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Risk Factors for Anatomic Leakage in Advanced Ovarian Cancer Surgery

NCT04604964 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 515

Last updated 2020-10-27

No results posted yet for this study

Summary

Cytoreductive surgery is currently the main treatment for advanced epithelial ovarian cancer (AEOC), and the complete disease removal (RT=0) or the achievement of an optimal residual disease (RT \< 1 cm) remain the factors with the greatest prognostic impact, both in primary debulking surgery (PDS) and interval debulking surgery (IDS).

To achieve the no residual disease (RT=0), several surgical manoeuvres are often needed both at the upper and lower abdomen, including intestinal resections.

Recto-sigmoid resection is certainly the most frequent of intestinal resections, and it is also the one with the highest risk of complication.

Albeit rare, anastomosis leakage (AL) is a life-threating condition and therefore it is the most feared of intestinal complications.

The aim of this large single-center retrospective study was to assess the AL rate in patients subjected to colorectal resection and anastomosis during primary surgery (PDS or IDS) for advanced ovarian cancer, in a third referral centre for gynecologic oncology with ESGO certification.

In addition, we evaluated several possible pre/intra and post-operative risk factors for AL in order to identify, at an early stage, the population at greatest risk, and attempt to reduce the morbidity and mortality of this severe post-operative complication

Conditions

  • Intestinal Anastomotic Leak

Interventions

OTHER

Evaluation of anastomotic leakage occurrence

Anastomotic leakage was defined as the communication between the intra and extraluminal compartments due to a defect in the integrity of the intestinal wall originating from the staple line of the neo-rectal reservoir between the colon and rectum

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Barbara Costantini, MD · Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2019-10-31
Completion
2020-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04604964 on ClinicalTrials.gov