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10.1245/ASO.2005.12.036
Annals of Surgical Oncology 12:117-123 (2005)
© 2005 Society of Surgical Oncology
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Original Article

Prospective Evaluation of Quality of Life of Patients Receiving Either Abdominoperineal Resection or Sphincter-Preserving Procedure for Rectal Cancer

Christian E. Schmidt, MD, MPH1, Beate Bestmann, MA2, Thomas Küchler, PhD2, Walter E. Longo, MD, MBA3 and Bernd Kremer, MD, PhD1

1 Department of General and Thoracic Surgery, University of Kiel, Arnold-Heller-Str. 7, 24105, Kiel, Germany
2 Reference Center for Quality of Life, University of Kiel, Arnold-Heller-Str. 5, 24105 Kiel, Germany
3 Department of Surgery, Section of Gastrointestinal Surgery, Yale University School of Medicine, P.O. Box 208062, New Haven, Connecticut 06520-8062

Correspondence: Address correspondence and reprint requests to: Christian E. Schmidt, MD, MPH; E-mail: cewschmidt{at}yahoo.de.


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 PATIENTSAND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
Background: Study results on quality of life (QoL) between patients receiving an anterior resection (AR) or abdominoperineal resection (APR) for rectal cancer vary greatly. A main reason is grounded in unequal methodology. The aims of this study were to assess differences in perceived QoL over time among patients treated with AR or APR with a recommended study design and methodology.

Methods: In a prospective study, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 and a tumor-specific module were administered to patients with rectal cancer before surgery, at discharge, and 3, 6, and 12 months after the operation. Comparisons were made between patients receiving an AR and those receiving an APR.

Results: Two hundred forty-nine patients were included; 46 patients received an APR and 203 an AR. QoL data were available for 212 patients, of which 112 were female and 100 male. No differences in the distribution of age, sex, or tumor stage were observed between groups. EORTC function scales showed no significant differences, including body image scales, between patients receiving an AR and those receiving an APR. In symptom scores, AR patients had more difficulty with diarrhea and constipation, whereas patients with APR experienced more impaired sexuality and pain in the anoperineal region. At discharge, patients receiving an AR were more confident about their future.

Conclusions: QoL in patients receiving an AR and those receiving an APR is not different. Although patients with APR experience more impaired sexuality, patients receiving an AR experience decreases in QoL because of impaired bowel function.

Key Words: Quality of life • Rectal cancer • Abdominoperineal resection • Anterior resection • Differences • Outcome


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
PATIENTSAND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 
In modern rectal cancer surgery, the state-of-theart technique is to avoid a permanent colostomy whenever possible.1–3 Many studies have indicated that a permanent stoma has a detrimental effect on perceived quality of life (QoL) in such patients.3–9 However, these findings were inconsistent, and some recent studies found even better QoL in patients who received an abdominoperineal resection (APR) than in those who received an anterior resection (AR).10,11 The main reason for these discrepancies can be found in the different methods and study designs that were applied to measure QoL. These include the instruments for assessment, which include interviews, nonstandardized questionnaires, nonvalidated instruments, retrospective study designs, and small sample sizes. Of almost 60 articles on the subject in the English language, only 15 were prospective studies, and only 5 used established and validated questionnaires.10 Camilleri-Brennan and Steele11 outlined these shortcomings and concluded that despite the flood of data on the subject, the present situation of research into QoL in patients with rectal cancer is unsatisfactory. Guidelines for the assessment of QoL in clinical cancer trials do exist, but they are infrequently applied.12

This study was conducted to investigate differences in QoL between patients receiving an AR and those receiving an APR, by using a recommended and proven method. Clinical end points were defined as complication rates and survival. The investigation was designed as a prospective single-center study with a follow-up of 12 months after surgery. The sample size chosen was large enough to adjust for potential confounding variables such as age, sex, and tumor stage.


   PATIENTSAND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTSAND METHODS
RESULTS
 DISCUSSION
 REFERENCES
 
In this prospective study, 249 patients with rectal cancer who had undergone resection in our department from January 1997 to December 2002 were evaluated. From this sample, 46 patients had received an APR and 203 patients an AR. Only patients in whom surgery was performed with a curative attempt and who were free of recurrence throughout the study period were included. Both clinical and QoL data had to be available for at least three time points for each patient. Patients with psychiatric disorders and those who had a rectal resection for benign diseases or gynecological tumors were excluded. We also excluded 53 patients who received a temporary fecal diversion and 21 patients in whom an ultra-low resection and reconstruction with pouch was performed. Our main focus was on QoL data and less on clinical data. Informed consent to use patient data is routinely obtained from patients before surgery in our department.

All patients received a questionnaire asking about sociodemographics and the effect of cancer on QoL. The questionnaires were handed out before surgery and at discharge. After surgery, the patients’ physicians were contacted before questionnaires were mailed, to determine survival status and, when applicable, cause of death. The questionnaires were mailed to the patients 3, 6, and 12 months after the operation. Details of medical history, medication use, histology of the tumor, stage of disease, and therapy given were collected from the patients’ records. General cancer-related QoL was measured by using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC-QLQ-C30).13 In this questionnaire, QoL is assessed on seven dimensions: functional status, role function, general symptoms, cognitive, emotional, social functioning, and financial strain. In addition to the general questionnaire, we used a tumor-specific module that was developed according to the guidelines of the EORTC.14 This additional instrument was recently validated.15 It focuses on fecal incontinence, diarrhea, specific pain, and other colorectal symptoms. Items focusing on sexual disorders and colostomy-related problems (irrigation, prolapse, and skin disorders) were added.15 Both questionnaires contain questions related to the previous week. Four response categories scored from 1 (not at all) to 4 (very much) are possible. The scoring systems are organized such that a higher score indicates better function and more symptoms (more distress). Thus, a high score for a functional scale or global health status/QoL represents a high level of functioning or high QoL, but a high score for a symptom scale or item, as in the specific module, represents a high level of symptomatology or problems.16 The principle for the scoring is to estimate the average of the items that contribute to the scale; this is the raw score. A linear transformation is used to standardize the raw score, so that scores range from 0 to 100.16

Results are presented as percentages and proportions. All distributions and frequencies were compared by {chi}2 test. Age and data on length of stay were compared by unpaired Student’s t-test. Because QoL data were not normally distributed, nonparametric methods and analysis of variance were used in the statistical analysis. The scoring was performed according to the EORTC-QLQ-C30 scoring manual16: scales were calculated when at least half of the items were completed by the patients. A global {alpha} of P < .05 was considered statistically significant, whereas a mean difference of ≥ 10 points represents a clinically significant difference. 17 Data were analyzed with SPSS for Windows (Version 11.0; SPSS Inc., Chicago, IL).


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTSAND METHODS
 RESULTS
DISCUSSION
 REFERENCES
 
Among the 249 potentially available patients, 6 patients died during the time period as a result of their disease. QoL data were available for 212 patients for at least 3 time points. Five addresses of patients were unknown, and 2 questionnaires are still missing. Comparisons were made between patients who received an AR and APR. Complications consisted of wound infections, temporary bladder dysfunction, anastomosis leakage, dehiscence of laparotomy incision, and bleeding.

The group of patients receiving an AR and APR consisted of 112 female and 100 male patients. Differences regarding the proportion of female and male patients were not observed between groups ({chi}2 test; P = .097). The median age was 65.3 years (APR, 64.0 years;AR, 65.8 years), with a range from 31 to 90 years. The distribution of tumor stage was similar between groups (P=.821). Complications were insignificantly higher in patients receiving APR and had no adverse effect on QoL or sexuality at any time point. A total of 128 patients underwent adjuvant treatment (i.e., a combination of radiotherapy and chemotherapy). The proportion of patients who received this comprehensive therapy was similar between groups (51.2%vs. 52.1%). Patient characteristics are listed in Table 1Go. Comparing the age distribution between groups, we did not find a significant difference (P=.788). Because of the balanced distribution of potential confounders and small sample size, we used the Mann-Whitney U-test to compare QoL changes over time between groups. In the EORTC function scales, no significant differences were found between patients receiving an APR and AR, as shown in Table 2Go. The symptom scales showed significant differences for nausea/vomiting and for diarrhea from discharge until 12 months after surgery; these were worse for patients who received an AR, as shown in Table 3Go.


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  		TABLE 1. Patient characteristics
 

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  		TABLE 2. EORTC-QLQ-C30 function scales
 

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  		TABLE 3. EORTC-QLQ-C30 symptom scales
 
In the module scales, significant differences were found between groups: patients who received an APR had significantly worse sexual function from 3 months throughout the time observed and felt more distress because of that impairment. In addition, significantly more pain in the anoperineal region was reported at 6 months after surgery. Patients with an AR had more problems with flatulence at 12 months after surgery and had more pain when passing stools at 6 months after surgery. Furthermore, patients without a colostomy were more confident about their future at discharge than those with a permanent stoma. All significant differences are listed in Table 4Go.


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  		TABLE 4. Colorectal cancer–specific module scales15
 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTSAND METHODS
 RESULTS
 DISCUSSION
REFERENCES
 
This study prospectively assessed QoL differences between patients undergoing APR and AR for rectal cancer in a region in Germany. The sample size was large enough to adjust for potential confounders such as age, sex, and tumor stage.18 The method applied was recommended elsewhere, and inclusion/exclusion criteria were austere enough to minimize skewing of data.7,10,17 The instruments for assessing QoL were proven for their psychometric properties; the EORTC-QLQ-C30, in particular, has shown its reliability in various studies.7,10,19–21 Because the official module for colorectal cancer patients is not yet validated, we used a recently validated module for colorectal cancer patients that was developed according to the guidelines of the EORTC.14,15,22,23 The module has proven psychometric properties in several studies, as determined by a Cronbach {alpha} of .762.15–24

In contrast to previous findings, APR patients in our study did not have worse QoL scores than AR patients on the EORTC function scale and most symptom scales.2–6 Instead, patients who received an AR reported more bowel-related symptoms until 12 months after surgery. Function and body image–related factors after surgery were similar for both groups.

In the module scales, significant differences were seen for sexuality and flatulence. Whereas patients who received an APR experienced more impaired sexuality, patients who received an AR had significantly more complaints about flatulence and diarrhea. Even if patients who receive an APR are not able to experience diarrhea as do patients who receive an AR, because of their colostomy, values for diarrhea were significantly higher than those in a comparable general population (diarrhea value, 2.8; SD, 11.7).25

The findings for sexuality are similar to those from other studies.7,19,26,27 Impairment of sexuality in patients after an APR occurs because of the extended resection and, therefore, greater damage sustained to the pelvic autonomic nerves and the pelvic floor.28 However, as shown in this study, this does not necessarily lead to a significantly decreased general QoL, although sexuality remains a substantial part of subjective well-being.29–31 Other research performed in patients with spinal cord injuries and chronic inflammatory bowel disease has indicated that colostomies in general might not have such a detrimental effect on QoL as is usually assumed.32,33 This is especially important when problems with diarrhea remain the alternative to a colostomy, as is the case in patients with chronic inflammatory bowel disease. 34,35

Some investigators have conducted interviews after surgery, and others have used non–cancer-specific or nonvalidated questionnaires. In a study by Kuzu et al.,4 QoL was assessed after surgery by using the Short Form 36 (SF-36) and a questionnaire that asked participants about their work responsibilities, sexual life, and religious worship. They found that all eight subscales of the SF-36 were poorer for APR than for other surgical procedures. In addition, social life and work responsibilities were significantly more affected.4 Tumor stage and age were, however, not adjusted, and the study focused on men. Furthermore, the SF-36 is not cancer specific, and a tumor-specific module for patients with rectal cancer was not used. Therefore, there might be a lack of specific information in that study. Other studies are limited in their generalization because of very small numbers of patients included.5,36,37

The present status of research in this field shows inconsistencies between studies in terms of methodological issues and sample sizes.7,10 Renner et al.2 concluded from their findings that because of technical advantages in rectal cancer surgery and negative effects on QoL, a permanent colostomy should be avoided in most patients. Their study did not adjust for age or sex and did not use validated instruments. Investigators who used validated cancer and tumor-specific questionnaires and adjusted confounders had different findings 1 year after surgery.7,10,20,38 Camilleri-Brennan and Steele38 found no difference in global QoL scores between patients who received an APR and those who received an AR. However, patients who had an AR had a better perception of body image than those who underwent an APR, as measured on the tumor-specific module scales, but were more prone to experience constipation.38 They related their findings to better stoma care in patients who received an APR. These findings are comparable to ours; however, standardized training by a specialized nurse is performed in every stoma patient in our department. The training starts in the clinic and is continued at the patients’ homes. Therefore, this might have influenced the effects in our study.39

Well-designed studies support our findings: Grumann et al.10 found that patients undergoing APR did not have a poorer QoL than patients undergoing AR. Instead, they observed that patients undergoing low AR had worse QoL levels than those undergoing APR. QoL was deteriorated by incontinence-related problems for patients with AR and by negative body image through a colostomy for patients receiving an APR.10 These results are to some extent consistent with our results and support the use of appropriate methods and sufficient sample sizes to investigate special issues of QoL in rectal cancer patients. Although inclusion criteria were strict and recommended methods were applied in their study, important issues such as sexuality were not investigated, although sexuality is known to be worse in patients receiving an APR.26,27 Another study by Williams and Johnston40 found more depression in APR patients 1 year after surgery. We could not confirm these findings. Psychological function was similar in patients with a colostomy and in patients without a colostomy and did not vary over time. However, patients who received an AR were more confident about their future at discharge than those who received an APR. These findings support the general interpretation of Grumann et al.10 that patients awaiting a sphincter-preserving procedure confidently approach surgery because they are convinced that the procedure will be of benefit to them but feel disillusioned when their continence is compromised after surgery. However, patients with a colostomy are likely to discover that their preoperative worries of how a colostomy will disrupt their everyday life do not materialize as expected, especially when modern stoma-care materials are used. This may lead to a better QoL rating.10,41

In this study, we investigated the overall QoL of patients after APR and AR. Although traditional parameters such as survival and complication rates failed to differentiate between the two surgical procedures, the combination of a general cancer-related QoL questionnaire and a tumor-specific module discriminated between patients receiving an APR and those receiving an AR. Whereas patients receiving an APR experience more from pain and impaired sexuality, QoL in patients receiving an AR is decreased mainly by diarrhea and other bowel symptoms. However, this study has limitations. The narrow definition of our study group may produce nonrepresentative results; therefore, conclusions from the results should be made cautiously.18 Most epidemiological studies suggest that the incidence of rectal cancer is higher in men than in woman. We included more women (53.8%) than men (46.2%), and this might indicate a small sex bias. Furthermore, training for stoma patients may lead to a better perception of QoL in our patients39; however, we do not know whether this factor is relevant. Thus, further research in this field should be conducted with established and proven methods to provide clinicians with valuable information on QoL in patients with rectal cancer. This can be important when making individualized decisions together with a patient before surgery. In conclusion, and according to the findings in other studies on QoL in patients receiving AR or APR, we infer that patients receiving an APR have restrictions in their QoL related to their impaired sexuality and to increased pain in the anoperineal region at 6 months after surgery. However, patients receiving a sphincter-preserving operation also experience a deteriorated QoL that is largely driven by postoperative diarrhea.

Received for publication December 29, 2003. Accepted for publication October 6, 2004.


   REFERENCES
TOP
 ABSTRACT
 INTRODUCTION
 PATIENTSAND METHODS
 RESULTS
 DISCUSSION
 REFERENCES
 

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