Gynecologic CancerNCT05942209
ECO-LEAK Technique: Early Detection of Colorectal Anastomotic Leakage by Transvaginal Ultrasound
An observational study of Gynecologic Cancer and Anastomotic Leak, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Gynecologic Cancer, Anastomotic Leak, Cytoreductive Surgery
- What is being tested?
- ECO-LEAK transvaginal ultrasound, ECO-LEAK with CT-Scan or rectoscopy and CT-Scan or rectoscopy
- How many people
- 766 participants
- Where
- 1 siteSpain
- Study dates
- 17 Apr 2023to 1 Apr 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with gynecological cancer with colorectal resection and anastomosis
Who may be able to join
- Woman sex
- Age between 21-99 years old
- Colorectal resection and anastomosis
- Anastomosis upper from 5 cm from anal verge
- Signed informed consent
Who cannot join
- No colorectal anastomosis after resection
- Ultralow colorectal anastomosis (< 5 cm)
- Insufficient vaginal cuff for TV-US examination
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Manel Montesinos Albert, Resident, +34 677 751 148, manelmontesinosalbert@gmail.com
Victor Lago Leal, Doctor
About this study
Official title: Diagnostic and Preventive Strategies for Colorectal Anastomotic Leakage in Patients With Gynecologic Tumors
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.
Read the 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
- Conditions
- Gynecologic Cancer, Anastomotic Leak, Cytoreductive Surgery
- Being tested
- ECO-LEAK transvaginal ultrasound, ECO-LEAK with CT-Scan or rectoscopy, CT-Scan or rectoscopy
- Keywords
- transvaginal ultrasound, enema, anastomotic leakage, Computed Tomography Scan (CT-SCAN)
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECO-LEAK transvaginal ultrasoundDiagnostic test
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.
ECO-LEAK with CT-Scan or rectoscopyDiagnostic test
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.
CT-Scan or rectoscopyDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| ECO-LEAK transvaginal ultrasound | A transvaginal ultrasound is performed with a transrectal enema performed routinely during 4th-6th post-operative day Receives: 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) | 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 Receives: 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 | Women with colo-rectal anastomosis with a CT-SCAN or rectoscopy image test performed routinely during 4th-6th post-operative day Receives: Diagnostic Test: ECO-LEAK transvaginal ultrasound; Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy; Diagnostic Test: CT-Scan or rectoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start17 Apr 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 766 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra, Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario Virgen de la Arrixaca, Hospital Universitario 12 de Octubre, Imperial College London, Kliniken Essen-Mitte, Charite University, Berlin, Germany, Instituto Nacional de Cancerologia, Columbia, Hospital Britanico, University of the Republic, Uruguay, Hospital Erasto Gaertner
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942209
- Sponsor's protocol ID
- 2022-837-1
- Other IDs
- Victor Lago Leal
- Status last verified
- Jan 2023
- First submitted
- 14 Jun 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Bristow RE, del Carmen MG, Kaufman HS, Montz FJ. Radical oophorectomy with primary stapled colorectal anastomosis for resection of locally advanced epithelial ovarian cancer. J Am Coll Surg. 2003 Oct;197(4):565-74. doi: 10.1016/S1072-7515(03)00478-2.
PubMed 14522325Bartl T, Schwameis R, Stift A, Bachleitner-Hofmann T, Reinthaller A, Grimm C, Polterauer S. Predictive and Prognostic Implication of Bowel Resections During Primary Cytoreductive Surgery in Advanced Epithelial Ovarian Cancer. Int J Gynecol Cancer. 2018 Nov;28(9):1664-1671. doi: 10.1097/IGC.0000000000001369.
PubMed 30371563Valenti G, Vitagliano A, Morotti M, Giorda G, Sopracordevole F, Sapia F, Lo Presti V, Chiofalo B, Forte S, Lo Presti L, Tozzi R. Risks factors for anastomotic leakage in advanced ovarian cancer: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2022 Feb;269:3-15. doi: 10.1016/j.ejogrb.2021.12.007. Epub 2021 Dec 13.
PubMed 34942555Lago V, Fotopoulou C, Chiantera V, Minig L, Gil-Moreno A, Cascales-Campos PA, Jurado M, Tejerizo A, Padilla-Iserte P, Malune ME, Di Donna MC, Marina T, Sanchez-Iglesias JL, Olloqui A, Garcia-Granero A, Matute L, Fornes V, Domingo S. Risk factors for anastomotic leakage after colorectal resection in ovarian cancer surgery: A multi-centre study. Gynecol Oncol. 2019 Jun;153(3):549-554. doi: 10.1016/j.ygyno.2019.03.241. Epub 2019 Apr 3.
PubMed 30952369Lago V, Segarra-Vidal B, Cappucio S, Angeles MA, Fotopoulou C, Muallem MZ, Manzanedo I, Iglesias JLS, Chacon E, Padilla-Iserte P, Fagotti A, Ferron G, Kluge L, Vargiu V, Del M, Scambia G, Minig L, Tejerizo A, Segovia MG, Cascales-Campos PA; OVA-LEAK Collaborative Group; Hervas D, Domingo S. OVA-LEAK: Prognostic score for colo-rectal anastomotic leakage in patients undergoing ovarian cancer surgery. Gynecol Oncol. 2022 Oct;167(1):22-27. doi: 10.1016/j.ygyno.2022.08.004. Epub 2022 Sep 2.
PubMed 36058743
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Preventive Strategies for Colorectal Anastomotic Leakage in Patients With Gynecologic Tumors
- ClinicalTrials.gov ID
- NCT05942209
- Acronym / sponsor ID
- 2022-837-1
- Conditions
- Gynecologic Cancer, Anastomotic Leak, Cytoreductive Surgery
- Keywords
- transvaginal ultrasound, enema, anastomotic leakage, Computed Tomography Scan (CT-SCAN)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 766 participants (estimated)
- Lead sponsor
- Instituto de Investigacion Sanitaria La FeUniversity, hospital or other
- Collaborators
- Clinica Universidad de Navarra, Universidad de Navarra, Instituto de Investigación Hospital Universitario La Paz, Hospital Universitario Virgen de la Arrixaca, Hospital Universitario 12 de Octubre, Imperial College London, Kliniken Essen-Mitte, Charite University, Berlin, Germany, Instituto Nacional de Cancerologia, Columbia, Hospital Britanico, University of the Republic, Uruguay, Hospital Erasto Gaertner
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ECO-LEAK transvaginal ultrasound | – | Diagnostic Test: ECO-LEAK transvaginal ultrasound, Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy, Diagnostic Test: CT-Scan or rectoscopyA transvaginal ultrasound is performed with a transrectal enema performed routinely during 4th-6th post-operative day |
| ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy) | – | Diagnostic Test: ECO-LEAK transvaginal ultrasound, Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy, Diagnostic Test: CT-Scan or rectoscopyWomen 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 |
| CT-SCAN and/or rectoscopy | – | Diagnostic Test: ECO-LEAK transvaginal ultrasound, Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy, Diagnostic Test: CT-Scan or rectoscopyWomen with colo-rectal anastomosis with a CT-SCAN or rectoscopy image test performed routinely during 4th-6th post-operative day |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with gynecological cancer with colorectal resection and anastomosis
Key inclusion criteria (5 listed)
- Woman sex
- Age between 21-99 years old
- Colorectal resection and anastomosis
- Anastomosis upper from 5 cm from anal verge
- Signed informed consent
Key exclusion criteria (3 listed)
- No colorectal anastomosis after resection
- Ultralow colorectal anastomosis (< 5 cm)
- Insufficient vaginal cuff for TV-US examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECO-LEAK transvaginal ultrasoundAfter 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 | CT-SCAN and/or rectoscopy, ECO-LEAK transvaginal ultrasound, ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy) |
| ECO-LEAK with CT-Scan or rectoscopyAfter 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 and/or rectoscopy, ECO-LEAK transvaginal ultrasound, ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy) |
| CT-Scan or rectoscopyAfter 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 | Diagnostic test | CT-SCAN and/or rectoscopy, ECO-LEAK transvaginal ultrasound, ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy) |
Primary outcome
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
Time frame: 24 months
ECO-LEAK for anastomotic leakage diagnosis in women after colorectal resection and anastomosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Background: PubMed 14522325Bristow RE, del Carmen MG, Kaufman HS, Montz FJ. Radical oophorectomy with primary stapled colorectal anastomosis for resection of locally advanced epithelial ovarian cancer. J Am Coll Surg. 2003 Oct;197(4):565-74. doi: 10.1016/S1072-7515(03)00478-2.
- Background: PubMed 30371563Bartl T, Schwameis R, Stift A, Bachleitner-Hofmann T, Reinthaller A, Grimm C, Polterauer S. Predictive and Prognostic Implication of Bowel Resections During Primary Cytoreductive Surgery in Advanced Epithelial Ovarian Cancer. Int J Gynecol Cancer. 2018 Nov;28(9):1664-1671. doi: 10.1097/IGC.0000000000001369.
- Background: PubMed 34942555Valenti G, Vitagliano A, Morotti M, Giorda G, Sopracordevole F, Sapia F, Lo Presti V, Chiofalo B, Forte S, Lo Presti L, Tozzi R. Risks factors for anastomotic leakage in advanced ovarian cancer: A systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2022 Feb;269:3-15. doi: 10.1016/j.ejogrb.2021.12.007. Epub 2021 Dec 13.
- Background: PubMed 30952369Lago V, Fotopoulou C, Chiantera V, Minig L, Gil-Moreno A, Cascales-Campos PA, Jurado M, Tejerizo A, Padilla-Iserte P, Malune ME, Di Donna MC, Marina T, Sanchez-Iglesias JL, Olloqui A, Garcia-Granero A, Matute L, Fornes V, Domingo S. Risk factors for anastomotic leakage after colorectal resection in ovarian cancer surgery: A multi-centre study. Gynecol Oncol. 2019 Jun;153(3):549-554. doi: 10.1016/j.ygyno.2019.03.241. Epub 2019 Apr 3.
- Background: PubMed 36058743Lago V, Segarra-Vidal B, Cappucio S, Angeles MA, Fotopoulou C, Muallem MZ, Manzanedo I, Iglesias JLS, Chacon E, Padilla-Iserte P, Fagotti A, Ferron G, Kluge L, Vargiu V, Del M, Scambia G, Minig L, Tejerizo A, Segovia MG, Cascales-Campos PA; OVA-LEAK Collaborative Group; Hervas D, Domingo S. OVA-LEAK: Prognostic score for colo-rectal anastomotic leakage in patients undergoing ovarian cancer surgery. Gynecol Oncol. 2022 Oct;167(1):22-27. doi: 10.1016/j.ygyno.2022.08.004. Epub 2022 Sep 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Cancer and Anastomotic Leak, run by Instituto de Investigacion Sanitaria La Fe at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manel Montesinos Albert, Resident (+34 677 751 148, manelmontesinosalbert@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05942209, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.