- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07289568
Surgical Outcomes in Splenic Flexure Cancers: A Multicenter Comparison of Segmental vs. Extended Hemicolectomy (SPARROW Study) (SPARROW)
Surgical Outcomes in Splenic Flexure Cancers: A Prospective, Multicentric Observational Cohort Study Comparing Segmental Hemicolectomy and Extended Hemicolectomy - The SPARROW Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34752
- Acibadem University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of Postoperative Ileus After Surgery for Splenic Flexure Cancer
Time Frame: 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.
|
Within 30 days after surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Bilgi Baca, MD, Professor of Surgery, Acibadem University Istanbul Turkey
Publications and helpful links
General Publications
- Kuzu MA, Benlice C, Parvaiz A, Gorgun E, Bertelsen CA, Wexner S, Dozois EJ, Hohenberger W, Miskovic D, Sugihara K, Spinelli A, Wiggers T, Lee WY, Moslein G, Tsarkov P, Basany EE, Patron Uriburu JC, Perez RO, Lynch C, Liu Z, Hahnloser D, Nilsson PJ, Chowdri NA, Brown G, Rouanet P, Madoff RD, West NP, Sahin T, Elhan AH, Bordeianou LG; Colon Cancer Delphi Consensus Study Group. Standardizing the Definition of Each Colon Cancer Segment: Delphi Consensus on Clinical Decision-Making for Oncologic Outcomes. Dis Colon Rectum. 2025 Jul 1;68(7):835-844. doi: 10.1097/DCR.0000000000003739. Epub 2025 Apr 11.
- Gebauer S, Schootman M, Xian H, Xaverius P. Neighborhood built and social environment and meeting physical activity recommendations among mid to older adults with joint pain. Prev Med Rep. 2020 Feb 11;18:101063. doi: 10.1016/j.pmedr.2020.101063. eCollection 2020 Jun.
- Wang C, Wang C, Qiu J, Gao J, Liu H, Zhang Y, Han L. Ultrasensitive, high-throughput, and rapid simultaneous detection of SARS-CoV-2 antigens and IgG/IgM antibodies within 10 min through an immunoassay biochip. Mikrochim Acta. 2021 Jul 20;188(8):262. doi: 10.1007/s00604-021-04896-w.
- Hohenberger W, Weber K, Matzel K, Papadopoulos T, Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation--technical notes and outcome. Colorectal Dis. 2009 May;11(4):354-64; discussion 364-5. doi: 10.1111/j.1463-1318.2008.01735.x. Epub 2009 Nov 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Intestinal Obstruction
- Pathological Conditions, Signs and Symptoms
- Colorectal Neoplasms
- Colonic Neoplasms
- Ileus
- Anastomotic Leak
- Postoperative Complications
- Surgical Procedures, Operative
- Digestive System Surgical Procedures
- Surgical Procedures, Colorectal
- Colectomy
Other Study ID Numbers
- 2025.249.IRB2.115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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