A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?

NCT05547568 | Completed

• 1 other identifier: 2022Ao002*
• Study Type: observational
• Target: 219
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators tend to highlight pre and peroperative factors that predict major postoperative complication after a surgery for resection of peritoneal carcinomatosis. Factors associated with major postoperative complications were used to elaborate un predictive nomogram model. A score was assigned for each factor of the nomogram which correspond to the weight of the association of the factor with the occurrence of the major postoperative complication. The nomogram assessed the probability of major postoperative complication after surgery by adding up the scores identified on the "Points" scale for each factor. The total score projected from the "Total points" axis to the "Risk of major postoperative complication" axis, indicated the probability of major postoperative complication occurrence. A cut-off of total score was calculated to identify patients at low or high risk for major postoperative complications. The developed nomogram may be a helpful tool to adapt postoperative monitoring of patients after surgery of peritoneal carcinomatosis resection according to the risk of occurrence of a major postoperative complication.

Conditions

Peritoneal Carcinomatosis

Outcome Measures

Primary Outcomes (1)

• Major postoperative complications (Dindo-Clavien ≥ 3 grade)

  Follow-up to 90 postoperative days

Interventions

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peritoneal carcinomatosis from various origins suitable for a curative cytoreductive surgery.

You may qualify if:

• Patients with peritoneal carcinomatosis from various origins.
• Suitable for curative surgery
• With a ECOG performance status ≤ 2

You may not qualify if:

• Age \< 18 years old

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

MeSH Terms

Conditions

Peritoneal Neoplasms

Interventions

Cytoreduction Surgical Procedures; Hyperthermic Intraperitoneal Chemotherapy

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; 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: SPONSOR

Study Record Dates

• First Submitted: September 16, 2022
• First Posted: September 21, 2022
• Study Start: September 1, 2012
• Primary Completion: July 1, 2021
• Study Completion: January 1, 2022
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

FR (1)