Ovarian CancerNCT06458361
Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer
An observational study of Ovarian Cancer, run by Zhongda Hospital at 1 site in China.
Trial summary
This study was a multicenter, retrospective cohort study. Although advancements in surgical techniques have mitigated the incidence of intestinal anastomotic fistula, complete avoidance remains elusive. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 401 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: All inpatients undergoing colorectal resection for patients with ovarian, fallopian tube and peritoneal cancer from January 2018 to June 2023 from multiple study centres were selected for the study.
Who may be able to join
- Patients with postoperative pathological diagnosis of primary ovarian, fallopian tube or peritoneal cancer
- Patients undergoing tumour cytoreductive surgery combined with colorectal resection and stage I intestinal anastomosis
- No history of other malignant tumours
- Complete case data
Who cannot join
- Previous combination of malignant tumours of other organs
- Comorbidities with serious diseases related to other organs
- Patients undergoing secondary tumour cytoreduction
Trial locations and contacts
1 site in 1 country.
About this study
This study was a multicenter, retrospective cohort study. Although advancements in surgical techniques have mitigated the incidence of intestinal anastomotic fistula, complete avoidance remains elusive. Anastomotic leakage (AL) complications directly impinge on postoperative quality of life and pose life-threatening risks if inadequately managed. Given AL's adverse prognostic implications and the financial strain on patients' families, identifying its risk factors aids in perioperative risk assessment, enabling timely clinical decisions on interventions to enhance prognosis and curtail adverse outcomes and economic investments.
Read the detailed description
Optimal cytoreduction, particularly in advanced cases, significantly extends 5-year survival compared to cases with residual disease exceeding 1 cm. Consequently, ultra-radical tumor cytoreduction procedures, commonly performed in advanced ovarian cancer, entail the excision of abdominopelvic tissues affected by the primary ovarian malignancy, including segments of the bowel, bladder, spleen, gallbladder, diaphragm, and other organs. Rectosigmoid resection (RSR) emerges as the predominant bowel resection, followed by colon and small bowel resections. Intestinal anastomosis post-RSR is indispensable for bowel reconstruction but bears a notable risk of postoperative anastomotic fistula (AL), a major complication. AL incidence rates fluctuate over time, reported between 8-14% in OC surgery patients undergoing RSR.
AL imposes considerable burdens, encompassing elevated hospital costs, prolonged stays, heightened rates of secondary admissions and surgeries, and mortality rates ranging from 3% to 21%. Furthermore, AL delays the commencement of adjuvant chemotherapy, detrimentally impacting overall survival and representing a significant consequence of colorectal surgery.
- Conditions
- Ovarian Cancer
- Being tested
- Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosis
- Keywords
- Anastomotic Leakages, Risk Factors, Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosisProcedure or surgery
Also called Age, BMI, marital status, history of hypertension, history of diabetes mellitus
Basic information about ovarian cancer patients and factors associated with preoperative, intraoperative and postoperative periods
| Study group | Role | What they receive |
|---|---|---|
| Anastomotic Leakage | Anastomotic Leakage in the first month after surgery Receives: Procedure: Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosis | |
| non-anastomotic Leakage | non-anastomotic Leakage in the first month after surgery Receives: Procedure: Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Risk Factors and a Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer
Risk Factors
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Jan 2018
- Primary completion30 Jun 2025
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Shen, Zhongda Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458361
- Sponsor's protocol ID
- 2024040145
- Status last verified
- Jul 2026
- First submitted
- 8 Jun 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06458361
- Acronym / sponsor ID
- 2024040145
- Conditions
- Ovarian Cancer
- Keywords
- Anastomotic Leakages, Risk Factors, Ovarian Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Zhongda HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 13 Jun 2024 (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.
This study was a multicenter, retrospective cohort study. Although advancements in surgical techniques have mitigated the incidence of intestinal anastomotic fistula, complete avoidance remains elusive. Anastomotic leakage (AL) complications directly impinge on postoperative quality of life and pose life-threatening risks if inadequately managed. Given AL's adverse prognostic implications and the financial strain on patients' families, identifying its risk factors aids in perioperative risk assessment, enabling timely clinical decisions on interventions to enhance prognosis and curtail adverse outcomes and economic investments.
Detailed description
Optimal cytoreduction, particularly in advanced cases, significantly extends 5-year survival compared to cases with residual disease exceeding 1 cm. Consequently, ultra-radical tumor cytoreduction procedures, commonly performed in advanced ovarian cancer, entail the excision of abdominopelvic tissues affected by the primary ovarian malignancy, including segments of the bowel, bladder, spleen, gallbladder, diaphragm, and other organs. Rectosigmoid resection (RSR) emerges as the predominant bowel resection, followed by colon and small bowel resections. Intestinal anastomosis post-RSR is indispensable for bowel reconstruction but bears a notable risk of postoperative anastomotic fistula (AL), a major complication. AL incidence rates fluctuate over time, reported between 8-14% in OC surgery patients undergoing RSR.
AL imposes considerable burdens, encompassing elevated hospital costs, prolonged stays, heightened rates of secondary admissions and surgeries, and mortality rates ranging from 3% to 21%. Furthermore, AL delays the commencement of adjuvant chemotherapy, detrimentally impacting overall survival and representing a significant consequence of colorectal surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastomotic Leakage | – | Procedure: Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosisAnastomotic Leakage in the first month after surgery |
| non-anastomotic Leakage | – | Procedure: Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosisnon-anastomotic Leakage in the first month after surgery |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All inpatients undergoing colorectal resection for patients with ovarian, fallopian tube and peritoneal cancer from January 2018 to June 2023 from multiple study centres were selected for the study.
Key inclusion criteria (4 listed)
- Patients with postoperative pathological diagnosis of primary ovarian, fallopian tube or peritoneal cancer
- Patients undergoing tumour cytoreductive surgery combined with colorectal resection and stage I intestinal anastomosis
- No history of other malignant tumours
- Complete case data
Key exclusion criteria (3 listed)
- Previous combination of malignant tumours of other organs
- Comorbidities with serious diseases related to other organs
- Patients undergoing secondary tumour cytoreduction
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 |
|---|---|---|
| Type of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosisAlso: Age, BMI, marital status, history of hypertension, history of diabetes mellitusBasic information about ovarian cancer patients and factors associated with preoperative, intraoperative and postoperative periods | Procedure or surgery | Anastomotic Leakage, non-anastomotic Leakage |
Primary outcome
Risk Factors and a Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer
Time frame: 1 month after surgery
Risk Factors
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Zhongda Hospital 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 16 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Risk Factors and a Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jul 2026.