Suture Techniques to Reduce the Incidence of Incisional Hernia After Midline Laparotomy; Long-Term Follow-Up of the STITCH Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 560
- 试验地点
- 9
- 主要终点
- Incisional hernia occurrence (and timeto incisional hernia outcome).
研究概览
简要总结
Rationale: Incisional hernias (IH) are a frequent complication after abdominal surgery. Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70% in high-risk patients after open surgery. To investigate different fascia closure techniques in the prevention of IHs, the STITCH trial (NCT01132209) was designed. The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy. Patients were randomly assigned to the intervention group (small bites 5 mm x 5 mm) or the control group (large bites 1 cm x 1 cm). The study showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision.
So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group.
Objective: The primary objective of this study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.
详细描述
Rationale: Incisional hernias (IH) are a frequent complication after abdominal surgery. Prevalence of an IH varies depending on the previous abdominal procedure but could be as high as 70% in high-risk patients after open surgery. To investigate different fascia closure techniques in the prevention of IHs, the STITCH trial (NCT01132209) was designed, a randomized controlled trial in which 560 patients were included between October 2009 and March 2012. The study compared two different closure techniques for closure of a midline incision in adult patients undergoing an elective abdominal laparotomy. Patients were randomly assigned to the intervention group (small bites 5 mm x 5 mm) or the control group (large bites 1 cm x 1 cm). It showed that small bites are much more effective than large bites in the prevention of an incisional hernia when closing a midline incision.
So far, it has not been studied whether there is still a long-term difference in incidence of incisional hernia between the small bites and the large bites group.
Objective: The primary objective of this study study is to determine the difference in incidence of IH between the small bites and the large bites group after 10 years of follow-up from time of randomization in the STITCH trial. The secondary objectives are to measure quality of life (QoL), body image and cosmetic results, and abdominal wall function through questionnaires and physical examination in those patients who are still alive.
Study design: Assessment of long-term follow-up (10-13 years) of a randomized controlled multicenter study based on retrospective review of patient files and relevant imaging of the entire trial population, as well as questionnaires and physical and radiological examination of patient who are still alive.
Study population: Of the 560 included patients in the original STITCH trial, 545 completed the 1-year follow-up.
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
- Single (Outcomes Assessor)
盲法说明
Outcome assessors of previous radiological imaging and imaging created during our Long-term follow up will be blinded to the assigned randomization arm.
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In order to be eligible to participate in this study, a subject must meet the following criteria:
- •Available signed informed consent form for the original STITCH trial of the patients who are still alive.
- •Or if the patients has died, the medical records are reviewed.
- •A potential subject who meets the following criteria will be excluded from participation in this study:
- •Patients that on the original informed consent form of the STITCH trial, checked the box that they did not want to be approached for future follow-up studies.
排除标准
- 未提供
研究组 & 干预措施
Small bites suturing technique of the abdominal wall during midline laparotomy
In the experimental group of 288 patients the small bites technique was applied with bite widths of 0,5 cm and inter suture spacing of 0,5 cm with the use of PDS plus ll 2-0 single suture material with a 31 mm needle placed in the linea alba. In the small bites technique, twice as many stitches will be placed per sutured cm, with a smaller needle and thinner suture material.
干预措施: Small bites technique (Procedure)
Large bites suturing technique of the abdominal wall during midline laparotomy
As control the conventional large bites technique (mass closure) was applied with bites widths of 1 cm and inter-suture spacing of 1 cm with the use of PDS plus ll 1-0 double loop suture material with a 48 mm needle.
干预措施: Conventional large bites closure (Procedure)
结局指标
主要结局
Incisional hernia occurrence (and timeto incisional hernia outcome).
时间窗: Patients will have a follow-up of up to 12 years, with most patients having a follow-up between 10 and 12 years.
Incisional hernia occurrence after operation clinical and/or radiological diagnosis.
次要结局
- AWF.(Patients will have a follow-up of up to 12 years.)
- Quality of life of the patient.(Patients will have a follow-up of up to 12 years.)
- Cosmetic results, cosmesis.(Patients will have a follow-up of up to 12 years.)
- Body image.(Patients will have a follow-up of up to 12 years.)
- Quality of life of the patient.(Patients will have a follow-up of more than 10 years.)
研究者
Prof. dr. Pieter J Tanis
Prof.dr. P.J. Tanis
Erasmus Medical Center