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

Last updated: July 19, 2023
Sponsor: Instituto de Investigacion Sanitaria La Fe
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vaginal Cancer

Pelvic Cancer

Treatment

ECO-LEAK with CT-Scan or rectoscopy

ECO-LEAK transvaginal ultrasound

CT-Scan or rectoscopy

Clinical Study ID

NCT05942209
2022-837-1
Victor Lago Leal
  • Ages 21-99
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Woman sex
  • Age between 21-99 years old
  • Colorectal resection and anastomosis
  • Anastomosis upper from 5 cm from anal verge
  • Signed informed consent

Exclusion

Exclusion Criteria:

  • No colorectal anastomosis after resection
  • Ultralow colorectal anastomosis (< 5 cm)
  • Insufficient vaginal cuff for TV-US examination

Study Design

Total Participants: 766
Treatment Group(s): 3
Primary Treatment: ECO-LEAK with CT-Scan or rectoscopy
Phase:
Study Start date:
April 17, 2023
Estimated Completion Date:
April 01, 2025

Study Description

Cytoreductive surgery is the cornerstone of advanced ovarian cancer treatment and often requires the performance of a modified posterior pelvic exenteration (MPE) or colorectal resection (CRR), ideally followed by an end-to-end colorectal anastomosis with the goal of achieving optimal cytoreduction. One of the most challenging complications of this procedure is anastomotic leakage (AL) which is considered a life-threatening situation with a reported incidence between 1.24% and 9% in patients with ovarian cancer making any adjuvant postoperative treatment challenging and therefore having a negative impact on the overall prognosis.

In order to diagnose the presence of anastomotic leakage in female patients after colorectal anastomosis we devised this diagnostic test during the postoperative period.

The ECO-LEAK test is performed in the following sequence, after informing the patient and obtaining her consent. The patient is placed in gynaecological position/ lithotomy. Then basal transvaginal ultrasound is performed with the aim of describing the presence or absence of free fluid or other ultrasound findings (sagittal and transverse scan). Simultaneously transanal foley catheter is introduced and filled the balloon of the probe by direct visualization. Then transvaginal ultrasound with enema is performed with insertion of 180cc of serum under ultrasound vision with probe in vagina and sagittal and mid-sagittal cut. If no new free peri-anastomotic/pelvic fluid appears, the test is considered negative. If there is an appearance of pelvic free fluid (previously absent) or an increase in free fluid with respect to the baseline examination (fluid present at the beginning of the examination) peri anastomosis/pelvic, the test is considered positive.

In conclusions, anastomotic leak can occur despite a normal intraoperative anastomosis check-up. Transvaginal ultrasound associated with a transrectal enema (ECO-LEAK) performed during post operative period might represent an useful tool for anastomotic leak diagnosis. A prospective study is needed in order to determine its accuracy

Connect with a study center

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

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