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Effects of HIPEC on Postoperative Bowel Motility and Complications

P

Peking University

Status

Active, not recruiting

Conditions

Gastro Intestinal Cancer
Adhesion Prevention
Bowel Functions
HIPEC

Treatments

Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Study type

Observational

Funder types

Other

Identifiers

NCT07353177
2025PHB566-001

Details and patient eligibility

About

This retrospective cohort study was conducted at our institution, involving patients with gastric cancer, appendiceal mucinous neoplasm, or colon cancer who underwent CRS with or without HIPEC between January 2017 and December 2023.

Patient selection criteria would include all the following: 1) Karnofsky performance status (KPS) score >50; 2) stage T4b (American Joint Committee on Cancer [AJCC] 8th edition stage) or peritoneal metastasis was confirmed during or after surgery; 3) life expectancy >3 months; 4) peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3; and 5) acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation. The exclusion criteria were defined as follows: 1) Performance of emergency surgery due to intestinal obstruction or perforation; 2) a history of inflammatory bowel disease (IBD); 3) two or more independent surgical procedures on the gastrointestinal tract; and 4) who received postoperative enema. Patients were divided into two groups based on the treatment strategy: (1) surgery alone (No-HIPEC group); (2) surgery combined with HIPEC (HIPEC group).

Enrollment

193 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of gastric, appendiceal, or colon malignant tumors of stage T4b or peritoneal metastases;
  • Karnofsky performance status (KPS) score >50;
  • Life expectancy >3 months;
  • Peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3;
  • Acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation.

Exclusion criteria

  • Emergency surgery due to intestinal obstruction or perforation;
  • A history of inflammatory bowel disease (IBD);
  • Two or more independent surgical procedures on the gastrointestinal tract;
  • Postoperative enema.

Trial design

193 participants in 2 patient groups

Patients diagnosed with PM or stage T4b who underwent surgery were included
Description:
Patient selection criteria would include all the following: 1) Karnofsky performance status (KPS) score \>50; 2) stage T4b (American Joint Committee on Cancer \[AJCC\] 8th edition stage) or peritoneal metastasis was confirmed during or after surgery; 3) life expectancy \>3 months; 4) peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3; and 5) acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation. The exclusion criteria were defined as follows: 1) Performance of emergency surgery due to intestinal obstruction or perforation; 2) a history of inflammatory bowel disease (IBD); and 3) two or more independent surgical procedures on the gastrointestinal tract.
Patients diagnosed with PM or stage T4b who underwent surgery combined with HIPEC
Description:
Patient selection criteria, as previously published \[26\], would include all the following: 1) Karnofsky performance status (KPS) score \>50; 2) stage T4b (American Joint Committee on Cancer \[AJCC\] 8th edition stage) or peritoneal metastasis was confirmed during or after surgery; 3) life expectancy \>3 months; 4) peripheral white blood cell count ≥3,500/mm3 and platelet count ≥80,000/mm3; and 5) acceptable liver, renal, cardiovascular, pulmonary, and coagulation function, and other major organ functions were able to endure a major operation. The exclusion criteria were defined as follows: 1) Performance of emergency surgery due to intestinal obstruction or perforation; 2) a history of inflammatory bowel disease (IBD); and 3) two or more independent surgical procedures on the gastrointestinal tract.
Treatment:
Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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