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 für 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.
|Overall||J-Pouch(N=80)||Side to End(N=87)|
|Age at surgery||60.8±10.4||89||60.8±9.4||91||60.1±10.5||0.61a|
|Small bowel obstruction||4(10.8)||3(15.8)||1(6.3)|
|QOL 12 months|
|FACT-C total score||110.1±16.2||52||109.2±16.9||57||110.8±15.7||0.61a|
|FACT-C Total outcome index score||67.4±11.1||54||67.2±11.6||59||67.6±10.8||0.86a|
|QOL 24 months|
|FACT-C Fact-G total score||90.8±13.8||61||90.3±14.9||64||91.4±12.9||0.67a|
|FACT-C Total outcome index score||68.0±11.1||60||68.1±11.8||64||67.9±10.4||0.93a|
|SF-12 Mental Component Score||52.8±7.9||55||52.5±8.3||62||53.0±7.5||0.76a|
|SF -12 Physical Component Score||48.7±9.2||55||49.1±8.6||62||48.3±9.7||0.63a|
|No. of Bowel Movements in a Day (24 hrs)||3.3±1.9|
3 [2, 4]
3 [2, 4]
3 [2, 5]
|FISI Total Score||14.0±10.5||58||14.8±10.9||60||13.2±10.1||0.42a|
|Statistics presented as Mean ± SD, Median [P25, P75], Median (min, max) or N (column %).p-values: a=ANOVA,|
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