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Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer

Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06458361
Enrollment
401
Registered
2024-06-13
Start date
2018-01-01
Completion date
2026-07-01
Last updated
2026-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Anastomotic Leakages, Risk Factors, Ovarian Cancer

Brief 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. 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.

Interventions

PROCEDUREType of bowel resection, surgical complexity score, intraoperative blood loss, perioperative erythrocyte transfusion, type of anastomosis

Basic information about ovarian cancer patients and factors associated with preoperative, intraoperative and postoperative periods

Sponsors

Zhongda Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

1. Patients with postoperative pathological diagnosis of primary ovarian, fallopian tube or peritoneal cancer 2. Patients undergoing tumour cytoreductive surgery combined with colorectal resection and stage I intestinal anastomosis 3. No history of other malignant tumours 4. Complete case data

Exclusion criteria

1. Previous combination of malignant tumours of other organs 2. Comorbidities with serious diseases related to other organs 3. Patients undergoing secondary tumour cytoreduction

Design outcomes

Primary

MeasureTime frameDescription
Risk Factors and a Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer1 month after surgeryRisk Factors

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026