A randomized, controlled pilot study of the safety and efficacy of 4% icodextrin solution in the reduction of adhesions following laparoscopic gynaecological surgery.

BACKGROUND: Adhesion-related readmissions are frequent sequelae to gynaecological surgery. Attempts to prevent adhesions by separating healing peritoneal surfaces include site-specific barriers and hydroflotation by instilled solutions. Rapid absorption limits the effectiveness of solutions such as Ringer's lactated saline (RLS). This pilot study assessed the safety, tolerability and preliminary effectiveness of a non-viscous, iso-osmolar solution of 4% icodextrin, an alpha-1,4 glucose polymer with prolonged intraperitoneal residence, in reducing adhesions after laparoscopic gynaecological surgery. METHODS: Women aged > or = 18 years, requiring laparoscopic adnexal surgery (n = 62), were entered into a randomized, open-label, assessor-blinded, multicentre study to compare 4% icodextrin with RLS. Treatments were coded in blocks of four with equal randomization to each group, and pre-allocated to consecutively numbered patients. At least 100 ml per 30 min was used for intra-operative lavage, with 1 l instilled post-operatively. Per protocol analysis included all eligible patients (n = 53); reformation analysis required one or more baseline adhesion (n = 42). Incidence, extent and severity of post-operative adhesions were assessed at second-look laparoscopy after 6-12 weeks. Procedures were video-taped for third party, blinded assessment. RESULTS: Safety and tolerability (laboratory variables, adverse events, clinical follow-up) were good with no difference between treatments. A shift analysis of incidence-ranked adhesions (n = 53) showed apparent improvements in more patients with icodextrin than RLS (37 versus 15%; not significant). Adhesion score reduction (n = 42) was more frequent in icodextrin- than RLS-treated patients: incidence (52 versus 32%), extent (52 versus 47%), and severity (65 versus 37%). Despite greater baseline adhesions, median reformation was less after icodextrin (24%) than RLS (60%). The pilot study group sizes were not powered for statistical significance. CONCLUSIONS: In this preliminary study, 4% icodextrin lavage plus instillation was well tolerated and reduced adhesion formation and reformation following laparoscopic gynaecological surgery. A Phase III pivotal study is currently in progress.

Low valsalva leak-point pressure and success of retropubic urethropexy.

The aim of this study was to determine whether an isolated low Valsalva leak-point pressure (VLPP) is predictive of intrinsic sphincter deficiency (ISD) and can be an independent risk factor for retropubic urethropexy failure in patients with a normal maximal urethral closure pressure (MUCP). Twenty-four women with urodynamically proven genuine stress incontinence with low VLPP (<60 cmH2O) and normal MUCP (>20 cmH2O) were evaluated subjectively and objectively by complex urodynamic testing before and after undergoing a modified Burch urethropexy. Success rates were then compared to historical success rates for subjects with ISD treated with retropubic urethropexy using an exact one-sample test for binomial proportions. Patients were followed postoperatively for a mean of 11.1 months, with a range of 5-16 months. Twenty-two of the 24 (91.7%) were continent on postoperative cystometry. This differs significantly from the published success rates of 50% (P < 0.001), if a low VLPP alone were predictive of ISD. Retropubic urethropexy was successful in the majority of our patients with genuine stress incontinence with a low VLPP and normal MUCP.

Determinants of voiding after three types of incontinence surgery: a multivariable analysis.

OBJECTIVE: To determine the time to normal voiding in women after various surgical procedures for genuine stress urinary incontinence (GSUI) or urethral hypermobility. METHODS: One hundred one women had bladder neck suspensions. Suprapubic catheters were used in 94 women and intermittent self-catheterization in seven to manage urinary retention after surgery. We used a standardized protocol to record days to adequate postoperative voiding. Univariable and multivariable regression analyses were used to determine clinical, urodynamic, and surgical factors that independently influenced time to adequate postoperative voiding. RESULTS: Women met the criteria for adequate voiding a mean of 7.1 days after modified open Burch procedures (n = 43), 9.5 days after anterior colporrhaphies with suburethral plication (n = 24), and 19.1 days after vaginal wall sling procedures (n = 34). The type of bladder neck suspension was independently associated with increasing time to void (P =.001). Multivariable regression analysis determined other factors significantly associated with longer time to adequate postoperative voiding: advancing age, previous vaginal bladder neck suspension, increasing volume at first sensation on bladder filling, higher postvoid residual urine volume (preoperative), and postoperative cystitis. Detrusor pressure, abdominal straining on pressure flow voiding study, and other concurrent surgeries were not significantly associated with postoperative voiding time in this model. CONCLUSIONS: Time to adequate voiding after bladder neck suspension was influenced by type of surgical procedure, postoperative cystitis, and several demographic and urodynamic factors. This study does not support using pressure flow studies to predict women at risk of voiding dysfunction.

Effect of oxiplex* films (PEO/CMC) on adhesion formation and reformation in rabbit models and on peritoneal infection in a rat model.

OBJECTIVE: To assess the efficacy of Oxiplex (FzioMed, Inc., San Luis Obispo, CA) barriers. DESIGN: Film of polyethylene oxide and carboxymethylcellulose (Oxiplex) were tested for strength and tissue adherence. Films were selected for evaluation in models for biocompatability and adherence. Three films were selected for evaluation in efficacy studies, and one was evaluated for effects on bacterial peritonitis. Handling characteristics of Oxiplex film were evaluated via laparoscopy. SETTING: University laboratory. PATIENT(S): Rabbits, rats, pigs. INTERVENTION(S): Placement of Oxiplex prototypes at the site of injury. MAIN OUTCOME MEASURE(S): Mechanical properties, biocompatibility, tissue adherence, adhesion development, infection potentiation, and device handling. RESULT(S): Mechanical tests indicated that tensile strength and elongation were inversely correlated. All films tested had excellent tissue adherence properties. Selected films, based on residence time and biocompatibility, prevented adhesion formation in all animals and were highly efficacious in preventing adhesion reformation. The optimal Oxiplex prototype prevented adhesion reformation in 91% of the animals. This Oxiplex film, dyed to allow visualization, prevented adhesion reformation and did not affect bacterial peritonitis. In a laparoscopic model, the Oxiplex film, delivered in FilmSert forceps, via a 5.0-mm trocar, rapidly unfurled and could be easily applied to tissue with strong adherence. CONCLUSION(S): These data show development of an adhesion prevention material that is tissue adherent, can be placed via laparoscopy, and does not affect host resistance.

Intraoperative transvesical cystoscopy for urogynecologic procedures.

Intraoperative cystoscopy is a useful adjunct to surgical procedures that may compromise the integrity of the lower urinary tract. Ureteral injury and the placement of intravesical sutures are risks, especially at teaching facilities, during operations such as retropubic urethropexy, paravaginal repair, or even simple hysterectomy. The conventional use of transurethral cystoscopy during open surgical cases may require repositioning of the patient if not previously placed in Allen stirrups. Alternative practices of bladder examination include placement of a standard cystoscope via an intentional cystotomy through the dome of the bladder. The authors have implemented the direct insertion of a 2 mm microlaparoscope through the bladder dome to verify an intact lower urinary system and found this method to be both efficacious and safe. Visualization is not compromised by the slightly smaller visual field compared to the standard 0 degrees or 30 degrees cystoscope. The perspective of the bladder neck region may be more easily oriented from the superior viewing angle. The authors prefer transvesical cystoscopy with the microlaparoscope for its ease of use, compared to their experience of performing a small cystotomy or routine transurethral cystoscopy.

Interobserver variation in the assessment of pelvic organ prolapse.

The aim of this study was to determine the interobserver agreement of two grading systems for pelvic organ prolapse: the vaginal profile and the International Continence Society (ICS) draft proposal. Forty-nine consecutive women referred for evaluation of urinary incontinence and/or pelvic organ prolapse were studied. Patients were first examined by a physician and a nurse clinician using the vaginal profile, followed by an examination according to the technique described in the ICS draft proposal for standardization of terminology (1994). kappa statistic and Pearson's correlation coefficient were used to determine interobserver variability for the ICS system by overall stage, by stage-specific comparison, and by specific anatomic location. The vaginal profile was evaluated by obtaining a kappa for overall degree of prolapse, stage-specific comparison and by anatomic area. The kappa for the ICS stage was 0.79 (P < 0.001), and the kappa for the vaginal profile by area of greatest prolapse was 0.68 (P < 0.001), indicating substantial interobserver agreement for both systems. The ICS system was noted to have substantial interobserver agreement by a stage-specific comparison. All anatomic locations of the ICS staging system were found to correlate significantly, and a high degree of interobserver precision was found. The vaginal profile also showed significant interobserver agreement by overall degree of prolapse, by specific degree of prolapse, and by anatomic area. It was concluded that both the proposed ICS staging system and the traditional vaginal profile show significant interobserver agreement both by overall stage, stage-specific analysis and specific location. The registered nurse examination correlated well with the physician examination, indicating that the most important factor in obtaining reproducible results may be definition and close attention to examination technique.

The role of endocervical curettage at cervical conization for high-grade dysplasia.

OBJECTIVE: To quantify the risk of invasive cancer above the location where the conization specimen was taken in patients with an endocervical curettage (ECC) positive for dysplasia at conization for high-grade cervical intraepithelial neoplasia (CIN), and to determine if any pathologic features may influence this risk. METHODS: The charts of 104 patients who underwent cervical conization for high-grade dysplasia followed by repeat conization or hysterectomy at Los Angeles County + University of Southern California Women's Hospital between January 1986 and December 1992 were reviewed retrospectively. Patients with invasive cancer or glandular dysplasia on the initial conization were excluded. The ECC performed immediately after conization biopsy (conization ECC) was benign in 63 patients and contained dysplasia in 41. All available conization ECC specimens that contained dysplasia were evaluated for volume of dysplasia and degree of cytologic atypia. Fisher exact test was used for statistical comparison between and within groups. RESULTS: Invasive cancer was not present in any patients in the benign ECC group but was present in nine (22%) patients in the dysplasia group (P < .0001); five of these patients had microinvasion (no more than 3 mm of stromal invasion and no lymph-vascular space involvement) and four had frank invasion. Comparison of patients with involved endocervical margins revealed that none of 37 patients in the benign ECC group versus eight of 27 patients in the dysplasia group had invasive cancer (P < .0005). All patients with invasion were 35 years or older and all patients with frank invasion were 50 years or older. Neither volume nor cytologic grade of dysplasia in the ECC was predictive of invasion in the residual cervix. CONCLUSIONS: An ECC at conization positive for dysplasia is an important predictor of invasion in the residual cervix of patients whose conization reveals high-grade intraepithelial neoplasia and should be routinely performed. Women 50 years or older with both a positive endocervical margin and conization ECC should undergo repeat conization before further therapy. Women under 50 years of age should undergo repeat conization if fertility is not desired; otherwise, close follow-up is necessary to exclude the presence of an invasive lesion in the residual cervix.