ASA - 2007 Abstracts - A Randomized Multicenter Trial To Compare Long-Term Functional Outcome and Complications of Surgical Procedures For Low Rectal Cancers

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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*
Parameter	Coloplasty (CP-1)	Straight (SA)	P*	J pouch (JP)	Coloplasty (CP-2)	P*
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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