Colon CancerSPARROWNCT07289568
Surgical Outcomes in Splenic Flexure Cancers: A Multicenter Comparison of Segmental vs. Extended Hemicolectomy (SPARROW Study)
An observational study of Colon Cancer and Splenic Flexure Mobilization, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Cancer, Splenic Flexure Mobilization, Right Hemicolectomy
- What is being tested?
- Colectomy
- Type of treatment
- Surgery or procedure
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Oct 2025to Oct 2030
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study will include adult patients diagnosed with splenic flexure adenocarcinoma who undergo elective curative resection (segmental or extended hemicolectomy) at participating tertiary colorectal surgery centers in Turkey and Europe. All patients will be treated according to the surgeon's standard practice and institutional protocols. Data will be collected prospectively for both perioperative and follow-up outcomes as part of the multicenter SPARROW Study.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Colon Cancer, Splenic Flexure Mobilization, Right Hemicolectomy, Left Hemicolectomy, Segmental Colectomy, Extended Hemicolectomy
- Being tested
- Colectomy
- Keywords
- Splenic Flexure Cancer, Colorectal Cancer, Colon Adenocarcinoma, Overall Survival, Anastomotic Leak, Ileus, Postoperative Complications, Surgical Outcomes, Right Hemicolectomy, Left Hemicolectomy, Segmental Colectomy, Extended Hemicolectomy
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms, Anastomotic Leak, Ileus, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColectomyProcedure or surgery
Also called Extended Hemicolectomy, Segmental Colectomy
Extended hemicolectomy involves removal of a larger segment of colon that includes the splenic flexure tumor and its associated lymphatic drainage. The procedure typically includes ligation of the relevant feeding arteries-such as the right, middle, and left colic branches-and resection of adjacent colon segments to achieve an oncologically adequate specimen with tension-free anastomosis. The extent of resection and vascular ligation is determined according to surgeon preference and tumor location. This approach may be performed using open, laparoscopic, or robotic techniques, depending on institutional practice.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Ileus After Surgery for Splenic Flexure Cancer
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.
Measured: Within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start5 Oct 2025
- Primary completionOct 2028 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bilgi Baca, MD, Professor of Surgery, Principal investigator, Acibadem University Istanbul Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289568
- Sponsor's protocol ID
- 2025.249.IRB2.115
- Acronym
- SPARROW
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the published results will be shared, including baseline demographic information, surgical approach (segmental vs. extended hemicolectomy), operative characteristics, short-term perioperative outcomes, and follow-up survival data. No directly identifiable information (such as names, contact details, or institutional identifiers) will be included. Data will be available in a secure, de-identified format for qualified researchers upon reasonable request to the SPARROW Study Steering Committee through the Turkish Society of Colon and Rectal Surgery (TKRCD), following approval of a data-use agreement and ethical review.
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.
PubMed 40214091Gebauer 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.
PubMed 32140385Wang 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.
PubMed 34282508Hohenberger 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.
PubMed 19016817
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Outcomes in Splenic Flexure Cancers: A Prospective, Multicentric Observational Cohort Study Comparing Segmental Hemicolectomy and Extended Hemicolectomy - The SPARROW Study
- ClinicalTrials.gov ID
- NCT07289568
- Acronym / sponsor ID
- SPARROW / 2025.249.IRB2.115
- Conditions
- Colon Cancer, Splenic Flexure Mobilization, Right Hemicolectomy, Left Hemicolectomy, Segmental Colectomy, Extended Hemicolectomy
- Keywords
- Splenic Flexure Cancer, Colorectal Cancer, Colon Adenocarcinoma, Overall Survival, Anastomotic Leak, Ileus, Postoperative Complications, Surgical Outcomes
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 5 Oct 2025 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include adult patients diagnosed with splenic flexure adenocarcinoma who undergo elective curative resection (segmental or extended hemicolectomy) at participating tertiary colorectal surgery centers in Turkey and Europe. All patients will be treated according to the surgeon's standard practice and institutional protocols. Data will be collected prospectively for both perioperative and follow-up outcomes as part of the multicenter SPARROW Study.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColectomyAlso: Extended Hemicolectomy, Segmental ColectomyExtended hemicolectomy involves removal of a larger segment of colon that includes the splenic flexure tumor and its associated lymphatic drainage. The procedure typically includes ligation of the relevant feeding arteries-such as the right, middle, and left colic branches-and resection of adjacent colon segments to achieve an oncologically adequate specimen with tension-free anastomosis. The extent of resection and vascular ligation is determined according to surgeon preference and tumor location. This approach may be performed using open, laparoscopic, or robotic techniques, depending on institutional practice. | Procedure or surgery | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Results publication: PubMed 40214091Kuzu 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.
- Results publication: PubMed 32140385Gebauer 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.
- Results publication: PubMed 34282508Wang 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.
- Results publication: PubMed 19016817Hohenberger 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the published results will be shared, including baseline demographic information, surgical approach (segmental vs. extended hemicolectomy), operative characteristics, short-term perioperative outcomes, and follow-up survival data. No directly identifiable information (such as names, contact details, or institutional identifiers) will be included. Data will be available in a secure, de-identified format for qualified researchers upon reasonable request to the SPARROW Study Steering Committee through the Turkish Society of Colon and Rectal Surgery (TKRCD), following approval of a data-use agreement and ethical review.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bilgi Baca, MD, Professor of Surgery principal investigator
Acibadem University Istanbul Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Splenic Flexure Mobilization, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Ileus After Surgery for Splenic Flexure Cancer (time frame: Within 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07289568, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.