Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-25 @ 3:05 PM
Study NCT ID:
NCT07289568
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-12-17
First Post:
2025-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Surgical Outcomes in Splenic Flexure Cancers: A Multicenter Comparison of Segmental vs. Extended Hemicolectomy (SPARROW Study)
Sponsor:
Acibadem University
Organization:
Study Overview
Official Title:
Surgical Outcomes in Splenic Flexure Cancers: A Prospective, Multicentric Observational Cohort Study Comparing Segmental Hemicolectomy and Extended Hemicolectomy - The SPARROW Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPARROW
Brief Summary:
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.
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.
Detailed Description:
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:
Postoperative ileus (incidence and duration)
Anastomotic leakage
Wound infection
Total postoperative complications
Secondary Outcomes:
Lymph node yield and R0 resection rate
Postoperative mortality
Operation time and estimated blood loss
Hospital stay, return to regular diet, and time to first flatus
Reoperation rates
3-year overall survival (OS) and disease-free survival (DFS)
Timeline:
Study start: 2025
Enrollment period: 24 months
Follow-up: 36 months per patient
Total duration: approximately 5 years
Ethical Conduct:
Ethical approval was obtained from the Koç University Ethics Committee. Each participating center will obtain local ethics approval. The study adheres to the principles of the Declaration of Helsinki and Good Clinical Practice (GCP).
Expected Impact:
This will be the first prospective multicenter observational study to compare segmental and extended hemicolectomy for splenic flexure cancers. The results will help standardize surgical decision-making and improve patient outcomes for this uncommon and technically challenging tumor location.
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:
Postoperative ileus (incidence and duration)
Anastomotic leakage
Wound infection
Total postoperative complications
Secondary Outcomes:
Lymph node yield and R0 resection rate
Postoperative mortality
Operation time and estimated blood loss
Hospital stay, return to regular diet, and time to first flatus
Reoperation rates
3-year overall survival (OS) and disease-free survival (DFS)
Timeline:
Study start: 2025
Enrollment period: 24 months
Follow-up: 36 months per patient
Total duration: approximately 5 years
Ethical Conduct:
Ethical approval was obtained from the Koç University Ethics Committee. Each participating center will obtain local ethics approval. The study adheres to the principles of the Declaration of Helsinki and Good Clinical Practice (GCP).
Expected Impact:
This will be the first prospective multicenter observational study to compare segmental and extended hemicolectomy for splenic flexure cancers. The results will help standardize surgical decision-making and improve patient outcomes for this uncommon and technically challenging tumor location.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: