A National, Registry Based Study of Clinical Results After Emergency Operation for Perforated Diverticulitis to Compare Laparoscopic Lavage and Resection Surgery in Routine Use.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 669
- 试验地点
- 1
- 主要终点
- Need for further surgical interventions within 12 months of index surgery
研究概览
简要总结
The aim of this study is to evaluate clinical results and effect on health and well-being in patients operated for perforated diverticulitis with purulent peritonitis by laparoscopic lavage in Sweden when used outside of prospective studies/trials and in comparison with the traditional treatment, i.e. colon resection with or without stoma formation.
A secondary aim is to evaluate the outcome after fecal peritonitis.
The hypothesis is that laparoscopic lavage as treatment for perforated diverticulitis with purulent peritonitis is safe, efficient and cost saving, when used in routine health care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients registered in the Patient registry with ICD 10 codes K57 classified as emergency admissions and with the Nordic Medico-Statistical Committee (NOMESCO) code JAH01(diagnostic laparoscopy), JFB46 (resection of sigmoid colon), JFB60 (resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB61 (laparoscopic resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB63 (other colon resection, colostomy and closure of the distal stump), JAK04 (laparoscopy and peritoneal lavage), JAW97 (other laparoscopic operation involving abdominal wall, mesentery, peritoneum or the omentum)
排除标准
- •Patients where hospital records reveal that the index admission was misclassified (not perforated diverticulitis) will be excluded.
- •Patients classified as Hinchey 1-
- •No informed consent received or withdrawal of consent (questionnaire)
结局指标
主要结局
Need for further surgical interventions within 12 months of index surgery
时间窗: 12 months
Number of patients in need of further surgical interventions within 12 months after index surgery.
次要结局
- Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.(90 days)
- Patient reported outcome after treatment for perforated diverticulitis, function(3 years)
- Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.(36 months)
- Mortality (90 days and 12 months respectively).(12 months)
- Colon cancer diagnosis(12 months)
- Health economics with regard to the two different treatment modalities.(2 years)
- Patient reported outcome after treatment for perforated diverticulitis, quality of life(3 years)
- Need for further surgical interventions within 24 months of index surgery(24 months)
研究者
Eva Haglind, MD, PhD, professor
MD, PhD, professor
Sahlgrenska University Hospital, Sweden