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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Diagnostic and Preventive Strategies for Colorectal Anastomotic Leakage in Patients With Gynecologic Tumors

Conditions
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Gynecologic Cancer, Anastomotic Leak, Cytoreductive Surgery

Intervention / Treatment
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* Diagnostic Test: ECO-LEAK transvaginal ultrasound
* Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy
* Diagnostic Test: CT-Scan or rectoscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECO-LEAK transvaginal ultrasound<br>A transvaginal ultrasound is performed with a transrectal enema performed routinely during 4th-6th post-operative day | Diagnostic Test: ECO-LEAK transvaginal ultrasound<br>* 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.<br>Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy<br>* 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.<br>Diagnostic Test: CT-Scan or rectoscopy<br>* 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<br>|
| ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)<br>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 | Diagnostic Test: ECO-LEAK transvaginal ultrasound<br>* 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.<br>Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy<br>* 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.<br>Diagnostic Test: CT-Scan or rectoscopy<br>* 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<br>|
| CT-SCAN and/or rectoscopy<br>Women with colo-rectal anastomosis with a CT-SCAN or rectoscopy image test performed routinely during 4th-6th post-operative day | Diagnostic Test: ECO-LEAK transvaginal ultrasound<br>* 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.<br>Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy<br>* 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.<br>Diagnostic Test: CT-Scan or rectoscopy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To ascertain the sensitivity, specificity , positive predictive value and negative predictive value of the test to diagnose an anastomotic leak after colorectal resection during post-operative period | ECO-LEAK for anastomotic leakage diagnosis in women after colorectal resection and anastomosis | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transvaginal ultrasound, enema, anastomotic leakage, Computed Tomography Scan (CT-SCAN)