"Cross" Closure for Reconstructing the Perineal Wound of Abdominoperineal Resection in Rectal and Anal Cancer Patients: a Multi-center, Randomized, Open-Label, Positive, Parallel Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 346
- 主要终点
- Complication rate of perineal wound
研究概览
简要总结
How to reduce the complications of perineal wound after abdominoperineal resection (APR) has always been a hot topic in the medical field.To reduce the complications of perineal wound and the primary healing of perineal wound must meet the two principles of "unobstructed drainage" and " reduced tension closure".This concept is similar to the concepts of closure of enterostomy in rectal cancer patients. It was reported that use of cross-stitch closure can significantly reduce complications of closure of enterostomy. So the investigator ever used the "cross" closure to reconstruct the perineal wound of APR, which was really decrease the complications of perineal wound. However, more clinical trails was needed to confirm the conclusion.
详细描述
Perineal wound problems after abdominoperineal resection (APR) for rectal cancer is reported in up to 25%～66% of patients,if the perineum does not heal primarily, the secondary wound healing may prolong hospital stay, may necessitate surgical reintervention, and often requires intensive wound care for several months. Great efforts have been taken to reduce the complications of perineal wound of APR, but the incidence of the perineal wound complications are not effectively decreased.
It was reported that one of the most important factors to determine the primary healing of perineal wound is whether the anterior sacral drainage and perineal stump drainage are sufficient and effective or not, which is similar to the concept of closure of enterostomy.
Previously, it was reported that "cross" closure is an effective method of skin closure for stoma reversal, which allows increased surgical exposure, reduces suture, smooth drainage, aesthetic healing simplifies wound care, and gives a neat cosmetic result.
Therefore, because of the success use of "cross" closure in stoma reversal to reduce the complications of perineal wound, the investigator used the "cross" closure to reconstruct the perineal wound of APR, and it really can decrease the complications of perineal wound. However, more clinical trails are needed to confirm the conclusion.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old;
- •ECOG performance status: 0-2;
- •Histologically confirmed rectal cancer or anal canal cancer;
- •Completely resected the primary tumor;
- •No evidence of distant metastasis;
- •Tolerable general anesthesia;
- •Total radiation dose of 45-50 Gy needed if the patient needs to receive routine segmental radiotherapy;
- •Provision of written informed consent.
排除标准
- •Emergency surgery required when the patients combined with acute ileus, perforation and hemorrhage;
- •Extralevator abdominoperineal resection needed;
- •American Society of Anesthesiologists (ASA) IV or V;
- •Combined with other tumors;
- •Severe mental illness;
- •(7)Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease; (8)Expectation of lateral lymph node dissection preoperatively
研究组 & 干预措施
Traditional Closure
Patients receive primary closure discontinuously for reconstruction of APR perineal wound
干预措施: Traditional Closure (Procedure)
"Cross" Closure
Patients receive "cross" closure for reconstruction of APR perineal wound
干预措施: "Cross" closure (Procedure)
结局指标
主要结局
Complication rate of perineal wound
时间窗: Within 30 days after operation
the complications of perineal wound are include wound infection, wound effusion, wound liquefaction, wound dehiscence, seroma or hematoma ,delayed wound healing, presacral or perineal abscess, perineal or pelvic floor hernia
次要结局
- The incidence of each complication of perineal wound(Within 30 days after surgery)
- The volumes of presacral drainage(Within 3, 5, 7 days after surgery)
- The volumes of presacral residual cavity hydrops(3 and 7 days postoperatively)
- CTCAE grade for complications of perineal wound(Within 30 days after surgery)
- Hospital stay after surgery(Within 30 days after surgery)
- Primary wound healing rate(Within 30 days after operation)
- The rate of reoperation(Within 30 days after surgery)
- The times of dressing change of perineal wound(Within 3, 5, 7 days after surgery)
- Removal time of presacral drainage tube(Within 30 days after surgery)
- Scar scores for perineal wound and evaluation of patients' overall satisfaction(Within 30 days after surgery)
- The operation time(Intraoperatively)