Effects of HIPEC on Postoperative Bowel Motility and Complications

NCT07353177 | Active Not Recruiting

• 1 other identifier: 2025PHB566-001
• Study Type: observational
• Target: 193
• Locations: 1 country
• Sites: 1

Brief 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

HIPEC; Gastro Intestinal Cancer; Adhesion Prevention; Bowel Functions

Outcome Measures

Primary Outcomes (2)

• Time to first defecation after surgery

  Perioperative

• Length of postoperative stay

  Perioperative

Secondary Outcomes (1)

• Incidence of postoperative complications

  Perioperative

Study Arms (2)

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

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 ℃.

Patients diagnosed with PM or stage T4b who underwent surgery combined with HIPEC

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking university people's hospital

Beijing, China

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Interventions

Hyperthermic Intraperitoneal Chemotherapy

Intervention Hierarchy (Ancestors)

Chemotherapy, Adjuvant; Combined Modality Therapy; Therapeutics; Drug Therapy; Hyperthermia, Induced

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending doctor

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 20, 2026
• Study Start: April 20, 2025
• Primary Completion: April 30, 2026
• Study Completion: May 30, 2026
• Last Updated: January 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

CN (1)