Low Powered Colorectal Anastomosis After Rectal Excision : An Exploratory, Observational, Prospective, IDEAL Stage 2b International Cohort Study (OASIS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 15
- 主要终点
- To assess and compare the rate of anastomotic leakage at 1 month after rectal excision between double and single-stapling low colorectal anastomosis using advanced powered stapler
研究概览
简要总结
The objectiive of this prospective, international cohort is to compare two anastomotic techniques (DS vs TTSS) by collecting data during the surgery, and postoperatively (morbidity and functional outcomes).
The choice of technique is left to the discretion of the surgeon based on her/his practices.
详细描述
There are a variety of available anastomotic techniques to facilitate restorative surgery following total mesorectal excision (TME) for rectal cancer. However, there is no good quality evidence demonstrating the superiority of any single technique with regards to the potential sequalae of restorative surgery including anastomotic leakage and functional impact. Double-stapled anastomotic technique (DST) for colorectal anastomosis is the most widely used technique worldwide. An alternative to DST is the hand-sewn coloanal anastomotic (CAA) technique, which is traditionally reserved for patients with ultralow rectal tumours requesting restorative surgery or in cases of technical difficulties whereby a low colorectal anastomosis is converted to a coloanal anastomosis. More recently, the Transanal Transection and Single Staple anastomosis (TTSS) technique has been described. The TTSS technique has the potential to mitigate the difficulties encountered with DST and the potential complications and long-term functional sequalae encountered with handsewn anastomosis. Moreover, powered mechanical circumferential staplers represent a significant advancement in colorectal surgery, particularly in performing anastomosis following rectal excision. These devices are designed to provide consistent staple formation and controlled tissue compression, reducing the variability associated with manual stapling.
AL has a significant impact on clinical, patient-reported, and oncological outcomes. To mitigate the impact of AL a diverting stoma is routinely used to protect the distal anastomosis and facilitate anastomotic healing, with these stomas reversed once the integrity and patency of the distal anastomosis is confirmed. However, there is a significant complication profile associated with the routine use of diverting stomas. Through the incorporation of appropriate pre-operative risk stratification and careful post-operative surveillance a selective stoma strategy is associated with good clinical and functional outcomes.
The use of Double-stapled anastomotic technique (DST) or Transanal Transection Single-Stappled (TTSS) by laparoscopic or robotic approach, using or not a defunctionning stoma could not be separately tested in randomized trial.
In this exploratory, observational, prospective, IDEAL stage 2b International cohort study, we aim to include 400 patients with resection rectal and low powered colorectal anastomosis.
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
- •Patients with rectal cancer lower than 12 cm from the anal verge requiring either a stapling anastomosis below 7 cm from the anal verge,
- •Patients with powered mechanical anastomosis (INTOCARE devices)
- •Patients with no metastasis
- •Patients operated on by mini-invasive rectal excision (laparoscopic, robotic or TaTME);
- •Patients with or without defunctioning ileostomy;
- •Patients with or without neoadjuvant treatment;
- •Patient who benefits by medicare system;
- •Signed and dated informed consent
排除标准
- •Patients with handsewn anastomosis
- •Patients with perforated rectal cancer or preoperative pelvic sepsis ;
- •Patients with inflammatory bowel disease;
- •Patients operated on in emergency ;
- •Patients with extended-TME or pelvic exenteration;
- •Pregnancy or breast feeding period
- •Legal incapacity or physical, psychological social or geographical status interfering with the patient's ability to agree to participate in the study
- •Persons deprived of liberty or under guardianship
结局指标
主要结局
To assess and compare the rate of anastomotic leakage at 1 month after rectal excision between double and single-stapling low colorectal anastomosis using advanced powered stapler
时间窗: From the surgery to one month
Proportion of anastomotic leakage (clinical and radiological) at 1 month after rectal surgery between double- and single-stapling low colorectal anastomosis using advanced powered stapler.
次要结局
- Overall morbidity and mortality rates at 1 month(At 1 month after the end of the surgery)
- The rate of anastomotic leakage at 6 and 12 months after rectal surgery;(At 12 month after the end of the surgery)
- Quality of life with QLQ C30 questionnaire(At 1, 6 and 12 months after rectal surgery)
- Quality of life with QLQ CR29 questionnaire(At 1,6 and 12 months after rectal surgery)
- Qualiy of life with EQ5D-5L(At 1, 6 and 12 months after rectal surgery)
- Digestive function with LARS score(At 1, 6 and 12 months after rectal surgery)
- Anal Incontinence with Wexner score ( or Vaizey score)(At 1,6 and 12 months after rectal surgery)
- Female Sexual Function Index (FSFI) scale scores(At 1, 6 and 12 months after rectal surgery)
- International Index of Erectile Function (IIEF)-5(At 1,6 and 12 months after rectal surgery)
- International Prostate Symptom Score (IPSS)(At 1, 6 and 12 months after surgery)
- Predictive factors for anastomotic fistula(From the surgery to 12 months)