Clinical trial · Observational
ECO-LEAK Technique: Early Detection of Colorectal Anastomotic Leakage by Transvaginal Ultrasound
Diagnostic and Preventive Strategies for Colorectal Anastomotic Leakage in Patients With Gynecologic Tumors
NCT05942209CI-TRIAL-00068176unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anastomotic Leak | — | UNRESOLVED | — |
| Cytoreductive Surgery | — | UNRESOLVED | — |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-Scan or rectoscopy | Diagnostic Test | — | UNRESOLVED |
| ECO-LEAK transvaginal ultrasound | Diagnostic Test | — | UNRESOLVED |
| ECO-LEAK with CT-Scan or rectoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- ECO-LEAK transvaginal ultrasound
- description
- A transvaginal ultrasound is performed with a transrectal enema performed routinely during 4th-6th post-operative day
- interventionNames
- Diagnostic Test: ECO-LEAK transvaginal ultrasound
- Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy
- Diagnostic Test: CT-Scan or rectoscopy
- label
- ECO-LEAK with other diagnostic method (Computed Tomography Scan or rectoscopy)
- description
- 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
- interventionNames
- Diagnostic Test: ECO-LEAK transvaginal ultrasound
- Diagnostic Test: ECO-LEAK with CT-Scan or rectoscopy
- Diagnostic Test: CT-Scan or rectoscopy
- label
- CT-SCAN and/or rectoscopy
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (5)
- BACKGROUNDBristow 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
- BACKGROUNDBartl 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
- BACKGROUNDValenti 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
- BACKGROUNDLago 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
- BACKGROUNDLago 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