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

Instituto de Investigacion Sanitaria La Fe

Status: Enrolling

Conditions: Gynecologic Cancer; Cytoreductive Surgery; Anastomotic Leak

Treatments: Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy; Diagnostic Test: CT-Scan or rectoscopy; Diagnostic Test: ECO-LEAK transvaginal ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05942209

2022-837-1

Victor Lago Leal (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 766 estimated patients

Sex: Female

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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 criteria

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

Trial design

766 participants in 3 patient groups

ECO-LEAK transvaginal ultrasound

Description:

A transvaginal ultrasound is performed with a transrectal enema performed routinely during 4th-6th post-operative day

Treatment:

Diagnostic Test: ECO-LEAK transvaginal ultrasound

Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy

Diagnostic Test: CT-Scan or rectoscopy

ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)

Description:

Women with colo-rectal anastomosis with a CT-SCAN (Computed Tomography Scan) or rectoscopy image test performed routinely during 4th-6th post-operative day and a transvaginal ultrasound

Treatment:

Diagnostic Test: ECO-LEAK transvaginal ultrasound

Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy

Diagnostic Test: CT-Scan or rectoscopy

CT-SCAN and/or rectoscopy

Description:

Women with colo-rectal anastomosis with a CT-SCAN or rectoscopy image test performed routinely during 4th-6th post-operative day

Treatment:

Diagnostic Test: ECO-LEAK transvaginal ultrasound

Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy

Diagnostic Test: CT-Scan or rectoscopy