PL Narducci Department of Obstetrics and Gynecology General Hospital San Giovanni Battista Foligno, ITALY

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NESA DAYS 2018 New European Surgical Academy Perugia, April 19-21, 2018 EXCELLENCE IN FEMALE SURGERY PROLAPSE RECONSTRUCTIVE SURGERY IN SEXUALLY ACTIVE WOMEN LAPAROSCOPIC ANTERIOR ABDOMINAL WALL COLPOPEXY PL Narducci Department of Obstetrics and Gynecology General Hospital San Giovanni Battista Foligno, ITALY 1

Great challenge: surgical resolution of prolapse responding to patient expectatives TRY TO SOLVE PROBLEM WITHOUT CREATING NEW ONES INDIVIDUALIZE THE OPERATION based on problem assessment and patient requirements: type and extent of deficiency asymptomatic or symptomatic which stymptoms age vaginal habitability or not patient characteristics possible gynecological pathology associated LARGE CHOICE OF OPERATION TECHNIQUES ADOPT THE MOST SUITABLE OPERATION The best interest of the patient is the only interest to be considered 2

SURGICAL OPTIONS based on: general medical conditions sexually active YES / NO RECONSTRUCTIVE OBLITERATIVE Vaginal approach Abdominal approach Vaginal approach *colpohysterectomy, culdoplasty (McCall), large anterior and posterior colporraphies and fascia plication * Colpocleisis 3

RECONSTRUCTIVE SURGERY Objectives : 1) Anatomically and functionally correct the prolapse, removing symptoms 2) Preserve vaginal habitability 4

ADVANCED APICAL PROLAPSE also high-grade (III-IV stage) multicompartment anterior and posterior in sexually active women KEY POINT OF OPERATION : APICAL SUSPENSION De Lancey Level I support 5

VAGINAL RECONSTRUCTIVE SURGERY APICAL SUSPENSION AT: LIGAMENTS : uterosacral ( Mc Call ; Shull ) sacrospinous myorraphies, paravaginal repair Manchester repair WITH MESH : ICS (Papa Petros infracoccygeal sacropexy) Transvaginal Mesh Procedures (prepackaged kits) 6

LAPAROSCOPIC ABDOMINAL RECONSTRUCTIVE SURGERY APICAL SUSPENSION with mesh: 1) To the promontory ( SACROCOLPOPEXY ) 2) To the abdomial wall: laterally ( POPS Longo) anteriorly (ANTERIOR COLPOSUSPENSION Shaw- Dubuisson ) 7

SURGICAL MANAGEMENT OF PELVIC ORGAN PROLAPSE Vaginal approach Abdominal approach Each technique has its own success and complication rate, and surgeons must individualize the surgical plan for each patient, weighting the risks and benefits AN UPDATE ON SURGICAL OPTIONS AND OUTCOMES MEASURES (efficacy, complications, quality of life) 8

CONCERNING VAGINAL APPROACH Sacrospinous vaginal fixation 5-15% recurrent prolapse Petri Acta Obst Gyn Scand 2011 No difference in the adjusted objective, subjective success rates and sexual function between hysteropexy and hysterectomy Tsia-Shu Lo J Obst. Gyn. Research 2015 Native tissue VS biological graft repair : no significant differences except recurrent anterior prolapse increased with native tissue repair Native tissue VS polypropylene mesh repair: with native tissue increased awareness of prolapse, increased risk of repeat surgery for prolapse and increased recurrence af anterior compartement prolapse. However, with native tissue repair reduced risk of de novo SUI, bladder injury, mesh complications Maher C Cochrane Database Syst Rev 2016 9

Larouche M et al, J Obstet Gynaecol Can 2017 TRANSVAGINAL MESH PROCEDURES FOR PELVIC PROLAPSE Guideline reviewes STATEMENTS : *risk of vaginal mesh exposure averaging 12% *the improved anatomical success rate of TVM is associated with an increased overall reoperation rate compared with native tissue repairs (prolapse recurrence, mesh exposure, de novo SUI, pain) RECOMMENDATIONS : *training specific to TVM *patient selection *preoperative counselling 10

CONCERNING ABDOMINAL APPROACH Sacral colpopexy (open abdominal, laparoscopic or robotic-assisted laparoscopic technique) has a high-effectivity (good durability and quality of life performance) FIGO Warking Group Report Neurourol Urodynam 2017 Meta-analysis and systematic rewiew on Laparoscopic sacrocolpopexy VS Robot-assisted laparoscopic sacrocolpopexy (RALSC): RALSC significantly longer, costs significantly higer, estimated blood loss and complications are similar Pan K Int J Gynaecol Obstet 2016 Sacral colpopexy : less awareness of prolapse, less repeat surgery, less recurrent prolapse, less dispareunia compared with Vaginal procedures. Sacral colpopexy is considered the gold standard for apical vaginal prolapse Maher C Cochrane Database Syst Rev 2016 11

Lucot JP, Cosson M, Wattiez A et al, EUR UROL 2018 SAFETY OF VAGINAL MESH SURGERY VERSUS LAPAROSCOPIC MESH SACROPEXY FOR CYSTOCELE REPAIR: RESULTS OF PROSTHETIC PELVIC FLOOR REPAIR RANDOMIZED CONTROLLED TRIAL Laparoscopic sacropexy is a valuable option for primary repair of cystocele in sexually active patients. Laparoscopic sacropexy is safer than TVM and sexual function is better preserved Laparoscopic sacropexy may not be feasible in all cases 12

CONCERNING SURGICAL MESH FDA regulation of Trans Vaginal Mesh (2008 alert, 2011 statement,2016 reclassification): serious complications are not rare; TVM for POP as class III ( high-risk), with the exception of the mesh for SUI treatment and the mesh for abdominal repair of POP (class II, moderate risk) AUGS and ACOG recommendations and guidelines 2016-2017 The decision on surgical alternatives should be made by the patient and her surgeon. Use of TVM for POP repair should be limited to those individuals in whom the benefit outweighs the risk; Instead a ban on mesh, AUGS has recommended the implementation of credentialing guidelines so that mesh procedure are performed by qualified surgeons (surgical skills, experience and knowledge); New products must demonstrate long term safety and efficacy; Sacrocolpopexy is a highly effective and durable procedure used to treat apical uterine and vault POP 13

LARGE CHOICE OF OPERATION TECHNIQUES: MANY ARE TRADIONAL REPAIRS BUT STILL EFFICIENT AND SUITABLE FOR PECULIAR OCCURRENCE Certainly: The vaginal route is always efficient, also with native tissue No misuse of mesh Always mininvasive approach, by vaginal or laparoscopic route( no laparotomy) Abdominal approach, laparoscopic, is more expensive but it reduces recurrence and mesh-related complications, assuring stable lenght and diameter of vagina One implication is that a patient operated for genital prolapse shoud be managed in centers that use all approaches 14

Laparoscopic abdominal approach with suspension to the promontory: promontofixation (sacrocolpopexy) 15

CURRENT STATUS OF LAPAROSCOPIC SACROCOLPOPEXY: A REVIEW Ganatra et al Eur Urol 2009 OUTCOMES 11 studies n 1197 LSC Operative time 158 min ( 96-286 ) Conversion 0-3% Infrequent intra- and post-operative complications Follow-up 24,6 months Patient satisfaction 94,4% Anatomical cure rate 92% Erosion 2,7% (0-9% ) ; ASC 3-12% ; TVM 10% Recurrence 4% (apical: infrequent; anterior and posterior: more common) Reoperation 6,2 % Sexual funciton: improved 83% Intestinal dysfunction 9,8% ( 0-25% ) Urinary dysfunction: infrequent 2 mesh ( ant. and post. ) : reduced relapse 16

Critical issues of sacrocolpopexy Critical surgical steps: stitch on the promontory; preparation of rectovaginal space up to elevator ani muscle; uterine conservation; nerve sparing surgery Possible complications : haemorrahge, pain, vaginal mesh exposure, mesh erosion into viscera (bladder, rectum, bowel), sacral discitis or osteomyelitis May not be feasible in all cases 17

Laparoscopic abdominal approach with suspension to the lateral abdominal wall :POPS (Longo) 18

Abdominal approach with suspension to the anterior abdominal wall: anterior colposuspension(shaw) (open surgery) SHAW H.N.: Prolapse of vaginal vault following hysterectomy; new methods of repair; presidential adress. West Journ. Surgery, 56, 127, 1948 19

OPEN SURGERY 20

DUBUISSON JB et al. Laparoscopic repair of pelvic organ prolapse by lateral suspension with mesh: a continuos series of 218 patients Gynecol Obstet Fertil 39: 127-131 2011 21

Laparoscopic anterior colposuspension (Shaw Dubuisson) 22

Operative time and technique 1) Self-tailored mesh strip in polypropylene 2) (Subtotal hysterectomy) 3) Preparation of vesical(recto) vaginal space 4) Colpocervical anchorage of strip arms with non absorbable stitchs 5) Small skin incision of anterior abdominal wall, bilateral, 4 cm under OT and 6/7 cm from median line 6) Bilateral extraperitoneal tunnelling of mesh strip, through above mentioned incision, tensioning and tension-free fixation to abdominal muscular-aporeunotic flat 7) Accurate peritonization 8) Culdoplasty (Moschowitz) 9) (Uterine morcellation, if subtotal hysterectomy) 23

1) Mesh strip 24

2) Subtotal hysterectomy 25

3) Vesical and recto vaginal spaces 26

4) Colpocervical anchorage 27

5) Abdominal skin incision 28

6) Extraperitoneal tunnelling of strips Round ligament Retroperitoneal strip Laparoscopic forceps 29

7) Peritonization, tensioning and tension-free fixation to anterior abdominal wall Round lig Mesh strip Uterus 30

8) Culdoplasty 31

JB Dubuisson et al, Int Urogynecology J 2017 PATIENT SATISFACTION AFTER LAPAROSCOPIC LATERAL SUSPENSION WITH MESH FOR PELVIC ORGAN PROLAPSE : OUTCOME REPORT OF A CONTINUOUS SERIES OF 417 PATIENTS 2003-2011 n 417 LLS 78,4% asymptomatic 91,6% anatomic success anterior compartment 93,6% anatomic success apical compartment 85,3% anatomic success posterior compartment 4,3% mesh exposure ( % inferior with macroporous monofilamentous mesh) 7,3% reoperation rate 85% situation improved and satisfaction with absence of concomitant hysterectomy LLS is a safe technique with promising results 32

PL Narducci, U Narducci It J Gynaec Obstet 1989 ANTERIOR ABDOMINAL WALL COLPOPEXY USING A POLYTETRAFLUORETHYLENE STRIP (GORE-TEX) FOR GENITAL PROLAPSE AND PRESERVATION OF VAGINAL FUNCTION 1983-1985 n 54 cases, follow-up 2-4 years ; Open abdominal hysterectomy, anterior colpopexy, culdoplasty, Gore-tex OPEN SURGERY 33

34

From 1983 to 1991 a series of 131 cases of anterior abdominal wall colpopexy with a Gore-tex strip ( open surgery ) In 42 cases follow-up to 29 years 3 ( 7% ) removal for exposure/infection 6 ( 14% ) reoperation for symptomatic recurrence 33 ( 79% ) good subjective and objective result PL Narducci, U Narducci Ost Gyn Foligno 35

Departement of Obst Gyn General Hospital of Foligno LAPAROSCOPIC ANTERIOR ABDOMINAL WALL COLPOPEXY From November 2014 to September 2017 a series of 52 patients with POP 29 hysterocystocele III-IV stage 15 + rectocele II-III stage 8 vaginal vault III-IV stage Prolapse type (POP-Q stage ) 36

Selected according to: *severe symptomatic prolapse (pain; dysuria; dyspareunia) *wish to preserve vaginal function *possibile associated benign uterine and/or ovarian pathology *test with ring-shaped clip average age 52 (41-71) BMI 26 (21-33) 37

By Laparoscopy : 26 subtotal hysterectomy with bilateral salpingectomy, with or without ovariectomy, +anterior colpocervicosuspension +culdoplasty 18 anterior colpocervicosuspension with uterine conservation + prophylactic bilateral salpingectomy, with or without ovariectomy + culdoplasty 8 anterior colposuspension and culdoplasty 38

Mesh Polypropylene type I monofilament macroporous mesh Titanised 39

Results Operative average time 96 min ( 50 min with uterine conservation or in vault prolapse) No conversion No intraoperative complication Minimal bleeding Postoperative complications: 1 abdominal wall hematoma Hospital stay duration 3/4 days 2 cases of abdominal wall pain 40

Results at 6-32 months after prolapse surgery 5 (10%) asymptomatic cystoceles II stage( persistance / recurrence) 1 ( 2% ) reoperation for symptomatic cystocele III stage No mesh exposure / rejection No urinary incontinence de novo OBJECTIVE CURE RATE 88% 1 (2%) dysuria 2 (4%) painful symptomatology No dispareunia PERSONAL CURE RATE 96% 41

CONCLUSION Easier operation with reduced risk compared to sacrocolpopexy (no critical steps) Easier possible uterine conservation Efficient operation in apical prolapse treatment, also severe and multicompartment The association of culdoplasty is considered essential With mesh cervical anchorage, reduced risk of exposure and improved resistance 42

The LAPAROSCOPIC ANTERIOR COLPOSUSPENSION is an effective alternative to sacrocolpopxy, to be used in a personalized surgical treatment of prolapse 43

Management of reconstructive surgery Hospital of Foligno Knowledge of all the surgical options in order to personalize operation We have abandoned transvaginal mesh repair, except for some selected cases of ICS In selected cases, persistent use of fascial vaginal surgery Laparoscopic option prevailing for severe apical prolapses, and for 3 years, preferably anterior colposuspension 44

OBJECTIVE OF PROLAPSE OPERATION: *Answer to patient requirement *Mininvasive surgery preferred in less complicated operation *Reduced risk of recurrence *Reduced risk of complication, incluede for use of mesh that means : SOLVE PROBLEMS WITHOUT CREATING NEW ONES 45