Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665635
Status:
RECRUITING
Last Update Posted:
2023-02-09
First Post:
2020-11-30
Brief Title:
Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery
Sponsor:
Cukurova University
Organization:
Cukurova University
Study Overview
Official Title:
Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery BROSEOC
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Ovarian cancer is the most common cause of death in gynecological cancer Approximately 75 of epithelial ovarian cancers are detected at an advanced stage Metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface Metastasis mostly occurs in the peritoneum omentum and intestines The rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood
Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy Surgery is the basis of the treatment and the main goal is to achieve no residual visible tumor complete cytoreduction R0 The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team Multiple surgical procedures total hysterectomy bilateral salpingo-oophorectomy total omentectomy peritonectomy retroperitoneal lymphadenectomies such as pelvic and paraaortic bowel resections splenectomy distal pancreatectomy various resections related to the bladder liver stomach and diaphragm may be required to achieve complete or optimal cytoreduction
In the involvement of the rectosigmoid colon primarily the serosa then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread and therefore most of the involvement is observed in the seromuscular layer In seromuscular infiltration resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed There are advantages and disadvantages of each method in terms of morbidity Although there are retrospective studies evaluating recurrence and survival between both methods as far as investigators know no randomized prospective studies have been conducted comparing these two methods The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study
Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy Surgery is the basis of the treatment and the main goal is to achieve no residual visible tumor complete cytoreduction R0 The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team Multiple surgical procedures total hysterectomy bilateral salpingo-oophorectomy total omentectomy peritonectomy retroperitoneal lymphadenectomies such as pelvic and paraaortic bowel resections splenectomy distal pancreatectomy various resections related to the bladder liver stomach and diaphragm may be required to achieve complete or optimal cytoreduction
In the involvement of the rectosigmoid colon primarily the serosa then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread and therefore most of the involvement is observed in the seromuscular layer In seromuscular infiltration resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed There are advantages and disadvantages of each method in terms of morbidity Although there are retrospective studies evaluating recurrence and survival between both methods as far as investigators know no randomized prospective studies have been conducted comparing these two methods The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None