Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04604964 |
| Other study ID # |
DIPUSVSP-03-02-2032 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 2011 |
| Est. completion date |
September 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Catholic University of the Sacred Heart |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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
Description:
The investigators performed a retrospective analysis of the pre-operative, intra-operative
and post-operative (surgical outcomes and early complications rate) characteristics, of a
series of patients undergoing primary surgery (PDS or IDS) for AEOC at"Fondazione Policlinico
Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Department of
Gynecologic Oncology" between December 2011 and October 2019.
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: /= 1000 U/mL),
surgical timing (PDS vs IDS), Predictive Index Value (PIV) at initial diagnosis (
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.
