Over the period of analysis, 113 women (94.2%) and 7 men (5.8%) underwent a total of 120 anal sphincter repairs (median overall age 59, range 16–84 years). Of the cohort, 56 (46.6%) were > 60 years of age and 17 (14.2%) > 70 years of age at the time of surgery. In presentation 97.5% complained of incontinence to solid stool, 99.2% to liquid stool and 100% had gaseous incontinence with 88% reporting urgency of defaecation and 65% regular soiling. The median duration of incontinence symptoms was 120 months (range 10–480 months). The cause of the sphincter injury was obstetric-related in 98 (81.6%) cases, following anal fistula surgery in 10 (8.3%), after other proctologic surgery (abscess drainage, internal anal sphincterotomy and haemorrhoidectomy) in 8 (6.6%) and with perineal trauma in 4 (3.3%) cases. Table 1 shows the clinical features and demographics of the operated cohort outlining their preoperative CCIS and the presence of concomitant pelvic floor disorders on clinical examination, as well as the surgical procedures performed to improve continence as well as to deal with ancillary anorectal pathology.
Table 1.– Demographic, preoperative and operative data for the whole group.
|
n = 120
|
Age (years) *
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59 (16–84)
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Gender
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Male
|
7 (6)
|
Female
|
113 (94)
|
Duration of symptoms before surgery (Months) *
|
120 (10–480)
|
Baseline CCIS
|
Total*
|
18 (9–20)
|
0–8
|
0 (0)
|
9–15
|
11 (9.2)
|
> 15
|
109 (90.8)
|
Preoperatory Manometric Variables
|
RP (LNR: 65 mmHg) ‡
|
27 (20–35)
|
MSP (LNR: 140 mmHg) ‡
|
50 (38–64)
|
SL (cm) ‡
|
2.6 (2–3)
|
Endoanal Ultrasound (81)
|
EAS defect
|
81 (100)
|
IAS defect
|
41 (50.6)
|
Previous Obstetric History ¥
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Vaginal Deliveries
|
98 (86.7)
|
Episiotomy (Range 1–5)
|
78 (69)
|
Third-Fourth degree tear
|
41 (36.3)
|
Concomitant Pelvic Floor Disorders ¥
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Rectocele
|
15 (13)
|
Recto-Vaginal Fistula
|
10 (9)
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Pelvic floor descent
|
9 (8)
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Rectal Prolapse
|
4 (3.5)
|
Enterocele
|
3 (2.6)
|
Anal Incontinence Surgical Techniques
|
Apposition Sphincteroplasty
|
1 (0.83)
|
Overlapping Sphincteroplasty
(119 cases / 99.1%)
|
OSph Alone
|
12 (10)
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OSph + ALev
|
14 (11.6)
|
OSph + IAS repair
|
16 (13.3)
|
OSph + ALev + IAS repair
|
68 (56.6)
|
OSph + TPFR
|
8 (6,6)
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OSph + Postanal Repair
|
1 (0.83)
|
Associated Pathologies Surgical Treatment
|
Rectocele
|
13 (10.8)
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Corman´s graft
|
8 (6.6)
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Recto-Vaginal Fistula
|
6 (5)
|
Enterocele
|
2 (1.66)
|
Hemorrhoidectomy
|
2 (1.66)
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Rectal Prolapse (Delorme)
|
1 (0.83)
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Rectal Villous Adenoma Removal
|
1 (0.83)
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Data are expressed as number of patients and percentage. |
* Median and range values. |
‡ Median and Interquartile range (IQR). |
¥ Data referred just to women. |
CCIS: Cleveland Clinic Incontinence Score; RP: Resting pressure; MSP: Maximum squeeze pressure; SL: Sphincter length; LNR: Laboratory normal reference; EAS: External anal sphincter; IAS: Internal anal sphincter; OSph: Overlapping Sphincteroplasty; ALev: Anterior levatorplasty; TPFR: Total Pelvic Floor Repair. |
The EAS defect was anteriorly located in 105 (87.5%) cases, lateral in 11 (9.2%) and posterior in 4 (3.3%). The mean angle of separation of the muscle ends was 126º (range 90–180º; SD = 28º). An overlapping sphincteroplasty (OS) was performed in 119 cases (99%) with one direct apposition repair and with a concomitant levatorplasty in 90 (75%) of the patients An IAS repair was performed in 84 (70%) cases. There was one reactionary haemorrhage requiring a return to the operating theatre with haemostasis and resuturing. There were 24 (20%) wound infections all of which healed within 2–6 weeks by secondary intention. Of the cohort 105 (87.5%) were available for follow-up with 8 patients who died from unrelated events including one with chronic dementia who was unavailable for assessment along with 6 patients lost to follow-up. The median follow-up period was 120 months (range 60-173.7 months) with the shortest follow-up of 24 months and the longest at 372 months. The follow-up was > 5 years in 95 (79%) and > 10 years in 60 (50%) of the cases.
Table 2 shows the recorded CCIS values demonstrating significant improvement at all measured postoperative time periods when compared with the baseline (P < 0.001). This is shown graphically in Fig. 2. The baseline and last follow-up CCIS values were compared in 3 symptomatic severity groups. There were 90.8% with a preoperative CCIS > 15 compared with 2.5% postoperatively (P < 0.001). Preoperatively, there were 9.2% with a recorded CCIS between 9–15 compared with 6% of postoperative cases (P < 0.001) and 0% of cases with a preoperative CCIS < 8 compared with 91.5% of postoperative cases (P < 0.001).
Table 2.- Comparison of preoperative values of CCIS with that of the different postoperative periods.
CCIS: Cleveland Clinic Incontinence Score; 95%-CI: 95% Confidence Interval; Preop: Preoperative; Postop: Postoperative; SD: Standard Deviation; Mean Dif: Mean Difference; m: months; Last F-U: Last Follow-up.
In the assessment at 5 years there was a significant improvement in the CCIS when compared with baseline for patients undergoing all types of repair (overlapping sphincteroplasty, P = 0.05; levatorplasty, P = 0.006 and IAS plication, P = 0.009). Of those undergoing a sphincteroplasty alone 78 (65%) reported good continence with the remaining 42 requiring ancillary treatment (Fig. 3). In this group, 4 patients underwent a repeat sphincteroplasty with a mean period between surgeries of 109 months (range 54–132 months) and with good functional outcome in 2 cases. Overall, an acceptable functional outcome was achieved in 92.9% of cases at final evaluation using a variable combination and sequence of BFT, SNS and PTNS therapies with 8 patients with an unsatisfactory outcome. There was no difference in the likelihood of a successful functional outcome between those undergoing a sphincteroplasty alone and those who required ancillary treatments (97.1% vs. 85.7%, respectively). No significant differences were noted in the resting or squeeze manometric evaluations when compared with baseline, however, there was a significant increase in the mean HPZ length from 2.6–3.2 cm (P = 0.032).
Table 3 shows the results of a univariate analysis to determine which factors correlated with either the need for an ancillary treatment over and above surgery or with a good functional outcome adjudged as > a 50% improvement in the recorded CCIS. There were no specific clinical or operative factors identified for either category. Overall there were 112 (93.3%) of the patients who considered their outcome as either good or excellent on the Browning-Parks Scale, 114 (95%) satisfied on simple clinical assessment and 115 (96.2%) reporting a clear improvement over their subjective preoperative status. In all, 104/105 patients questioned would undergo the same procedure again under similar circumstances.
Table 3.- Univariate analysis of possible factors that could influence clinical results in terms of additional treatments necessity or global success at end follow-up time.
|
Need of Additional Treatments
|
Satisfactory Results
(> 50% Reduction in CCIS)
|
|
No
n (%)
|
Yes
n (%)
|
p
|
No
n (%)
|
Yes
n (%)
|
p
|
Age (years) *
|
53.9 (17)
|
56.4 (13)
|
0.4
|
56 (14)
|
53.8 (15)
|
0.67
|
Sex
|
Female (113)
|
73 (64.6)
|
40 (35.4)
|
0.71
|
8 (7.6)
|
97 (92.4)
|
0.45
|
Male (7)
|
5 (71.4)
|
2 (28.6)
|
0 (0)
|
7 (100)
|
Duration of FI (months) *
|
55.4
|
39.6
|
0.29
|
51.1
|
49.2
|
0.95
|
Location of Sphincter Tear
|
Anterior (104)
|
67 (64.4)
|
37 (35.6)
|
0.49
|
7 (7.2)
|
90 (92.8)
|
0.71
|
Posterior or Lateral (16)
|
11 (68.8)
|
5 (31.3)
|
1 (6.7)
|
14 (93.3)
|
Tear Grades*
|
126 (27)
|
126 (30)
|
0.93
|
115 (30)
|
128 (27)
|
0.27
|
IAS Repair
|
Yes (84)
|
54 (64.3)
|
30 (35.7)
|
0.8
|
4 (5.1)
|
74 (94.9)
|
0.21
|
No (36)
|
24 (66.7)
|
12 (33.3)
|
4 (11.8)
|
30 (88.2)
|
Levatorplasty
|
Yes (82)
|
55 (67.1)
|
27 (32.9)
|
0.48
|
6 (7.8)
|
71 (92.2)
|
0.69
|
No (38)
|
23 (60.5)
|
15 (39.5)
|
2 (5.7)
|
33 (94.3)
|
Associated Surgical Techniques
|
Yes (33)
|
25 (75.8)
|
8 (24,2)
|
0.13
|
2 (6.7)
|
28 (93.3)
|
0.9
|
No (87)
|
53 (60.9)
|
34 (39.1)
|
6 (7.3)
|
76 (92.7)
|
* Figures represent mean values and standard deviation; p value is for Student´s T test. |
CCIS: Cleveland Clinic Incontinence Score; M: Male; F: Female; FI: Fecal Incontinence; IAS: Internal Anal Sphincter. |