NCT07616310

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jan 2024Dec 2028

Study Start

First participant enrolled

January 10, 2024

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 1, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

April 9, 2026

Last Update Submit

May 29, 2026

Conditions

Ovarian Cancer (OvCa)

Keywords

Rectosigmoid ResectionRectosigmoid Lesion Excision

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival(PFS)

    Two years progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.

    Two years after the surgery

Secondary Outcomes (5)

  • Local recurrence rate in the pelvic region(LPR)

    Two years after the surgery

  • Overall Survival(OS)

    Five years since being included

  • Surgical Complications(SC)

    Two months after the surgery

  • Ratio of R0

    On the day of the surgery

  • Quality of Life(QoL)

    Five years after the surgery

Study Arms (2)

Rectosigmoid Lesion Excision

EXPERIMENTAL

rectosigmoid lesion excision +tumor cell debulking surgery

Procedure: Rectosigmoid Lesion Excision +tumor cell debulking surgery

Rectosigmoid Resection

ACTIVE COMPARATOR

rectosigmoid resection +tumor cell debulking surgery

Procedure: Rectosigmoid Resection +tumor cell debulking surgery

Interventions

Rectosigmoid Lesion Excision +tumor cell debulking surgeryPROCEDURE

Surgery for pelvic rectosigmoid tumors

Rectosigmoid Lesion Excision
Rectosigmoid Resection +tumor cell debulking surgeryPROCEDURE

Rectosigmoid Resection +tumor cell debulking surgery

Rectosigmoid Resection

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (16)

  • Tozzi 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: 28073597RESULT

  • Rosati 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: 33586073RESULT

  • Rosati 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: 33575871RESULT

  • Plotti 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: 26725211RESULT

  • Park 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: 33968784RESULT

  • Muallem 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.

    PMID: 32221020RESULT

  • Muallem MZ, Kluge L, Sayasneh A, Sehouli J, Zocholl D, Muallem J, Miranda A. A Promising Approach for Primary Cytoreductive Surgery for Advanced Ovarian Cancer: Survival Outcomes and Step-by-Step Description of Total Retroperitoneal en-Bloc Resection of Multivisceral-Peritoneal Packet (TROMP). J Pers Med. 2022 May 29;12(6):899. doi: 10.3390/jpm12060899.

    PMID: 35743684RESULT

  • Kuroki L, Guntupalli SR. Treatment of epithelial ovarian cancer. BMJ. 2020 Nov 9;371:m3773. doi: 10.1136/bmj.m3773.

    PMID: 33168565RESULT

  • Khatib G, Seyfettinoglu S, Guzel AB, Gulec UK, Unlugenc H, Vardar MA. Feasibility and rationale of a novel approach in advanced ovarian cancer surgery: Bat- shaped en-bloc total peritonectomy and total hysterectomy salpingo-oophorectomy with or without rectosigmoid resection (Sarta-Bat approach). Gynecol Oncol. 2021 Apr;161(1):97-103. doi: 10.1016/j.ygyno.2020.11.011. Epub 2020 Nov 21.

    PMID: 33234261RESULT

  • Hiu S, Bryant A, Gajjar K, Kunonga PT, Naik R. Ultra-radical (extensive) surgery versus standard surgery for the primary cytoreduction of advanced epithelial ovarian cancer. Cochrane Database Syst Rev. 2022 Aug 30;8(8):CD007697. doi: 10.1002/14651858.CD007697.pub3.

    PMID: 36041232RESULT

  • Fernandes MC, Nikolovski I, Long Roche K, Lakhman Y. CT of Ovarian Cancer for Primary Treatment Planning: What the Surgeon Needs to Know-Radiology In Training. Radiology. 2022 Sep;304(3):516-526. doi: 10.1148/radiol.212737. Epub 2022 May 24.

    PMID: 35608442RESULT

  • Bryant A, Hiu S, Kunonga PT, Gajjar K, Craig D, Vale L, Winter-Roach BA, Elattar A, Naik R. Impact of residual disease as a prognostic factor for survival in women with advanced epithelial ovarian cancer after primary surgery. Cochrane Database Syst Rev. 2022 Sep 26;9(9):CD015048. doi: 10.1002/14651858.CD015048.pub2.

    PMID: 36161421RESULT

  • Bernard L, Boucher J, Helpman L. Bowel resection or repair at the time of cytoreductive surgery for ovarian malignancy is associated with increased complication rate: An ACS-NSQIP study. Gynecol Oncol. 2020 Sep;158(3):597-602. doi: 10.1016/j.ygyno.2020.06.504. Epub 2020 Jul 6.

    PMID: 32641239RESULT

  • Arora V, Somashekhar SP. Essential surgical skills for a gynecologic oncologist. Int J Gynaecol Obstet. 2018 Oct;143 Suppl 2:118-130. doi: 10.1002/ijgo.12619.

    PMID: 30306588RESULT

  • 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: 17000396RESULT

  • Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763.

    PMID: 36633525RESULT

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Central Study Contacts

Jing Fei

CONTACT

+86 13732238958feijing@zju.edu.cn

Zhigang Zhang

CONTACT

+86 15088621550zzg2011@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2026

First Posted

June 1, 2026

Study Start

January 10, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)