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

Gynecologic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942209
• Other study ID #: 2022-837-1
• Secondary ID: Victor Lago Leal
• Status: Recruiting
• Start date: April 17, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: January 2023
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: Manel Montesinos Albert, Resident
• Phone: +34 677 751 148
• Email: manelmontesinosalbert[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

diagnosis of anastomotic leakage in patients undergoing colorectal anastomosis.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 766
• Est. completion date: April 1, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Cytoreductive Surgery
• Gynecologic Cancer

Intervention

Diagnostic Test:
• ECO-LEAK transvaginal ultrasound
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 rectoscopy
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 rectoscopy
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

Locations

Country	Name	City	State
Spain	Hospital Universitari i Politecnic La Fe	Valencia

Sponsors (12)

Lead Sponsor

Collaborator

Instituto de Investigacion Sanitaria La Fe

Charite University, Berlin, Germany, Clinica Universidad de Navarra, Universidad de Navarra, Hospital Britanico, Hospital Erasto Gaertner, Hospital Universitario 12 de Octubre, Hospital Universitario Virgen de la Arrixaca, Imperial College London, Instituto de Investigación Hospital Universitario La Paz, Instituto Nacional de Cancerologia, Columbia, Kliniken Essen-Mitte, University of the Republic, Uruguay

Country where clinical trial is conducted

Spain, 

References & Publications (5)

Bartl 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. — View Citation

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. — View Citation

Lago 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. — View Citation

Lago 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. — View Citation

Valenti 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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