Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery
NCT ID: NCT04665635
Last Updated: 2024-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2021-03-01
2026-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rectosigmoid resection
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.
Rectosigmoid seromuscular tumor shaving
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Negative colonoscopy ( no mucosal involvement)
* Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration
* ECOG \<3
* ASA \<3
Exclusion Criteria
* Rectosigmoid mucosal infiltration
* Total or subtotal colectomy necessitating large bowel infiltrations
* ECOG \>2
* ASA \>2
18 Years
FEMALE
No
Sponsors
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Cukurova University
OTHER
Responsible Party
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Ghanim Khatib
Associate professor, MD
Locations
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Cukurova University
Adana, , Turkey (Türkiye)
Cukurova University
Adana, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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Erkilinc S, Karatasli V, Demir B, Cakir I, Can B, Karadeniz T, Gokcu M, Sanci M. Rectosigmoidectomy and Douglas Peritonectomy in the Management of Serosal Implants in Advanced-Stage Ovarian Cancer Surgery: Survival and Surgical Outcomes. Int J Gynecol Cancer. 2018 Nov;28(9):1699-1705. doi: 10.1097/IGC.0000000000001368.
Gallotta V, Fanfani F, Vizzielli G, Panico G, Rossitto C, Gagliardi ML, Margariti PA, Salerno MG, Zannoni GF, Pacelli F, Scambia G, Fagotti A. Douglas peritonectomy compared to recto-sigmoid resection in optimally cytoreduced advanced ovarian cancer patients: analysis of morbidity and oncological outcome. Eur J Surg Oncol. 2011 Dec;37(12):1085-92. doi: 10.1016/j.ejso.2011.09.003. Epub 2011 Sep 25.
Aletti GD, Podratz KC, Jones MB, Cliby WA. Role of rectosigmoidectomy and stripping of pelvic peritoneum in outcomes of patients with advanced ovarian cancer. J Am Coll Surg. 2006 Oct;203(4):521-6. doi: 10.1016/j.jamcollsurg.2006.06.027. Epub 2006 Aug 23.
Other Identifiers
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105/17- Ov01
Identifier Type: -
Identifier Source: org_study_id
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