NCT04604964|Completed
Risk Factors for Anatomic Leakage in Advanced Ovarian Cancer Surgery
Risk Factors for Anastomotic Leakage in Advanced Ovarian Cancer Surgery: A Large Single Centre Experience
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Risk Factors for Anastomotic Leakage in Advanced Ovarian Cancer Surgery: A Large Single Centre Experience
Sponsor study identifier
observational
515
1 country
1
Study Start
December 2011
Actual (reported)Primary Completion
October 2019
Actual (reported)Study Completion
September 2020
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Actual (reported)October 2019
Actual (reported)September 2020
Actual (reported)October 11, 2020
Actual (reported)October 27, 2020
Actual (reported)Anastomotic leakage
To assess the anastomotic leakage rate in patients subjected to recto-sigmoid resection during debulking surgery for ovarian cancer
up to 30 days after surgery
Pre-operative risk factors for anastomotic leakage
just before surgery
Intra-operative risk factors for anastomotic leakage
During surgery
Post-operative risk factors for anastomotic leakage
up to 30 days after surgery
Patients undergoing recto-sigmoid resection and concurrent anastomosis during debulking surgery (primary or interval debunking surgery) for advanced epithelial ovarian cancer.
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Patients with histological diagnosis of epithelial ovarian, fallopian or peritoneal cancer (FIGO stage IIB-IVB), judged suitable for surgery by clinicians, and who underwent recto-sigmoid resection and anastomosis with curative intent between December 2011 and October 2019
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Rome, RM, 00168, Italy
Barbara Costantini, MD
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
515 participants (actual enrollment reported by the registry).
First Submitted
October 11, 2020
First Posted
October 27, 2020
Study Start
December 2011
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 2019
Actual (reported)Study Completion
September 2020
Actual (reported)Last Updated
October 27, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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