Trial Title:
ECO-LEAK Technique: Early Detection of Colorectal Anastomotic Leakage by Transvaginal Ultrasound
NCT ID:
NCT05942209
Condition:
Gynecologic Cancer
Anastomotic Leak
Cytoreductive Surgery
Conditions: Official terms:
Anastomotic Leak
Conditions: Keywords:
transvaginal ultrasound
enema
anastomotic leakage
Computed Tomography Scan (CT-SCAN)
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
ECO-LEAK transvaginal ultrasound
Description:
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.
Arm group label:
CT-SCAN and/or rectoscopy
Arm group label:
ECO-LEAK transvaginal ultrasound
Arm group label:
ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)
Intervention type:
Diagnostic Test
Intervention name:
ECO-LEAK with CT-Scan or rectoscopy
Description:
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.
Arm group label:
CT-SCAN and/or rectoscopy
Arm group label:
ECO-LEAK transvaginal ultrasound
Arm group label:
ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)
Intervention type:
Diagnostic Test
Intervention name:
CT-Scan or rectoscopy
Description:
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
Arm group label:
CT-SCAN and/or rectoscopy
Arm group label:
ECO-LEAK transvaginal ultrasound
Arm group label:
ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)
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.
Detailed 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
Criteria for eligibility:
Study pop:
Women with gynecological cancer with colorectal resection and anastomosis
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Female
Minimum age:
21 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Hospital Universitari i Politecnic La Fe
Address:
City:
Valencia
Zip:
46026
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Manel Montesinos Albert, Resident
Phone:
+34 677 751 148
Email:
manelmontesinosalbert@gmail.com
Investigator:
Last name:
Victor Lago Leal, Doctor
Email:
Principal Investigator
Start date:
April 17, 2023
Completion date:
April 1, 2025
Lead sponsor:
Agency:
Instituto de Investigacion Sanitaria La Fe
Agency class:
Other
Collaborator:
Agency:
Clinica Universidad de Navarra, Universidad de Navarra
Agency class:
Other
Collaborator:
Agency:
Instituto de Investigación Hospital Universitario La Paz
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario Virgen de la Arrixaca
Agency class:
Other
Collaborator:
Agency:
Hospital Universitario 12 de Octubre
Agency class:
Other
Collaborator:
Agency:
Imperial College London
Agency class:
Other
Collaborator:
Agency:
Kliniken Essen-Mitte
Agency class:
Other
Collaborator:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Collaborator:
Agency:
Instituto Nacional de Cancerologia, Columbia
Agency class:
Other
Collaborator:
Agency:
Hospital Britanico
Agency class:
Other
Collaborator:
Agency:
University of the Republic, Uruguay
Agency class:
Other
Collaborator:
Agency:
Hospital Erasto Gaertner
Agency class:
Other
Source:
Instituto de Investigacion Sanitaria La Fe
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05942209
