Surgical Outcomes in Splenic Flexure Cancers: A Multicenter Comparison of Segmental vs. Extended Hemicolectomy (SPARROW Study)

Official title

Surgical Outcomes in Splenic Flexure Cancers: A Prospective, Multicentric Observational Cohort Study Comparing Segmental Hemicolectomy and Extended Hemicolectomy - The SPARROW Study

Overview

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.

Interventions

• Procedure 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 locati

Primary outcome measures

• Incidence of Postoperative Ileus After Surgery for Splenic Flexure Cancer [Time frame: Within 30 days after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Turkey (Türkiye) · 1 center

• Acibadem University — Istanbul

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 Defi PMID 40214091
• 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. PMID 32140385
• 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. PMID 34282508
• 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. PMID 19016817

Identifiers

NCT: NCT07289568 · 2025.249.IRB2.115

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗