Presentation on theme: "SUTURELESS VAGINAL HYSTERECTOMY AN UPDATE…"— Presentation transcript:
1SUTURELESS VAGINAL HYSTERECTOMY AN UPDATE… ByMOUNIR M. F. El-HAO ,PROF OF OB & GYN.AIN SHAMS UNIVERSITY , CAIRO , EGYPT..
2Sutureless Vaginal Hysterectomy. The need for CHANGE ?Patient,s BENEFIT or surgeon’s EGO ?Better technique ?Better results ?
3This technology depends on: INTRODUCTIONThis technology depends on:Mechanical energy or pressure& electrical energy remodelling of the vessel tissue creating collagen seal out of native vessel protein (denature collagen and elastin in vessel wall).Levy B. & Emery L. (2003): Randomized Trial of Suture versus Electrosurgical Bipolar Vessel Sealing in Vaginal Hysterectomy. ACOG; 102(1):
4RatesAustralia 40% USA 36% Italy 15.5% France 5.8%
6INTRODUCTIONA Cochrane review on the surgical approach to hysterectomy for benign gynaecological disease, published in 2006, concluded that:Vaginal hysterectomy should be performed in preference to abdominal hysterectomy, where possible.Johnson N.; Barlow D.; Lethaby A., et al. (2005): Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database of Systematic Reviews, Issue 2: CD
8The extent of laparotomy and vaginal surgery should be based on the SurgeonPreference(Indication)Experiencewith abdominal and vaginal surgery
9vaginal hysterectomyDespite fastest and least expensive it is used in only 23% of the hysterectomies performed in the United States
10INTRODUCTIONTraditionally, many surgeons have avoided vaginal hysterectomy or used it only in carefully selected patients .WHYKives S.L.; Levy B.S.; Levine R.L., et al. (2003): for the American Association of Gynaecologic Laparoscopists. Laparoscopic-assisted vaginal hysterectomy: J Am Assoc Gynaecol Laparosc: 10:135-8.
11HAEMOSTASIS.Achieving hemostasis is fundamental in all surgical approaches.clips, staples, sutures, ultrasonic, and monopolar or bipolar coagulation.
12EBVS electrosurgical bipolar vessel sealing Seals vessels from 1 to 7 mm in diameter,Precise amount of bipolar energy and pressure to fuse collagen and elastin within the vessel walls.withstand a minimum of three times normal systolic pressure.Space requirements are less for EBVS
13SEALING. Sealing is achieved with minimal sticking and charring. Thermal spread to adjacent tissues is approximately 0.5 to 2 mm.The result is permanent.
14In a study comparing the electrosurgical bipolar vessel sealing (EBVS) system to ultrasonic coagulation, bipolar coagulation, surgical clips, and sutures,the electrosurgical bipolar vessel sealing (EBVS) system created seals that (were stronger than the other energy-based ligation methods and comparable in strength with that of mechanical ligation techniques. )
15AIM OF THE WORKTo assess the safety and efficacy of using the electrosurgical bipolar vessel sealing (EBVS) system for securing the pedicles during vaginal hysterectomy in comparison with the conventional method of securing the pedicles by suture ligation & does it permit the expansion of the spectrum of vaginal hysterectomy indications.
16STUDY TEAM. MOUNIR FAWZY ELHAO, PROF KHALED IBRAHIM , A PROF. IHAB SERAG, TUTOR.MOHAMMA ELLEITHY, A.TUTOR.
17These new technologies also reduce the risk of adverse reactions: Vessels sealed using autologous tissues are unlikely to have adverse responses to foreign materials, such as sutures, staples, or clips. Finally, the reduction in needle use reduces the potential for injury during vessel ligation. Although in skilled hands vaginal hysterectomy may be performed using standard techniques even in difficult patients, the electrosurgical bipolar vessel sealer technology should permit the less experienced vaginal surgeon an opportunity to expand the indications for vaginal hysterectomy
18Setting:The study was carried out in Ain-shams University maternity Hospital.Study group:Women admitted for vaginal hysterectomy for benign disease.Type of the study:Prospective randomized Double blind controlled study.
19Population:Includes 100 patients undergoing vaginal hysterectomy [divided into 4 groups]:Group L1: vaginal hysterectomy using electrosurgical bipolar vessel sealing system (EBVS) for securing the pedicles in the patients with the traditional indications for vaginal hysterectomy.Group S1: vaginal hysterectomy using traditional suturing for securing the pedicles in the patients with the traditional indications for vaginal hysterectomy.Group L2: vaginal hysterectomy using electrosurgical bipolar vessel sealing system (EBVS) for securing the pedicles in the challenging (difficult) vaginal hysterectomies.Group S2: vaginal hysterectomy using traditional suturing for securing the pedicles in the challenging (difficult) vaginal hysterectomies.
20Inclusion criteria for L1 & S1 groups: 1st or 2nd degree uterine descent.Uterine size < 10 weeks.Benign pathology.Multigravid patients.Vaginal canal should be ample.The posterior & lateral vaginal fornices should be wide and deep.Subpubic angles > 90°.
22Inclusion criteria for L2 & S2 groups: Benign pathology.No uterine descent.Vaginal canal should be adequate.The posterior & lateral vaginal fornices should be adequate.Subpubic angles = 70-90°.Uterine size weeks or previous uterine operation [caesarean section-myomectomy-surgery involving the tubes or the ovaries].
23Then each patient in the study will be tested for the following endpoints Operative timeOperative blood lossHospital stay.Any postoperative complications including:1ry haemorrhage.2ry haemorrhage.Postoperative infection and febrile morbidity.The need for readmission.The need for laparotomy
24PILOT STUDY ON SVH. Started december 2004. Patient fit for vaginal hysterectomy allocated sequentially randomised and blindly into two groups.Comparing the efficacy of bipolar vessel sealing technique with routine vaginal hysterectomy.
27PATIENTSSample sizeSample size103 Women admitted for vaginal hysterectomy for benign disease were chosen according to calculations that indicated a sample size of 50 subjects in each treatment arm would have 80% power with 95% confidence to detect a 20% difference between procedure times with electrosurgical bipolar vessel sealer versus suture ligature.
28haemostatic technique Patients groupsGROUP L= L 1+ L2ELECTROSURGICAL BIPOLAR VESSEL SEALING (EBVS)GROUP S= S 1+ S2TRADITIONAL SUTURE LIGATURE
34RESULTSEBVSOperative dataOPERATIVE DATAIn the current study, in about one third (33%) of the cases debulking techniques were required to complete the operation, salpingoophorectomy was done in 20 cases either unilateral or bilateral if needed according to the clinical situation.
35RESULTSEBVSOperative dataSometimes other gynaecological procedures like classical repair (CR), sacrospinous fixation (SSF), transobturator mesh (TOM) or transvaginal tape (TVT) were done after completing the vaginal hysterectomy for associated gynaecological indications.
37Group L compared with Group S RESULTSOperative dataTABLE 2Group L compared with Group SGroup L(n=50)Group S(n=53)P valueOperative time (min) = median (range)Circumcision time10 (5-20)10 (5-20)0.653Pedicle dissection time37.5 (10-115)70 (30-135)< 0.001Vault closure time7.5 (5-15)0.280Total operative time52.5 (25-125)90 (50-240)Intraoperative blood loss (ml) = median (range)230(40-690)360( )Postoperative haemoglobin (gm/dl) = mean (SD)9.9(1.6)9.3(1.4)0.033Postoperative haematocrit (%)= mean (SD)32 (4.8)28.9 (4.3)<Data are median (range) or mean (SD).P < 0.05 denotes statistical significance.
38Group L1 compared with Group S1 RESULTSOperative dataTABLE 3Group L1 compared with Group S1Group L1(n=26)Group S1(n=28)P valueOperative time (min) = median (range)Circumcision time10 (5-15)10 (5-20)0.306Pedicle dissection time30 (10-60)60 (30-80)< 0.001Vault closure time5 (5-15)0.867Total operative time50 (25-75)75 (50-95)Intraoperative blood loss (ml) = median (range)190(40-690)290( )0.453Postoperative haemoglobin (gm/dl) = mean (SD)10.1 (1.4)9.7(1.3)0.226Postoperative haematocrit (%)= mean (SD)32.8(5.0)29.4 (4.3)0.006Data are median (range) or mean (SD).P < 0.05 denotes statistical significance.
39Group L2 compared with Group S2 RESULTSOperative dataTABLE 4Group L2 compared with Group S2Group L2(n=24)Group S2(n=25)P valueOperative time (min)= median (range)Circumcision time5 (5-20)0.841Pedicle dissect time50 (20-115)85 (50-135)< 0.001Vault closure time10 (5-15)10 (5-20)0.049Total operative time72.5 (30-125)100 (65-240)Intraoperative blood loss (ml) = median (range)270( )425( )< 0.024Postoperative haemoglobin (gm/dl) = mean (SD)9.7(1.8)8.8(1.4)0.054Postoperative haematocrit (%)= mean (SD)31.2(4.4)28.5 (4.3)0.025Data are mean (SD) or median (range).P < 0.05 denotes statistical significance.
40RESULTSEBVSOperative datathe current study, the intraoperative blood loss was significantly lower in Groups L, and L2 than groups S, and S2 correspondingly, the role of EBVS in reducing the operative blood loss was more pronounced in the difficult cases [Groups L2].
42Patients who have indications for traditional vaginal hysterectomy do not need abdominal hysterectomy,or laparoscopic hysterectomy.
43Post operative Pain.Deserves to be studied in a well controlled trial
44WHY SVH? Good potentials. Easier. Quicker Bloodless. Less infection. Less pain.
45Intra operative.Time ,Bleeding and recovery are all shorter than average for other techniques.
46Sutureless vaginal hysterectomy using electrosurgical bipolar vessel sealer is a good alternative to the use of sutures in routine vaginal hysterectomy.
47When the competent surgeon is equipped with such devices, conversion of an abdominal hysterectomy to the vaginal route is both attainable and preferred.
48RESULTSEBVSOperative dataIn the current study, the total operative time was significantly shorter in Groups L, L1 and L2 than groups S, S1 and S2 correspondingly and this shorting in the operative time resulted from shorting of the pedicle dissection time in Groups L, L1 and L2.
49DISCUSSIONEBVSSignificant reductions in procedure time when using EBVS was found in the three RCTs.Levy B. & Emery L. (2003): Randomized Trial of Suture versus Electrosurgical Bipolar Vessel Sealing in Vaginal Hysterectomy. ACOG; 102(1):Cronje H.S. & de Coning E.C. (2005): Electrosurgical bipolar vessel sealing during vaginal hysterectomy. Int J Gynaecol Obstet; 91(3):Hefni M.A. (2005): Safety and efficacy of using the LigaSure vessel sealing system for securing the pedicles in vaginal hysterectomy: randomized controlled trial. BJOG 2005; 112(3):
50RESULTSPostoperative dataPOSTOPERATIVE DATAThere was no significant statistical difference between the comparison groups as regard the duration of hospital stay.
5114 patients required hospitalization > 48 hours: RESULTSEBVSPostoperative data14 patients required hospitalization > 48 hours:6 had some medical problems like diabetes mellitus or ischemic heart disease8 had some complications related to the surgery like postoperative fever (4 patients) or major surgical complication (4 patients).
52RESULTSPostoperative dataThere was no significant statistical difference between the comparison groups as regard the rate of occurrence of complications:
53 pain with EBVS could be related to: Less manipulation, compression and traction.No foreign material;Tissue left distal to the suture or clip (including nerves) can necrose post-operatively and may cause pain and infection.Peirce S.C. & Crawford D.C. (2007): Centre for Evidence-based Purchasing; Purchasing and Supply Agency; Evidence review; Electrosurgical vessel sealing in vaginal hysterectomy. CEP November