Clinical trial · Interventional
Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced Ovarian Cancer
A Prospective Randomized Controlled Non-Inferiority Study Comparing the Efficacy of Lesion Excision Versus Rectosigmoid Resection in Pelvic Cytoreductive Surgery for Advanced Ovarian Cancer
NCT07616310CI-TRIAL-00113150RSEnTrailrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Colorectum is the most common site of metastasis in ovarian cancer. Regarding intestinal surgery, there is controversy over whether to choose bowel resection or tumor removal, and currently, there are no prospective randomized controlled studies comparing the oncological safety of these two surgical approaches. This study is a prospective randomized trial aimed at comparing the efficacy of rectosigmoid resection versus rectosigmoid-preserving lesion excision in advanced ovarian cancer surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer (OvCa) | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rectosigmoid Lesion Excision +tumor cell debulking surgery | Procedure | — | UNRESOLVED |
| Rectosigmoid Resection +tumor cell debulking surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Rectosigmoid Lesion Excision
- description
- rectosigmoid lesion excision +tumor cell debulking surgery
- interventionNames
- Procedure: Rectosigmoid Lesion Excision +tumor cell debulking surgery
- type
- ACTIVE_COMPARATOR
- label
- Rectosigmoid Resection
- description
- rectosigmoid resection +tumor cell debulking surgery
- interventionNames
- Procedure: Rectosigmoid Resection +tumor cell debulking surgery
Primary outcomes (1)
- measure
- Progression-free survival(PFS)
- timeFrame
- Two years after the surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily participate in this study and sign the informed consent form; * Age 18-70 years old; * Primary debulking surgery for epithelial ovarian cancer (including neoadjuvant chemotherapy), with or without abdominal and distant metastasis (≥ IIB stage); * Colonoscopy negative (no mucosal layer invasion); * Preoperative imaging (enhanced pelvic MRI) assesses the tumor's involvement of the intestinal surface and/or major parts of the mesentery; * Eastern Cooperative Oncology Group (ECOG) score \< 3; * American Society of Anesthesiologists (ASA) score \< 3. Exclusion Criteria: * Has a history of other malignant tumors or is undergoing other anti-tumor treatments; * Has severe underlying medical conditions that make surgery intolerable; * Epithelial ovarian cancer diagnosed incidentally during emergency surgery; * Participates in other clinical studies simultaneously; * Secondary cytoreductive surgery for epithelial ovarian cancer; * Patients who have received radiotherapy to the abdomen or pelvis before.
References
Publications (16)
- RESULTTozzi R, Hardern K, Gubbala K, Garruto Campanile R, Soleymani Majd H. En-bloc resection of the pelvis (EnBRP) in patients with stage IIIC-IV ovarian cancer: A 10 steps standardised technique. Surgical and survival outcomes of primary vs. interval surgery. Gynecol Oncol. 2017 Mar;144(3):564-570. doi: 10.1016/j.ygyno.2016.12.019. Epub 2017 Jan 7. PMID 28073597
- RESULTRosati A, Vargiu V, Santullo F, Lodoli C, Attalla El Halabieh M, Scambia G, Fagotti A, Costantini B. Rectosigmoid Mesorectal-Sparing Resection in Advanced Ovarian Cancer Surgery. Ann Surg Oncol. 2021 Oct;28(11):6721-6722. doi: 10.1245/s10434-021-09651-2. Epub 2021 Feb 14. PMID 33586073
- RESULTRosati A, Vargiu V, Santullo F, Lodoli C, Attalla El Halabieh M, Scambia G, Fagotti A, Costantini B. ASO Author Reflections: Rectosigmoid Mesorectal Sparing Resection: A Feasible Technique and a Viable Option in Advanced Ovarian Cancer Surgery. Ann Surg Oncol. 2021 Oct;28(11):6723-6724. doi: 10.1245/s10434-021-09665-w. Epub 2021 Feb 11. No abstract available. PMID 33575871
- RESULTPlotti F, Montera R, Aloisi A, Scaletta G, Capriglione S, Luvero D, De Cicco Nardone C, Basile S, Benedetti Panici P, Angioli R. Total rectosigmoidectomy versus partial rectal resection in primary debulking surgery for advanced ovarian cancer. Eur J Surg Oncol. 2016 Mar;42(3):383-90. doi: 10.1016/j.ejso.2015.12.001. Epub 2015 Dec 17. PMID 26725211
- RESULTPark SJ, Mun J, Lee EJ, Park S, Kim SY, Lim W, Song G, Kim JW, Lee S, Kim HS. Clinical Phenotypes of Tumors Invading the Rectosigmoid Colon Affecting the Extent of Debulking Surgery and Survival in Advanced Ovarian Cancer. Front Oncol. 2021 Apr 22;11:673631. doi: 10.3389/fonc.2021.673631. eCollection 2021. PMID 33968784
- RESULTMuallem MZ, Sehouli J, Miranda A, Richter R, Muallem J. Total retroperitoneal en bloc resection of multivisceral-peritoneal packet (TROMP operation): a novel surgical technique for advanced ovarian cancer. Int J Gynecol Cancer. 2020 May;30(5):648-653. doi: 10.1136/ijgc-2019-001161. Epub 2020 Mar 26.