Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146)

Chee Chee H Stucky, Barbara A Pockaj, Paul J. Novotny, Jeff A Sloan, Daniel J. Sargent, Michael J. O'Connell, Robert W. Beart, John M. Skibber, Heidi Nelson, Jane C. Weeks

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Abstract

Background: Postoperative outcomes of patients undergoing laparoscopic-assisted colectomy (LAC) have shown modest improvements in recovery but only minimal differences in quality of life (QOL) compared with open colectomy. We therefore sought to assess the effect of LAC on QOL in the short and long term, using individual item analysis of multi-item QOL assessments. Methods: QOL variables were analyzed in 449 randomized patients from the COST trial 93-46-53 (INT 0146). Both cross-sectional single-time and change from baseline assessments were run at day 2, week 2, month 2, and month 18 postoperatively in an intention-to-treat analysis using Wilcoxon rank-sum tests. Stepwise regression models were used to determine predictors of QOL. Results: Of 449 colon cancer patients, 230 underwent LAC and 219 underwent open colectomy. Subdomain analysis revealed a clinically moderate improvement from baseline for LAC in total QOL index at 18 months (P = 0.02) as well as other small symptomatic improvements. Poor preoperative QOL as indicated by a rating scale of ≥ 50 was an independent predictor of poor QOL at 2 months postoperatively. QOL variables related to survival were baseline support (P = 0.001) and baseline outlook (P = 0.01). Conclusions: Eighteen months after surgery, any differences in quality of life between patients randomized to LAC or open colectomy favored LAC. However, the magnitude of the benefits was small. Patients with poor preoperative QOL appear to be at higher risk for difficult postoperative courses, and may be candidates for enhanced ancillary services to address their particular needs.

Original languageEnglish (US)
Pages (from-to)2422-2431
Number of pages10
JournalAnnals of Surgical Oncology
Volume18
Issue number9
DOIs
StatePublished - Sep 2011

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Colectomy
Quality of Life
Nonparametric Statistics
iodonitrotetrazolium
Intention to Treat Analysis
Colonic Neoplasms

ASJC Scopus subject areas

  • Surgery
  • Oncology

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Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146). / Stucky, Chee Chee H; Pockaj, Barbara A; Novotny, Paul J.; Sloan, Jeff A; Sargent, Daniel J.; O'Connell, Michael J.; Beart, Robert W.; Skibber, John M.; Nelson, Heidi; Weeks, Jane C.

In: Annals of Surgical Oncology, Vol. 18, No. 9, 09.2011, p. 2422-2431.

Research output: Contribution to journalArticle

Stucky, Chee Chee H ; Pockaj, Barbara A ; Novotny, Paul J. ; Sloan, Jeff A ; Sargent, Daniel J. ; O'Connell, Michael J. ; Beart, Robert W. ; Skibber, John M. ; Nelson, Heidi ; Weeks, Jane C. / Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146). In: Annals of Surgical Oncology. 2011 ; Vol. 18, No. 9. pp. 2422-2431.
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abstract = "Background: Postoperative outcomes of patients undergoing laparoscopic-assisted colectomy (LAC) have shown modest improvements in recovery but only minimal differences in quality of life (QOL) compared with open colectomy. We therefore sought to assess the effect of LAC on QOL in the short and long term, using individual item analysis of multi-item QOL assessments. Methods: QOL variables were analyzed in 449 randomized patients from the COST trial 93-46-53 (INT 0146). Both cross-sectional single-time and change from baseline assessments were run at day 2, week 2, month 2, and month 18 postoperatively in an intention-to-treat analysis using Wilcoxon rank-sum tests. Stepwise regression models were used to determine predictors of QOL. Results: Of 449 colon cancer patients, 230 underwent LAC and 219 underwent open colectomy. Subdomain analysis revealed a clinically moderate improvement from baseline for LAC in total QOL index at 18 months (P = 0.02) as well as other small symptomatic improvements. Poor preoperative QOL as indicated by a rating scale of ≥ 50 was an independent predictor of poor QOL at 2 months postoperatively. QOL variables related to survival were baseline support (P = 0.001) and baseline outlook (P = 0.01). Conclusions: Eighteen months after surgery, any differences in quality of life between patients randomized to LAC or open colectomy favored LAC. However, the magnitude of the benefits was small. Patients with poor preoperative QOL appear to be at higher risk for difficult postoperative courses, and may be candidates for enhanced ancillary services to address their particular needs.",
author = "Stucky, {Chee Chee H} and Pockaj, {Barbara A} and Novotny, {Paul J.} and Sloan, {Jeff A} and Sargent, {Daniel J.} and O'Connell, {Michael J.} and Beart, {Robert W.} and Skibber, {John M.} and Heidi Nelson and Weeks, {Jane C.}",
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T1 - Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146)

AU - Stucky, Chee Chee H

AU - Pockaj, Barbara A

AU - Novotny, Paul J.

AU - Sloan, Jeff A

AU - Sargent, Daniel J.

AU - O'Connell, Michael J.

AU - Beart, Robert W.

AU - Skibber, John M.

AU - Nelson, Heidi

AU - Weeks, Jane C.

PY - 2011/9

Y1 - 2011/9

N2 - Background: Postoperative outcomes of patients undergoing laparoscopic-assisted colectomy (LAC) have shown modest improvements in recovery but only minimal differences in quality of life (QOL) compared with open colectomy. We therefore sought to assess the effect of LAC on QOL in the short and long term, using individual item analysis of multi-item QOL assessments. Methods: QOL variables were analyzed in 449 randomized patients from the COST trial 93-46-53 (INT 0146). Both cross-sectional single-time and change from baseline assessments were run at day 2, week 2, month 2, and month 18 postoperatively in an intention-to-treat analysis using Wilcoxon rank-sum tests. Stepwise regression models were used to determine predictors of QOL. Results: Of 449 colon cancer patients, 230 underwent LAC and 219 underwent open colectomy. Subdomain analysis revealed a clinically moderate improvement from baseline for LAC in total QOL index at 18 months (P = 0.02) as well as other small symptomatic improvements. Poor preoperative QOL as indicated by a rating scale of ≥ 50 was an independent predictor of poor QOL at 2 months postoperatively. QOL variables related to survival were baseline support (P = 0.001) and baseline outlook (P = 0.01). Conclusions: Eighteen months after surgery, any differences in quality of life between patients randomized to LAC or open colectomy favored LAC. However, the magnitude of the benefits was small. Patients with poor preoperative QOL appear to be at higher risk for difficult postoperative courses, and may be candidates for enhanced ancillary services to address their particular needs.

AB - Background: Postoperative outcomes of patients undergoing laparoscopic-assisted colectomy (LAC) have shown modest improvements in recovery but only minimal differences in quality of life (QOL) compared with open colectomy. We therefore sought to assess the effect of LAC on QOL in the short and long term, using individual item analysis of multi-item QOL assessments. Methods: QOL variables were analyzed in 449 randomized patients from the COST trial 93-46-53 (INT 0146). Both cross-sectional single-time and change from baseline assessments were run at day 2, week 2, month 2, and month 18 postoperatively in an intention-to-treat analysis using Wilcoxon rank-sum tests. Stepwise regression models were used to determine predictors of QOL. Results: Of 449 colon cancer patients, 230 underwent LAC and 219 underwent open colectomy. Subdomain analysis revealed a clinically moderate improvement from baseline for LAC in total QOL index at 18 months (P = 0.02) as well as other small symptomatic improvements. Poor preoperative QOL as indicated by a rating scale of ≥ 50 was an independent predictor of poor QOL at 2 months postoperatively. QOL variables related to survival were baseline support (P = 0.001) and baseline outlook (P = 0.01). Conclusions: Eighteen months after surgery, any differences in quality of life between patients randomized to LAC or open colectomy favored LAC. However, the magnitude of the benefits was small. Patients with poor preoperative QOL appear to be at higher risk for difficult postoperative courses, and may be candidates for enhanced ancillary services to address their particular needs.

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