Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-31 @ 1:26 PM
Study NCT ID:
NCT05564234
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2022-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Laparoscopy in Assessing Resectability of Ovarian Cancer
Sponsor:
Zagazig University
Organization:
Study Overview
Official Title:
Role of Laparoscopy in Assessing Tumor Resectability in Ovarian Cancer Cases
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Aim of Work is Prevention of unnecessary laparotomies and failed attempts to perform optimal cytoreduction in women with advanced ovarian cancer.
Detailed Description:
Ovarian cancer is diagnosed at advanced stages in 80% of cases, leading to 5-year survival of approximately 30 %. Tumor reductive surgery and platinum and taxane-based chemotherapy has been the mainstay of treatment for advanced disease . The presence of residual disease after primary debulking surgery is a highly significant prognostic factor in women with advanced ovarian cancer. In up to 60 % of women, residual tumor of \>1 cm is left behind after primary debulking surgery. These women might have benefited from neoadjuvant chemotherapy (NACT) prior to interval debulking surgery instead of primary debulking surgery followed by chemotherapy. Previous studies have demonstrated a clear survival benefit if resection to no gross residual disease (R0 resection) can be achieved, More extensive surgical procedures have been performed to achieve R0 status and have been associated with increased surgical morbidity. Accurate assessment of tumor burden at initial diagnosis using preoperative computed tomography, serum CA 125, and clinical factors has been used in models with variable success and has been difficult to standardize across surgical practices. It is important to determine at the time of diagnosis which patients should undergo primary tumor reductive surgery (TRS), and which should receive neoadjuvant chemotherapy (NACT) in order to minimize surgical morbidity and maximize the extent of cytoreduction. As such, several algorithms to predict the extent of disease encountered at cytoreductive surgery have been developed and evaluated . Fagotti et al. (2008) developed a laparoscopic scoring algorithm comprised of seven parameters: omental caking, peritoneal carcinomatosis, diaphragmatic carcinomatosis, mesenteric retraction, bowel infiltration, stomach infiltration, and liver metastases. . A laparoscopy-based scoring model developed by Fagotti et al.,(2008) demonstrated that a predictive index value score of 8 or greater had a specificity of 100%, positive predictive value of 100%, and negative predictive value of 70% for predicting a suboptimal primary tumor reductive surgery. Optimal tumor reductive surgery was defined as
1 cm or less in this model . Follow-up studies have demonstrated that laparoscopic scoring carries a low risk of complications; helps avoid unnecessary laparotomies in patients in whom cytoreduction to no gross residual disease would not be possible. To provide a more standardized approach to the management of patients with advanced ovarian cancer, this study will be performed to triage appropriate patients to laparoscopic scoring assessment using the previously validated scoring algorithm as reported by Fagotti, We will estimate the effects of the laparoscopic scoring algorithm in patients with advanced ovarian cancer to improve complete gross surgical resection rates and to determine the resulting clinical outcomes.
1 cm or less in this model . Follow-up studies have demonstrated that laparoscopic scoring carries a low risk of complications; helps avoid unnecessary laparotomies in patients in whom cytoreduction to no gross residual disease would not be possible. To provide a more standardized approach to the management of patients with advanced ovarian cancer, this study will be performed to triage appropriate patients to laparoscopic scoring assessment using the previously validated scoring algorithm as reported by Fagotti, We will estimate the effects of the laparoscopic scoring algorithm in patients with advanced ovarian cancer to improve complete gross surgical resection rates and to determine the resulting clinical outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: