CClinicalTrials.gg
Active, not recruitingNCT07353177Updated Jan 20, 2026

Effects of HIPEC on Postoperative Bowel Motility and Complications

An observational study in HIPEC, Gastro Intestinal Cancer and Adhesion Prevention, sponsored by Peking University People's Hospital. Active, not recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-01-20.

Sponsored by Peking University People's Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2026, 5 months ago, but the record still lists the study as active, not recruiting.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
193
Sex
All
01

Study 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).

02

Conditions studied

  • HIPEC
  • Gastro Intestinal Cancer
  • Adhesion Prevention
  • Bowel Functions
03

In context

Lead sponsor

Peking University People's Hospital is the lead sponsor of 584 studies on the registry; 233 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Involving patients with gastric cancer, appendiceal mucinous neoplasm, or colon cancer who underwent gastrectomy or hemicolectomy surgery with or without HIPEC between January 2017 and December 2023.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
193 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients diagnosed with PM or stage T4b who underwent surgery were included

    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

    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.

    Other: Hyperthermic Intraperitoneal Chemotherapy (HIPEC)

Interventions

  • 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 ℃.

06

What researchers measure

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

07

Study locations

1 site
  • Peking university people's hospital
    Beijing, China
08

References and documents

Publications

  • 1. Montori G, Coccolini F, Ceresoli M, Catena F, Colaianni N, Poletti E, Ansaloni L: The treatment of peritoneal carcinomatosis in advanced gastric cancer: state of the art. Int J Surg Oncol 2014, 2014:912418. 2. Zani S, Papalezova K, Stinnett S, Tyler D, Hsu D, Blazer DG, 3rd: Modest advances in survival for patients with colorectal-associated peritoneal carcinomatosis in the era of modern chemotherapy. J Surg Oncol 2013, 107(4):307-311. 3. Zhang JF, Lv L, Zhao S, Zhou Q, Jiang CG: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Combined with Surgery: A 12-Year Meta-Analysis of this Promising Treatment Strategy for Advanced Gastric Cancer at Different Stages. Ann Surg Oncol 2022, 29(5):3170-3186. 4. Patel M, Arora A, Mukherjee D, Mukherjee S: Effect of hyperthermic intraperitoneal chemotherapy on survival and recurrence rates in advanced gastric cancer: a systematic review and meta-analysis. Int J Surg 2023, 109(8):2435-2450. 5. Verwaal VJ, van Ruth S, de Bree E, van Sloothen GW, van Tinteren H, Boot H, Zoetmulder FA: Randomized trial of cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy and palliative surgery in patients with peritoneal carcinomatosis of colorectal cancer. J Clin Oncol 2003, 21(20):3737-3743. 6. Verwaal VJ, Bruin S, Boot H, van Slooten G, van Tinteren H: 8-year follow-up of randomized trial: cytoreduction and hyperthermic intraperitoneal chemotherapy versus systemic chemotherapy in patients with peritoneal carcinomatosis of colorectal cancer. Ann Surg Oncol 2008, 15(9):2426-2432. 7. Yan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F et al: Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol 2009, 27(36):6237-6242.

Individual participant data

Plan to share: Yes — The datasets used during the current study are available from the corresponding author on reasonable request.

Supporting information: Study protocol, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07353177
Lead sponsor
Peking University People's Hospital
Responsible party
Hongpeng Jiang (attending doctor, Peking University People's Hospital) — Principal investigator
First posted
Jan 20, 2026
Start date
Apr 20, 2025
Primary completion
Apr 30, 2026 (estimated)
Completion
May 30, 2026 (estimated)
Last update
Jan 20, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2025. You cannot join it, but the record below documents what was studied.

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