Materials and Methods

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Between 1999 and 2003 we carried out a total anorectal reconstruction (TAR) in 12 patients previously operated on with an APR by performing a perineal colostomy and placing an artificial bowel sphincter around the perineal stoma [20, 21]. This procedure was performed by three surgeons in different institutions according to a common protocol. Ten patients had been operated on for rectal cancer, one had had a colostomy in childhood for rectal agenesia and one patient had been treated with a Miles operation 10 years before for a giant benign connectival tumour of the pelvis (Table 1). One patient was male and 11 were female; the mean age was 54 years. The tumour stage in the patients with rectal cancer was T2N0M0 in five patients, T1N0M0 in three patients and T2N0M0 in one patient. All patients were carefully evaluated both psychologically and about their ability to manage the device. The procedure was approved by the local ethics committee. All the patients were informed about this technique and written consent was obtained from all of them.

The artificial sphincter was the same as that implanted in patients with FI [15-19]. The surgical timing was different for the patients. In nine cases a perineal colostomy was performed at the same time as the APR, and a sizer was placed around the colostomy (synchronous reconstruction). Three patients had the anorectal reconstruction, with the perineal colostomy and the sizer placement (delayed reconstruction)

Table 1. Patients and methods

Pts

Sex

Indications

Tumour stage

TIMING

1

M

Rectal agenesia

Synchronous

2

F

Pelvic tumour

Delayed

3

F

Rectal cancer

T1N0M0

Synchronous

4

F

Rectal cancer

T2N0M0

Synchronous

5

F

Rectal cancer

T1N0M0

Synchronous

6

F

Rectal cancer

T1N0M0

Synchronous

7

F

Rectal cancer

T2N0M0

Delayed

8

F

Rectal cancer

T2N0M0

Delayed

9

F

Rectal cancer

T2N0M0

Synchronous

10

F

Rectal cancer

T2N0M0

Synchronous

11

F

Rectal cancer

T1N0M0

Synchronous

12

F

Rectal cancer

T3N2M0

Synchronous

some years later. A wide mobilisation of the splenic flexure was necessary to easily transpose the colon stump to the perineal plane; this part of the operation obviously being much more difficult in the delayed procedure. In the stoma patient group a pre-operative RX enema was performed to evaluate the colon length. In all patients, after two or three months the sizer placed around the perineal colostomy was removed and easily replaced with the cuff of ABS. Then the other components of ABS were implanted (Figs. 1, 2). A protective loop ileostomy was performed in all the patients to deactivate the device until the complete healing of the surgical wounds. The patients were evaluated with manometry and defecography to assess the effectiveness of the device. Manometry was performed to measure the basal pressure both with the cuff deflated and with the cuff inflated. The grade of continence was measured according to the Wexner score system [22] (Wexner score ranges from 0 in case of normal continence to 20 for total FI). A certain degree of constipation occurred in two patients and was evaluated according to the Cleveland Clinic score [23] (it ranges from 0 in case of normal evacuation to 30 as maximum grade of constipation). The patients were treated with enemas and suppositories and trained to evacuate at regular times. The time required for the cuff to inflate again after evacuation was also measured. The improvement of QoL achieved was evaluated with a faecal incontinence QoL scale (FIQoL). A QLQ-C30 questionnaire was administered pre- and post-operatively to the stoma patients and only post-operatively in all other cases [24, 25].

The follow-up length was between 40 days and 62 months. None of the patients operated on for rectal cancer developed local or distant recurrences. Three patients had the cuff explanted for skin erosion and in one patient the device was totally removed as a consequence of the radiotherapy (Table 2, Figs. 3,4). The patient with TAR for rectal agenesia developed diarrhoea that influenced the continence score but it was successfully controlled with drugs and dietary measures. All the other patients achieved an objective good grade of continence.

The pressure with the cuff deflated ranged between 29.5 and 38 mmHg, and with the cuff inflated was between 58 and 70.3 mmHg (Table 3). The time required to reinflate the cuff ranged from 5 to 9 min. It must be considered that with TAR no comparison is possible between pre- and post-operative scores so that the use of this parameter does not provide the same objective assessment of continence reported in patients treated for FI.

All patients were trained to evacuate the neorec-tum at definite time intervals with the help of enemas

Table 2. Results

Pts

Complications

Continence score

1

Diarrhoea

9

2

Impaired evacuation

4

3

Impaired evacuation

4

4

Wound infection

6

5

None

3

6

Erosion ^ cuff explantation

7

None

5

8

None

3

9

Erosion ^ cuff explantation

10

Impaired evacuation

3

11

Erosion ^ cuff explantation

12

Radioth. ^ cuff explantation

Fig. 3. Complications of cuff of ABS implantation

Fig. 4. Complications of cuff of ABS implantation

Fig. 3. Complications of cuff of ABS implantation

Fig. 4. Complications of cuff of ABS implantation

Table 3. Manometric results (time to reinflate the cuff**)

Pts

Basal pressure*, cuff deflated

Basal pressure, cuff inflated

Continence score

1

29.5

58

9

2

31.4

59.3

8

3

38

60

7

4

30.7

70.3

5

5

32.3

62.2

7

6

Explanted

Explanted

Explanted

7

32.6

59.8

7

8

31.2

56

8

9

Explanted

Explanted

Explanted

10

35.2

60.3

5

11

Explanted

Explanted

Explanted

12

Explanted

Explanted

Explanted

*n.v. 40-100 mmHg; **n.v. 5-8 min and suppositories and, although three patients initially complained of impaired evacuation, an improvement of function was achieved (Table 4). After three months all patients were able to successfully evacuate the neorectum and experienced no particular difficulties in managing the device, that is, inflating and deflating the cuff of the artificial sphincter.

A psychological evaluation of stoma patients revealed a depressive status and their QoL was significantly improved by the ABS implant (delayed procedure). A post-operative evaluation of the QoL was also carried out in the "synchronous" group of patients and the results were similar to the stoma patients group. FIQoL scale demonstrated satisfaction in all cases (Tables 5,6).

Table 4. Impaired evacuation

Pts

Score* before training

Score after training

1

3

2

2

21

7

3

17

5

4

11

5

5

9

2

6

Explanted

Explanted

7

8

2

8

9

2

9

Explanted

Explanted

10

17

6

11

Explanted

Explanted

12

Explanted

Explanted

*Cleveland Clinic Score System: range 0 (normal evacua-tion)-30 (max. constipation)

*Cleveland Clinic Score System: range 0 (normal evacua-tion)-30 (max. constipation)

Table 5. QLQ-C30: delayed cases

Pre-op score

Post-

op score

Pts Age

Sex

Pathology

Q1

-28 Q29/30

Q1-28

Q29/30

2 33

F

Pelvic tumour

41

5

33

12

7 61

F

Rectal cancer

48

4

39

11

8 61

F

Rectal cancer

47

4

31

12

Del. mean score

45.3

4.3

34.3

11.7

Low first score (Q1-28) means good QoL. Second score (Q29/30) reports the patient self-evaluation (low scores mean bad QoL)

Low first score (Q1-28) means good QoL. Second score (Q29/30) reports the patient self-evaluation (low scores mean bad QoL)

Table 6. QLQ-C30: synchronous cases

Pre-op score

Pts Age Sex Pathology Q1-28 Q29/30

1

38

M

Rectal

3

65

F

Rectal

4

56

F

Rectal

5

52

F

Rectal

6

55

F

Rectal

9

54

F

Rectal

10

53

F

Rectal

11

62

F

Rectal

12

58

F

Rectal

Syn.

mean score

34.4

11.4

agenesia

37

10

cancer

38

10

cancer

32

12

cancer

30

13

cancer

//

//

cancer

//

//

cancer

33

12

cancer

//

//

cancer

//

//

Low first score (Q1-28) means good QoL. Second score (Q29/30) reports about the patient self-evaluation (low scores mean bad QoL)

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