Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Perineal wound healing
研究概览
简要总结
Non-randomized study of robot-assisted perineal reconstruction with rectus abdominis muscle flap in patients operated with abdominoperineal resection for irradiated locally advanced rectal or anal cancer. Operative time, complications, wound healing, pre- and postoperatively abdominal wall strength and patient related outcomes including sexual health will be registered.
详细描述
Inclusion criteria:
Patients > 18 years of age operated with robotic-assisted abdominoperineal resection for irradiated locally advanced rectal or anal cancer where robotic-assisted perineal and/or vaginal reconstruction has been performed with a rectus abdominis muscle flap.
Methods Up to 40 patients operated with robotic-assisted abdominoperineal resection with Da Vinci Xi surgical system (Intuitive Surgical, Sunnyvale, California, USA) and robotic-assisted reconstruction with a pedicled rectus muscle will be included in this prospective, non-randomized study.
In addition to the standardized post-operative care for patients with locally advanced rectal or anal cancer as specified by national guidelines, patients will be offered study-specific follow-up visits at 1, 6 and 12 months.
Complications are recorded by the accordion severity grading system of surgical complications. Patient related outcomes measures will be registered by using European organization for research and treatment of cancer Quality of life questionnaire Core 30 (EORTC QLQ-C30). Sexual health will be registered by a subset of questions from European organization for research and treatment of cancer Quality of life questionnaire Sexual health (EORTC QLQ-SH22).
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 or anal cancer
- •scheduled for robot-assisted abdominoperineal resection
- •reconstruction of pelvic floor and/or vagina with rectus abdominis muscle flap
排除标准
- •patients not eligible for robot-assisted procedure
- •rectus abdominis muscle not available for harvest
- •the expected wound defect is not suitable for reconstruction with rectus abdominis muscle flap
结局指标
主要结局
Perineal wound healing
时间窗: 3 months
Perineal wound healing at 3 months. Perineal wound has completely healed at clinical control 3 months postoperatively without need for further follow-up of the perineal wound. Any perineal complications are noted. * superficial wound infection * deep wound infection * minor wound dehiscence * major wound dehiscence * partial flap loss * total flap loss * perineal hernia * enterocutaneous fistula * stricture in neovagina * perineal wound dehiscence not related to flap * other complications
次要结局
- Late postoperative complications(Later than 30 days postoperatively)
- Quality of life - general(Preoperatively. 3 months and 12 months postoperatively.)
- Early postoperative complications(Within 30 days postoperatively)
- Quality of life - sexual(Preoperatively. 3 months and 12 months postoperatively.)
- Abdominal wall strength(Preoperatively. 3 months and 12 months postoperatively.)
研究者
Lars Frich
Consultant
Oslo University Hospital