index.html Issue 6, Vol. 3 (May-June 2016) ISSN 2249 – 5738 At The 8th Week Of Follow Up, Overall Patient Satisfaction Score Can Be Measured. By Patient Marking His Level Of Overall Satisfaction, 0 Meaning Not Satisfied, 1 Meaning Moderate Satisfaction And 2 Meaning Highly Satisfied From The Procedure. Injection Selerotherapy( IS ) Treatment Modality The Three ‘Variables. Pain Score During Procedure - Mild /Moderate /Severe Reduction In Bleeding Per Rectum- No Effect/ Reduced Bleeding /Fully Curved Overall Patient Satisfaction- Not Satisfied /Moderate Satisfaction/Fully Satisfied IV. INFERENCE For Susceptible ‘Case Selection Group’ Comprising Per-Rectal Bleeding & Or Other Manifestations Of Haemorrhidal Disease(Grade I, II, III) Patients, The Discrete Clinical Assessment Of Involved Ano-Rectal Pathology, With Properly Secured Compliace To ‘Described ManageMent Modality’ & Subsequent Follow Up, Observed Upto 90% Sign, Symptom Free Recovery. The Comparative Evaluation Of OverAll Result OutComes, In Limited InfraStructure Skill AvailAbility Circumstances, & Consideration Of Expected InEvitable Mortality & Morbidity OtherWise Accompanying, ‘Special Care Cases’, LikeExtensive, Circumferential Haemorrhoidal Disease, Recurrences (With/WithOut Previous Surgery), Geographical Prevalence Regions Of Disease With/WithOut Associated Co-Morbidities Of Different Origins, Extents (General +- Systemic) & Including Malignancy & Trauma, Encouragingly Provide Significant Support For The Described ManageMent Modality Scope, As Only Sufficient Or Adjuvant Procedure. V. CONCLUSION With the Advantages Of Safe, Secure, Easily Performed, Economical (Man Power, InfraStructure Wise), OPD Procedure, The Described “ManageMent Methodology Of Injection Sclerotherapy” For InterNal Haemorrhoidal Disease, Supported With Strict Compliance To ‘Case Selection’, Preparation, ‘Procedural Technique’, Subsequent ‘Post-Procedural Care & Evaluation’ With Regular FollwUp, For Further NeedFul, Can Be Accepted As Authenticated MangeMent Modality For Internal Haemorrhoidal Disease,With Comparable Result OutComes, Especially For Discussed Specific Care Cases, [42] [43] [44] [45] [46] In Limited Resources Cicumstances. VI. ACKNOWLEDGEMENT With Special Gratitude And Thanks, For All The “Study Material Resources‟ Consulted, Every Involved Personnel, During Last About (3) Decades MultiCentric Observations. & Dr.(Mrs.)Poonam Sahni, M.B.B.S, DGO(Gold-Medalist) For Her Constant Participation. R S. 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