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

NCT ID: NCT06458361

Last Updated: 2024-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2024-11-01

Brief Summary

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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

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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

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Ovarian Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Anastomotic Leakage

Anastomotic Leakage in the first month after surgery

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

Intervention Type PROCEDURE

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

non-anastomotic Leakage

non-anastomotic Leakage in the first month after surgery

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

Intervention Type PROCEDURE

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

Interventions

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Type 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

Intervention Type PROCEDURE

Other Intervention Names

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Age, BMI, marital status, history of hypertension, history of diabetes mellitus

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhongda Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yang Shen

Vice-President, Chief Physician, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongda Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yang Shen, M.D

Role: CONTACT

025-83262742

Yang Shen

Role: CONTACT

025-83262742

Facility Contacts

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Yang Shen, MD, PhD

Role: primary

025-83262742

Other Identifiers

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2024040145

Identifier Type: -

Identifier Source: org_study_id

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