Bilateral iliococcygeal fixation for vaginal vault prolapse and enterocele repair using a new suturing device the digital needle driver

Transcription

1 BJOG: an International Journal of Obstetrics and Gynaecology August 2005, Vol. 112, pp DOI: /j x SURGICAL TECHNIQUE Bilateral iliococcygeal fixation for vaginal vault prolapse and enterocele repair using a new suturing device the digital needle driver Haim Krissi, a Stuart L. Stanton b The objective of our study was to evaluate the surgical feasibility, efficacy and safety of the digital needle driver (DND 202), a modified, flexible surgical device, during iliococcygeal fixation (ICF) for vaginal vault prolapse and enterocele repair. A prospective longitudinal study was carried out among 21 consecutive patients who underwent bilateral iliococcygeal fixation at St George s Hospital, London. All patients filled a comprehensive questionnaire for pre- and post-operative prolapse, urinary, bowel and sexual symptoms and underwent pre- and post-operative site-specific vaginal examination, following the standardized International Continence Society scoring for prolapse, pre-operative urodynamic studies and analysis of the surgical results. The outcome measures were the feasibility of the procedure, the time needed, intra- and post-operative complications, shortterm post-operative prolapse-associated symptoms and pelvic organ prolapse quantification. The mean age of the patients was 65 [5] years and the mean body mass index (kg/m 2 ) was 23 [2.7]. In addition to ICF, 8 patients underwent vaginal hysterectomy, 18 had posterior repairs, 7 had anterior repairs and 6 had TVT. The mean time for ICF was 20 [11] minutes, the mean blood loss per surgical procedure was 264 [225] ml and the mean hospitalization time was 4.6 [1.2] days. Postoperatively, one patient had mesh erosion. At shortterm post-operative evaluation none of the patient had prolapse symptoms. There was a statistically significant improvement in all stages of the apical and posterior walls prolapse ( p < 0.001). The mean total vaginal length was significantly shorter postoperatively (7.8 [1.0] cm vs 6.6 [1.4] cm, p < 0.001). Thus, we can conclude that the use of DND device may facilitate the vaginal approach for vaginal vault prolapse and enterocele repair. Introduction The reported incidence of post-hysterectomy vaginal vault prolapse varies between 0.2% and 1%. 1 The management of symptomatic vaginal vault prolapse and enterocele is challenging. Abdominal sacrocolpopexy seems to be the most common abdominal operation for vaginal vault prolapse and has a long term success rate of %. 2 The vaginal approach has less morbidity and a swifter and a less painful recovery. 3,4 Sacrospinous fixation (SSF) and uterosacral suspension are common vaginal techniques. Iliococcygeal fixation (ICF) or pre-sacrous fixation is an alternative vaginal technique first described by Inmon in Various authors have reported a success rate of over a Department of Obstetrics and Gynecology, Beilinson Hospital, Petah-Tiqva, and Sackler Faculty Of Medicine, Tel-Aviv University, Israel b Pelvic Reconstruction and Urogynaecology Unit, Department of Obstetrics and Gynaecology, St George s Hospital, London, UK Correspondence: Dr H. Krissi, Department of Obstetrics and Gynecology, Rabin Hospital (campus Beilinson), Petach Tikva 49000, Israel. D RCOG 2005 BJOG: an International Journal of Obstetrics and Gynaecology 90% with this technique after a follow up of three to five years. 6,7 The suggested advantages of ICF include a lower rate of post-operative cystocele, decreased complications including pain from nerve entrapment or bleeding from blood vessels in the sacrospinous ligaments, decreased technical difficulty in performing the procedure and the final surgical result mimics more closely the anatomic supports of the upper vagina. A recent study compared SSF to ICF and found no significant difference in success or complication rates. 8 The main technical inconvenience in both procedures is the need for a wide dissection and manipulation of the needle deep in the pelvic tissues. Various suturing devices including the Deschamps ligature carrier, the Miya hook and the Shutt suture punch 9 have been developed to facilitate suture placement in the confined area of the pelvis, mainly for SSF. The Deschamps ligature carrier is a solid long-handled aneurysm needle with a small diameter, curved and fenestrated tip, which is loaded with the suture and introduced into the medial aspect of the sacrospinous ligament and then retrieved using a small hook. The Miya hook is a solid, angled device that anchors a suture through the sacrospinous ligament, which is then retrieved using a hook. The Shutt suture punch has a scissorlike action, with a hollow needle that carries a suture and when closed over the sacrospinous ligament the suture

2 1146 SURGICAL TECHNIQUE is inserted into it and then retrieved through the other jaw of the instrument. All of these lack the flexibility of the digital needle driver (DND), and most of them do not offer significant advantage over the standard needle holder. Levy et al. 10 reported successful preliminary results using a new flexible suturing instrument, the DND during SSF in 25 patients without major complications. We have used this device during ICF and report our experience. Methods Between August 2001 and February 2002, 21 consecutive women underwent ICF with the DND for the treatment of symptomatic vaginal vault prolapse and enterocele. A local institutional ethical approval for the study was obtained. All patients were fully informed and consented beforehand. Pre-operatively, all women were evaluated with a comprehensive questionnaire used by the urogynaecology unit at St George s Hospital, for prolapse, urinary, bowel and sexual symptoms. 11 The original questionnaire was developed in 1978 and has been modified since to take account of the additional domains of urogynaecology (e.g. bowel and sexual function). Each question has a No/ Yes answer and Yes answers are then graded in terms of quantity and quality. Complete physical, pelvic and site-specific vaginal examinations were performed in the left lateral position using a Sim s speculum during a Valsalva manoeuvre. The prolapse was described using the standardised pelvic organ prolapse quantification (POP-Q) scoring and staging systems for POP-Q. 12 All patients underwent pre-operative urodynamic evaluation with prolapse reduction using a ring pessary to identify incontinence or voiding difficulties. Twin-channel subtracted cystometry with fluid filled bladder and rectal pressure lines, and uroflowmetry, were performed using the Lectromed US6000 system (Lectromed UK, Letchworth, UK). The patient was seated upright and the bladder filled with sterile water at room temperature, at Fig. 1. The DND 202 device. The thimble element is connected with a flexible cable to an operating mechanism. Fig. 2. The preloaded thimble is mounted on the surgeon s finger to leave the ventral part exposed for palpation. 100 ml/minute. Provocative measures such as water stimulation and cough were used to provoke detrusor instability. Urethral pressure profilometry was performed only if the patient had had previous continence procedures or bladder neck surgery, with a dual microtip sensor at the 9 o clock position using a mechanical puller at a rate of 1 mm/second. Intrinsic sphincter defect profiles, both static and dynamic (coughing at maximum effort), were performed with a minimum bladder volume of 200 ml. Urodynamic stress incontinence was diagnosed if urine loss was demonstrated with coughing at maximal cystometric capacity in the absence of a detrusor contraction. In the case of combined vaginal prolapse and stress incontinence, tension-free vaginal tape (TVT) was performed. All data were documented and registered on electronic data sheets. The DND 202 device is a sterile instrument consisting of a thimble connected by a flexible cable to an operating mechanism (Fig. 1). The thimble element contains a surgical needle and a cartridge preloaded with suture material (number 0 polydioxanone, Ethicon). The device is mounted on the surgeon s finger to leave the ventral part exposed for palpation. The opposite hand uses the control box to operate the device. The mechanism contains a semi-circular needle that horizontally penetrates the tissue to a fixed depth of 5 7 mm and retrieves the suture material (Fig. 2). All patients received pre-operative antibiotic prophylaxis of metronidazole and cephradine and 5000 units of fractionated heparin for deep vein thrombosis prophylaxis. The patient was placed in the dorsal lithotomy position, under general anaesthesia, and was catheterised before the operation. In a patient with uterine prolapse, a vaginal hysterectomy with or without bilateral salpingo-oophorectomy was performed before the ICF. In a patient with a previous hysterectomy, the posterior vaginal wall was opened with midline longitudinal incision and the rectovaginal fascia freed from the vagina with sharp dissection and continued to the pelvic sidewall where the ischial spine is the landmark for identifying the iliococcygeal anteriorly (caudally).

3 SURGICAL TECHNIQUE 1147 Table 1. Patients characteristics. Characteristic Mean, median or n* Age (years) 65 [5] Parity 2 (1 6) Body mass index (BMI) 23.9 [2.7] Duration of prolapse symptoms (months) 27 [23] Menopausal 21 (100) Hormonal replacement therapy 7 (33) Previous surgery ** 13 (62) * Data are given as mean [SD], median (range) or n (%). ** See text. The surgeon s index finger palpated the ischial spine and the right iliococcygeal. The DND was mounted on the surgeon s finger and placed in the pararectal space just medial to the lateral third of the iliococcygeal muscle (1 cm caudal to the ischial spine). The needle was advanced in a circular path through the muscle and fascia, penetrating to a fixed depth of 5 mm. It then engaged a loop of suture material and retrieved this through the fascia. The device was then removed from the vagina leaving a loop of suture material anchored in the iliococcygeal muscle and fascia. After confirming that the suture was secure, the surgeon used the loop to secure that side of the vaginal vault. This was repeated on the other side after reloading the device with a new cartridge. If a posterior or anterior repair was required this was then performed, and after closure of the posterior vaginal wall, the iliococcygeal sutures were tied on either side to elevate the vault. When there was urodynamically proven stress incontinence, a TVT procedure was performed after the prolapse surgery. For recurrent prolapse repair we used a prolene mesh (Johnson & Johnson, Brussels, Belgium) to reinforce the endopelvic fascia, securing this to the iliococcygeal fascia using the fixation sutures. All patients were advised to avoid strenuous activities and coitus for six weeks. Post-operatively, the patients were reevaluated with the comprehensive urogynaecologic questionnaire and sitespecific pelvic examination. Outcome measures included Table 3. Surgical data. Data are presented as mean [SD], median (range) or n (%). Parameter Mean hospitalization (days) 4.6 [1.2] Mean time for ICF procedure (minutes) 20 [11] Mean blood loss (ml) 264 [225] Suture relocation* 4 (19) Major intraoperative haemorrhage 1 (5) Post-operative complications Mesh erosion 1 (5) Vaginal infection 1 (5) Transient voiding difficulty 3 (14) * Relocation of the suture was required when there was a doubt of the position or anchorage of the sutures. the surgical feasibility of the procedure, operation time, intra- and post-operative complications, as well as the subjective short term improvement in prolapse-associated symptoms and the objective pelvic organs prolapse stage. A computerised database was created and all pertinent clinical data were collected prospectively and evaluated at the end of the study period. The results were analysed by Stata 5.0 statistical software (Stata Corp., College Station, Texas). Statistical analysis was performed on the paired observation for each woman, before and after the operation. For a given symptom or physical findings, the proportion of women who improved was calculated. Improvement was defined as subjective symptoms and objective physical findings after the operation compared with those before the operation. The sign test was used to compare pre- and postoperative POP-Q measurements and the proportion of preoperative prolapse-associated symptoms to post-operative symptoms. Significance was set at 5%. Results Twenty-one consecutive patients underwent bilateral ICF using the DND device. Patient characteristics and pre-operative symptoms are shown in Tables 1 and 2. Thirteen patients (62%) had had a previous hysterectomy (six Table 2. Pre- and post-operative symptoms. Table 4. POP-Q stage of pre- and post-operative vaginal examination. Symptom Preoperative (n ¼ 21) Postoperative (n ¼ 21) Vaginal bulge 21 0 < Urine incontinence 4 1 NS Voiding difficulty 3 0 NS Urgency, frequency and/or nocturia 6 4 NS Incomplete bowel emptying 4 0 NS Constipation 4 2 NS Decreased sexual activity** 6 NA NA Dyspareunia 2 NA NA NA ¼ none applicable (did not resume intercourse); NS ¼ not significant. * Performed by sign test. ** Only six patients were potentially sexually active. P* Site of prolapse Pre-operative stage (n ¼ 21) Post-operative stage (n ¼ 21) 0 I II III IV 0 I II III IV Anterior wall NS Posterior wall <0.005 Cervix/vaginal vault <0.001 Data are number of patients with prolapse of each stage of the POP-Q system. 12 Anterior wall data combine points Aa and Ba from POP-Q system; posterior wall data combine points Ap and Bp; cervix/vaginal vault data combine points C and D. NS ¼ not significant. * Performed by sign test, comparing pre-operative with post-operative findings. P*

4 1148 SURGICAL TECHNIQUE vaginal hysterectomy and seven abdominal hysterectomy), nine (43%) had had previous prolapse surgery (six cystocele repair and three rectocele repair) and seven (33%) had had a previous Burch colposuspension. Pre-operative urodynamic tests with prolapse reduction demonstrated stress incontinence in four patients, detrusor instability in three, mixed urinary incontinence in two and three had voiding difficulty. The procedure-related data are shown in Table 3. In addition to ICF, 8 patients with stage III uterine prolapse underwent vaginal hysterectomy, 18 had posterior repairs, 7 had anterior repairs and 6 had TVT. In 14 cases, a prolene mesh (Johnson & Johnson) was used to support the vault. Complications were rare (Table 3). One patient bled more than 1000 cc from small pelvic divisions of the internal iliac vessels during pelvic dissection to reach the iliococcygeal fascia before we used the DND device. The bleeding continued despite attempts at local haemostasis, and blood transfusion and embolisation using interventional radiography were therefore carried out. The patient recovered fully from the surgery and was discharged after five days. We had no other intra-operative complications. One patient had mesh erosion that was surgically corrected, one patient had vaginal infection treated with oral antibiotics as an outpatient and three patients had short term (less than a month) voiding difficulties after TVT (two patients) or anterior repair (one patient). At short term two-month post-operative evaluation (range 8 14 weeks), none of the patients had a symptom of vaginal bulge (P < 0.005), but there were no other significant improvements in symptoms (Table 2). On site-specific pelvic examination, there was a significant reduction in the number of patients with no prolapse or minimal descent (stage 0 or I) of any compartment (Table 4). However, the mean vaginal length was shorter post-operative (7.8 [1.0] vs 6.6 [1.4] cm, P < 0.001), although the genital hiatus width and perineal body length were not significantly different from pre-operative values. Discussion Our data are the first study describing the DND device for ICF surgery and demonstrate that the DND is a useful device to assist with suture placement during iliococcygeus fixation. It allows accurate suture placement by palpation without wide dissection. However, we are aware that there are weaknesses in the data from this study, which was not randomised, did not have a control group and only studied a small number of patients with short follow up. The short term results might be confounded by the variety of additional procedures carried out at the same time. Vaginal vault prolapse and enterocele can be difficult to correct, especially in sexually active patients. A variety of abdominal and vaginal surgical techniques have been described but there is no consensus on the best procedure. The only prospective randomised study comparing vaginal and abdominal approaches for prolapse showed a higher reoperation rate for vaginal compared with abdominal surgery for recurrent prolapse. 13 Surgery for vaginal vault wall prolapse has several goals: relief of symptoms, restoration of normal bowel and bladder function and maintenance of satisfactory sexual intercourse. The standard approach to ICF 5 8 is to use wide dissection to display the iliococcygeal fascia and then insert sutures using a conventional needle holder. Several instruments were designed to simplify vaginal vault prolapse repair The frequently used instruments include the Deschamps ligature carrier (Codman & Shurtleff, New Bedford, Massachusetts) and the Miya hook introduced by Miyazaki. 17 The latter requires difficult maneuvering of the device and did not decrease the rate of vascular injury by the needle tip. Sharp 18 described the Shutt suture punch, which was modified by Nichols 19 to be the Nichols ligature carrier (BEI Medical systems, Chatsworth, California). None of these devices is used for ICF. The flexible DND provides good suture anchorage with ease and certainty and avoids the problem of needle retrieval in the deep pelvis. The DND was constructed especially for the ICF the needle is at right angles to the finger, as opposed to being in line with it for the SSF. The thimble aids in the exact placement of the needle into the iliococcygeal fascia without the need for a wide dissection or visualisation of the iliococcygeal fascia. The flexibility allows the finger easily to palpate anatomical structures, and particularly the landmark of the ischial spine, which is difficult to visualise. A fixed surgical penetration of 5 7 mm provides a safe mechanism to minimise vascular and other injuries. In the complication recorded here, active haemorrhage occurred during pelvic dissection before placing the thimble on the fascia. This complication has not been encountered since and was probably due to a more proximal placing of the suture in relationship to the ischial spine. As the bleeding continued it was arterial and failed to respond to suturing interventional radiography using arterial injection of polyvinyl alcohol particles, which was readily available, was used. We felt it justified at an early stage to resort to this. The embolisation was immediately effective, the patient remained under observation in ITU overnight and returned to the ward the following day. The device can be used in either hand and therefore allows placement of both right and left sutures with ease. This overcomes the disadvantages of the unilateral SSF. On trial the device has proved reliable, easy to use and speedy. Minimal mechanical adjustment has been required during the trial. Cartridges are preloaded with O-polydioxanone ( Ethicon, Johnson & Johnson, Brussels, Belgium) and the same cartridge can be reloaded at the time of operation for use on the other side. Mesh erosion is a potential complication of prolene. This is a feature associated with synthetic mesh and our

5 SURGICAL TECHNIQUE 1149 experience using synthetic mesh for secondary repair relates to anterior and posterior colporrhaphy and vault repair. We have encountered mesh erosions in these situations and now use biological mesh [small intestinal submucosa (SIS), Cook, Indiana, USA] as our choice for reinforcing the repair. There is obviously a need for long term follow up for these patients, and ideally for a prospective, randomised controlled trial comparing DND to other procedures. This pilot study shows the DND device to be an important addition to current surgical options because of its ease of use and efficiency. Acknowledgments The authors would like to thank Professor Martin Bland from St George s Hospital Medical School, London, for his help in data processing and statistical analysis. References 1. Barrington JW, Edwards G. Post hysterectomy vault prolapse. Int Urogynecol J Pelvic Floor Dysfunct 2000;11: Valaitis SR, Stanton SL. Sacrocolpopexy: a retrospective study of a clinician s experience. Br J Obstet Gynaecol 1994;101: Kohli N. Enterocele. In: Cardozo L, Staskin D, editors. Textbook of Female Urology and Urogynaecology, 1st edition. London: Isis Medical Media, 2001: Lemack G, Zimmern P. Endofascial reconstruction of vaginal vault prolapse and the levator myorrhaphy. In: Stanton SL, Zimmern P, editors. Female Pelvic Reconstructive Surgery, 1st edition. London: Springer, 2003: Inmon WB. Pelvic relaxation and repair prolapse of vagina following hysterectomy. South Med J 1963;56: Shull BL, Capen CV, Riggs MW, Kuehl TJ. Bilateral attachment of the vaginal cuff to iliococcygeal fascia: an effective method of cuff suspension. Am J Obstet Gynecol 1993;168: Meeks GR, Washburne JF, McGehee RP, Wiser WL. Repair of vaginal vault prolapse by suspension of the vagina to iliococcygeal ( prespinous) fascia. Am J Obstet Gynecol 1994;171: Maher CF, Murray CJ, Carey MP, Dwyer P, Ugoni AM. Iliococcygeal or sacrospinous fixation for vaginal vault prolapse. Obstet Gynecol 2001;98: Nichols D. Central compartment defects. In: Rock J, Thompson J, editors. Te Linde s Operative Gynecology, 8th edition. Philadelphia: Lippincott and Raven, 1997: Levy G, Barlfai G, Brodman M. A digital needle driver to streamline sacrospinous vagina vault suspension. J Soc Laparoendosc Surg 2001 [abstract no. 123]. 11. Cardozo L, Stanton SL, Bennett A. Design of a urodynamic questionnaire. Br J Urol 1978;50: Bump RC, Mattiasson A, B0 K, et al. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 1996;175: Benson J, Lucente V, McLellan E. Vaginal versus abdominal reconstructive surgery for the treatment of pelvic support defects: a prospective randomised study with long-term outcome evaluation. Am J Obstet Gynecol 1966;175: Gilberti C. Transvaginal sacrospinous colpopexy by palpation a new minimally invasive procedure using an anchoring system. Urology 2001;67: Schlesinger RE. Vaginal sacrospinous ligament fixation with the autosuture endostitch device. Am J Obstet Gynecol 1997;176: Veronjkis DK, Nichols DH. Ligature carrier specifically designed for transvaginal sacrospinous colpopexy. Obstet Gynecol 1997;89: Miyazaki FS. Miya hook ligature carrier for sacrospinous ligament suspension. Obstet Gynecol 1987;70: Sharp TR. Sacrospinous suspension made easy. Obstet Gynecol 1993; 82: Nichols DH. Sacrospinous fixation for massive eversion of the vagina. Am J Obstet Gynecol 1982;142: Accepted 9 November 2004