RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. NAME OF THE CANDIDATE AND ADDRESS:

SHINYMOL K.V(SR.CATHERINE FRANCIS)

DEPT OF GENERAL SURGERY

ST. JOHN’S MEDICAL COLLEGE HOSPITAL

JOHN NAGAR, SARJAPUR ROAD,

KORAMANGLA, BANGALORE: 560034

2. NAME OF THE INSTITUTE: ST. JOHN’S MEDICAL COLLEGE HOSPITAL, BANGALORE.

3. COURSE OF STUDY AND SUBJECT: MS GENERAL SURGERY

4. DATE OF ADMISSION TO THE COURSE: 25th MARCH 2010

5. TITLE OF TOPIC: A COMPARATATIVE STUDY OF OPEN SURGERY VERSUS RADIOFREQUENCY ABLATION WITH SCLEROTHERPY FOR THE MANAGEMENT OF VARICOSE VEINS.

6.1 NEED FOR THE STUDY

1. Top of page

2. Abstract

3. Introduction

4. Methods

5. Results

6. Discussion

7. Acknowledgements

8. References

Lower limb varicose veins are the commonest of all the vascular disorders. They may impair quality of life (QoL)Despite their benign nature, varicose veins have considerable clinical and socioeconomic impact. Surgery has been shown to correct this impairment

The commonest underlying cause is incompetence of the great saphenous venous system. Conventional surgery to eliminate this abnormal venous reflux involves saphenofemoral disconnection at the saphenofemoral junction (SFJ) and stripping of the great saphenous vein (GSV) above the knee, frequently accompanied by phlebotomies of minor varicosities. Stripping is not always successful and usually no assessment is made as to whether the stripper has indeed passed down the GSV or in to its tributaries Unsuccessful stripping is likely to increase the risk of recurrence Groin dissection and stripping may cause significant early morbidity owing to bruising, haematoma, pain, cutaneous nerve injury and wound infection, and delay recovery and return to work.

Minimal access endovenous techniques are becoming popular. They involve ablating the GSV using chemical or thermal energy, thus avoiding vein stripping and groin dissection. This might potentially reduce early postoperative morbidity, hasten recovery and enable an early return to normal activities. The Radio Frequency Ablation Closure procedure is used to obliterate the vein lumen with high-frequency alternating current delivered via an endoluminal catheter with bipolar electrodes, placed by percutaneously under duplex ultrasonography. Several studies have demonstrated that the procedure is safe, with a vein occlusion rate of 90–100 per cent and a patient satisfaction rate of over 90 per cent In a developing country like India the benefits of RFA over open surgery in terms of quality of life, early complications etc have to be weighed over its costs. There have been no such studies done in our country .

|2. REVIEW OF LITERATURE | |

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|Over the last decade endovenous ablation has gained popularity over stripping and ligation as a technique for elimination of | |

|saphenous vein reflux. One of the endovenous technique is a radiofrequency based procedure. Newer methods of delivery of | |

|radiofrequency were introduced in 2007. | |

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|The first randomized clinical trial, which included 28 patients in Finland, compared radiofrequency ablation (RFA) with | |

|conventional surgery and demonstrated reduced pain, shorter hospital stay and faster return to normal activities in those who | |

|underwent RFA.[2] Endovenous obliteration hence may offer advantages over the conventional stripping operation in terms of | |

|reduced postoperative pain, shorter sick leaves, and faster return to normal activities, and it appears to be cost-saving for | |

|society, especially among employed patients.[6] Current evidence based on randomized trials consistently demonstrates | |

|significant early benefits after RFA in suitable patients with varicose veins. Five-year outcomes from large cohort studies | |

|appear comparable to those after conventional surgery.[7] Several studies have demonstrated that the procedure is safe, with a | |

|vein occlusion rate of 90–100 per cent and a patient satisfaction rate of over 90 per cent[3] | |

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6.3 OBJECTIVES OF THE STUDY

To compare the short term outcome between open surgery versus endovenous radiofrequency ablation with sclerotherapy done at our centre in terms of pain_less/more. Hospital stay-needed or not Complications-hematoma, nerve injury rates, wound infection.

7 MATERIALS AND METHODS

Study design: prospective comparative observational cohort study.

There is no randomisation in this study.Patients will undergo either open surgery or endovenous Radio frequency ablation depending on patient choice and fitness ability for radio frequency ablation

In RFA very tortuous long saphenous vein is not suitable and in open surgeries fitness for anaesthesia is looked for.

Statistical methods: χ2 test or Fisher's exact test will be used for comparison of proportions, and t test for continuous data. QoL data will be analysed by means of SPSS® for Windows® version 17 using recommended scoring methods and syntax files.

Duration of study: 1st September 2010 to1st March 2012

7.1 Source of data:

50 patients with symptomatic varicose veins who belong to CEAP classification 2-6 due to great sapheno vein (GSV) incompetence, with perforator incompetence admitted in SJMCH will be studied . Data of standard pre operative work up in terms of Clinical and assessment, radiological(varicose vein duplex scan ) will recorded . Patient-based outcomes will record at 1 and 4 weeks after intervention.

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|Inclusion criteria |

|Age between 18 and 70 years, either sex, elective admission |

| GSV reflux (primary or recurrent) on duplex imaging and requiring surgery. |

|Duplex scan confirmed suitability for RFA |

|Patient fit for general/regional anaesthesia |

|Physical condition allowing ambulation after the procedure |

|Patient able to give informed consent |

|Requirement for intervention agreed between patient and surgeon |

|Availability of patients for all follow up visits |

|Exclusion criteria |

|Varicose veins without GSV incompetence on duplex imaging |

|Associated small sapheno and deep venous incompetence on duplex imaging |

|Tortuous GSV above the knee felt to be unsuitable for catheterisation |

|GSV diameter less than 3 mm or more than 12 mm in the supine position |

|Thrombus in the GSV |

|Patients with a pacemaker or internal defibrillator |

|Concomitant peripheral arterial disease(ankle: brachial pressure index less than 0.9) |

|Pregnancy |

7.2 METHODS OF COLLECTION OF DATA

Patients aged between 18 and 70 years who presented to the outpatient department with symptomatic varicose veins ie. Clinical Etiologic Anatomic Path physiologic (CEAP) [ table1] clinical class 2–6 will undergo clinical and radiological assessment. Patients will undergo either open surgery or endovenous Radio frequency ablation depending on patient choice and fitness ability for radio frequency ablation

Table1

|Grade |Description |

|C 0 |No evidence of venous disease. |

|C 1 |Superficial spider veins (reticular veins) only  |

|C 2 |Simple varicose veins only |

|C 3 |Ankle oedema of venous origin (not foot oedema) |

|C 4 |Skin pigmentation in the gaiter area (lipodermatosclerosis) |

|C 5 |A healed venous ulcer |

|C 6 |An open venous ulcer |

Post op period follow up third post op day, at the end of first and fourth post op week. Repeat duplex scan will be done at the end of first post op week. And the following will be recorded:

Immediate post op period:

1. Duration of the surgery

2. Drop in haemoglobin

3. Post op pain scores

4. Post op wound complications in terms of Wound infection and cellulites

End of first post op week:

1. Return to normal activities

2. Patients satisfaction

3. Quality of life

4. Duplex scan assessment to see for GSVablation

Pain will be evaluated using a 10-cm unmarked visual analogue scale (VAS) and patient-reported grading of severity (none, very mild, mild, moderate, severe, and very severe). Patient satisfaction will be assessed using a 10-cm unmarked VAS and a grading system (A to D, with A rated best) based on their willingness to recommend the procedure to others, or to undergo the same procedure on the opposite leg, if required

7.3 INVESTIGATIONS AND INTERVENTION REQUIRED

Duplex ultrasonography

All operations will perform under general/ regional/local (tumescence) anaesthesia

Open surgery patients will undergo flush ligation of the saphenofemoral junction+ long sapheno vein stripping +multiple perforator ligation and phlebotomies of varicosities.

Radiofrequency ablation patients will undergo radiofrequency ablation to long sapheno vein and injection sclerotherapy of incompetent perforator and varicosities under ultra sound duplex scan guidance

Consent Informed consent will be taken as per standard procedure that is followed in the institution

7.4 ETHICAL CLEARANCES

8. REFERENCES

1. Subramonia, S. and Lees, T. (2010), Randomized clinical trial of radiofrequency ablation or conventional high ligation and stripping for great saphenous varicose veins. British Journal of Surgery, 97: 328–336. doi: 10.1002/bjs.6867

2. Rautio T, Ohinmaa A, Perälä J, Ohtonen P, Heikkinen T, Wiik H et al. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: a randomized controlled trial with comparison of the costs. J Vasc Surg 2002; 35: 958–965.

3. Merchant RF, DePalma RG, Kabnick LS. Endovascular obliteration of saphenous reflux: a multicenter study. J Vasc Surg 2002; 35: 1190–1196.

4. Kistner RL, Masuda EM. A practical approach to the diagnosis and classification of chronic venous disease. In Vascular Surgery (5th edn), RutherfordRB (ed.). W. B. Saunders: Philadelphia, 2000; 1990–1999.

5. Chandler JG, Pichot O, Sessa C, Schuller-Petrovic S, Kabnick LS, Bergan JJ. Treatment of primary venous insufficiency by endovenous saphenous vein obliteration. Vasc Surg 2000; 34: 201–214.

6. Endovenous obliteration versus conventional stripping operation in the treatment of primary varicose veins: A randomized controlled trial with comparison of the costs. Tero Rautio, MDa, Arto Ohinmaa, PhDb,et al(J Vasc Surg 2002;35:958-65)

7. Merchant RF, Pichot O; Closure Study Group. Long-term outcomes of endovenous radiofrequency obliteration of saphenous reflux as a treatment for superficial venous insufficiency. J Vasc Surg 2005; 42: 502–509.

8.Signature of the candidate:

9. Remarks of the guide:

11. Name and designation of

11.1 Guide:

11.2 Signature:

11.5 Head of the department:

11.6 Signature:

12.1 Remarks of the chairman and principal:

12.2 Signature:

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