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低位直肠癌患者行括约肌间直肠切除术加或不加马龙顺行可控灌肠术:一项随机、前瞻性、单盲临床试验。

Inter sphincter rectal resection with and without Malone ante grade continence enema in cases with low rectal cancer: A randomized, prospective, single-blind, clinical trial.

作者信息

Alvandipour Mina, Karami Mohammad Yasin, Azadfar Mahmood, Yazdani Charati Jamshid

机构信息

Gastrointestinal Cancer Research Center, Non-Communicable Diseases Institute, Mazandaran University of Medical Science, Sari, Iran.

Breast Diseases Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.

出版信息

Caspian J Intern Med. 2022 Summer;13(3):546-554. doi: 10.22088/cjim.13.3.546.

Abstract

BACKGROUND

Fecal incontinence is the main morbidity of inter-sphincteric resection (ISR) in ultra-low rectal cancer. Malone Ante grade Continence Enema (MACE) has been proposed for these patients. We aimed to compare the quality of life outcomes in cases with ultra-low rectal cancer who had undergone ISR±MACE.

METHODS

The current randomized clinical study was accomplished for two years from December 2016 to February 2018 in Imam Khomeini Hospital (Sari City, I.R.Iran) on 30 patients (15 in each group) with rectal cancer. The inclusion criteria of the study were stage 1 and 2a of low rectal cancer with type 2 and 3 of Rullier's classification, those who received neoadjuvant chemo radiotherapy. The exclusion criteria were comorbidity diseases, immune deficiency, poor follow-up. The follow-up period was one year. The Quality of Life (Qol) was reported as primary endpoint. The EORTC QLQ-C30 score and Wexner questionnaires were used. SPSS Version 22 was used. A -value less than 0.05 was considered statistically significant.

RESULTS

The mean age of patients was 56.23± years. The overall Qol score was better in the ISR-MACE (P=0.023). The overall Qol was lower in women than in men in both groups. Low anterior resection syndrome score was lower in the ISR plus MACE group than the ISR group (P=0.030). The Wexner score revealed better scores in the ISR with MACE group than the ISR without MACE group (p<0.0001).

CONCLUSION

Patients who underwent ISR plus MACE surgery had better defecation control and better quality of life than patients without MACE.

摘要

背景

大便失禁是超低位直肠癌行括约肌间切除术(ISR)后的主要并发症。对于这些患者,已提出马龙顺行性节制灌肠术(MACE)。我们旨在比较接受ISR±MACE的超低位直肠癌患者的生活质量结果。

方法

2016年12月至2018年2月,在伊朗萨里市伊玛目霍梅尼医院对30例直肠癌患者(每组15例)进行了为期两年的随机临床研究。该研究的纳入标准为低直肠癌1期和2a期,Rullier分类2型和3型,接受新辅助放化疗的患者。排除标准为合并症、免疫缺陷、随访不佳。随访期为一年。生活质量(Qol)作为主要终点进行报告。使用欧洲癌症研究与治疗组织生活质量核心问卷(EORTC QLQ-C30)评分和韦克斯纳问卷。使用SPSS 22版。P值小于0.05被认为具有统计学意义。

结果

患者的平均年龄为56.23±岁。ISR-MACE组的总体Qol评分更好(P = 0.023)。两组中女性的总体Qol均低于男性。ISR加MACE组的低位前切除综合征评分低于ISR组(P = 0.030)。韦克斯纳评分显示,ISR联合MACE组的评分优于未行MACE的ISR组(p < 0.0001)。

结论

与未行MACE的患者相比,接受ISR加MACE手术的患者排便控制更好,生活质量更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a5e/9348201/84013165067e/cjim-13-546-g001.jpg

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