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Aim of Work is Prevention of unnecessary laparotomies and failed attempts to perform optimal cytoreduction in women with advanced ovarian cancer.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant chemotherapy | Active Comparator | cases with predictive index value score 8 or greater in which primary cytoreductive surgery was not feasible were were referred for neoadjuvant chemotherapy then interval cytoreductive surgery was done |
|
| primary cytoreductive surgery | Active Comparator | cases with predictive index value score less than 8 were offered primary cytoreductive surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laparoscopy then primary cytoreductive surgery | Procedure | Laparoscopy was used to calcautation of fagotti PIV score , if less than 8 primary cytoreductive surgery were done. |
|
| Measure | Description | Time Frame |
|---|---|---|
| complete gross resection of tumor | The primary outcome for our study included improving complete gross resection rates at tumour cytoreductive surgery compared to historical data and avoids futile laparotomy defined as residual tumour with a maximum diameter more than 1 cm after primary cytoreductive surgery. | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison between the accuracy of laparoscopy and CT with contrast on the abdomen | The secondary outcomes included comparison between laparoscopic assessment and preoperative CT with contrast according to the accuracy of detection of
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| wael hu elbrombly, MD | faculty of medicine,zagazig univeristy | Study Director |
| hanan at ghaly, MD | faculty of medicine,zagazig univeristy | Study Director |
| mohamed ab lashin, MD | faculty of medicine,zagazig univeristy | Study Director |
| muhannad mo azab, Msc | faculty of medicine,zagazig univeristy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine, Zagazig Univeristy | Zagazig | Sharqia Province | 44511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16791447 | Background | Fagotti A, Ferrandina G, Fanfani F, Ercoli A, Lorusso D, Rossi M, Scambia G. A laparoscopy-based score to predict surgical outcome in patients with advanced ovarian carcinoma: a pilot study. Ann Surg Oncol. 2006 Aug;13(8):1156-61. doi: 10.1245/ASO.2006.08.021. Epub 2006 Jun 21. | |
| 18801470 | Background | Fagotti A, Ferrandina G, Fanfani F, Garganese G, Vizzielli G, Carone V, Salerno MG, Scambia G. Prospective validation of a laparoscopic predictive model for optimal cytoreduction in advanced ovarian carcinoma. Am J Obstet Gynecol. 2008 Dec;199(6):642.e1-6. doi: 10.1016/j.ajog.2008.06.052. Epub 2008 Sep 17. |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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| laparoscopy then neoadjuvant chemotherapy followed by interval cytoreductive surgery | Procedure | Laparoscopy was used to calcautation of fagotti PIV score and provides the histological diagnosis , if score more than 8 the patient were received neoadjuvant chemotherapy followed by interval cytoreductive surgery |
|
| baseline |
| surgical morbidity. | any complication during surgery or postoperative morbidity | 1 month |
| 30095787 | Background | Fleming ND, Nick AM, Coleman RL, Westin SN, Ramirez PT, Soliman PT, Fellman B, Meyer LA, Schmeler KM, Lu KH, Sood AK. Laparoscopic Surgical Algorithm to Triage the Timing of Tumor Reductive Surgery in Advanced Ovarian Cancer. Obstet Gynecol. 2018 Sep;132(3):545-554. doi: 10.1097/AOG.0000000000002796. |
| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |