Objective
The purpose of this study was to develop and test a unique, new pelvic floor surgery complication scale and compare it with an existing validated measure.
Study Design
Surgeons from 2 clinical trials networks rated complications based on perceived patient bother, severity, and duration of disability to develop a Pelvic Floor Complication Scale (PFCS). PFCS scores were calculated for subjects in 2 multicenter pelvic floor surgical trials. The PFCS and modified Clavien-Dindo scores were evaluated for associations with length of hospitalization, satisfaction, and quality-of-life measures (Health Utilities Index, Short Form-36, Urogenital Distress Inventory, and Incontinence Impact Questionnaire).
Results
We calculated PFCS scores for 977 subjects. Higher PFCS and Clavien-Dindo scores similarly were associated with longer length of hospitalization ( P < .01), lower satisfaction ( P < .01), lower Health Utilities Index scores ( P = .02), lower Short Form-36 scores ( P = .02), higher Urogenital Distress Inventory scores ( P < .01), and Incontinence Impact Questionnaire scores ( P < .01) at 3 months. No associations were present at 1 year.
Conclusion
The PFCS compares favorably to the validated modified Clavien-Dindo instrument.
Pelvic floor disorders, like pelvic organ prolapse and urinary incontinence, often impair a woman’s quality of life (QoL) but rarely, in themselves, result in significant morbidity or death. The surgical procedures that are used to correct these conditions impart some risk of morbidity. Given this, patients and physicians must weigh carefully the benefits and risks of various treatment options when considering surgery. Successful surgical outcomes should take into account perioperative and postoperative morbidity. For example, a surgery that has excellent anatomic and symptomatic improvement, but increased morbidity, may not be as desirable as a surgery that has good anatomic and symptomatic improvement with minimal morbidity. Unfortunately, our ability to compare the outcomes of different procedures or surgical approaches is hampered by a lack of uniform reporting of perioperative morbidity. Perioperative complications are generally reported in surgical studies; however, complications are often reported only as a summation or are divided into major and minor categories at the discretion of the author.
In recent years, clinical investigators published several surgical complication grading systems that allow more uniform classification and reporting of perioperative complications. These systems broadly classify complications into 1 of several groups and are intended for use in all surgical disciplines. The Clavien-Dindo system classifies complications into 1 of 4 categories that are based on the type of therapy that is needed to correct the complication. This system is reproducible, easy to apply, has been validated compared with complexity of surgery and length of hospital stay in general surgery populations, and has been used recently in several studies that have evaluated pelvic reconstructive procedures. However, current systems are not condition specific and do not take into account the unique complications that are associated with pelvic reconstructive surgery. The objective of this study was to develop a peri- and postoperative complication scale that is specific to pelvic reconstructive surgery and to compare its ability to predict factors that are associated with perioperative morbidity with the Clavien-Dindo system.
Materials and Methods
Investigators from the Pelvic Floor Disorders Network and the Urinary Incontinence Treatment Network rated specific intraoperative plus immediate and delayed postoperative complications on a scale from 0-10 based on severity, patient bother, and duration of disability. Scoring was as follows: 0 = none, no bother, no clinical significance; 2 = minor, bother, no clinical significance, transient, self-limited; 4 = minor, bother, requires intervention; 6 = major, no risk or low risk, no long-term sequelae; 8 = major, moderate or high risk, long-term sequelae; and 10 = major, life threatening, permanent disability. We then created the Pelvic Floor Complication Scale (PFCS) using the information that we had obtained ( Table 1 ).
| Morbidity | Mean | SD |
|---|---|---|
| Intraoperative (before leaving operating room) | ||
| OR1: Bowel injury with colostomy | 8.2 | 0.7 |
| OR2: Bowel injury with resection and primary repair | 6.9 | 1.0 |
| OR3: Bowel injury with primary repair (does not include serotomy) | 5.9 | 1.4 |
| OR4: Vascular injury that requires vascular surgeon | 7.7 | 1.3 |
| OR5: Ureteral injury that requires reanastomosis | 7.0 | 0.9 |
| OR6: Ureteral injury that requires stent | 5.8 | 1.3 |
| OR7: Ureteral injury that is resolved with removal of suture | 4.4 | 1.6 |
| OR8: Aspiration pneumonia | 6.6 | 1.3 |
| OR9: Transfusion | 5.2 | 1.4 |
| OR10: Estimated blood loss >1000 mL | 5.3 | 1.7 |
| OR11: Urethral injury | 5.8 | 1.3 |
| OR12: Cystotomy that requires repair | 4.7 | 1.2 |
| OR13: Cystotomy that does not require repair | 3.1 | 1.2 |
| Immediately postoperation (after leaving operating room to discharge) | ||
| IP1: Thromboembolic event (deep venous thrombosis/pulmonary embolism) | 8.0 | 1.4 |
| IP2: Small bowel obstruction | 7.0 | 1.2 |
| IP3: Ileus (reversal in diet advance) | 3.8 | 1.2 |
| IP4: Persistent nausea/vomiting >24 hours (cause uncertain) | 3.6 | 1.3 |
| IP5: Postoperative fever that requires antibiotics (cause uncertain) | 3.5 | 1.1 |
| IP6: Postoperative fever that resolves without antibiotics | 2.3 | 1.2 |
| IP7: Myocardial infarction/congestive heart failure | 8.6 | 1.0 |
| IP8: Wound infection with fascial dehiscence | 7.2 | 1.3 |
| IP9: Wound infection/separation with suprafascial dehiscence | 5.0 | 1.2 |
| IP10: Wound infection/seroma/hematoma with no dehiscence (cellulitis resolved with antibiotics) | 4.0 | 0.9 |
| IP11: Fistula | 7.5 | 1.3 |
| IP12: Neuropathy that is persistent at time of discharge | 6.0 | 1.6 |
| IP13: Neuropathy that resolves before discharge | 3.1 | 1.4 |
| IP14: Urinary tract infection (bacteriuria, pyuria, treated with antibiotics) | 3.3 | 1.1 |
| IP15: Bleeding: reoperation required | 7.3 | 1.1 |
| IP16: Bleeding: transfusion required | 5.3 | 1.3 |
| IP17: Bleeding: observation only | 3.4 | 1.4 |
| IP18: Reoperation because of an unrecognized bladder injury | 6.9 | 0.9 |
| IP19: Reoperation because of an unrecognized ureteral injury | 7.6 | 0.9 |
| IP20: Reoperation because of an unrecognized bowel injury | 8.3 | 1.0 |
| IP21: Reoperation because of any other complication of original surgery | 7.2 | 0.9 |
| IP22: Pneumonia | 5.7 | 1.4 |
| IP23: Pulmonary edema | 5.9 | 1.5 |
| IP24: Mental status changes | 6.0 | 1.6 |
| IP25: Pelvic abscess | 6.6 | 1.5 |
| IP26: Sepsis, disseminated intravascular coagulation | 9.0 | 1.1 |
| Delayed postoperative (after discharge) | ||
| DP1: Thromboembolic event (deep venous thrombosis/pulmonary embolism) | 8.2 | 1.4 |
| DP2: Small bowel obstruction | 7.1 | 1.0 |
| DP3: Ileus (reversal in diet advance) | 4.6 | 1.4 |
| DP4: Persistent nausea/vomiting (cause uncertain) | 4.3 | 1.5 |
| DP5: Postoperative fever that requires antibiotics (cause uncertain) | 4.1 | 1.1 |
| DP6: Postoperative fever that resolves without antibiotics | 2.7 | 1.2 |
| DP7: Myocardial infarction/congestive heart failure | 8.6 | 1.1 |
| DP8: Wound infection with fascial dehiscence | 7.5 | 1.2 |
| DP9: Wound infection/separation with suprafascial dehiscence | 5.3 | 1.3 |
| DP10: Wound infection/seroma/hematoma – no dehiscence (cellulitis resolved with antibiotics) | 4.3 | 1.2 |
| DP11: Fistula | 7.6 | 1.1 |
| DP12: Urinary tract infection (bacteriuria, pyuria, treated with antibiotics) | 3.5 | 1.1 |
| DP13: Bleeding, reoperation required | 7.5 | 1.2 |
| DP14: Bleeding, transfusion required | 5.6 | 1.5 |
| DP15: Bleeding, observation only | 3.6 | 1.5 |
| DP16: Reoperation because of an unrecognized bladder injury | 7.0 | 1.1 |
| DP17: Reoperation because of an unrecognized ureteral injury | 7.7 | 1.2 |
| DP18: Reoperation because of an unrecognized bowel injury | 8.5 | 1.1 |
| DP19: Reoperation because of any other complication of original surgery | 7.4 | 1.0 |
| DP20: Pneumonia | 5.7 | 1.5 |
| DP21: Pulmonary edema | 5.9 | 1.5 |
| DP22: Mental status changes, dementia | 6.0 | 1.7 |
| DP23: Pelvic abscess | 6.7 | 1.4 |
| DP24: Sepsis, disseminated intravascular coagulation | 9.0 | 1.1 |
| DP25: Readmission secondary to a complication of original surgery | 6.3 | 1.4 |
| DP26: Graft erosion that requires surgical excision | 6.0 | 1.4 |
| DP27: Graft erosion trimmed in office | 4.1 | 1.1 |
| DP28: Graft erosion expectantly managed | 3.3 | 1.2 |
| DP29: Suture erosion | 3.5 | 1.1 |
| DP30: Urinary retention that requires surgical revision. | 6.1 | 1.3 |
| DP31: Prolonged urinary retention (>4 wk) that requires catheterization | 4.7 | 1.3 |
| DP32: Transient urinary retention (<4 wk) | 3.2 | 1.3 |
| DP33: Persistent neuropathy at (≥6 wk) | 7.1 | 1.5 |
| DP34: Granulation tissue | 3.1 | 1.2 |
PFCS scores were calculated retrospectively during the first postoperative year for participants in 2 randomized pelvic floor surgical trials: colpopexy and urinary reduction efforts (CARE), which compared abdominal sacrocolpopexy with or without Burch colposuspension in stress continent women and the stress incontinence surgical treatment efficacy trial (SISTEr), which compared Burch colposuspension and fascial sling in women with stress incontinence. This analysis was exempt from Institutional Review Board review. We excluded women with no 3-month follow-up data. Complications for each study had been evaluated already, adjudicated, and transferred into a database. Information from these databases was extracted to help identify the complication onset, resolution, severity, and treatment. Definitions were created for each complication to use as a guide for cases in which the information from the database was insufficient to categorize the complication ( Table 1 ). For example, clear, mutually exclusive definitions were constructed to distinguish wound infections with separation (suprafascial dehiscence) from seroma, hematoma, or cellulitis (without dehiscence and/or resolved with antibiotics). When a reoperation or readmission was required for a complication, the highest single PFCS score that was related to the complication was selected.
Two independent investigators reviewed all complications that occurred during the first year after surgery in each study and assigned a time period and PFCS score. A third investigator adjudicated any discrepancies that occurred. There were 3 time periods: perioperative (operating room to discharge), 3 postoperative months (discharge to 90 days), and 1 postoperative year (91-365 days). Complications that were being actively managed over >1 time period generated a separate complication score for each time period. An example of this includes a vaginal mesh exposure that was trimmed in the office at 2 months and in the operating room at 6 months after the surgery. Individual complication scores for each time period were summed. We defined the PFCS composite score as the sum of all complications that occurred during the perioperative and 3-month postoperative time periods. Medical complications that were >6 weeks after surgery and were not believed by 3 reviewers to be related to the original surgery did not receive a PFCS score.
Patient demographics that were collected included age, race, marital status, education, tobacco use, menopause status, previous pelvic surgery, diabetes mellitus, body mass index, and preoperative pelvic organ prolapse quantification examination stage. QoL measures that included the Health Utilities Index (HUI) for SISTEr, Short Form-36 Health Survey (SF-36) for CARE, and Urogenital Distress Inventory (UDI) and Incontinence Impact Questionnaire (IIQ) for both studies were available at baseline, 3 months, and 1 year. HUI ranged from 0-1; higher value indicate better health, but scores can also be negative (lowest possible value, −0.36), which reflects health states that are considered worse than death. The mental and physical component summary scores of the SF-36 range from 0–100 (higher scores indicate better health). UDI scores range from 0–300, and IIQ scores range from 0–400 (higher scores indicate worse QoL). Satisfaction was measured by a global satisfaction question with a 5-point Likert scale from “very dissatisfied” to “very satisfied” at 3 months and 1 year. Additionally, surgical information that included the route of surgery, type of anesthesia, length of surgery, and postoperative length of hospitalization (LOH) was obtained.
Complications were also assessed with a modified Clavien-Dindo scale. The original Clavien-Dindo scale was validated for immediate postoperative complications before discharge in a general surgical population. The scale ranges from grade I-IV; higher scores indicate more severe complications. Grade I includes complications requiring no medications or specific medications and wound infections treated at the bedside. Grade II includes other medications, blood transfusions, and total parenteral nutrition. Grade III requires surgical, endoscopic, or radiologic management and grade IV involves life-threatening complications with intermediate or intensive care unit treatment. Grade V includes patient death. The modified version of this scale was used according to the original specifications with 1 exception: complications were also categorized during surgery and at time periods after discharge. Clavien-Dindo scores for SISTEr subjects were calculated for all delayed postoperative complications; Clavien-Dindo scores for CARE subjects were calculated for only those delayed postoperative complications that were believed to be associated with the original surgery.
We then examined associations between PFCS composite scores and LOH, QoL, and satisfaction at 3 months with general linear fit models (LOH, HUI, and SF-36) and ordinal logistic regression for satisfaction. Because UDI and IIQ had a large proportion of subjects with 0 values, a 2-step analysis was run. The first step used a logistic model to evaluate the association between a PFCS composite score and a dichotomous UDI score (0 vs scores >0). The second step used a general linear model to evaluate the association between PFCS composite score and UDI score for all subjects with a UDI score >0 (log [e-base] transformed before analysis). Each analysis was adjusted for the corresponding baseline QoL scores when available (HUI, SF-36, UDI, and IIQ). We chose to analyze the 2 studies (CARE and SISTEr) as 1 combined group because the goal of this study was to evaluate the PFCS among various patients who had undergone reconstructive pelvic surgery. Because the 2 study populations and types of procedures were inherently different, we also adjusted each analysis for the study (CARE and SISTEr). We performed similar analyses for Clavien-Dindo score at 3 months. In addition, we examined associations between PFCS and Clavien-Dindo 1-year scores and 1-year outcomes. In all analyses, PFCS was treated as a continuous variable, and Clavien-Dindo was treated as a categoric variable. The associations for PFCS and Clavien-Dindo scores were compared with the use of Pearson and Spearman correlation coefficients ( R -square) or Akaike Information Criterion. A probability value of < .05 was considered statistically significant.
Results
Scale development
Forty-seven surgeons participated, which yielded a mean score and standard deviation for each complication ( Table 1 ). The highest score was 9.0 for sepsis/disseminated intravascular coagulation and lowest 2.3 for postoperative fever that did not require antibiotics. Standard deviations ranged from 0.7–1.7 for all complications.
Demographics and scale assessment
Participants included 977 women (CARE, 322 women; SISTEr, 655 women); baseline characteristics and surgical information are listed in Table 2 . Mean age was 55 years, and mean body mass index was 29 kg/m 2 . Most of the women were non-Hispanic white (79%), married (71%), and menopausal (75%) and had had pelvic surgery (70%). Most women had stage 2 or 3 prolapse (44% and 31%, respectively). Median LOH was 2 days (quartile range, 1–3 days). Table 3 contains the QoL measures at baseline, 3 months and 1 year plus satisfaction at 3 months and 1 year. All variables improved from baseline, and 90% of the women were somewhat or very satisfied at 3 months.
| Variable | Measure |
|---|---|
| Age, n a | 54.9 ± 11.1 |
| Body mass index, kg/m 2a | 29.0 ± 5.8 |
| Race, n (%) | |
| Non-Hispanic white | 774 (79.3) |
| Hispanic | 81 (8.3) |
| Non-Hispanic black | 60 (6.1) |
| Non-Hispanic other | 61 (6.3) |
| Marital status, n (%) | |
| Married or living as married | 687 (70.7) |
| Separated, divorced, widowed | 285 (29.3) |
| Education, n (%) | |
| Completed ≥4 years of college | 242 (24.8) |
| Some college/Associate degree | 358 (36.6) |
| Less than or equivalent to complete high school | 377 (38.6) |
| Current tobacco use, n (%) | 116 (11.9) |
| Menopause, n (%) | |
| After menopause | 735 (75.3) |
| Before menopause | 241 (24.7) |
| Previous pelvic surgery, n (%) | 684 (70) |
| Diabetes mellitus, n (%) | 62 (6.3) |
| Pelvic organ prolapse quantification examination, n (%) | |
| Stage 0 | 30 (3.1) |
| Stage 1 | 132 (13.5) |
| Stage 2 | 431 (44.1) |
| Stage 3 | 305 (31.2) |
| Stage 4 | 79 (8.1) |
| Surgery route, n (%) | |
| Combined abdominal and vaginal | 521 (53.3) |
| Abdominal | 456 (46.7) |
| Type of anesthesia, n (%) | |
| General | 851 (87.1) |
| Other | 126 (12.9) |
| Length of surgery, min a | 151.4 ± 67.1 |
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