Clinical trial NCT04665635: Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery
Official title: Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epithelial Ovarian Cancer
Rectosigmoid Cancer Metastatic
Keywords: epithelial ovarian cancer
Rectosigmoid resection
Seromuscular tumor shaving
recurrence
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Epithelial ovarian cancer
* Negative colonoscopy ( no mucosal involvement)
* Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration
* ECOG \<3
* ASA \<3

Exclusion Criteria:

* Nonepithelial ovarian cancers
* Rectosigmoid mucosal infiltration
* Total or subtotal colectomy necessitating large bowel infiltrations
* ECOG \>2
* ASA \>2

Primary outcomes:
measure: Local pelvic recurrence
timeFrame: 0-60 months.
measure: Recurrence-free survival
timeFrame: 0-60 months.
Secondary outcomes:
measure: Cancer specific survival
timeFrame: 0-100 months
measure: Surgery related morbidities
timeFrame: 90 days.
measure: Health related Quality of life
timeFrame: 0-24 months.
measure: Overall survival
timeFrame: 0-100 months.
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University
city: Adana
country: Turkey
facility: Cukurova University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.