LATA-IBD Trial a Laparoscopic and Transanal IPAA-surgery Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Conversion rate to open surgery
研究概览
简要总结
This study compares the operative and functional outcomes of adding a transanal pathway to laparoscopic pelvic pouch surgery. The transanal pathway enables the surgeon to have better control when dividing the rectum and it may improve visualization in pelvic dissection. This could decrease the need for conversion to open surgery, reduce complications, postoperative pain, hospital stay and improve bowel function after surgery. The study compares two consecutive groups of patients at a single institution. The transanally operated group consists of 22 patients with prospectively collected data between 2018-2020 and the traditional laparoscopic group consists of 17 patients with retrospectively collected data operated between 2015-2016. Inclusion criteria for the transanal group were patients over 18 years with either ulcerative colitis or familial adenomatous polyposis who were possible to operate with laparoscopic surgery and who had signed an informed consent.
The studys primary objective is to investigate if there is a difference in the frequency of conversions to open surgery or anastomotic leakage of the anastomosis between the pelvic pouch and the anal canal. Secondary objectives are mortality, bleeding, operative time, complications, reoperations, hospital stay, readmissions to hospital and bowel function two years after surgery.
详细描述
Study Design This is a prospective feasibility study comparing consecutive patients undergoing ta-IPAA with a historical cohort of patients treated with lap-IPAA at the same institution.
Endpoints The primary endpoints were conversion rate and anastomotic leakage rate. Conversion was defined as the need for laparotomy before pouch construction and/or specimen extraction, or the requirement to extend or alter the initial incision during pouch construction. Anastomotic leakage was defined and graded according to the International Study Group of Rectal Cancer (18).
Secondary endpoints included mortality, intraoperative bleeding, operative time, postoperative complications (graded according to the Clavien Dindo classification (19)), reoperations, readmissions, length of hospital stay and pouch function. Pouch function was assessed using the Öresland score (OS) (20) two years after surgery. The OS consists of 11 parameters measuring bowel function after IPAA and ranges from 0-15 (higher scores indicate worse function). Scores ≥8 are associated with impaired pouch function and reduced quality of life. Pouch failure was defined as the need for a diverting stoma or excision of the pouch.
Data collection Study data were collected prospectively using a paper case report form (CRFs) completed at predefined time points: preoperatively, intraoperatively, at hospital discharge and 3, 6, 12 and 24 months after ta-IPAA. For the historical control group, data were retrieved retrospectively from medical records. Intraoperative data were excluded from the lap-IPAA group, as these could not be reliably retrieved.
Training The surgical team consisted of three colorectal surgeons and experienced operating room nurses, all with prior expertise in laparoscopic Total Mesorectal Excision (TME) and IPAA-surgery. The team underwent formal training in taTME-surgery, including participation in dedicated courses, observational visits and on-site proctoring by an international center with significant experience in ta-IPAA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Conversion rate to open surgery
时间窗: During surgery
Rate of patients with abdominal incision before pouch construction or changed or extended abdominal incision during pouch construction.
Anastomotic leakage rate
时间窗: Within 24 months after surgery
Rate of anastomotic leakage as defined by the international study group of cancer. A defect of the intestinal wall at the anastomotic site (including suture and staple lines of neorectal reservoirs) leading to a communication between the intra- and extraluminal compartments.
次要结局
未报告次要终点
研究者
Bjarne Melvas
Senior consultant,
Sahlgrenska University Hospital