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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| Zhejiang University | OTHER |
| Zhejiang Provincial People's Hospital | OTHER |
| Zhejiang Cancer Hospital |
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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.
Gastrointestinal surgeries, such as intestinal resection and anastomosis, ileostomy and/or colostomy, have become an important step in more than 50% of advanced ovarian cancer tumor cell reduction surgeries. Among them, the sigmoid colon rectum is the main intestinal site affected by ovarian cancer metastasis. To achieve R0 tumor reduction surgery, partial sigmoid colon rectum resection is often performed simultaneously. However, approximately 2.3-6.8% of patients undergoing this surgery have intestinal anastomotic leakage, 17-18% of patients require prophylactic or permanent colostomy, and 40% of patients will experience changes in bowel habits and other rectal anterior low resection syndrome after surgery, which reduces the quality of life of the patients.
Numerous studies have found that the rectosigmoid colon involvement in ovarian cancer mainly occurs in the serosa, followed by the muscular layer, and finally the mucosa. Moreover, in 80% of cases, the involvement is limited to the seromuscular layer. Therefore, some studies have suggested that for seromuscular layer infiltration, resection of the rectosigmoid colon during cytoreductive surgery may not be necessary, and partial resection of the intestinal wall or tumor enucleation can be considered. Although tumor enucleation can preserve the rectosigmoid colon when it is involved, some studies have raised concerns about its oncological safety. These studies argue that not resecting the rectosigmoid colon may leave microscopic tumor residues, leading to a decrease in survival rates. In contrast, recent retrospective clinical studies have supported that, compared with intestinal resection, tumor enucleation of the rectosigmoid colon does not affect the prognosis of advanced ovarian cancer. Regarding intestinal metastasis of ovarian cancer, the current National Comprehensive Cancer Network(NCCN) guidelines for ovarian cancer state that preoperative neoadjuvant chemotherapy does not improve survival and therefore do not recommend it. Instead, the guidelines suggest direct surgical treatment. As for the surgical approach, the guidelines only require achieving R0 resection of the intestinal tumor, without specifying whether it is intestinal segment resection or tumor enucleation. Therefore, both rectosigmoid colon resection and tumor enucleation while preserving the rectosigmoid colon are common surgical methods in clinical practice. The investigator analyzed 130 cases of advanced ovarian cancer treated surgically in the investigator's hospital from 2015 to 2021, comparing the rectosigmoid colon resection group with the tumor enucleation group while preserving the rectosigmoid colon. The investigator found no difference in progression-free survival between the two groups, a conclusion consistent with published studies.
As there are currently no prospective randomized controlled studies comparing the oncological safety of these two surgical approaches, this study is a prospective randomized study comparing the efficacy of rectosigmoid resection and rectosigmoid-sparing tumor debulking in advanced ovarian cancer surgery. It was designed and led by the Second Affiliated Hospital of Zhejiang University School of Medicine, with the participation of multiple domestic hospitals. The study strictly adheres to Good Clinical Practice(GCP) requirements, is strictly managed, and records data truthfully to provide genuine and scientific research data. This study will provide satisfactory cytoreductive surgery and standardized treatment for enrolled patients, ensuring the patients's benefits. The study will provide reliable clinical evidence for the management of the intestinal tract in cytoreductive surgery for advanced ovarian cancer and introduce new surgical methods to improve the prognosis and quality of life of ovarian cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rectosigmoid Lesion Excision | Experimental | rectosigmoid lesion excision +tumor cell debulking surgery |
|
| Rectosigmoid Resection | Active Comparator | rectosigmoid resection +tumor cell debulking surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rectosigmoid Lesion Excision +tumor cell debulking surgery | Procedure | Surgery for pelvic rectosigmoid tumors |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate in the pelvic region(LPR) | The proportion of cases with local recurrence in the pelvic area among the total number of enrolled cases | Two years after the surgery |
| Overall Survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Fei | Contact | +86 13732238958 | feijing@zju.edu.cn | |
| Zhigang Zhang | Contact | +86 15088621550 | zzg2011@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28073597 | Result | 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. | |
| 33586073 |
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| OTHER |
| Huzhou Central Hospital | OTHER |
| Ningbo Women & Children's Hospital | OTHER |
| Shaoxing People's Hospital | OTHER |
| The Central Hospital of Lishui City | OTHER |
| Women's Hospital School Of Medicine Zhejiang University | OTHER |
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| Rectosigmoid Resection +tumor cell debulking surgery | Procedure | Rectosigmoid Resection +tumor cell debulking surgery |
|
OS is defined as the time from the date of randomization until death
| Five years since being included |
| Surgical Complications(SC) | It refers to all the cases where the subjects experienced surgery-related complications, including the type, incidence rate, and severity (graded according to CTCAE V5.0) | Two months after the surgery |
| Ratio of R0 | The proportion of cases that underwent R0 resection (complete resection) among the total number of enrolled cases. | On the day of the surgery |
| Quality of Life(QoL) | All the subjects will complete the quality of life questionnaire within the specified time until the end event occurs. | Five years after the surgery |
| 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. |
| 33575871 | Result | 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. |
| 26725211 | Result | 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. |
| 33968784 | Result | 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. |
| 32221020 | Result | 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. |
| 35743684 | Result | 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. |
| 33168565 | Result | Kuroki L, Guntupalli SR. Treatment of epithelial ovarian cancer. BMJ. 2020 Nov 9;371:m3773. doi: 10.1136/bmj.m3773. |
| 33234261 | Result | 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. |
| 36041232 | Result | 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. |
| 35608442 | Result | 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. |
| 36161421 | Result | 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. |
| 32641239 | Result | 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. |
| 30306588 | Result | 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. |
| 17000396 | 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. |
| 36633525 | Result | 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. |
| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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