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)

NCT07098182RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrollment

50

Start Date

2025-11-27

Completion Date

2026-10-01

Study Type

INTERVENTIONAL

Official Title

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)

Interventions

Clamping and restauration of arterial blood of the inferior mesenteric artery

Conditions

Rectal CancerColon CancerOvarian Cancer

Eligibility

Age Range

18 Years+

Sex

ALL

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,

Outcome Measures

Primary Outcomes

Measurement of the variation in vascularization of the descending colon with or without clamping of the inferior mesenteric artery quantified by the method selected during the exploratory phase of the primary endpoint.

Measurement of vascularization at the end of the descending colon with and without clamping the inferior mesenteric artery at its origin (interrupting arterial flow in the left colic artery) according to the quantification method selected in the exploratory evaluation phase. * If Indocyanine green intraveinous injection: measurement of decrease in staining time and increase in intensity * If Blood Pressure by catheter, doppler or saturation: percentage increase all the measures will define the same measure, that is to say, the vascularization of the descending colon

Time frame: During the surgery

Secondary Outcomes

Quantification of blood pressure in the marginal artery of the colon descending after clamping of the IMA at its origin then without clamping of the left colic artery by the other three method

Measurement of blood pressure after catheterization of the marginal artery of the descending colon. Measurement of systemic blood pressure at the same time. The measurement will be performed using an arterial catheter.

Time frame: During the surgery

Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.

On the intraoperative Thoraco Abdomino Pelvis scanner, measure of the diameter in mm of the left colic artery.

Time frame: Before the surgery. At the baseline

Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.

On the intraoperative Thoraco Abdomino Pelvis scanner, measure the distance in mm between the origin of the inferior mesenteric artery.

Time frame: Before the surgery. At the baseline

Study of the anatomy of the lower mesenteric artery and its branches after arterial reconstruction of scanner performed preoperatively.

On the intraoperative Thoraco Abdomino Pelvis scanner, evaluate the presence of dividing branches.

Time frame: Before the surgery. At the baseline

Evaluation of the operative parameters (operating time).

operating time : in minutes: time between opening and closing of the skin

Time frame: During the surgery

Evaluation of the operative parameters (duration of dissection of the inferior mesenteric artery).

inferior mesenteric artery dissection time : in minutes: time between the beginning of the dissection of the I and completion

Time frame: During the surgery

Evaluation of the operative parameters (duration of dissection of the left colic artery).

left colic artery dissection time : in minutes:MA time between the beginning of the artery dissection and completion

Time frame: During the surgery

Evaluation of the operative parameters (intraoperative bleeding).

intraoperative bleeding in mL: estimated total volume of blood, measured by aspiration and impregnated compresses.

Time frame: During the surgery

Evaluate postoperative parameters (within 30 days of surgery): rate of anastomotic leakage, rate of surgical recovery, duration of bowel function recovery.

Data recovery within 30 days of surgery: anastomotic leakage rate (number of patients with anastomotic leakages confirmed by scan within 30 days of surgery), surgical recovery rate (number of patients for whom a re-intervention was necessary following a postoperative complication) and duration of bowel recovery (in days, defined by the 1st gas/stool emission after the intervention, defined by a clinical assessment of the surgeon).

Time frame: 30 days after the surgery

Number of resected lymph-nodes.

Total number of lymph nodes taken from the surgical specimen analysed in anatomopathology

Time frame: 30 days after the surgery

Percentage of conservation of the colic artery.

Success Percentage of conservation of the colic artery among included patient in the study.

Time frame: 30 days after the surgery

Locations

Icm Val D'Aurelle, Montpellier, France

Linked Papers

Prise en charge chirurgicale du cancer épithélial de l’ovaire – première ligne et première rechute

Based on recently published data, these recommendations present some evolutions in the surgical management of high grade epithelial ovarian cancers. In apparently early stages (FIGO I and II), surgical staging must be undertaken to confirm the absence of both peritoneal lesions and lymph node involvement (that might change stage and management). Neoadjuvant chemotherapy is not indicated, surgical exploration should be performed upfront, by laparotomy, to reduce the risk of rupture of the primary tumor. In advanced stages, the first step is to evaluate the feasibility of primary surgery with complete tumor cytoreduction. If it appears unfeasible, 3 or 4 cycles of neoadjuvant chemotherapy are administered before interval surgey. Whether it is implemented in the primary or interval setting, surgery must be performed by experimented teams, in an approved facility, having developed a rehabilitation program. Lymph node dissection is not mandatory if no adenopathies have been identified by imaging and by peroperative palpation. At first relapse, the surgical decision must be made by a multidisciplinary team, using scores predictive of complete cytoreduction (AGO or iMODEL criteria). Similarly as in first line, the objective is to achieve resection without any residual disease. Surveillance after first-line treatment must be adapted, according to the probability of another complete cytoreduction in case of late relapse, especially in patients who benefited from primary complete surgery and maintained good performance status.