跳至主要内容
临床试验/CTRI/2020/04/024819
CTRI/2020/04/024819尚未招募不适用

Low anterior resection syndrome in patients undergoing sphincter preservation surgery for rectal cancers, factors affecting it and change in quality of life over time

Regional Cancer Centre1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年4月27日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
1
主要终点
Incidence of LARS syndrome in patients undergoing low anterior resection for rectal cancer.

研究概览

简要总结

For most surgeons andpatients , rectal cancer sphincter preservation is of paramount importance , wheneveroncologically feasible. Surgeons seek extra pride in putting efforts for sphincter preservation even in a very lowrectal cancer. The oncologic outcome is same as the Abdominoperineal resection,the surgery resulting in extirpation of sphincter function  .But in reality up to 70% patients, aftersphincter saving surgery for rectal cancer have significant bowel dysfunctionaffecting their quality of life(1-3).This is called Low Anterior Resection Syndrome (LARS).Thesymptoms of the LARS are multiple or frequent defecations, incomplete bowelmovements, repetitive defecatory attempts resulting in passage of small amountsof stool within a few hours(clustering),fecal incontinence( disorders rangingfrom minimal soiling or flatus incontinence to major incontinence of liquid and/or solid stools, urgency (that is the impossibility of retaining fecal emissionmore than 15 minutes after the sensation). We intend to study the incidence of LARS in our patients and also the factors affecting the causation of such symptoms after surgery.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing low anterior resection in Regional Cancer centre, Trivandrum at least one year before the recruitment date and who voluntarily give informed consent to participate in the study.

排除标准

  • 1.History of any pelvic surgery for malignancy in the past 2.History of radiation to pelvis for reasons other than neo adjuvant radiation for rectal cancer at present 3.Recurrent cancers 4.Presence of inflammatory bowel disease 5.Presence of irritable bowel syndrome 6.History of surgery for hemorrhoids, fissure or anal fistula 7.History of pelvic inflammatory disease 8.History of pelvic peritonitis in the past 9.History of Pelvic floor disease or incontinence of neuro muscular origin.

结局指标

主要结局

Incidence of LARS syndrome in patients undergoing low anterior resection for rectal cancer.

时间窗: Post surgery, 3 months and 6 months post op.

次要结局

  • Factors affecting the causation of low anterior resection syndrome and changes in QoL in these patients.(Post surgery, 3 months and 6 months post op.)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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