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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06458361
Other study ID # 2024040145
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date November 1, 2024

Study information

Verified date June 2024
Source Zhongda Hospital
Contact Yang Shen, M.D
Phone 025-83262742
Email shenyang@seu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 300
Est. completion date November 1, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Intervention

Procedure:
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

Locations

Country Name City State
China Zhongda Hospital Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Risk Factors and a Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer Risk Factors 1 month after surgery
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