Viewing Study NCT06458361



Ignite Creation Date: 2024-06-16 @ 11:51 AM
Last Modification Date: 2024-10-26 @ 3:32 PM
Study NCT ID: NCT06458361
Status: RECRUITING
Last Update Posted: 2024-06-13
First Post: 2024-06-08

Brief Title: Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer
Sponsor: Zhongda Hospital
Organization: Zhongda Hospital

Study Overview

Official Title: Identification of Risk Factors and Construction of Prediction Model for Postoperative Intestinal Anastomotic Leakage in Ovarian Cancer
Status: RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 ALs 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None