Surgical Issues in Gynecology

Educational Objectives

The goal of this program is to optimize surgical outcomes for patients undergoing gynecologic and urogynecologic procedures. After hearing and assimilating this program, the clinician will be better able to:

1.   Recognize the potential for medical malpractice liability associated with use of vaginal mesh in pelvic recon­structive surgery

2.   Counsel patients about potential complications associated with vaginal mesh in pelvic reconstructive surgery

3.   Determine which patients are appropriate candidates for laparoscopic hysterectomy

4.   Describe procedures for performing laparoscopic hysterectomy

5.   Utilize techniques for detecting and repairing urinary tract injuries secondary to gynecologic surgery

Faculty Disclosure

In adherence to ACCME Standards for Commercial Support, Audio-Digest requires all faculty and members of the planning committee to disclose relevant financial relationships within the past 12 months that might create any per­sonal conflicts of interest. Any identified conflicts were resolved to ensure that this educational activity promotes quality in health care and not a proprietary business or commercial interest. For this program, the following has been disclosed: Dr. Francis is on the Speakers’ Bureau of Pfizer and Coloplast.

Acknowledgments

Dr. Swift was recorded at the Medical University of South Carolina’s 40th Annual Ob/Gyn Spring Symposium, held on March 23-25, 2009 in Charleston. Dr. Francis was recorded at the Medical College of Georgia’s Clinical Ap­proaches to Obstetrics and Gynecology, held June 27-29, 2008 in Savannah.

Use of Mesh in Pelvic Reconstructive Surgery

Steven Swift, MD, Professor, Department of Obstetrics and Gynecology, Medical University of South Carolina, Charleston

Introduction: role of mesh in pelvic reconstructive surgery unclear; use driven by manufacturer’s marketing without supportive data; Food and Drug Administration (FDA) did not require proof of safety because of previous approval of predicate devices (ie, other devices placed in human body and composed of same materials [eg polypropylene suture]); in October 2008, FDA issued public health notification alerting healthcare practitioners of complications associated with mesh in repair of pelvic organ prolapse and stress urinary incontinence (SUI); recommended physi­cians obtain specialized training for mesh placement techniques, be aware of risks, and inform patients of potential complications associated with mesh; speaker considers FDA recommendation without clinical purpose; serves as “red flag” for medical malpractice plaintiff’s attorneys

Emergence of mesh: correction of pelvic organ prolapse has high failure rate; evidence suggests 60% recurrence rate with standard anterior and posterior repairs; 30% of patients require reoperation; surgeons looking for “holy grail” for prevention of recurrence of pelvic organ prolapse after repair; occurs in 10% of patients, vs 5% recurrence rate with abdominal wall hernia repair (much simpler procedure)

Types of mesh: biologic  —  autografts (requires harvesting); allograft (cadaveric fascia graphs); xenografts (derived from pig and cow organs); synthetic  —  (all polypropylene); Cochrane review  —  showed synthetic mesh associated with higher success rates and less erosion than biologic mesh in abdominal sacra colpopexy on vaginal vault; per­forming hysterectomy at time of abdominal sacral colpopexy increases risk for mesh erosion to 30% to 40%; un­known whether adding reinforcing mesh to transvaginal repairs or using new mesh kits beneficial

Success of anterior repair: study showed that 2 yr after repair, 60% of subjects scored stage 2 via pelvic organ pro­lapse quantification (POP-Q) system (defined as anatomic failure); however, 90% of patients report no symptoms

Addition of vaginal mesh repair kit: anatomic success rate 90% (POP-Q stage £1); however, complications of mesh exposure occur in ³15% of patients; mesh exposure causes continuous watery, bloody discharge; sexual dysfunc­tion and dyspareunia rates £30%; attempts to reduce exposure  —  decrease amount of permanent material in mesh; retrospective chart review looked for evidence of fewer recurrences with Vipro (Vicryl [polyglaction 910]/polypro­pylene 50/50 composite mesh); recurrence remained in 10% range; with newer surgical techniques (eg, midline col­potomy instead of inverted T-incision), risk for erosion remained in 10% range; overall incidence of erosion 10% and reoperation rates 5% to 10%

Are we moving forward? meta-analysis revealed 10 randomized controlled trials (RCTs) comparing standard ante­rior repair with and without mesh augmentation; odds ratio (OR) for recurrence after anterior repair with biologic mesh £1; insufficient data to calculate OR for anterior repair with synthetic mesh; erosion rates with synthetics »10% (vs .67% with biologics); prospective observational study  —  185 participants (having anterior repair without mesh) in Sweden; symptomatic recurrences »10%; 2-yr RCT of anterior repair with and without synthetic mesh  —  looking at anatomic and symptomatic relief; 202 participants randomized, with 90% follow-up at 24 mo; 17% without mesh and 4% with mesh reported bulge; 8% exposure with mesh; overall, no difference in prolapse symp­toms between groups

Speaker’s perspective on mesh: biologic and synthetic meshes have role in pelvic organ prolapse; due to lack of studies, manufacturers may discontinue marketing out of concern about medical malpractice lawsuits; risk for ero­sion with synthetic meshes 5% to 10%; little risk for exposure with biologic mesh; dyspareunia concern with syn­thetic mesh possibly overstated; counsel patients appropriately about potential for complications; partner dyspareunia (“hispareunia”) reported with mesh

Laparoscopic Hysterectomy: Tips and Tricks

Sean L. Francis, MD, Associate Professor; Chief, Section of Urogynecology and Pelvic Surgery; Chief, Section of General Obstetrics and Gynecology, Medical College of Georgia, Savannah

Epidemiology of hysterectomy: second most commonly performed surgery (cesarean delivery most common); 37% of women in United States undergo hysterectomy by 55 to 60 yr of age; 650,000 hysterectomies performed annu­ally in United States; Centers for Disease Control and Prevention (CDC) breakdown by surgical approach (1994 to 1999)  —63% abdominal; 23% vaginal; 9.9% laparoscopic; remaining percentage supracervical and radical; sur­geons need to become familiar with laparoscopic hysterectomy to remain competitive; Cochrane Database System­atic Review of 27 randomized controlled trials (RCTs)  —  compared outcomes of different surgical approaches to hysterectomy; vaginal hysterectomy shown superior (signicantly lower morbidity and cost, and shorter recovery) and should be performed whenever possible

Comparative data: abdominal  —  shorter operating times; fewer urinary tract injuries; laparoscopic  —less intraoper­ative blood loss; smaller drop in hemoglobin; speedier return to normal activities; fewer wound infections; fewer unspecified infections or febrile episodes

Classification system; total laparoscopic hysterectomy (TLH)  —  ligation of uterine vessels and closure of vaginal cuff through laparoscope; laparoscopic-assisted vaginal hysterectomy (LAVH)  —  vaginal closure of vaginal cuff, with or without laparoscopic ligation of uterine vessels; laparoscopic supracervical hysterectomy (LSH)  —  uterus removed above cervix through laparoscope

Preoperative preparation: patient selection  —  small body mass index; small uterus (£9 wk); avoid patients with lung or heart disease (because of steep Trendelenburg); avoid patients with large broad ligament or lower uterine segment fibroids; bowel preparation  —  sodium phosphate laxative (eg, Fleet Phospho-soda) or polyethylene glycol electrolyte solution (eg, GoLYTELY) recommended (relax bowel, providing better exposure compared to magne­sium citrate); plan  —  advance planning important; rehearse procedure using models; practice laparoscopic suturing (remember to rotate wrist when suturing); write down suturing steps; decide on type of hysterectomy (ie, LSH, TLH or LAVH)

Total versus subtotal hysterectomy: 1900 to 1940s, majority of hysterectomies subtotal (supracervical); 1940s and 1950s (before Papanicolaou testing), subtotal procedure raised concern about risk for cervical cancer; studies re­ported incidence of cervical stump cancer 0.3% to 10.7%; review of RCTs of 733 women undergoing total or sub­total hysterectomy for benign gynecologic conditions showed no evidence of difference in rates of incontinence, constipation, or measures of sexual function; subtotal group more likely to have ongoing cyclical vaginal bleeding 1 yr after surgery

Operating room set-up and patient positioning: equipment on towers permits unencumbered movement in operat­ing room; video monitors placed left and right of field ergonomically beneficial for surgeon; steep Trendelenburg moves bowel out of way in preparation for trocar placement; tuck patient’s arms using towels; devices to aid in Trendelenberg  —  special tables, stirrups, shoulder supports, and vacuum back pads; nerve injury reported with shoulder supports, so speaker uses stirrups only

Equipment: uterine manipulators  —  options include Vcare, Rumi System, lucite rode or EEA sizer; bipolar coagu­lation system  —  maximum temperature £450 degrees; protein disorganizes to form clot between 50 to 100° C; va­porization of water desiccates tissue at 400° C; eschar form when tissue destroyed at 400° C; slow; other options  —Harmonic Scalpel; Gyrus (uses plasma kinetics); maximum temperature 100° C with Ligasure; senses tissue im­pedance; fast; shown to reduce blood loss; laparoscopic suturing  —consider Lapra-Ty suture clip and self-articulat­ing needle drivers

General rules of laparoscopic dissection: apply same rules used for abdominal hysterectomy; elevate uterus during uterine vessel ligation; start uterine vessel ligation high on uterus; dissect retroperitoneally; stay midline when dis­secting bladder flap; choose method of ligation; perform cystoscopy if any concern about ureteral injury

Robotic-assisted surgery: advantages  —  ultimate control; precise tissue manipulation; 3-dimensional visualization; facilitates surgeon ergonomics; tremor elimination; disadvantages  —  cost; no tactile feedback; requires reliance on team; speed (slower until surgeons gain ex-perience); what does the future hold for robotic-assisted surgery?  —  allows surgeons to help others at remote locations; facilitates difficult laparoscopic procedures; allows more sur­geons to perform procedures laparoscopically

Summary: vaginal hysterectomy remains preferred procedure for hysterectomy; consider LSH to decrease rate of TAH and shorten postoperative hospital stays; rehearse and choose equipment; mimic rules of dissection for TAH; look for robotic-assisted surgery as way of future

Intraoperative Injuries of the Urinary Tract

Dr. Francis

Rates of injuries to urinary tract: oncologic surgery, 1.1% to 5.5%; benign pelvic surgery, 0.3%; radical hysterec­tomy, »2.2%; all gynecologic procedures and cesarean deliveries, »1%; comprise significant proportion of medical malpractice lawsuits; keys to prevention  —  knowledge of anatomy; adequate exposure (ACOG cites 50% of injuries attributable to poor exposure); surgical technique (counter traction and adequate dissection); frequent review

Anatomy: kidneys  —  difficult to injure; located retroperitoneally between level of 12th thoracic and 3rd lumbar ver­tebrae; right kidney lies inferior compared to left because of liver; left is longer; surrounded by perirenal adipose (enclosed by pararenal fat); lie against psoas muscle; renal arteries originate from 5th branch of aorta; veins follow arteries and empty into vena cava; study of 1085 laparoscopic urologic procedures showed no kidney injuries; new complications likely to occur with advent of new laparoscopic procedures; ureters  —  major target for injury; 22 to 30 cm in length; one-half of length within and one-half outside of pelvis; vascular and lymphatic blood supply within adventitia surrounding ureter; run retroperitoneally over psoas muscle; enters pelvis over bifurcation of iliac vessels; travels along medical leaf of broad ligament; passes 2.3 cm lateral to cervix (the more obese, the closer to cervix); goes underneath uterine vessels to bladder; blood supply from several sources; blood supply derived from medial aspect within abdomen and lateral aspect within pelvis; series of longitudinal vessels run parallel in adven­titia; same principles used in abdominal surgery apply to laparoscopic surgery

Types of injuries: ureteral injuries  —  second most commonly injured organ of urinary tract; occur most commonly during abdominal hysterectomy; common areas of injury close to cervix and at pelvic brim over bifurcation of common iliac artery; injuries during open and laparoscopic surgery  —  transection; suture ligation; crush; devascu­larization; kink; fibrotic stricture; cautery thermal injury; endourologic surgery  —  perforation; stricture formation (from scoping ureter); intussusception; prolapse into bladder

Other anatomic sites of injury: bladder  —  large target, but well-protected; lies behind symphysis pubis; 6 layers of transitional epithelium, surrounded by lamina propria, detrusor envelope, peritoneum, adipose; blood supplied by inferior and superior vesical arteries; innervated by hypogastric and pudendal nerves; urethra  —  increased preva­lence of injury with advent of tension-free vaginal tape (TVT) and trans-obturator tape (TOT) procedures for SUI

Bladder injury: most commonly injured organ in urinary tract; incidence after major gynecologic surgery »0.8%; incidence during laparoscopy .02% to 8.3% (depends on learning curve; TVT studies showed learning curve with bladder perforation from 0-20%); injuries caused by laparoscopic stapler, TVT, needles and small punctures; morbidity related to delay in recognition of injury to urinary tract

Ureteral injury  —  cystoscopy recommended with any suspicion of injury; creatinine elevated only »0.3% with in­jury to ureter (other ureter compensating); high index of suspicion with incontinence or back pain

Diagnosis: data show anterior colporrhaphy most common cause of ureteral compromise; intraoperative diagnosis  —retrograde ureteral stents, retrograde ureterogram, and cystoscopy with indigo carmine; postoperative diagnosis  —flank pain, peritonitis, watery discharge; check serum creatinine to distinguish between vaginal and kidney discharge (high creatinine if from kidney); indigo carmine; ultrasonography, computed tomography; tam­pon test; ureterovaginal fistula  —  inject indigo carmine into bladder and administer oral phenazopyridine (eg, Pyridium); orange-colored urine evidence of ureter injury; blue urine evidence of bladder injury; purple urine ev­idence of bladder and ureter injury; kidney injury  —  consultation recommended; ureteral injury  —  remove of­fending instrument with needle or minor crush injury; check for peristalsis (although peristalsis does not ensure ureter intact); if extensive crush or ligation, stent for 10 to 14 days)

Repair of urinary tract injuries:

Transection of ureter: careful debridement; creation of watertight, tension-free, spatulated or fish-mouth anastomo­sis; ensure adequate ureteral and retroperitoneal drainage; maintain adventitia to maintain ureteral blood supply; primary closure with interrupted 4.0 or 5.0 polyglactin 910 (inflammation demonstrated with chromic); reim­plant if injury at distal third or last 5 cm of ureter; use psoas hitch or Boari flap; can mobilize kidneys, but speaker recommends urologic consultation

Bladder repair: needle injuries  —  tension-free vaginal taping; speaker leaves catheter in place for »7 days

Laparoscopic cystotomy repair: urethra  —  use 4.0 or 5.0 interrupted absorbable suture; stay perpendicular to ure­thra to avoid stricture; vesicovaginal fistulas  —studies show some will close if catheter left in place 5 to 6 mo; wait 6 wk to 2 mo postsurgery for surgical repair (vaginal or abdominal approach); fibrin glue reserved for poor surgical candidates; drain bladder during surgery

Suggested Reading

Brubaker L. Editorial: partner dyspareunia (hispareunia). Int Urogynecol J Pelvic Floor Dysfunct. 17:311, 2006; Collinet P et al: Transvaginal mesh technique for pelvic organ prolapse repair: mesh exposure management and risk factors. Int Urogynecol J Pel­vic Floor Dysfunct 17:315, 2006; Foon R et al: Adjuvant materials in anterior vaginal wall prolapse surgery: a systematic review of effectiveness and complications. Int Urogynecol J Pelvic Floor Dysfunct 19:1697, 2008; Johnson N et al: Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev 19:CD003677; Lethaby A et al: Total versus sub­total hysterectomy for benign gynaecological conditions. Cochrane Database Syst Rev 29:CD004993; Swift SE: “First do no harm” and the emerging story of the vaginal reconstructive mesh implant. Int Urogynecol J Pelvic Floor Dysfunct 18:983, 2007; Talamini MA et al: Technology in the operating suite. JAMA 293:863, 2005; Weber AM et al: Anterior colporrhaphy: a ran­domized trial of three surgical techniques. Am J Obstet Gynecol 185:1299, 2001