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.
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 | 0.61a | ||
Pre-op BMI | 27.5±11.6 | 95 | 28.7±16.8 | 90 | 26.3±4.9 | 0.20a | ||
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 | 0.61a | ||
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 | ||
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) | 0.28a | ||
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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