Preserving the superior left colic artery to improve blood flow to the descending colon before reconnecting the bowel after left-sided, rectal, or ovarian cancer surgery
Clinical Study Evaluating the Contribution of Preserving the Superior Left Colic Artery to the Vascularization of the Descending Colon Prior to Colorectal Anastomosis During Left-Sided or Rectal Resections for Colorectal or Ovarian Cancer. (Revascularisation Colique)
This trial will test in adults having left colon, rectal, or ovarian cancer surgery whether preserving the superior left colic artery and temporarily managing the inferior mesenteric artery improves blood flow to the descending colon and reduces healing problems after the bowel is reconnected.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut du Cancer de Montpellier - Val d'Aurelle Academic / other |
| Locations | 1 site (Montpellier, Herault) |
| Trial ID | NCT07098182 on ClinicalTrials.gov |
What this trial studies
Surgeons will temporarily clamp and then restore arterial flow of the inferior mesenteric artery while preserving the superior left colic artery to evaluate perfusion of the descending colon prior to performing colorectal anastomosis. Perfusion will be assessed intraoperatively, likely using indocyanine green fluorescence angiography where appropriate, to guide the surgical decision about the length and viability of the bowel to be reconnected. The procedure is applied to adults undergoing left colectomy, rectal resection, or ovarian cytoreductive surgery that requires colorectal resection. Outcomes of interest include measures of colonic vascularization and postoperative anastomotic complications.
Who should consider this trial
Good fit: Adults over 18 with histologically proven left colon or rectal adenocarcinoma or ovarian carcinoma who are scheduled for left-sided colorectal resection and can give informed consent, have WHO performance status <3, and are affiliated to French social security are eligible.
Not a fit: Patients without a visible left colic artery on preoperative vascular mapping, those with contraindications to indocyanine green, prior abdominal vascular surgery, severe renal failure (GFR <30), or who do not actually require colorectal resection are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, this approach could lower anastomotic leak rates and improve healing by ensuring better blood supply to the reconnected bowel segment.
How similar studies have performed: Previous surgical series and perfusion-imaging studies suggest that preserving arterial branches and using intraoperative fluorescence angiography can reduce anastomotic problems, but randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male/ female aged over 18 years, * Histologically proven left colon or rectal adenocarcinoma OR ovarian carcinoma (with potential colorectal resection), * Scheduled surgery for left colic or rectal carcinoma// Scheduled surgery for ovarian carcinoma with potential colorectal resection, * Surgical indication of colo-rectal resection validated in RCP and confirmed during the operative exploration (ovarian cancer, * WHO Status \< 3 * Patient who has given informed, written and express consent, * Patient (s) affiliated to a French social security. Exclusion Criteria: * Contraindication to indocyanine green: thyroid adenoma, hyperthyroidism, hypersensitivity or allergy to one of the components, severe renal failure (GFR \<30 ml/min/1.73m2), * Patient with a history of abdominal vascular surgery * Patient (e) not having left colic artery on vascular mapping of preoperative abdominal-pelvic scanners, * Patient whose regular follow-up is not possible for psychological, family, social or geographical reasons, * Patient (s) under guardianship, curatorship or safeguard of justice, * Pregnant and/or breastfeeding patient,
Where this trial is running
Montpellier, Herault
- Icm Val D'Aurelle — Montpellier, Herault, France (Recruiting)
Study contacts
- Study coordinator: Aurore MOUSSION
- Email: aurore.moussion@icm.unicancer.fr
- Phone: 467613102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.