Prevention of Petersen's Hernia After Laparoscopic Gastrectomy for Gastric Cancer, Prospective, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 444
- 试验地点
- 2
- 主要终点
- post-operative 3-yr Petersen's hernia incidence
研究概览
简要总结
- Aim of this study To compare the cases underwent operation to treat intestinal obstruction caused by Peterson hernia within 3 years after laparoscopic gastrectomy between closure method and Mefix methods.
- Primary end point: The cases underwent operation to treat intestinal obstruction caused by Peterson hernia within 3 years after laparoscopic gastrectomy was not- inferior between Closure and MEFIX.
- Secondary endpoint: Procedures' times (minutes), bleeding, Hospital stays (days) Occurrence of postoperative small bowel obstruction within 30 days after surgery, Short-term complications within 30 days after surgery, Occurrence of Petersen's Hernia according to the use of anti-adhesion agents, anastomotic methods, CLOSURE or MEFIX previous surgical suture condition, hernia degree, and bowel condition (strangulation, perforation) at the timing of emergent operation for treatment of Petersen's Hernia obstructions
详细描述
-
Background
-
Petersen's hernia after gastrectomy Petersen's hernia was reported in 1900 by German surgeon Walther Petersen following the occurrence of an internal hernia after gastrectomy and gastrojejunostomy (G-J) 1[]. Petersen's hernia occurs in the free space posterior to a G-J site after any type of G-J and is caused by herniation of the small bowel through the defect between the small bowel mesentery and the transverse mesocolon.
As shown in CT figure in Figure 1, the small bowel mesentery rotates and twists, leading to an emergency situation in which necrosis of the entire small intestine occurs due to decreased blood circulation of the small intestine The occurrence rate of Petersen's hernias after laparoscopic Roux-en-Y G-J is approximately 1.7~9.7%
- Peterson's hernia can occur in the RNY esophagojejunal anastomosis after gastrectomy, or after the RNY gastrojejunostomy and Billroth type 2 anastomosis after distal gastrectomy. Also, it can occur after the obesity surgery RNY gastric bypass surgery.
- The incidence of internal hernia has been reported to be higher in laparoscopic approaches than in open gastrectomy One possible cause of the increasing incidence of Petersen's hernias is the recent development of minimally invasive surgery. A higher incidence of internal hernia is reported in minimally invasive gastrectomy than in open gastrectomy.
After open surgery, adhesion was made between the small bowel and the operative wound site, however with minimally invasive surgery, adhesion is remarkably decreased, not only because of the disappearance of the open wound in the upper abdomen but also the use of antiadhesive agent Therefore, non-absorbable sutures require the closure of Peterson's spaces, and according to report of Blockhuys M, the frequency of internal hernia decreased after closure of Petersen's space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •: histological proven primary gastric adenocarcinoma
- •no evidence of other distant metastasis
- •R0 resection
- •laparoscopic or robotic gastrectomy
- •and reconstructed by Roux-en-Y reconstruction or the Billroth II procedure
- •patient with appropriate conditions of activity; 0 or 1 on Eastern Cooperative Oncology Group (ECOG) scale
- •patient who have not previously received chemotherapy or radiation treatment in the abdomen.
- •patinet who signed the consent form
- •cTNM stage I or II or III
排除标准
- •active double cancer (synchronous and metachronous double cancer within 5 disease-free years),
- •carcinoma in situ,
- •open gastrectomy,
- •reconstructed by Billroth I procedure,
- •gastric cancer recurrence, ;a history of gastrectomy. ;
- •a patient who has the history of abdominal surgery except laparoscopic appendectomy and gallbladder resection, and laparoscopic gynecologic surgery due to benign disease, and Cesarean section.
- •a patient who need co-ordination for other organs in preoperative examination (However, laparoscopic cholecystectomy is included in the selection criteria due to gallbladder polyps, and gallbladder disease).
- •Pregnant women, lactating women
- •a patient with mental illness (a person diagnosed with mental illness in medical records)
- •a patient who are taking corticosteroid whole-body (including herbal medicine)
- •a patient who has an uncontrolled history of angina or myocardial infarction within six months of the study;
- •uncontrolled hypertension
- •a patient who has a serious respiratory disease that requires continuous oxygen therapy;
结局指标
主要结局
post-operative 3-yr Petersen's hernia incidence
时间窗: post-operative 3-yr
Petersen's hernia incidence with operation for hernia reduction due to severe abdominal pain
次要结局
- subgroup analysis of gastrectomy range and reconstruction method(complication within 30 days after surgery)
- post-operative 5-yr Petersen's hernia incidence(post-operative 5-yr)
- Postoperative morbidity and bowel obstruction incidence(complication within 30 days after surgery)
- subgroup analysis of antiadhesive agent use(complication within 30 days after surgery)