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Feasibility Study on the Application of Colonoscopy for Locating the Proximal Colonic Resection Margin in Sphincter-Preserving Surgery for Rectal Cancer After Neoadjuvant Chemoradiotherapy

Feasibility Study on the Application of Colonoscopy for Locating the Proximal Colonic Resection Margin in Sphincter-Preserving Surgery for Rectal Cancer After Neoadjuvant Chemoradiotherapy - CoLoMarS Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115042
Enrollment
Unknown
Registered
2025-12-22
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer

Interventions

Colonoscopy localization group:In this study, we applied intraoperative colonoscopy to accurately localize the proximal non-irradiated colon beyond the tumor, thereby reducing the extent of resection.

Sponsors

Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Age between 18 and 80 years old (inclusive of 18 and 80); 2)Pathologically confirmed diagnosis of rectal adenocarcinoma; 3)Completion of neoadjuvant chemoradiotherapy; 4)Candidate for sphincter-preserving surgery; 5)No severe stenosis at the tumor site; the lumen allows passage of colonoscopy/gastroscopy to visualize the mucosal surface and vascular network of the proximal bowel beyond the lesion; 6)Preoperative cardiac, pulmonary, hepatic, and renal functions sufficient to tolerate surgery; 7)Preoperative ASA physical status classification of I–III; 8)The patient and family members are able to understand the study protocol, are willing to participate in this study, and have signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1)Age 80 years; 2)History of inflammatory bowel disease resulting in inability to identify normal mucosa endoscopically; 3)History of other malignant tumors; 4)Patients with colorectal polyposis syndrome in whom polyps cannot be completely removed endoscopically; 5)Inadequate bowel preparation precluding endoscopic recognition of mucosa; 6)Previous placement of intestinal stents; 7)Presence of contraindications to endoscopy; 8)Inability to tolerate surgery; 9)Insufficient length of mobilized splenic flexure colon to allow safe anastomosis; 10)Other serious comorbidities that may affect postoperative recovery; 11)Simultaneous or metachronous (within 5 years) malignancy; 12)Patients with intestinal obstruction, perforation, bleeding, or other conditions requiring emergency surgical resection; 13)History of previous pelvic or urinary system surgery; 14)ASA physical status classification IV or V; 15)Severe psychiatric disorders; 16)Severe emphysema, interstitial pneumonia, or ischemic heart disease rendering the patient unable to tolerate surgery; 17)History of unstable angina or myocardial infarction within 6 months; 18)History of cerebral infarction or cerebral hemorrhage within 6 months; 19)Continuous systemic corticosteroid therapy within 1 month; 20)Patient or family members unable to understand the conditions and objectives of the study.

Design outcomes

Primary

MeasureTime frame
Pathological scoring differences between sites with normal mucosal vascular pattern and sites with unclear mucosal vascular pattern under colonoscopy in radiation enteritis.;

Secondary

MeasureTime frame
incidence of anastomotic leakage;overall complication incidence;preoperative and postoperative anal function;

Countries

China

Contacts

Public ContactZhifen Chen

Fujian Medical University Union Hospital

chenzhifen@fjmu.edu.cn+86 159 6019 3761

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026