ECO-LEAK Technique: Early Detection of Colorectal Anastomotic Leakage by Transvaginal Ultrasound

Summary

The main hypothesis is that anastomotic leakage can be predicted peri- and postoperatively.To this end, the aim is to establish the accuracy of transvaginal ultrasound with transrectal enema (Ecoenema-TV) for the diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis.

diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis.

Conditions

• Gynecologic Cancer
• Anastomotic Leak
• Cytoreductive Surgery

Interventions

DIAGNOSTIC_TEST

ECO-LEAK transvaginal ultrasound

After performing the colorectal anastomosis, the patient is monitored postoperatively both clinically and analytically, with serial laboratory tests including PCR and procalcitonin. In the absence of symptoms on the 4th to 5th day an ultrasound - ecoenema is performed. First, the Foley catheter is inserted via the transanal route with instillation of 180cc of serum under ultrasound guidance with a probe in the vagina, using a sagittal and midline cut. In case there is the appearance of free pelvic fluid (previously absent) or an increase in free fluid compared to the baseline examination (fluid present at the beginning of the examination) around the anastomosis/pelvic area, the test will be considered positive.

DIAGNOSTIC_TEST

ECO-LEAK with CT-Scan or rectoscopy

After performing the colorectal anastomosis, the patient is monitored postoperatively both clinically and analytically, with serial laboratory tests including PCR and procalcitonin. In the absence of symptoms on the 4th to 5th day, a CT scan or rectoscopy is performed, along with an ecoenema.

DIAGNOSTIC_TEST

CT-Scan or rectoscopy

After performing the colorectal anastomosis, the patient is monitored postoperatively both clinically and analytically, with serial laboratory tests including PCR and procalcitonin. In the absence of symptoms on the 4th to 5th day, a CT scan or rectoscopy is performed

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra

  collaborator OTHER

• Instituto de Investigación Hospital Universitario La Paz

  collaborator OTHER

• Hospital Universitario Virgen de la Arrixaca

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• Kliniken Essen-Mitte

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• Instituto Nacional de Cancerologia, Columbia

  collaborator OTHER_GOV

• Hospital Britanico

  collaborator OTHER

• University of the Republic, Uruguay

  collaborator OTHER

• Hospital Erasto Gaertner

  collaborator OTHER

• Instituto de Investigacion Sanitaria La Fe

  lead OTHER

Eligibility

Min Age

21 Years

Max Age

99 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-17

Primary Completion

2024-11-30

Completion

2025-04-01

Countries

• Spain

Study Locations