Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04665635

Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Led by Cukurova University · Updated on 2024-08-29

120

Participants Needed

2

Research Sites

300 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with epithelial ovarian cancer
  • Negative colonoscopy showing no mucosal involvement
  • Intraoperative confirmation of serosal or seromuscular rectosigmoid infiltration
  • Eastern Cooperative Oncology Group (ECOG) performance status less than 3
  • American Society of Anesthesiologists (ASA) physical status classification less than 3
Not Eligible

You will not qualify if you...

  • Non-epithelial ovarian cancers
  • Presence of rectosigmoid mucosal infiltration
  • Need for total or subtotal colectomy due to large bowel infiltration
  • ECOG performance status greater than 2
  • ASA physical status classification greater than 2

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Cukurova University

Adana, Turkey (Türkiye), 01330

Not Yet Recruiting

2

Cukurova University

Adana, Turkey (Türkiye), 01330

Actively Recruiting

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Research Team

G

Ghanim Khatib, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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