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LEIDEN, The Netherlands -- One fifth of temporary stomas created after surgery for rectal cancer became permanent, according to a Dutch study.
Primary stomas were created in 523 of 924 (57%) rectal cancer patients after a low anterior resection, and 19% of the stomas of these patients were never reversed, reported Cornelis van de Velde, M.D., of Leiden University Medical Center, and colleagues in the Dutch Colorectal Cancer Group, in the Lancet Oncology.
Of the stomas that were closed during follow-up, 97% were closed in the first year, so that if a stoma was not closed by 12 months, it would probably become permanent, they wrote.
The findings emerged from the total mesorectal excision (TME) trial, a prospective, randomized multicenter study of the effects of short-term preoperative radiotherapy in 1,861 patients. Creation of stomas and time to stoma reversal were analyzed retrospectively by use of multivariate analysis.
In the analysis, 924 Dutch patients with rectal cancer who underwent a low anterior resection were selected from the TME trial. A primary stoma was defined as one created at the time of total mesorectal excision.
Postoperative complications and secondary constructed stomas, a stoma created during a second or subsequent procedure after total mesorectal excision, were associated with a high likelihood of a stoma becoming permanent, the researchers said.
Stomas were created at a secondary surgical procedure in 93 of 401 patients (23%) for reasons other than recurrence. These secondary procedures were done mainly for clinical anastomosis leakage in 61 (66%) or abscess, sepsis, or peritonitis in 18 (19%).
Taken together, the researchers said, 616 of 924 (67%) patients received a temporary stoma, either at initial or at secondary surgery, the researchers said.
In multivariate analyses (where hazard ratio of less than 1 indicates decreased likelihood of stoma reversal) postoperative complications and secondary stoma construction were associated with a high likelihood of a permanent stoma. However, the researchers said, perioperative complications were not a limiting factor for stoma closure (hazard ratio, 0.84; 95% confidence interval, 0.68-1.04, P = 0.103). Radiotherapy was also not a significant risk factor ((hazard ratio, 1.13; 95% confidence interval, 0.92-1.38, P=0.244).
Age older than 70 was a significant factor for a decreased likelihood of stoma closure (hazard ratio, 0.79; 95% confidence interval, 0.62-1.02, P = 0.029), as well as fear of increased comorbidity in the elderly and patients' refusal to undergo more surgery.
Additionally, post-op complications, such as infection, contributed to less frequent stoma reversal (hazard ratio, 0.73; 95% confidence interval, 0.57-0.93, P = 0.012). Generally, secondary stomas, created after complications, were less frequently closed (49% versus 86%, P<0.0001), possibly because after initial curative treatment for rectal cancer, these patients were more willing to accept a stoma.
Other risk factors for not having a stoma removed might relate to technical surgical problems especially those in creating a primary anastomosis, they said.
Postoperative complications are an important limiting factor for stoma reversal because, after occurrence of these complications, patients and surgeons might be reluctant to reverse the stoma, so a substantial proportion of these stomas are never closed, the Dutch surgeons wrote. Future guidelines for stoma creation and closure should consider these factors, they said.
The TME trial included 84 of 102 hospitals in Holland, so that the study indicates common practice in the country. However, all extrapolations should be made carefully, the researchers said, because no information on treatment policy in a nontrial setting was made and only Dutch patients were studied in total mesorectal excision.
In addition, they said, patients' preferences, morbidity, which sometimes results in a new stoma, and mortality were not included in this analysis.
These findings do not suggest that the unreversed stomas should not have been made, but show that temporary stomas should be created as if they are to be permanent. Correct placement that helps lifelong handling is of utmost importance, Dr. van de Velde and his colleagues said.
Eventually, the loss of quality of life due to an unreversed stoma needs to be counterbalanced with the patient's comorbidity, which might limit successful stoma reversal. Only in this way, the investigators said, can an individualized decision on stoma reversal be made.
In an attempt to lower clinical anastomotic leakage and variability in patients with rectal cancer, a prospective audit has been instituted in Holland to provide data that will guide surgeons toward a more standardized and evidence-based approach in stoma formation, Dr. van de Velde and his colleagues said.
"Only then can treatment be further tailored to the individual patient with rectal cancer," they concluded.