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

NCT05942209 | Unknown DMC

• 2 other identifiers: 2022-837-1Victor Lago Leal
• Study Type: observational
• Target: 766
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gynecologic Cancer; Anastomotic Leak; Cytoreductive Surgery

Keywords

transvaginal ultrasound; enema; anastomotic leakage; Computed Tomography Scan (CT-SCAN)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

ECO-LEAK transvaginal ultrasound

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

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

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

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

Interventions

ECO-LEAK transvaginal ultrasound DIAGNOSTIC_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.

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 rectoscopy DIAGNOSTIC_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 and/or rectoscopy; ECO-LEAK transvaginal ultrasound; ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)

CT-Scan or rectoscopy DIAGNOSTIC_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

CT-SCAN and/or rectoscopy; ECO-LEAK transvaginal ultrasound; ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with gynecological cancer with colorectal resection and anastomosis

You may qualify if:

• Woman sex
• Age between 21-99 years old
• Colorectal resection and anastomosis
• Anastomosis upper from 5 cm from anal verge
• Signed informed consent

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 14522325 BACKGROUND

• 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.

  PMID: 30371563 BACKGROUND

• 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.

  PMID: 34942555 BACKGROUND

• 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.

  PMID: 30952369 BACKGROUND

• 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.

  PMID: 36058743 BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak

Interventions

Tomography, X-Ray Computed; Proctoscopy

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Manel Montesinos Albert, Resident

CONTACT

+34 677 751 148; manelmontesinosalbert@gmail.com

Victor Lago Leal, Doctor

CONTACT

+34 699 686 698; victor.lago.leal@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2023
• First Posted: July 12, 2023
• Study Start: April 17, 2023
• Primary Completion: November 30, 2024
• Study Completion: April 1, 2025
• Last Updated: July 21, 2023

Record last verified: 2023-01

Locations

ES (1)