Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Epithelial Ovarian Cancer Clinical Trial

Official title:

Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665635
• Other study ID #: 105/17- Ov01
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: Cukurova University
• Contact: Ghanim Khatib, MD
• Phone: +903223386060
• Email: ghanim.khatib[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms
• Rectosigmoid Cancer Metastatic

Intervention

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.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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 patie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local pelvic recurrence	Only the pelvic recurrences determined after the last chemotherapy cycle.	0-60 months.
Primary	Recurrence-free survival	The time from the last chemotherapy cycle to determination of any recurrence in any location.	0-60 months.
Secondary	Cancer specific survival	Time from diagnosis to the death date due to ovarian cancer.	0-100 months
Secondary	Surgery related morbidities	Any surgery related morbidity during 90 days.	90 days.
Secondary	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.	0-24 months.
Secondary	Overall survival	Time from diagnosis to the death date due to any cause.	0-100 months.