Ovarian Cancer (OvCa)RSEnTrailNCT07616310
Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced Ovarian Cancer
A study testing Rectosigmoid Lesion Excision +tumor cell debulking surgery and Rectosigmoid Resection +tumor cell debulking surgery in people with Ovarian Cancer (OvCa), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer (OvCa)
- What is being tested?
- Rectosigmoid Lesion Excision +tumor cell debulking surgery and Rectosigmoid Resection +tumor cell debulking surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: A Prospective Randomized Controlled Non-Inferiority Study Comparing the Efficacy of Lesion Excision Versus Rectosigmoid Resection in Pelvic Cytoreductive Surgery for Advanced Ovarian Cancer
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.
Read the detailed description
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.
- Conditions
- Ovarian Cancer (OvCa)
- Being tested
- Rectosigmoid Lesion Excision +tumor cell debulking surgery, Rectosigmoid Resection +tumor cell debulking surgery
- Keywords
- Rectosigmoid Resection, Rectosigmoid Lesion Excision
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectosigmoid Lesion Excision +tumor cell debulking surgeryProcedure or surgery
Surgery for pelvic rectosigmoid tumors
Rectosigmoid Resection +tumor cell debulking surgeryProcedure or surgery
Rectosigmoid Resection +tumor cell debulking surgery
| Study group | Role | What they receive |
|---|---|---|
| Rectosigmoid Lesion Excision | Experimental | rectosigmoid lesion excision +tumor cell debulking surgery Receives: Procedure: Rectosigmoid Lesion Excision +tumor cell debulking surgery |
| Rectosigmoid Resection | Active comparator | rectosigmoid resection +tumor cell debulking surgery Receives: Procedure: Rectosigmoid Resection +tumor cell debulking surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival(PFS)
Two years progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
Measured: Two years after the surgery
Secondary outcomes (5)
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
Measured: Two years after the surgery
Overall Survival(OS)
OS is defined as the time from the date of randomization until death
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Five years after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start10 Jan 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Ovarian Cancer (OvCa)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Tongji Hospital, Zhejiang University, Zhejiang Provincial People's Hospital, Zhejiang Cancer Hospital, Huzhou Central Hospital, Ningbo Women & Children's Hospital, Shaoxing People's Hospital, The Central Hospital of Lishui City, Women's Hospital School Of Medicine Zhejiang University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07616310
- Sponsor's protocol ID
- 2023-0804
- Acronym
- RSEnTrail
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28073597Rosati 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.
PubMed 33586073Rosati 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.
PubMed 33575871Plotti 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.
PubMed 26725211Park 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.
PubMed 33968784Muallem 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.
PubMed 32221020Muallem 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.
PubMed 35743684Kuroki L, Guntupalli SR. Treatment of epithelial ovarian cancer. BMJ. 2020 Nov 9;371:m3773. doi: 10.1136/bmj.m3773.
PubMed 33168565Khatib 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.
PubMed 33234261Hiu 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.
PubMed 36041232Fernandes 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.
PubMed 35608442Bryant 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.
PubMed 36161421Bernard 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.
PubMed 32641239Arora 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.
PubMed 30306588Aletti 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.
PubMed 17000396
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Non-Inferiority Study Comparing the Efficacy of Lesion Excision Versus Rectosigmoid Resection in Pelvic Cytoreductive Surgery for Advanced Ovarian Cancer
- ClinicalTrials.gov ID
- NCT07616310
- Acronym / sponsor ID
- RSEnTrail / 2023-0804
- Conditions
- Ovarian Cancer (OvCa)
- Keywords
- Rectosigmoid Resection, Rectosigmoid Lesion Excision
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Tongji Hospital, Zhejiang University, Zhejiang Provincial People's Hospital, Zhejiang Cancer Hospital, Huzhou Central Hospital, Ningbo Women & Children's Hospital, Shaoxing People's Hospital, The Central Hospital of Lishui City, Women's Hospital School Of Medicine Zhejiang University
- Study start
- 10 Jan 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectosigmoid Lesion Excision | Experimental | Procedure: Rectosigmoid Lesion Excision +tumor cell debulking surgeryrectosigmoid lesion excision +tumor cell debulking surgery |
| Rectosigmoid Resection | Active comparator | Procedure: Rectosigmoid Resection +tumor cell debulking surgeryrectosigmoid resection +tumor cell debulking surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rectosigmoid Lesion Excision +tumor cell debulking surgerySurgery for pelvic rectosigmoid tumors | Procedure or surgery | Rectosigmoid Lesion Excision |
| Rectosigmoid Resection +tumor cell debulking surgeryRectosigmoid Resection +tumor cell debulking surgery | Procedure or surgery | Rectosigmoid Resection |
Primary outcome
Progression-free survival(PFS)
Time frame: Two years after the surgery
Two years progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
5 secondary outcomes
Local recurrence rate in the pelvic region(LPR)
Time frame: Two years after the surgery
Overall Survival(OS)
Time frame: Five years since being included
Surgical Complications(SC)
Time frame: Two months after the surgery
Ratio of R0
Time frame: On the day of the surgery
Quality of Life(QoL)
Time frame: Five years after the surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Results publication: PubMed 28073597Tozzi 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.
- Results publication: PubMed 33586073Rosati 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.
- Results publication: PubMed 33575871Rosati 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.
- Results publication: PubMed 26725211Plotti 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.
- Results publication: PubMed 33968784Park 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.
- Results publication: PubMed 32221020Muallem 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.
- Results publication: PubMed 35743684Muallem 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.
- Results publication: PubMed 33168565Kuroki L, Guntupalli SR. Treatment of epithelial ovarian cancer. BMJ. 2020 Nov 9;371:m3773. doi: 10.1136/bmj.m3773.
- Results publication: PubMed 33234261Khatib 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.
- Results publication: PubMed 36041232Hiu 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.
- Results publication: PubMed 35608442Fernandes 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.
- Results publication: PubMed 36161421Bryant 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.
- Individual participant dataSharing planned: No
Related trials for Ovarian Cancer (OvCa)
Active, not recruitingPhase 3
The IPLA-OVCA Trial, Intra-Peritoneal Local Anaesthetics in Ovarian Cancer
Advanced Ovarian Cancer
RecruitingPhase 1
A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
Advance Solid Tumors
RecruitingPhase 3
A Study of Azenosertib (ZN-c3) Versus Investigator's Choice Chemotherapy in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
Ovarian Cancer
RecruitingPhase 1/2
A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
Solid Tumor, Adult, Colorectal Cancer
Not yet recruitingObservational study
A Prospective Observational Study of Senaparib in the Treatment of Epithelial Ovarian Cancer
Ovarian Cancer (OvCa)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectosigmoid Lesion Excision +tumor cell debulking surgery and Rectosigmoid Resection +tumor cell debulking surgery in people with Ovarian Cancer (OvCa), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jing Fei (+86 13732238958, feijing@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival(PFS) (time frame: Two years after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07616310, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.