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Active Not RecruitingNCT07353177

Effects of HIPEC on Postoperative Bowel Motility and Complications

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

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
193 (estimated)
Sponsor
Peking University People's Hospital · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

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).

Conditions

Interventions

TypeNameDescription
OTHERHyperthermic Intraperitoneal Chemotherapy (HIPEC)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 ℃.

Timeline

Start date
2025-04-20
Primary completion
2026-04-30
Completion
2026-05-30
First posted
2026-01-20
Last updated
2026-01-20

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07353177. Inclusion in this directory is not an endorsement.