Trial reportAnnals of surgery2015
Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04.
Trial report in Annals of surgery, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 38 papers, 4 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum
Quality of Life at 3 Years of Patients Treated by Abdominoperineal Resection or Rectal Resection and Coloanal Anastomosis for Cancer of the Lower Rectum.
Who cites it
38 citing papers in PubMed, 4 syntheses or guidelines pooled it, 85 citations in OpenAlex.
- Quality of life in restorative versus non-restorative resections for rectal cancer: systematic review.BJS open · 2021Pooled it
- Efficacy and safety of wait and see strategy versus radical surgery and local excision for rectal cancer with cCR response after neoadjuvant chemoradiotherapy: a meta-analysis.World journal of surgical oncology · 2020Pooled it
- Rectal Cancer, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2018Guideline
- Conversations for providers caring for patients with rectal cancer: Comparison of long-term patient-centered outcomes for patients with low rectal cancer facing ostomy or sphincter-sparing surgery.CA: a cancer journal for clinicians · 2016Pooled it
- Overall side effect assessment of oxaliplatin toxicity in rectal cancer patients in NRG oncology/NSABP R04.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2024Trial
- Trial
- Visualizing adverse events in clinical trials using correspondence analysis with R-package visae.BMC medical research methodology · 2021Trial
- Anorectal Function and Quality of Life in Patients With Early Stage Rectal Cancer Treated With Chemoradiation and Local Excision.Diseases of the colon and rectum · 2017Trial
- Organ preservation for clinical T2N0 distal rectal cancer using neoadjuvant chemoradiotherapy and local excision (ACOSOG Z6041): results of an open-label, single-arm, multi-institutional, phase 2 trial.The Lancet. Oncology · 2015Trial
- Development and validation of a multiparametric magnetic resonance imaging-based nomogram for predicting feasibility of sphincter-preserving surgery in mid-low rectal cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2026Article
- Analyses of adverse events and patient-reported outcomes with the toxicity index in cancer clinical trials.Cancer · 2025Review
- Quality of Life in Rectal Cancer Treatments: An Updated Systematic Review of Randomized Controlled Trials (2013-2023).Cancers · 2025Review
- Shared Decision Making in the Treatment of Rectal Cancer.Journal of clinical medicine · 2025Review
- Shared Decision-Making, Sphincter Preservation, and Rectal Cancer Treatment: Identifying and Executing What Matters Most to Patients.Clinics in colon and rectal surgery · 2024Review
- Quality of Life in Locally Advanced Carcinoma Rectum Patients During Various Phases of NACRT: An Indian Perspective.Indian journal of surgical oncology · 2024Article
- Long-term incidence of depression in rectal cancer patients with or without stoma: a population-based cohort study.Annals of surgical treatment and research · 2023Article
- Article
- Transanal total mesorectal excision combined with intersphincteric resection has similar long-term oncological outcomes to laparoscopic abdominoperineal resection in low rectal cancer: a propensity score-matched cohort study.Gastroenterology report · 2022Article
- Quality of life and function after rectal cancer surgery with and without sphincter preservation.Frontiers in oncology · 2022Article
- Clinical Robotic Surgery Association (India Chapter) and Indian rectal cancer expert group's practical consensus statements for surgical management of localized and locally advanced rectal cancer.Frontiers in oncology · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
15 authors at 5 institutions in 1 country.
Funding
Abstract
objectiveNational Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II-III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS).
methodsTo obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by nonrandomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, sex, stage, intended surgery, and randomly assigned chemoradiotherapy.
resultsOf 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at 1 year. For the EORTC QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P = 0.0005) at 1 year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P = 0.02) at 1 year than did those undergoing SSS. For the EORTC QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at 1 year (26.9 vs 21.5, P = 0.03). SSS patients reported worse gastrointestinal tract symptoms than did the APR patients (18.9 vs 15.2, P < 0.0001), as well as weight loss (10.1 vs 6.0, P = 0.002).
conclusionsSymptoms and functional problems were detected at 1 year by EORTC QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.