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临床试验/NCT04462705
NCT04462705已完成不适用

Abdominal Massage to Prevent Postoperative Ileus as Part of an Enhanced Recovery Program After Colorectal Surgery

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年8月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery

研究概览

简要总结

Post operative ileus refers to an disrupt in normal gastrointestinal motility responsible of nausea and vomiting. It occurs in about 15-20% of colorectal surgeries. Some preventive measures have been included in the Enhanced Recovery After Surgery Program such as early mobilisation and enteral feeding or minimal invasive approach.

Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported.

Various studies have evaluated the value of physiotherapy and massage for resumption of normal bowel function. A study from Rouen University Hospital demonstrated that a mechanical stress to the cuteaneous tissue by LPG Cellu M50® machine would reduce pain and lower the time to first flatus. Similar results were obtained after Cardiac surgery. In a preclinical study on operated rats, abdominal massage also improved normal bowel function recovery.

Physiotherapist plays a key role in RAC. Their action on respiratory function (movement of diaphragm) and musculoskeletal system (early walking) allows a faster recovery and a reduction of time of hospitalization. Even though the results on time to first flatus and anxiety seem interesting, Deep abdominal massage has never been evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult patients >18years (homme et femme de plus de 18 ans)
  • •Elective Patients undergoing colorectal surgery with intestinal anastomosis (Colectomy, Anterior Resection, intestinal resection or stoma closure) without protective stoma creation in an Enhanced Recovery After Surgery Program
  • •Able to give the consent
  • •Affiliated to Social Security

排除标准

  • •Mental disorders
  • •Cutaneous infection on the abdomen
  • •Pregrancy and breast feeding
  • •Patients unable to give their free consent (incarcerated, legal protection measures)

研究组 & 干预措施

Usual physiotherapeutic intervention

Active Comparator

the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline.

  • At D + 1 post-surgical:
    • First lift with verticalization.
    • A session with the Cliniflo® in a seated position.
    • Walk at least 100 m with the help of the physiotherapist.

At- D+2 and D+3 post-surgical Same session as on D+1 with progressive increase in the walking perimeter. Add up and down stairs on D+ 3

干预措施: Usual physiotherapeutic intervention and Abdominal Massage (Procedure)

abdominal massage and usual physiotherapeutic intervention

Experimental

the usual physiotherapeutic intervention (respiratory and walking exercices). Each patients will be treated following the ERAS Guideline.

  • At D + 1post-surgical:
    • First lift with verticalization.
    • A session with the Cliniflo® in a seated position.
    • Walk at least 100 m with the help of the physiotherapist.

At- D + 2 and D + 3 post-surgical Same session as on D + 1 with progressive increase in the walking perimeter. Add up and down stairs on D+ 3

In this experimental arm, a abdominal massage will be performed in addition to the usual physiotherapeutic intervention (respiratory and walking exercices).

The sessions take place on D+1, D+2 and D+3 post-surgical The first session is performed at least 20 hours after surgery (incision begins) Never within an hour of a meal. The session is timed.

干预措施: Usual physiotherapeutic intervention and Abdominal Massage (Procedure)

结局指标

主要结局

Evaluate the effect of abdominal massage on time to normal bowel function after colorectal surgery

时间窗: through study completion, 30 days

Time to normal bowel function

次要结局

未报告次要终点

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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