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ORIGINAL RESEARCH |
From the 1Pelvic Floor Center Danderyd Hospital, Division of Obstetrics and Gynecology, Stockholm, Sweden; and 2Division of Colon and Rectal Surgery, University of Minnesota, Minneapolis, Minnesota.
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ABSTRACT |
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 ABSTRACT MATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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METHODS: Twenty-three patients who completed evaluation preoperatively and 1 year after surgery were assessed at a 3-year follow-up. Clinical examination was performed preoperatively, and at the 1- and 3-year follow-ups, with the pelvic organ prolapse quantification system. Symptom assessment was performed with a validated bowel function questionnaire including questions on sexual function.
RESULTS: There were no graft-related complications during the 3 years following surgery. Preoperatively, all patients had stage II prolapse of the posterior vaginal wall and a rectocele verified at defecography. At the 1-year follow-up, 11 of 29 patients (38%) had rectocele of stage II or more, and 4 patients were reoperated. At 3-year follow-up 7 of 23 patients (30%) had rectocele of stage II or more. When including the 4 early anatomical recurrences, a total of 11 of 27 patients (41%) had rectocele of stage II or more at 3-year follow-up. Preoperatively, all patients reported varying degrees of rectal emptying difficulties and symptoms of bowel dysfunction. There was a significant decrease in rectal emptying difficulties (P < .01), sense of incomplete evacuation (P < .01), need for manually assisted defecation (P < .05), and symptoms of pelvic heaviness (P < .001) at the 3-year follow-up compared with preoperatively. Cure of rectal emptying difficulties was reported by fewer than 50% of patients. There were no significant changes in anal incontinence scores or symptoms of sexual dysfunction at the 3-year follow-up compared with preoperatively.
CONCLUSION: Rectocele repair using porcine dermal graft was associated with an unsatisfactory anatomical cure rate and persistent bowel-emptying difficulties in the majority of patients 3 years postoperatively.
LEVEL OF EVIDENCE: II-3
Symptoms of bowel emptying difficulties are usually the primary outcome variables when assessing rectocele repair, and cure or improvement rates ranging between 62% and 91% have been reported after posterior colporraphy.2,7,8,10 Posterior colporrhaphy has traditionally been associated with dyspareunia, attributed to the use of levator ani plication.11,12 Anatomical cure rates and symptom alleviation using the site-specific or midline fascia plication techniques have been reported similar to posterior colporraphy, but site-specific fascia repair may be associated with higher anatomical recurrence rates and similar rates of dyspareunia.13 Transanal rectocele repair may provide satisfactory anatomical and subjective outcomes but has been related to de novo or deteriorating anal incontinence.17,18 Thus, unsatisfying postoperative outcomes, combined with an expected increase in demand of urogynecological care in the future,19 indicate a need for further innovations in rectocele surgery.
Use of biomaterial implants in vaginal wall reconstructive surgery has rapidly become en vogue, although the documentation on clinical outcome and in vivo safety is limited or absent altogether.20 We have previously reported on our findings evaluating safety aspects and clinical outcomes after rectocele repair using xenograft (Pelvicol, C. R. Bard, Murray Hill, NJ) at short-term follow-up.21,22 Because clinical data on the use of grafts in pelvic reconstructive surgery is limited to 1 year postoperatively, long-term outcome and complications are unknown. This study was undertaken to evaluate at 3 years postoperatively the clinical outcome of rectocele repair using xenograft.
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MATERIALS AND METHODS |
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ABSTRACTMATERIALS AND METHODSRESULTSDISCUSSIONREFERENCES |
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All patients were initially referred to our department because of symptomatic rectocele with bowel emptying difficulties. The 3-year follow-up was performed at a mean of 38 (range 34–43) months after surgery. Mean age at surgery was 63.3 (range 42–73) years, mean parity was 2.1 (range 0–4), and mean body mass index was 24 (range 19–32). Preoperatively, 22 patients were postmenopausal, 7 patients were treated with oral hormone replacement therapy, and 12 patients used vaginal estrogen suppositories. Four patients had previously undergone hysterectomy, 7 patients genital prolapse surgery other than hysterectomy or rectocele repair, 5 patients salpingo-oophorectomy, 8 patients appendectomy, 2 patients cholecystectomy, and 1 patient surgery for small bowel obstruction.
The xenograft used in the present study (Pelvicol) has been U.S. Food and Drug Administration (FDA)- and CE-approved for permanent use in humans (manufacturer’s information). The acellular graft is processed from porcine dermis and consists of collagen type I fibrils and elastin. The collagen fibrils have been reinforced by additional hexamethylene di-isocyanate cross-linking to resist the degrading action of tissue collagenases. The complex Pelvicol manufacturing process involves numerous steps to remove tissue fat, enzymatic trypsin extraction to remove cellular components, and the formation of additional intra- and intermolecular cross-links mediated by hexamethylene di-isocyanate.
All patients underwent a standardized procedure. A transverse incision was made at the mucocutaneous border, and the posterior vaginal wall was incised up to the posterior fornix. The vaginal mucosa was dissected from the rectovaginal wall, and the levator muscles were identified. A 4 x 7 cm Pelvicol graft was attached to the levator muscles, the perineal body, and the upper rectovaginal wall with interrupted polyglactin sutures (size 0). The excessive mucosal fold was removed and the mucosa closed in the mid-line with interrupted sutures.
Six of the patients underwent simultaneous vaginal enterocele repair, where a simplified peritoneal closure was performed by using circular invaginating sutures after opening the cul-de-sac peritoneum through a vaginal approach. Three patients underwent a concurrent anterior colporrhaphy, 2 patients a vaginal hysterectomy, and 1 patient a cervical amputation.
Clinical examination was performed preoperatively, at the 1-year follow-up, and at the 3-year follow-up. All patients were clinically examined in the supine position by the same physician using the pelvic organ prolapse quantification system (POP-Q). Methods, definitions, and descriptions conformed to the standards recommended by the International Continence Society.23 For the purpose of this study, postoperative stage 0–I at point Bp was considered anatomical success, whereas Bp of stage II or more was considered a failure. Postoperatively, graft-related complications were registered in a separate protocol.
Defecography was performed preoperatively and at the 12-month follow-up. These results have been reported previously.22 Symptom assessment was performed with a written standardized questionnaire completed preoperatively and at the 1- and 3-year follow-ups. The validated bowel function questionnaire is recommended for use by the Swedish Society of Colorectal Surgeons and include 20 questions about bowel function and defecation habits.24 Four standardized response alternatives were given to each question (no, 
1/week, > 1/week, and daily). The Cleveland Clinic Incontinence Score (CCIS) was used to measure degree of anal incontinence (0 = perfect continence, 1–7 = good continence, 8–14 = moderate incontinence, 15–20 = severe incontinence, and 
21 = complete incontinence).25 Pelvic heaviness and sexual function were measured with a visual analog scale, graded 0–10. The questionnaire also included questions regarding general health and surgical and obstetric histories.
To evaluate postoperative outcome, nonparametric statistics were used. Wilcoxon signed rank test for dependent samples was used to compare ordinal data, whereas the Wilcoxon matched pairs test was used for continuous numeric data. Subanalyses on covariates were performed using logistic uni- and multivariate regression analysis. P < .05 was considered significant for all analyses. Cleveland Clinic Incontinence Score results were reported as mean ± standard deviation (SD).
The study was approved by the Local Ethics Committee at Karolinska Hospital, Karolinska Institutet, Stockholm, Sweden. All patients gave their informed consent before participating in the study. The mesh manufacturing company had no influence over the design, execution, or interpretation of the study.
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RESULTS |
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Preoperatively all patients had stage II prolapse of the posterior vaginal wall, and all patients had a rectocele verified at defecography. Four patients had stage II or more prolapse of the anterior vaginal wall, and 3 patients stage II or more prolapse of the middle compartment.
At the 1-year follow-up, there was a significant reduction of rectocele size at clinical quantification (P < .001) (Table 2), although 11 of 29 patients (38%, 95% confidence interval [CI] 20–60%) had stage II or more rectocele. Subanalysis using logistic regression did not identify age, body mass index (BMI), parity, age at menopause, topical or oral hormone replacement treatment, or surgeon as predictive factors for the postoperative outcome. All patients with a stage II or greater rectocele at clinical examination had a rectocele or more than 2 cm at the postoperative defecography.
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At the 3-year follow-up, there was a significant reduction of rectocele size at clinical quantification (P < .001) (Table 2), although 7 of 23 patients (30%, 95% CI 12–48%) had rectocele of stage II or greater. When adding the 4 early anatomical recurrences, a total of 11 of 27 patients (41%, 95% CI 20–60%) had rectocele of stage II or greater at 3-year follow-up. Subanalysis using logistic regression did not identify age, BMI, parity, age at menopause, topical or oral hormone replacement treatment, or surgeon as predictive factors for the postoperative outcome. Five of 7 patients with a rectocele of stage II or more at POP-Q 3 years postoperatively, had a rectocele of more than 2 cm at the 1-year postoperative defecography.
Preoperatively, all patients presented with a rectocele of more than 2 cm at defecography, with a mean size of 2.6 cm (range 2.5–6.5 cm). At the 1-year follow-up, 12 of 23 patients still had a rectocele at defecography measuring a mean of 2.8 cm (range 2–4 cm).
Preoperatively, all patients asserted varying degrees of rectal emptying difficulties and symptoms of bowel dysfunction. Manually assisted defecation was reported by 12 of 23 patients. Mean CCIS was 2.4 ± 3.3 SD, and 1 patient was classified as moderately incontinent. Preoperatively, 15 of 23 patients were sexually active, and some degree of pelvic heaviness was reported by all patients.
At the 1-year follow-up, there was a significant decrease in rectal emptying difficulties (P < .01), sense of incomplete evacuation (P < .01), and symptoms of pelvic heaviness (P < .01) compared with preoperatively (Tables 3 and 4). Mean CCIS was 2.9 ± 4.7 SD (P = .8), 2 patients were classified as moderately incontinent, and 1 patient was severely incontinent. One of these patients had no incontinence symptoms preoperatively. Two patients reported improved incontinence scores. There was a significant difference in mean CCIS when comparing patients with anatomical rectocele recurrence and anatomical cure at 1-year follow-up (Table 5).
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At the 3-year follow-up, there was a significant decrease in rectal emptying difficulties (P < .01), sense of incomplete evacuation (P < .01), need for manually assisted defecation (P < .05), and symptoms of pelvic heaviness (P < .001) compared with preoperatively (Table 3 and 4). Mean CCIS was 2.6 ± 4.0 SD (P = .6), 2 patients were classified as moderately incontinent, and 1 patient was severely incontinent. One of these patients had no incontinence symptoms preoperatively. Three patients reported improved incontinence scores. There was no significant difference in mean CCIS when comparing patients with anatomical rectocele recurrence and anatomical cure at the 3-year follow-up (Table 5).
There were no significant changes in coital frequency, feelings of discomfort at intercourse, superficial dyspareunia, abdominal dyspareunia, or the number of sexually active patients at the 1- or 3-year follow-up compared with preoperatively (Table 4). Five of 7 patients with anatomical recurrence were sexually active at the 3-year follow-up, but they did not differ significantly in coital frequency, feelings of discomfort at intercourse, superficial dyspareunia, or abdominal dyspareunia compared with patients without anatomical rectocele recurrence (Table 4).
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DISCUSSION |
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Our most important finding was the persistent deterioration in anatomical outcome noted over the 3-year study period. In contrast to the high anatomical cure rates reported in 2 prospective cohort studies using a combination of site-specific repair and graft augmentation,26,27 we find our anatomical results unsatisfying, with a total anatomical recurrence rate of 41% at 3-year follow-up.
It is difficult to ascertain whether the high success rates in previous studies using biological grafts26,27 were a result of differences in graft characteristics or the site-specific repair preceding the positioning of the graft. Because our surgical repair relied entirely on the strength of the graft, it seems plausible that premature graft breakdown or absorption may explain our high recurrence rate. At reoperation of 4 patients with symptomatic rectocele recurrence at the 1-year follow-up, the graft was not macroscopically detectable at dissection, and graft absorption was considered the primary cause of recurrence in these patients.
When analyzing the 4 patients with early anatomical and symptomatic failures, we found no obvious differences from the rest of the study group other than a higher average BMI and a higher quantification at point Bp before surgery (Table 1). Three of 4 early recurrences had a BMI greater than 30, which generally is considered morbidly obese. It is possible that a more than average pelvic weight load combined with insufficient biomaterial durability caused an early recurrence. The use of biomaterials for pelvic reconstructive surgery in obese patients is in need of additional investigation.
In a previous study we found no adverse histological inflammatory reactions associated with graft rejection in our biopsies, nor at clinical inflammatory grading, within 1 year of rectocele repair using Pelvicol.21 In the present study, we were able to confirm that the xenograft did not provoke any clinical complications 3 years postoperatively and that hexamethylene di-isocyanate cross-linked porcine dermal grafts appear to be safe in terms of surgical morbidity.
Consistent with our previous findings,22 rectocele repair with xenograft alleviated symptoms of rectal emptying difficulties and incomplete evacuation at 3-year follow-up. At 3-year follow-up, there was also a decrease in the need for manually assisted defecation compared with preoperatively. The symptomatic improvement rates do, however, come at the cost of the unsatisfying anatomical outcome, and even though symptom improvement was highly statistically significant, it should be noted that subjective cure of symptoms associated with bowel emptying difficulties were reported in less than 50% of our patients (Table 3). The relatively low loss to follow-up decreased the risk of selection bias influencing our results since 23 of 25 patients eligible for follow-up (92%) participated in the 3-year checkup. Unfortunately, the 2 previous prospective studies reporting on graft augmented suture repair26,27 did not include any standardized preoperative symptom assessment. Subjective cure rates are therefore unknown, and a comparison is impossible.
Patients with rectocele may present concomitant symptoms of anal incontinence.28 Although some authors report a deterioration in anal sphincter function after rectocele repair,18 others report improved anal incontinence scores postoperatively.28 The surgical technique described in the present study was not associated with any significant changes in anal continence status measured by the CCIS when considering the entire study group (Table 5). The overall CCIS was, however, higher in patients with POP-Q stage II (ie, rectocele recurrence) than in patients with anatomical cure at the 1-year follow-up. The number of patients available for this subanalysis was limited at the 1-year follow-up (n = 4), and it is likely that one patient with severe incontinence caused the mean CCIS to rise disproportionally. At the 3-year follow-up when the number of patients with anatomical recurrence had increased (n = 7), there was no longer a statistically significant difference in CCIS. The relatively minor iatrogenic effect on continence status in our study may be attributed to avoiding dissection of the rectovaginal fascia, thereby preserving nerve fibers imbedded in the fibrous tissue fascia separating the anterior distal rectum from the posterior vagina, innervating the external anal sphincter.29
In the present study, rectocele repair with xenograft without additional tissue repair did not result in any significant changes in coital frequency, dyspareunia, or the number of patients sexually active postoperatively. Our findings contrast with results showing a deterioration of sexual function after vaginal prolapse surgery using a traditional Manchester repair.30 These results provide further substantiation of the assumption that levator ani plication in particular is associated with increased rates of dyspareunia, even though recent data suggest that the site-specific suture technique may also cause dyspareunia.13
Although there was a clear reduction in symptoms of pelvic heaviness, neither sexual function nor symptoms of pelvic heaviness differed between patients with a rectocele recurrence and those without (Table 4). A lack of correlation between clinical findings and symptoms has previously been described when dealing with both rectoceles and enteroceles. This discrepancy is poorly understood and needs to be addressed further.34
We recognize that the small number of patients in our study and the lack of a control group, are 2 shortcomings in our study. Despite these limitations, our study provides some indication of the durability of hexamethylene di-isocyanate–treated porcine dermal graft in the area and patients of intended use at long-term follow-up. Although we cannot explain why the graft seems to maintain its strength for a longer time period in some patients than in others, a plausible explanation could be innate differences in tissue collagenase activity.35 Because additional cross-linking does not make collagen-based grafts impervious to the degrading action of tissue collagenases,36 durability of dermal collagen grafts may vary between patients and may be associated with age37 and hormonal status.38 To specifically evaluate the importance of graft- or implant-augmented tissue repair compared with traditional suture techniques without graft augmentation, comparative studies are required. Graft breakdown or absorption may explain the steady deterioration in anatomical outcome over the 3-year study period. In our opinion, the use of collagen-based porcine grafts in pelvic organ prolapse surgery needs further evaluation before being adopted into daily clinical practice.
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Footnotes |
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doi:10.1097/01.AOG.0000192547.58102.ab
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REFERENCES |
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