ASA - Better Function With A Colonic J-pouch Or A Side-to-end Anastomosis? A Randomized Controlled Trial To Compare The Complications, Functional Outcome And Quality Of Life In Patients With Low Rectal Cancer After A J-pouch Or A Side-to- End Anastomosis

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Better Function With A Colonic J-pouch Or A Side-to-end Anastomosis? A Randomized Controlled Trial To Compare The Complications, Functional Outcome And Quality Of Life In Patients With Low Rectal Cancer After A J-pouch Or A Side-to- End Anastomosis
Massarat Zutshi*¹, Yann Parc*², Rhinehard Ruppert*³, Alois Fuerst*⁴, Werner Hohenberger*⁵, Susan Galandiuk⁶, Felix Hemminger*³, Henriette Goldcher*⁵, Emmanuel Tiret*², Alexander Heriot*⁷, Alexandra Aiello*¹, Tracy Hull¹
¹Cleveland Clinic Foundation, Cleveland, OH;²Hospital St. Antoine, Paris, France³Krankenhaus Munchen Neuperlach, Munich, Germany⁴Caritas-Clinic St. Josef, Regensberg, Germany⁵Zentrum f�r klinische Studien, Erlangen, Germany⁶University of Louisville, Louisville, KY;⁷Peter MacCallum Cancer Centre, Melbourne, Australia

Aim: To compare prospectively the complications and functional outcome of patients undergoing a JP or SE for treating low rectal cancer at 2-years.
Methods: A multicenter study randomized patients with low rectal cancer to receive either a JP or SE and followed for 12/24 months with SF-12&FACT-C surveys to evaluate quality of life(QOL). Fecal Incontinence Severity Index(FISI) evaluated bowel function. Univariate analysis compared JP/SE groups using Pearson's Chi-square/Fisher's exact test for categorical variables and ANOVA for continuous variables.
Results. (Table)236 patients enrolled, 46 ineligible, died or withdrew consent before surgery. 23(10%) failed randomization(15JP, 8SE) and received a straight anastomosis.The main presenting symptom was rectal bleeding(76%). BMI was similar in both groups. 92(55%) underwent radiotherapy (42JP, 40SE) and 89(54%) underwent preoperative chemotherapy(41JP,48 SE).The overall recurrence rate was 7%(similar in both groups).
Complications: 14/37 were Clavien Dindo Grade 3b,2 were 3a. Pouch necrosis was noted in 2(JP).
QOL: QOL scores using either instrument were similar at 12 and 24 months(p>0.05) in both groups.
Bowel Function: At 12 and 24 months the number of bowel movements/urgency/clustering and FISI scores were similar.
Conclusions: At 1 and 2 years after a JP or SE for low rectal cancer, QOL, bowel function and complications are comparable. Although choosing a particular procedure may depend on surgeon/patient choice or anatomical considerations at the time of surgery, SE functions similar to JP and may be chosen due to the ease of construction.



Table
	Overall	J-Pouch(N=80)		Side to End(N=87)
Factor		n	Statistics	n	Statistics	p-value
Age at surgery	60.8�10.4	89	60.8�9.4	91	60.1�10.5	0.61^a
Pre-op BMI	27.5�11.6	95	28.7�16.8	90	26.3�4.9	0.20^a
Sex
Female	73(30.9)		24(25.3)		37(38.9)	0.04
Complications						0.4
Leak	3(8.1)		2(10.5)		1(6.3)
Fistula	4(10.8)		1(5.3)		3(18.8)
Small bowel obstruction	4(10.8)		3(15.8)		1(6.3)
Hernia	3(8.1)		1(5.3)		2(12.5)
Wound Infection	5(13.5)		2(10.5)		3(18.8)
QOL 12 months
FACT-C total score	110.1�16.2	52	109.2�16.9	57	110.8�15.7	0.61^a
FACT-C Total outcome index score	67.4�11.1	54	67.2�11.6	59	67.6�10.8	0.86^a
QOL 24 months
FACT-C Fact-G total score	90.8�13.8	61	90.3�14.9	64	91.4�12.9	0.67^a
FACT-C Total outcome index score	68.0�11.1	60	68.1�11.8	64	67.9�10.4	0.93^a
SF-12 Mental Component Score	52.8�7.9	55	52.5�8.3	62	53.0�7.5	0.76^a
SF -12 Physical Component Score	48.7�9.2	55	49.1�8.6	62	48.3�9.7	0.63^a
Bowel Function
No. of Bowel Movements in a Day (24 hrs)	3.3�1.9 3 [2, 4] (1, 12)	56	3.1�1.7 3 [2, 4] (1, 10)	59	3.5�2.0 3 [2, 5] (0, 11)	0.28^a
FISI Total Score	14.0�10.5	58	14.8�10.9	60	13.2�10.1	0.42^a


Statistics presented as Mean � SD, Median [P25, P75], Median (min, max) or N (column %).p-values: a=ANOVA,

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