NCT07289568

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
54mo left

Started Oct 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress12%
Oct 2025Oct 2030

Study Start

First participant enrolled

October 5, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2025

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2030

Last Updated

December 17, 2025

Status Verified

October 1, 2025

Enrollment Period

3 years

First QC Date

November 18, 2025

Last Update Submit

December 15, 2025

Conditions

Keywords

Splenic Flexure CancerColorectal CancerColon AdenocarcinomaOverall SurvivalAnastomotic LeakIleusPostoperative ComplicationsSurgical OutcomesRight HemicolectomyLeft HemicolectomySegmental ColectomyExtended Hemicolectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    Within 30 days after surgery

Interventions

ColectomyPROCEDURE

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.

Also known as: Extended Hemicolectomy, Segmental Colectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acibadem University

Istanbul, Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsAnastomotic LeakIleusPostoperative Complications

Interventions

Colectomy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsIntestinal Obstruction

Intervention Hierarchy (Ancestors)

Surgical Procedures, ColorectalDigestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Bilgi Baca, MD, Professor of Surgery

    Acibadem University Istanbul Turkey

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2025

First Posted

December 17, 2025

Study Start

October 5, 2025

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2030

Last Updated

December 17, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
De-identified individual participant data (IPD) and supporting materials will be available beginning 12 months after publication of the primary manuscript and will remain available indefinitely for qualified researchers upon reasonable request.
Access Criteria
Qualified researchers affiliated with academic institutions, professional societies, or healthcare organizations may request access to the de-identified dataset, study protocol, statistical analysis plan, and informed consent form. Requests should be submitted in writing to the SPARROW Study Steering Committee via the Turkish Society of Colon and Rectal Surgery (TKRCD). Access will be granted after approval of the research proposal and signing of a data-use agreement ensuring ethical conduct, confidentiality, and non-commercial use. Data will be shared electronically through a secure, password-protected institutional platform.

Locations