Surgical Outcomes in Splenic Flexure Cancers: A Prospective, Multicentric Observational Cohort Study Comparing Segmental Hemicolectomy and Extended Hemicolectomy - The SPARROW Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Ileus After Surgery for Splenic Flexure Cancer
研究概览
简要总结
SPARROW Study: Surgical Outcomes in Splenic Flexure Cancer
Colonic cancers located at the splenic flexure where the transverse colon turns into the descending colon are uncommon and represent less than 10% of all colorectal cancers. Because of their unique location between the blood supply of the right and left colon, there is no clear agreement on which surgical method provides the best results.
Two main procedures are used:
Segmental hemicolectomy, which removes only the part of the colon containing the tumor, and
Extended hemicolectomy, which removes a larger section of the colon and more lymph nodes.
The SPARROW Study is a prospective, multicenter observational study designed to compare these two surgical approaches in patients with splenic flexure cancer. The study will include about 140 patients (70 in each group) from multiple tertiary colorectal centers in Turkey and Europe.
Researchers will collect information about each patient's surgery, recovery, and follow-up outcomes. The main outcomes include postoperative ileus, leakage at the surgical connection (anastomosis), wound infection, and total postoperative complications. Other outcomes include number of lymph nodes removed, complete tumor resection (R0), hospital stay, recovery time, reoperation, and 3-year overall and disease-free survival.
By analyzing both short- and long-term results, the SPARROW Study aims to provide high-quality evidence to guide surgeons in choosing the best and safest operation for patients with splenic flexure cancers.
All participants will provide written informed consent before joining the study. The study has received ethical approval from the Koç University Ethics Committee and will be conducted in accordance with the Declaration of Helsinki.
详细描述
Study Rationale:
Splenic flexure cancers pose unique surgical challenges due to their variable blood supply and lymphatic drainage. The optimal extent of resection remains controversial, with both extended right and left colectomy approaches showing different technical advantages. However, there are no prospective multicenter data comparing their perioperative and oncologic outcomes.
Study Design:
This is a prospective, multicenter observational cohort study involving tertiary colorectal cancer centers. The study will enroll 140 consecutive adult patients (≥18 years old) undergoing elective curative resection for histologically confirmed splenic flexure adenocarcinoma. Surgical approach-segmental or extended colectomy-will be chosen according to the operating surgeon's routine practice and preference, not assigned by randomization.
Primary Outcomes:
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients aged 18 years or older
- •Histologically confirmed adenocarcinoma of the splenic flexure
- •Elective surgical resection performed with curative intent (segmental colectomy or extended hemicolectomy)
- •Availability of complete perioperative and follow-up data
- •Written informed consent provided prior to participation
- •Surgery performed by colorectal or general surgeons meeting institutional eligibility criteria (≥20 colorectal cancer cases/year, ≥2 years of colorectal training)
排除标准
- •Emergency surgery for obstruction, perforation, or bleeding
- •Non-adenocarcinoma histology (e.g., lymphoma, neuroendocrine tumor, gastrointestinal stromal tumor)
- •Patients undergoing palliative resections, local excisions, or bypass procedures without curative intent
- •Presence of synchronous colorectal malignancy or distant metastasis requiring simultaneous resection
- •Previous colorectal resection involving the splenic flexure
- •Patients with incomplete clinical or pathological data or those lost to follow-up before 30 days postoperatively
结局指标
主要结局
Incidence of Postoperative Ileus After Surgery for Splenic Flexure Cancer
时间窗: Within 30 days after surgery
The presence of postoperative ileus will be evaluated as the main indicator of early perioperative recovery. Ileus is defined as intolerance to oral intake and absence of bowel function beyond the expected postoperative period, requiring nasogastric decompression or delayed diet advancement. Data will be collected from medical records and postoperative progress notes. Additional related variables-such as the duration of ileus, need for nasogastric tube reinsertion, and time to first flatus-will also be recorded.
次要结局
未报告次要终点