Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

NCT04665635 | Recruiting DMC

• 1 other identifier: 105/17- Ov01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Epithelial Ovarian Cancer; Rectosigmoid Cancer Metastatic

Keywords

epithelial ovarian cancer; Rectosigmoid resection; Seromuscular tumor shaving; recurrence

Outcome Measures

Primary Outcomes (2)

• Local pelvic recurrence

  Only the pelvic recurrences determined after the last chemotherapy cycle.

  0-60 months.

• Recurrence-free survival

  The time from the last chemotherapy cycle to determination of any recurrence in any location.

  0-60 months.

Secondary Outcomes (4)

• Cancer specific survival

  0-100 months

• Surgery related morbidities

  90 days.

• Health related Quality of life

  0-24 months.

• Overall survival

  0-100 months.

Study Arms (2)

Rectosigmoid resection

ACTIVE COMPARATOR

Procedure: Rectosigmoid resection

Rectosigmoid seromuscular tumor shaving

ACTIVE COMPARATOR

Procedure: Rectosigmoid resection

Interventions

Rectosigmoid resection PROCEDURE

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

Rectosigmoid resection; Rectosigmoid seromuscular tumor shaving

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (2)

Cukurova University

Adana, 01330, Turkey (Türkiye)

NOT YET RECRUITING

Cukurova University

Adana, 01330, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 30371561 BACKGROUND

• 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.

  PMID: 21945640 RESULT

• 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.

  PMID: 17000396 RESULT

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial; Recurrence

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ghanim Khatib, MD

CONTACT

+903223386060; ghanim.khatib@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 11, 2020
• Study Start: March 1, 2021
• Primary Completion: January 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (2)