Abstract
Background
Miles procedure is often necessary for patients with low rectal carcinoma. However, this operation often affects the quality of life of patients, to evaluate the advantages of improved operation (anal reconstruction), the quality of life and survival between patients undergoing anal reconstruction and patients undergoing traditional lower abdominal stoma after radical resection were analyzed.
Methods
The clinical data of 43 patients with low situated rectal carcinoma were retrospectively analyzed. 23 patients with left lower abdominal stoma after radical resection (Miles procedure) were divided into group A, and 20 patients with reconstruction of the anus in situ after radical resection were in group B. All patients were investigated by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR38 questionnaire, the clinical data are recorded. Independent sample T test was used to analyze the difference in quality of life between group A and group B at 3, 6, and 12 months after surgery, and Kaplan–Meier was used to compare the difference in overall survival between group A and group B.
Results
The results of T test showed that there were statistical significance in global health status and physical functioning between group A and group B at 3 and 6 months, but no statistical significance at 12 months (P = 0.024, P = 0.019, P = 0.115 for global health status; P = 0.004, P = 0.006, P = 0.065 for physical functioning, respectively). Emotional functioning and social functioning were also statistically significant between group A and group B at 3, 6, and 12 months (P = 0.041, P = 0.040, P = 0.034 for Emotional functioning; P = 0.020, P = 0.009, P = 0.032 for social functioning, respectively). This study also found that there was no statistical significance in body image and sexual functioning between group A and group B at 3 months, but there was statistical significance at 6 and 12 months(P = 0.098, P = 0.035, P = 0.045 for body image; P = 0.110, P = 0.048, P = 0.047 for sexual functioning, respectively). There were statistically significant about sexual enjoyment and defecation problems at 3, 6, and 12 months (P = 0.023, P = 0.028, P = 0.050 for sexual enjoyment; P = 0.013, P = 0.011, P = 0.050 for defecation problems, respectively).The results of Kaplan–Meier showed that the overall survival (OS) between group A and group B was not statistically significant (χ2 = 0.600, P = 0.439).
Conclusions
There was no difference in survival time between group A and group B, but compared with the patients with left lower abdominal stoma(group A), the quality of life was better in patients with reconstruction of the anus in situ (group B). It is significant to improve the traditional lower abdominal stoma operation.
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Introduction
Colorectal carcinoma is a health problem worldwide, and the morbidity and mortality are increased gradually in recent years, which was also becoming the leading cause of death in the population [1,2,3,4,5]. Patients with low situated rectal carcinoma often need lower abdominal stoma after surgical resection (Miles procedure). Surgical resection of early low rectal carcinoma can improve the survival of patients. However, lower abdominal stoma has a significant impact on the quality of life (QOL) of patients [6, 7]. Therefore, the quality of life is considered to be an important factor in evaluating the efficacy of surgery, and together with 5-year survival rate and progression-free survival rate [8,9,10,11,12]. The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and QLQ-CR38, two standardized EORTC questionnaires, were used: EORTC QLQ-C30 scale is often used to assess the quality of life of patients with carcinoma, as well as the specific EORTC QLQCR38 scale for patients with colorectal carcinoma, and QLQCR38 is a supplement to QLQCR30 [13,14,15].
In this study, 43 patients with low situated rectal carcinoma were enrolled. Among them, 23 patients underwent left lower abdominal stoma (Miles procedure), and other 20 patients underwent orthotopic anal reconstruction. The quality of life and overall survival of the patients treated with two different surgical methods were compared to assess whether there were statistical differences, and explore a more proper surgical method for these patients with low situated rectal carcinoma.
Materials and methods
Patients
We enrolled 43 patients with low situated rectal carcinoma who underwent open abdomen tumor resection at the Second Hospital of Lanzhou University (Gansu Province, China) between 2013 and 2014, these patients were treated by Folfox chemotherapy after surgery. The study was approved by the Ethics Committee of the Second Hospital of Lanzhou University, and the data were anonymously obtained and retrospectively analyzed. Informed consents from participants were also waived due to the complete anonymity of the patients. The clinical data of all patients were collected from the electronic medical records of the Second Hospital of Lanzhou University. This study was performed in accordance with the relevant guidelines and regulations, and conformed to the Declaration of Helsinki [16]. The inclusion criteria of patients included complete pathological and follow-up data, Assessment of preoperative CT and other modalities: T staging is between T1 and T3, without long distance metastasis, no other chronic diseases, and without any treatments before the surgery, the distance of the tumor from the anal verge less than 4 cm. The patients were not treated with radiotherapy before surgery. The exclusion criteria: patients who suffered from other tumor or other chronic diseases, or died from accidental death or other diseases, lack of pathological and follow-up data, long distance metastasis before the surgery. Ultimately, a total of 43 cases were eventually enrolled in this study, including 24 males and 19 females, aged 36–78 years, median age of 57 years.
Grouping and follow-up
All patients underwent surgery due to low situated rectal carcinoma, and because the distance of the tumor from the anal verge is less than 4 cm, the anus can not be preserved. It is necessary that all patients are treated by Miles procedure. Abdominoperineal Radical Operation of Rectal Cancer (Miles procedure): it is applicable to the patients with low situated rectal carcinoma which is under the peritoneal reflection, these patients must undergo lower abdominal stoma after radical resection. Anal reconstruction is similar to Dixon procedure, but different from Dixon. The operation is to reconstruct the anus in situ after resection of the tumor. Transabdominal resection of rectal carcinoma and presacral anastomosis (Dixon procedure): it is suitable for rectal carcinoma which is above peritoneal reflection, it is also known as anterior resection of the rectum and presacral anastomosis, which is suitable for the lower margin of the tumor which is above the dentate line 5 cm. Patients were randomly divided into group A or group B before the surgery, and then treated according to Miles operation or anal reconstruction. 23 patients with lower abdominal stoma after radical resection (Miles procedure) were as group A, 20 patients with orthotopic anal reconstruction after radical resection were as group B. The quality of life related indicators were assessed by EORTC QLQ-C30 and EORTC QLQ-C38 scale, and the survival data of patient was recorded by follow-up. The follow-up period was from the surgical date to the death date, and no patients died during follow-up, the follow-up dates from the surgical date to the end of 5 years.
Surgical details of anal reconstruction
To dissociate Intestinal tract according to TME
The dissociation of rectum and its mesentery are required to reach the pelvic floor. The retained sigmoid colon must be relaxed so that it can be pulled down and anastomosed. If it is necessary, the gastrointestinal ligaments should be cut off to free the splenic flexure and the descending colon. The rectal canal is exposed at the pelvic floor, and the distal segment is the internal sphincter. It is bluntly separated downward along the gap between the internal and external sphincters with scissors or fingers. Ring incision along the INTERSPHINCTER sulcus into the gap between the internal and external sphincters. The internal sphincter was separated from the external sphincter and the puborectal muscle according to the guidance of the abdominal surgeon, and the external anal sphincter, the puborectal muscle and the levator ani muscle were preserved. After the rectum and anal canal were completely free, the rectum was pulled down to the outside body, and the rectum was incised. The staging of the tumors was evaluated again by intraoperative observation of tumor infiltration and intraoperative rapid frozen pathological examination. Anal reconstruction was performed in eligible patients.
Intestinal dung bag, anal canal and anus plasty
After determining the position of the incision margin, the intestinal dung bag was reconstructed, and the intestinal tube at the position of the pelvic dung bag was longitudinally cut. The incision was about 2 cm long. After transverse suture, the intestinal tube was formed into an enlarged dung bag. The intestinal tube was pulled to the left and fixed on the left pelvic wall to form an enlarged dung bag with an arc. The intestinal tube in the position of the anal canal is sutured (purse string suture) with absorbable suture from the serosa layer of the intestinal wall, then the suture is tightened to form a narrow intestinal tube. It can be easily passed through two fingers. The intestinal tube is fixed from the pelvic cavity to the pelvic floor so that the narrow segment of the intestinal tube is in the position of the original anal canal. The intestinal tube is sutured and fixed from the perineum, and the intestinal tube of the tumor segment is resected, and the end of anal plasty is performed, as shown in Fig. 2. Notes for this operation: 1. To reduce the recurrence rate of tumors, the stage of tumors must be less than T3. 2. The external anal sphincter, puborectal, levator ani muscles must be preserved to ensure self-control of defecation and avoid anal incontinence, levator ani exercises should be performed after 3 weeks of surgery.
Questionnaires
Qlq-c30
QLQ-C30 is a core scale developed by EORTC for measuring the quality of life of cancer patients. There are 30 items in QLQ-C30: items 29 and 30 are in seven grades, and they are scored from 1 to 7 according to their answers. Other items are divided into 4 grades: none, a little, more, a lot, and 1–4 points in grading. Thirty items can be divided into 15 areas, including five functional areas (physiological, role, cognitive, emotional and social functions), three symptom areas (fatigue, pain, nausea and vomiting), one overall health condition, five functional areas and six single items [13, 17].
Qlq-cr38
QLQ-CR38 is a special quality of life questionnaire for patients with colorectal carcinoma developed by EORTC. It consists of 38 questions: 19 questions must be answered by all patients, and the remaining 19 questions are answered according to the male or female patients, with or without stoma. EORTC QLQ-CR38 can be divided into four functional scales (body image, sexual function, sexual feelings and prognostic expectations), eight symptom scales (voiding problems, gastrointestinal symptoms, respiratory symptoms, adverse reactions to chemotherapy, defecation problems, stoma-related problems, sexual problems in men and women, weight loss) [14].
Statistical analysis
SPSS 22.0 statistical software was used to analyze all data. Independent sample T test was used to compare the difference of quality of life between group A and group B. The results were expressed as mean (M) ± standard deviation (SD). Kaplan–Meier survival estimates model were used to assess the correlation of clinical factors with the overall survival (OS). P < 0.05 was considered statistically significant.
Results
Surgical figures of anus reconstruction from typical cases
Most of patients come to the hospital for bloody stool. For instance, a female patient was detected by colonoscopy for hematochezia. The lesion was about 2 cm in diameter and 2.5 cm away from the anal margin. During preoperative conversation, the patient and his family refused to have a lower abdominal stoma and asked for in situ anal reconstruction (Fig. 1a, b). A male patient was detected by colonoscopy for hematochezia. The lesion was about 2 cm in diameter and 2.5 cm away from the anal margin. During preoperative conversation, the patient and his family also refused to have a lower abdominal stoma and asked for in situ anal reconstruction (Fig. 1c, d).
Statistical results
Statistical results of QLQ-C30 questionnaire
The results of T test showed that there were statistical significance in global health status between group A and group B at 3 and 6 months (P = 0.024, P = 0.019, respectively), but no statistical significance at 12 months (P = 0.115); There were statistical significance in physical functioning between group A and group B at 3 and 6 months (P = 0.004, P = 0.006, respectively), but no statistical significance at 12 months (P = 0.065). There were statistical significance in emotional functioning between group A and group B at 3, 6, and 12 months (P = 0.041, P = 0.040, P = 0.034, respectively), and were statistical significance in Social functioning between group A and group B at 3, 6, and 12 months (P = 0.020, P = 0.009, P = 0.032, respectively). It was also found that there was statistical difference between group A and group B at 12 months for fatigue (P = 0.045) (Table 1).
Statistical results of QLQ-CR38 questionnaire
The results of T test also showed that there was no statistical significance in body image between group A and group B at 3 months(P = 0.098), but there were statistical significance at 6 and 12 months(P = 0.035, P = 0.045, respectively); There were statistically significant about sexual functioning between group A and group B at 6 and 12 months(P = 0.048, P = 0.047, respectively), but there was no statistical difference between group A and group B at 3 months(P = 0.11); There were statistically significant for sexual enjoyment between group A and group B at 3, 6, and 12 months (P = 0.023, P = 0.028, P = 0.050, and were statistically significant for defecation problem between two groups at 3, 6, and 12 months (P = 0.013, P = 0.011, P = 0.050, respectively) (Table 2).
The correlation between clinical factors and overall survival of patients with colorectal carcinoma were analyzed by Kaplan–Meier
The results of Kaplan–Meier showed that the progression free survival (PFS) of group A and group B was not statistically significant, The Median PFS was 1298 days in the patients of group A, and the Median PFS was 1464 days in the patients of group B (χ2 = 0.189, P = 0.664); However, the PFS of patients with rectal carcinoma is associated with lymph node metastasis. The median PFS of patients with lymph node-positive was 1201 days, and the PFS of patients with lymph node-negative was 1735 days (χ2 = 4.229, P = 0.040). The study did also not show that PFS was related to other clinical factors. And found that the overall survival (OS) of group A and group B was not statistically significant, The Median OS was 1522 days in the patients of group A, and the Median OS was 1276 days in the patients of group B (χ2 = 0.600, P = 0.439); However, the OS of patients with rectal carcinoma is associated with lymph node metastasis. The median OS of patients with lymph node-positive was 1185 days, and the OS of patients with lymph node-negative was 1819 days (χ2 = 6.333, P = 0.012). The study did also not show that OS was related to other clinical factors (Table 3, Figs. 2, 3).
Discussion
Rectal carcinoma is a common malignant tumor of the digestive tract, and more common in middle and low rectal carcinoma [18]. At present, the treatment of rectal carcinoma is a combination of surgical treatment and multidisciplinary treatment, and both emphasizing tumor radical treatment and ensuring the quality of life after surgery, stoma is a common surgical procedure for low rectal cancer, but it often affects the quality of life of patients [19,20,21]. Compared with Miles operation, Dixon operation has less damage to human physiological structure, and the quality of life of patients is better. The EORTC QLQ-C30 questionnaire consists of 30 questions which assess the quality of life in five functional scales (functional, physical, cognitive, emotional, social) as well as 6 symptoms (nausea and vomiting, pain, dyspnoea, insomnia, loss of appetite, constipation or diarrhoea); EORTC QLQ-CR38 consists of 2 functional scales (body image, sexual functioning) and symptom scales (gastrointestinal symptoms, problems related to having a stoma and sexual symptoms). EORTC QLQ-C30 and QLQ-CR38 are two effective scales to assess the quality of life of patients with colorectal carcinoma [6, 7, 22].
In previous clinical work, most of patients with stoma complained about the impact of stoma on their quality of life. To improve this situation, and because some patients do not accept Miles operation, the surgical procedure is improved by the surgeons in this group and reconstructed the anus in situ in some patients. In this study, 23 patients underwent left lower abdominal stoma (Miles procedure), and 20 patients underwent orthotopic anus reconstruction. The quality of life of these patients was investigated by EORTC QLQ-C30 scale and QLQ-CR38 scale, and overall survival of the patients also was compared. The results of this study showed that the OS of these patients is was no statistical difference, but left lower abdominal stoma can impact on the quality of life of patients with rectal carcinoma, the quality of life of patients underwent orthotopic anus reconstruction is better than the patients underwent left lower abdominal stoma. Some studies have also found that stoma has a negative impact on quality of life among patients with a stoma following surgery for colorectal carcinoma [7, 20, 23,24,25,26]. It is indeed a problem that patients with a stoma also deal with daily stoma-related practical management issues. Therefore, it is necessary to improve clinical practice and achieve better outcomes for these patients with low situated rectal carcinoma.
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Acknowledgements
This work was supported by grants from the scientific research project of Gansu health industry (No. GSWST2013-03).
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The study was approved by the Ethics Committee of the Second Hospital of Lanzhou University, and the data were anonymously obtained and retrospectively analyzed. The clinical data of all patients were collected from the electronic medical records of the Second Hospital of Lanzhou University. This study was performed in accordance with the relevant guidelines and regulations, and conformed to the Declaration of Helsinki.
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Informed consents from participants were also waived due to the complete anonymity of the patients.
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Du, P., Wang, SY., Zheng, PF. et al. Comparison of overall survival and quality of life between patients undergoing anal reconstruction and patients undergoing traditional lower abdominal stoma after radical resection. Clin Transl Oncol 21, 1390–1397 (2019). https://doi.org/10.1007/s12094-019-02106-x
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DOI: https://doi.org/10.1007/s12094-019-02106-x