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| A Randomized Multicenter Trial To Compare Long-Term Functional Outcome and Complications of Surgical Procedures For Low Rectal Cancers | Massarat Zutshi*1, Victor W Fazio*1, Feza Remzi1, R Ruppert2, Y Parc3, J Celebreeze, Jr.4, A Fuerst5, G Orangio6, N Hyman7, S Galanduik8
1Cleveland Clinic Foundation, Cleveland, OH;2Krankenhaus Munchen Neuperlach, Munich, Germany3Hospital Saint Antoine, Paris, France4Allegheny General Hospital, Pittsburgh, PA;5Caritas St Joseph Clinic, Regensberg, Germany6Georgia Colon and Rectal, Atlanta, GA;7Fletcher Allen Health Care, Burlington, VT;8University of Louisville, Louisville, KY
| Aim To compare prospectively complications and long-term functional outcome of patients undergoing coloplasty(CP),J Pouch(JP)or straight anastomosis(SA) for treatment of low rectal cancer.
METHODS: A multicentered study enrolled patients with low rectal cancer, and randomized to coloplasty CP-1 or SA if J- pouch was not feasible, or JP or coloplasty CP-2 if a J-pouch was feasible. Patients were followed for 24 months withFecal Incontinence Severity Index(FISI)and SF-36 surveys for quality of life(QOL)
RESULTS: 364 patients randomized. and evaluated for complications and recurrence.
Mean age was 60 years, 71% male.No difference was observed in the complications among the 4 groups. (Table)
297/364 were evaluated for functional outcome.No statistical difference seen in the bowel function between the CP-1 and SA groups.JP patients had fewer bowel movements, less clustering, used fewer pads and had a lower FISI than the CP-2 group .Other parameters were equivocal. QOL scores at 24 months were equal.
CONCLUSIONS: J pouch was superior to Coloplasty and SA with respect to short and long term function; ie. less frequency of stools; pad use; and fecal continence. CP1 functional outcome was similar to SA with some advantage in the short term with respect to fecal continence However, the QOL scores were equivocal.| Table : Inter-group comparison of demographics, complications and functional outcome. | | Parameter | Pouch Ineligible | P* | Pouch Eligible | P* | | Coloplasty (CP-1) | Straight
(SA) | J pouch
(JP) | Coloplasty
(CP-2) | | Age | 59.6 +/- 9.1 | 60.2 +/- 12.0 | 0.51 | 60.2 +/- 12.6 | 60.7 +/- 10.9 | 0.88 | | BMI | 30.4 +/- 7.1 | 31.4 +/- 6.2 | 0.48 | 27.5 +/- 6.1 | 26.3 +/- 5.6 | 0.21 | | Complication: Stricture | 6/47 (12.8%) | 5/49 (10.2%) | 0.69 | 7/137 (5.1%) | 5/131 (3.8%) | 0.61 | | Complication Fistula | 1/47 (2.1%) | 0/49 (0%) | 0.49 F | 2/137 (1.5%) | 4/131 (3.1%) | 0.5 F | | Complication: Anastomotic Separation | 4/47 (8.5%) | 5/49 (10.2%) | 0.53 F | 4/137 (2.9%) | 6/131 (4.6%) | 0.53 F | | Complication : Pouch/ Anastomotic Failure | 1/47 (2.1%) | 2/49 (4.1%) | 1.00 F | 4 /137 (2.9%) | 3/137 (2.3%) | 1.00 F | | Total Daily Bowel movements | 4 months
24 months | 5.5 (3.2,6.8)
2.5 (2,4) | 6 (5,8)
3 (2,4) | 0.26
0.94 | 3 (2,5)
2 (2,3) | 4 (2,7.5)
3 (2,4) | 0.03
0.007 | | Bowel movements : Day | 4 months
24 months | 4 (3,5)
2 (2,3) | 4 (4,6)
2 (1.2,3) | 0.36
0.78 | 3 (2,4)
2 (1,3)
Mean = 2.0 | 3 (2,5)
2 (1,3)
Mean = 2.6 | 0.08
0.01 | | Bowel movements : Night | 4 months
24 months | 1 (0,2)
0 (0,1) | 1 (1,4)
1 (0,1) | 0.13
0.49 | 0 (0,1)
0 (0,1) | 1 (0,2)
1 (0,1) | 0.03
0.20 | | Rush to open bowels | 4 months
24 months | 26/27 (96.3%)
19/23 (82.6%) | 26/33 (78.8%)
15/19 (78.9%) | 0.06 F
0.99 F | 71/102 (69.6%)
58/83 (69.9%) | 72/98 (73.5%)
60/73 (82.2%) | 0.55
0.08 | | Pad usage | 4 months
24 months | 15/27 (55.6%)
15/23 (65.2%) | 24/33 (72.7%)
16/19 (84.2%) | 0.17
0.29 F | 55/102 (53.9%)
61/83 (73.5%) | 69/98 (70.4%)
59/73 (80.8%) | 0.02
0.28 | | FISI | 4 months
24 months | 40.0 +/- 25.6
39.4 +/- 23.0 | 53.9 +/- 15.5
40.4 +/- 16.5 | 0.05
0.82 | 39.5 +/- 22.8
31.1 +/- 22.1 | 51.0 +/- 15.3
36.8 +/- 22.5 | 0.001
0.04 | | SF-36 MCS | 4 months
24 months | 48.6 +/- 9.2
52.1 +/- 8.5 | 44.4 +/- 10.6
47.0 +/- 11.6 | 0.18
0.09 | 51.5 +/- 9.2
52.4 +/- 8.9 | 49.6 +/- 9.7
53.5 +/- 7.8 | 0.20
0.47 | | SF-36 PCS | 4 months
24 months | 44.5 +/- 9.1
49.6 +/- 8.7 | 42.5 +/- 8.9
50.1 +/- 8.4 | 0.41
0.78 | 48.6 +/- 7.8
52.4 +/- 7.2 | 47.9 +/- 8.1
52.3 +/- 6.3 | 0.71
0.53 | * Quantitative data summarized as ‘mean+/-sd’ or ‘median (interquartile range)’, and compared using Wilcoxon Rank Sum test.
Categorical data summarized as ‘frequency/n (%)’, and compared using chi-square test, unless Fisher’s exact test (F). |
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