Clinical Trials Logo
  1. Home
  2. Laparotomy
  3. NCT01723280

Supplemental Oxygen - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial) — PROXI  

Laparotomy Clinical Trial

Official title:
Perioperative Inspiratory Oxygen Fraction - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)

Clinical Trial Summary

Aim: to investigate the effect of a high inspiratory oxygen fraction (FiO2) given during and after laparotomy procedures on occurrence of a subsequent, new or recurrent, cancer diagnosis at a long-term follow-up.

Background: A high inspiratory oxygen fraction (FiO2 = 0.80) has been linked to prevention of surgical site infection, but the Danish randomized clinical multicenter trial, the PROXI trial, found no difference in frequency of surgical site infection. In fact, long-term mortality was significantly increased with a hazards ratio of 1.30 in patients receiving 80% oxygen, and this appeared to be statistically significant in patients undergoing cancer surgery, but not in non-cancer patients.

At this point, no convincing mechanism explains the observed increased mortality after hyperoxia, as the long-term pathophysiological effects of oxygen are not fully understood.

Primary hypothesis of this follow-up study of the PROXI trial: Use of 80% oxygen increase the frequency of patients with a subsequent, new or recurrent, cancer.

Clinical Trial Description

n/a

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01723280
Study type Observational
Source Rigshospitalet, Denmark
Contact
Status Completed
Phase N/A
Start date October 2006
Completion date November 2012
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Completed NCT03827291 - QL Block With Exparel in Colectomy Phase 4
Recruiting NCT01719796 - Effect of TAP Block on Ventilatory Function Following Abdominal Surgery Phase 2
Completed NCT02596269 - Nefopam/Fentanyl Postoperative Intravenous Patient-Controlled-Analgesia Phase 2/Phase 3
Completed NCT00364741 - Supplemental Oxygen and Complications After Abdominal Surgery (The PROXI-trial) Phase 4
Terminated NCT00514566 - PDS vs Polyamide for Midline Abdominal Closure N/A
Recruiting NCT06089551 - Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery Phase 4
Withdrawn NCT03966768 - DuraMesh Laparotomy Study N/A
Recruiting NCT04985695 - Influence of Analgesic Technique on Post Operative Rehabilitation After Median Laparotomy N/A
Recruiting NCT03739944 - Different Surgical Approaches in Patients of Early-stage Cervical Cancer Phase 3
Terminated NCT01890408 - Continuous Preperitoneal Infusion of Ropivacaine After Open Liver Resection: Effect on Post-operative Recovery and Morbidity. Phase 2
Recruiting NCT00544583 - Continuous Versus Interrupted Abdominal Wall Closure After Emergency Midline Laparotomy Phase 2/Phase 3
Recruiting NCT04256798 - Perioperative Respiratory Care and Outcomes for Patients Undergoing High Risk Abdominal Surgery Phase 3
Recruiting NCT03738969 - Longitudinal Study of Different Surgical Approaches in Chinese Patients of Uterine Cervical Cancer
Completed NCT03989570 - Transversus Abdominis Plane Block Versus Erector Spinae Plane Block N/A
Not yet recruiting NCT04266535 - TCI vs Manually Controlled Infusion of Propofol
Completed NCT04065607 - Indications and Outcome of Laparostomy
Completed NCT01040013 - Gut Oxygenation and Laparoscopy Phase 2
Completed NCT00637936 - Respiratory Effects of Perioperative Oxygen During General Anaesthesia Phase 4
Recruiting NCT03963882 - NAC Followed by RH for the Treatment of LACC Phase 2