An interventional study of Rectosigmoid resection in Epithelial Ovarian Cancer and Rectosigmoid Cancer Metastatic, sponsored by Cukurova University. Recruiting at 2 sites in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by Cukurova University · Not applicable, Interventional, and Treatment
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.
2,695 studies on the registry are indexed under Ovarian Neoplasms; 726 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 2,030 interventional studies indexed under Ovarian Neoplasms.
Browse Ovarian Neoplasms studies →Cukurova University is the lead sponsor of 247 studies on the registry; 50 are open to participants now.
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Exclusion Criteria:
Procedure: Rectosigmoid resection
Procedure: Rectosigmoid resection
Most of the colorectal involvements are observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed.
Also known as: Rectosigmoid seromuscular tumor shaving
Local pelvic recurrence
Only the pelvic recurrences determined after the last chemotherapy cycle.
Time frame: 0-60 months.
Recurrence-free survival
The time from the last chemotherapy cycle to determination of any recurrence in any location.
Time frame: 0-60 months.
Cancer specific survival
Time from diagnosis to the death date due to ovarian cancer.
Time frame: 0-100 months
Surgery related morbidities
Any surgery related morbidity during 90 days.
Time frame: 90 days.
Health related Quality of life
HRQoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC QLQ-C30 version 3.0).The QLQ-C30 is a 30-item questionnaire that includes five multiitem functional scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), five single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, and diarrhoea), a question on financial impact; and a two-item global quality of life scale.The questionnaire generally has a four-point response scale (1 = "not at all", 4 = "very much").The questionnaire is planned to be performed within 1-2 weeks prior to the surgery (baseline), after 3-4 weeks of surgery before starting of adjuvant chemotherapy, at the end of adjuvant chemotherapy, and every three months in follow-up, until two years of follow-up.
Time frame: 0-24 months.
Overall survival
Time from diagnosis to the death date due to any cause.
Time frame: 0-100 months.
Plan to share: Yes
Supporting information: Study protocol
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Cukurova University