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临床试验/NCT03720262
NCT03720262招募中2 期

Prevention of Hernia After Loop Ileostomy Reversal

Karolinska Institutet5 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
招募中
入组人数
208
试验地点
5
主要终点
Hernia

研究概览

简要总结

PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery are randomized between retro muscular mesh Ultrapro Advanced or standard treatment without mesh.

详细描述

A temporary loop ileostomy is widely used when operating rectal cancer. The ostomy is then reversed in a separate operation. Morbidity of stoma reversal is significant, but not clearly defined. One complication in connection with stoma closure is development of hernia at the former stoma site.

A hernia is a weakening of the muscular layers and the connective tissue of the abdominal wall, which may cause pain and discomfort, as well as an inconvenient bulge. A hernia could also cause more serious complication of obstructed or strangulated bowel. According to international studies, the incidence of hernia at the ostomy site varies between 7% and 35%. Many of the studies are heterogenic and some of them include both colostomies and ileostomies. Among studies that focus on reversal of ileotomies the hernia incidence varies between 11-15%. Preliminary results from a retrospective study in Stockholm indicates a frequency of 7,9%.

The best method to avoid hernia after stoma closure is not known. Most commonly surgeons tend to close the fascia in one layer with monofilament suture. In the study mentioned above 91% of the operations were done with one-layer monofilament, mostly PDS. Use of prophylactic mesh in the abdominal wall has been proposed, but there is currently insufficient scientific evidence to recommend it as a routine.

The present study is focused on loop ileostomy closure after rectal cancer. A non-heterogenous group of ostomies will serve as a base to evaluate whether the incidence of hernia may be reduced. If this study detects a decreased frequency of hernia when using prophylactic meshes, it may lead to new recommendations for this patient group.

PHaLIR is a prospective, double-blinded randomized study in which patients planned for stoma reversal after rectal cancer surgery will be randomized to retro muscular mesh Ultrapro Advanced or standard treatment without mesh. Operating time, complications, LOS, pain, infections and postoperative hernia are to be studied. The patients will be identified and asked about participation when they come for postoperative control after rectal cancer operation and are planned for the ileostomy reversal after check of the rectal anastomosis. They will be given oral and written information and signed informed consent is required from all patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The patient and the surgeon performing the follow-up are masked for the allocation

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients operated for low anterior resection for rectal cancer with a diverting loop ileostomy and planned for stoma reversal

排除标准

  • Language barrier or cognitive disability
  • Recurrent cancer

研究组 & 干预措施

Mesh reinforcement

Experimental

Retro muscular mesh at the stoma site.

干预措施: Mesh reinforcement (Combination Product)

No reinforcement

Placebo Comparator

Standard closure of the abdominal wall

干预措施: No reinforcement (Other)

结局指标

主要结局

Hernia

时间窗: One year

Hernia at the site of the stomal closure

次要结局

  • Postoperative complications(Thirty days)
  • Operation time(Three hours)
  • Time for closing the stoma site(One hour)
  • Hospital stay(Seven days)
  • Postoperative pain(Thirty days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Åsa Hallqvist Everhov

MD, PhD

Karolinska Institutet

研究点 (5)

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