Quality of Life and Bowel Function Following Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer: A Report from a Single-Center Randomized Controlled Trial

Abstract

The aim of this study was to assess quality of life and bowel function in patients undergoing early vs. standard ileostomy closure. We retrospectively assessed patients from our previous randomized controlled trial. Patients with a temporary ileostomy who underwent rectal cancer surgery and did not have anastomotic leakage or other. Early closure (EC; 30 days after creation) and standard closure (SC; 90 days after creation) of ileostomy were compared. Thirty-six months (17–97) after stoma closure, we contacted patients by phone and filled in two questionnaires— The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and low anterior resection syndrome (LARS) score. This index trial was not powered to assess the difference in bowel function between the two groups. All the patients in the SC group had anastomosis <6 cm from the anal verge compared to 42 of 43 (97.7%) in the EC group. There were no statistically significant differences between EC (26 patients) and SC (25 patients) groups in the EORTC QLQ-C30 and LARS questionnaires. Global quality of life was 37.2 (0–91.7; ±24.9) in the EC group vs. 34.3 (0–100; ±16.2) in the SC (p = 0.630). Low anterior resection syndrome was present in 46% of patients in the EC and 56% in the SC group (p = 0.858). Major LARS was found more often in younger patients. However, no statistical significance was found (p = 0.364). The same was found with quality of life (p = 0.219). Age, gender, ileostomy closure timing, neoadjuvant treatment, complications had no effect of worse bowel function or quality of life. There was no difference in quality of life or bowel function in the late postoperative period after the early vs. late closure of ileostomy based on two questionnaires and small sample size. None of our assessed risk factors had a negative effect on bowel function o quality of life.

Early versus delayed defunctioning ileostomy closure after low anterior resection for rectal cancer: a meta-analysis and trial sequential analysis of safety and functional outcomes

“…This was performed 6 to 8 days after stoma creation to make sure that no patients with signs of anastomotic leakage were included Patient with a leak of contrast outside the rectum at the CT scan with a water-soluble contrast medium. Patients with diabetes, patients being treated with steroids, patients with linguistic difficulties, and patients with expected low compliance Rectal resection with TME (total mesorectal excision) for cancer Klek et al [ 29 ] (RCT) Poland Skawina Krakow Some concerns 2016–2017 Patients ≥ 18 years of age who had undergone anterior resection of the rectum with protective loop ileostomy for rectal adenocarcinoma Colorectal malignancy other than rectal adenocarcinoma, protective loop ileostomy performed for other indications (part of treatment for postoperative complication), lack of informed consent Low anterior resection of the rectum Gallyamov et al [ 28 ] (RCT) Russia NR Some concerns NR Total or partial mesorectal excision for rectal cancer with formation of a defunctioning ileostomy Radiological or endoscopic signs of anastomotic insufficiency, diabetes, steroid treatment, expected low compliance Total or partial mesorectal excision Bausys et al [ 31 ] (RCT) Dulskas et al [ 51 ] 3 Lithuania Vilnius Low risk 2011–2017 Patients over 18 years old with rectal cancer were screened and included in the study after the elective rectal resection with a temporary loop ileostomy. Patients were included in the study on the 10 th postoperative day if they did not meet any of the exclusion criteria Contraindications to the closure of temporary ileostomy, such as radiological/endoscopic or clinical signs of colorectal anastomosis insufficiency, also general contraindications for surgery such as signs of active infection or organ failure, which would contraindicate ileostomy closure 30 days after creation Elective rectal resection with colorectal anastomosis (lower than 6 cm from the anal verge) with a temporary loop ileostomy Elsner et al [ 30 ] (RCT) Switzerland NR Low risk …”

“…This resulted in 39 articles suitable for full-text review, where ten were retrospective studies, four were prospective non-randomised studies, eight included colostomy closure procedures, five had no comparative cohort, and one did not focus on the selected outcomes of interest. Finally, 11 RCTs were included for quantitative synthesis, of which seven were primary studies [18,[26][27][28][29][30][31] and four were secondary analyses of the primary RCTs [48][49][50][51] (Table 1). In total, 599 patients were allocated to either Early ileostomy closure (EC) (n = 306) or Delayed ileostomy closure (DC) (n = 293).…”

Early Closure of a Temporary Ileostomy in Patients with Rectal Cancer

“…Early closure of ileostomy may allow for earlier initiation of adjuvant therapy, potentially improving outcomes for patients. Overall, while the primary focus of this study was on the safety and efficacy of early closure of temporary ileostomy, it is important to recognize the potential benefits beyond the reduction in complications [16][17] . Early closure of ileostomy may have important implications for improving quality of life, reducing healthcare costs, and optimizing timing of adjuvant therapy for patients with rectal cancer 18 .…”

Early vs. standard reversal ileostomy: a systematic review and meta-analysis

“…The formation of a diverting stoma does not alleviate the risk of anastomotic leak. However, it substantially reduces the morbidity and mortality if one occurs [6].…”

“…Anastomotic leak and subsequent pelvic sepsis has been shown to significantly increase the risk of developing LARS [38]. The formation of a loop ileostomy to divert bowel contents away from the site of anastomosis is a well-established risk management strategy known to minimise the sequelae of an anastomotic leak and international widespread change is unlikely [6].…”