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NCT Number: NCT07353177

Effects of HIPEC on Postoperative Bowel Motility and Complications

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).

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking university people's hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Other

HIPEC was performed after gastrectomy or hemicolectomy, alimentary tract reconstruction and wound closure. Catheters, including the inflow and outflow tubes, were crossly placed into the abdominal cavity prior to primary abdominal closure. The temperature probes were placed on the inflow and outflow catheter tips. HIPEC was administered for 1 hour with an automatic HIPEC device (Thermochem НТ-1000 (ThermaSolutions, Inc., USA)). Perfusate used was Ringer's solution (5-6 L) mixed with cisplatin 50 mg/m2, 5-fluorouracil 500mg/m2 or raltitrexed 3 mg/m2, and warmed to an inflow temperature of 44 ℃.

Primary outcomes

  1. Time to first defecation after surgery

    Time frame: Perioperative

  2. Length of postoperative stay

    Time frame: Perioperative

Secondary outcomes

  1. Incidence of postoperative complications

    Time frame: Perioperative

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

Effects of Hyperthermic Intraperitoneal Chemotherapy on Postoperative Bowel Motility and Complications: A Single-Center Retrospective Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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