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临床试验/NCT00138957
NCT00138957撤回不适用

Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study

University Hospital, Gentofte, Copenhagen0 个研究点目标入组 20 人开始时间: 2005年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
20
主要终点
Stricture of stoma (Bougie, mm)

研究概览

简要总结

The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life.

详细描述

Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hernia. Symptoms associated with parastomal hernias goes from mild physical (pain) and cosmetic discomfort to life threatening conditions with obstruction, strangulation and perforation. Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem.

The surgical treatment of parastomal hernias is controversial. The best way to treat it is to restore the continuity of the intestine, but in permanent stomas, this is not an option. Many surgical techniques have been described when intervention is required, but the results are unacceptable. The traditional open techniques are local simple suturing of the fascia defect, stoma relocation, or repair with a prosthetic material either intraperitoneally or extraperitoneally (subfascial or onlay). Overall, the results of all methods are poor with high recurrence rates and high morbidity and mortality. Mesh repair has the lowest recurrence rate (0-39%) and stoma relocation and simple suture has reported recurrence rates on 0-76% and 46-100%, respectively. Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series. The results so far are encouraging, but the follow-up period is short.

Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall, we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future. Therefore, we find it interesting to investigate the technique in a prospective study

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 - 80 years
  • Indication for laparoscopic parastomal hernia repair in general anaesthesia.
  • Danish speaking
  • ASA group I-III
  • No remaining malignancy after former primary radical operation for colorectal cancer

排除标准

  • Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation
  • Incarcerated hernia (acute operation)
  • History of abuse or permanent morphine use
  • Expected bad compliance
  • Current systemic steroid use or other immuno-suppressive treatment
  • HIV-positive, pregnant or breast feeding
  • Medical conditions contraindicating general anaesthesia
  • Simultaneous operation for other ventral, inguinal or umbilical hernia
  • Epidural or spinal anaesthesia
  • Conversion to open procedure

结局指标

主要结局

Stricture of stoma (Bougie, mm)

Recurrence of parastomal hernia after 6 months (ultrasound and clinical)

Postoperative pain (Visual Analog Scale, VAS 0-100, Verbal Rating Scale, VRS 0-3)

Quality of life (SF-36 and Ostomy Adjustment Scale (OAS))

General well-being (VAS 0-100)

Postoperative ileus/paralysis > 24 hours

Patient's satisfaction (VAS 0-100)

Bandage problems (VRS 0-3)

次要结局

  • Medical and surgical complications

研究者

发起方
University Hospital, Gentofte, Copenhagen
申办方类型
Other

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