Risk Factors for Anatomic Leakage in Advanced Ovarian Cancer Surgery
NCT ID: NCT04604964
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
515 participants
OBSERVATIONAL
2011-12-31
2020-09-30
Brief Summary
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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
Detailed Description
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The enrolled population included all 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.
Patients with no evidence of colorectal involvement, and who therefore did not undergo recto-sigmoid resection, or patients with end-colostomy or end-ileostomy were excluded from the study.
Pre-operative clinical variables, surgical features and post-operative outcomes were retrospectively retrieved.
Several system scores, helpful in predicting operative risk, were used to classify patients' physiological status, as the American Society of Anesthesiologists (ASA) score, the Eastern Cooperative Oncology Group-Performance Status (ECOG-PS) and the Age-Adjusted Charlson Comorbidity Index (ACCI).
Patients with an ASA score \> 2, ECOG-PS \>/= 2 and an ACCI \> 2 were considered at high risk of post-operative complications.
Pre-operative albumin level below 30 mg/dl and pre-operative hemoglobin values below 10.0 g/dl were indicative respectively of a severely poor nutritional status and moderate-severe anemia.
Other demographic and surgical variables were recorded: age (\< 60 vs \>/= 60 year-old), body mass index (BMI) (divided into the following categories: underweight patients: BMI \<18, normal weight-overweight: BMI 18-30 and obese patients with BMI \>/= 30), International Federation of Gynecology and Obstetrics (FIGO) stage (FIGO stage 2014: \</= IIIA vs IIIC-IVB), smoking habit, Ca-125 tumor marker level at initial diagnosis (\< 1000 U/mL vs \>/= 1000 U/mL), surgical timing (PDS vs IDS), Predictive Index Value (PIV) at initial diagnosis (\</= 6 vs \> 6), presence of ascites (\< 500 mL vs \>/= 500 mL), Surgical Complexity Score (SCS) (SCS 1-2 vs SCS 3), estimated blood loss (EBL) (EBL \< 500 vs \>/= 500 mL) , intra-operative transfusions, additional surgical procedures performed and colorectal resection and anastomosis specific characteristics. The Common Terminology Criteria for Adverse Events v3.0 (CTCAE) was used to classify intra-operative complications (CTCAE 0-1 vs CTCAE \>/= 2).
The suspicion of anastomotic leakage (AL), suggested by general clinical signs as abdominal pain or distension, leukocytosis, fever, as well as more specific signs such as emission of gas, pus, or feces via the drains, the laparotomy incision, or the vagina, was ascertained by computed tomography (CT) with rectal contrast enema or simple contrast enema radiography with a water-soluble contrast agent.
The ultimate diagnostic procedure was re-laparotomy with direct verification of AL and/or fecal peritonitis.
Overall survival (OS) was calculated from the date of primary diagnosis to the date of death or to last follow-up visit for the patients still alive.
The primary end-point of the study was to assess the anastomosis leakage 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.
The secondary endpoints were to evaluate the influence of several possible pre/intra and post-operative risk factors on AL in order to identify, at an early stage, the population at greatest risk.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients undergoing recto-sigmoid resection plus anastomosis
Patients undergoing recto-sigmoid resection and concurrent anastomosis during debulking surgery (primary or interval debunking surgery) for advanced epithelial ovarian cancer.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* FIGO stage IIB-IVB
* patients judged suitable for surgery by clinicians
* patients subjected to recto-sigmoid resection and anastomosis with curative intent
Exclusion Criteria
* patients with end-colostomy or end-ileostomy
FEMALE
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Prof. Giovanni Scambia
Professor
Principal Investigators
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Barbara Costantini, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Locations
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Fondazione Policlinico Universitario A. Gemelli, IRCCS
Rome, RM, Italy
Countries
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Other Identifiers
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DIPUSVSP-03-02-2032
Identifier Type: -
Identifier Source: org_study_id