Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05522790
Other study ID # IRON_PREHAB
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 18, 2022
Est. completion date April 26, 2023

Study information

Verified date April 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In 2005, colorectal surgery in France represented nearly 40,000 procedures per year, of which 80% were scheduled and 70% were for carcinological purposes. Overall postoperative mortality was estimated at 3.4%, morbidity at 35% and average length of stay at 18 days. In addition, the number of newly diagnosed cases of colorectal cancer was 44,872 in 2017, making it the second leading cause of cancer in women and the third in men. The implementation of colorectal Enhanced Rehabilitation After Surgery (EARS) programs has resulted in a significant reduction in length of stay due to an approximately 50% decrease in postoperative complication rates and a faster return of patients to independence. However, despite the integration of RASC into routine practice, morbidity remains high with an estimated complication rate of 15-20%. The persistence of a high complication rate despite the rehabilitation measures can be explained in part by factors present preoperatively that impair postoperative recovery, such as the existence of comorbidities, low functional capacity, the presence of martial or nutritional deficiencies or glycemic imbalance. Links between the presence of these different "deficits", which may coexist, and postoperative morbidity and mortality have already been shown. Anemia is common in preoperative colorectal surgery and affects approximately one in two patients with cancer. In case of preoperative anemia, the frequency of postoperative complications and the length of stay are increased. Under these conditions, preoperative correction of anemia could facilitate postoperative recovery and reduce the incidence of postoperative complications. In colorectal cancer, anemia is the consequence of an absolute martial deficiency due to iron losses from bleeding and a functional martial deficiency due to decreased availability of iron for erythropoiesis due to inflammation. Correction of preoperative anemia is usually based on 2 types of molecules: iron and erythropoiesis stimulating agents. Erythropoiesis-stimulating agents are not recommended to correct anemia in cancer patients not receiving chemotherapy. Iron can be given orally or intravenously. Intravenous administration is more effective than oral administration in patients with colorectal cancer to correct preoperative anemia. In patients undergoing colon cancer surgery outside of a RAAC program, preoperative iron infusion appears to decrease the incidence of postoperative complications, improve the quality of postoperative recovery, and reduce length of stay. These gains do not appear to be related to correction of preoperative anemia, since preoperative intravenous iron increases hemoglobin levels by only 0.8 g/dl, on average. And, insufficiently to reduce the rate of postoperative transfusion in abdominal or general surgery. Also, the benefits observed with preoperative iron infusion seem to be more related to the direct effects of iron on cardiac and skeletal muscle than by correction of anemia. Since 2016, all patients undergoing scheduled colorectal surgery at the Paris Saint Joseph Hospital Group benefit from the application of a RAAC program. If we do not take into account patients who die during hospitalization (≈ 2%) and patients transferred to Follow-up and Rehabilitation Care (SSR) (≈15%), the impact of the application of a RAAC program is easily measured with the length of stay. Indeed, reducing the frequency of postoperative complications and improving the speed of postoperative recovery translates into reduced lengths of stay. Today, the average length of stay for all patients undergoing colorectal surgery at Saint Joseph Hospital is 7.5 days. The length of stay is longer (8.7 days) in patients with anemia preoperatively compared to those without anemia (7 days). Since 2017, anemic patients scheduled for colorectal surgery, have received intravenous iron infusion preoperatively at Paris Saint Joseph Hospital.


Recruitment information / eligibility

Status Completed
Enrollment 270
Est. completion date April 26, 2023
Est. primary completion date June 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient 18 years of age and older - Patient operated on for colorectal surgery between January 1, 2017 and December 31, 2021 - Patient with preoperative anemia (12 g/dl for women, 13 g/dl for men) - Patient hospitalized in conventional hospitalization Exclusion Criteria: - Patient undergoing emergency surgery - Patient without preoperative hemoglobin measurements - Patient under guardianship or curatorship - Patient deprived of liberty - Patient under court protection - Patient opposing participation in the study

Study Design


Locations

Country Name City State
France Groupe Hospitalier Paris Saint-Joseph Paris

Sponsors (1)

Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (2)

Greco M, Capretti G, Beretta L, Gemma M, Pecorelli N, Braga M. Enhanced recovery program in colorectal surgery: a meta-analysis of randomized controlled trials. World J Surg. 2014 Jun;38(6):1531-41. doi: 10.1007/s00268-013-2416-8. — View Citation

Munoz M, Laso-Morales MJ, Gomez-Ramirez S, Cadellas M, Nunez-Matas MJ, Garcia-Erce JA. Pre-operative haemoglobin levels and iron status in a large multicentre cohort of patients undergoing major elective surgery. Anaesthesia. 2017 Jul;72(7):826-834. doi: 10.1111/anae.13840. Epub 2017 Apr 6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative recovery speed This ouctome corresponds to the postoperative length of stay, which corresponds to the difference between the date of discharge and the date of the operation. Month 1
Secondary Rate of medical complications This ouctome corresponds to the distribution of patients according to the severity of postoperative medical complications measured with the Clavien Dindo scale. Month 1
Secondary Rate of surgical complications This ouctome corresponds to the distribution of patients according to the severity of postoperative surgical complications measured with the Clavien Dindo scale. Month 1
Secondary Rate of patients transfused This ouctome corresponds to the percentage of patients transfused and number of red blood cells (RBCs) per patient transfused. Month 1
Secondary Postoperative hemoglobin level This ouctome corresponds to the Postoperative hemoglobin level (nadir) corresponding to the lowest value measured postoperatively and before transfusion of packed red blood cells. Month 1
See also
  Status Clinical Trial Phase
Terminated NCT03746353 - Early Closure Versus Conventional Closure in Postoperative Patients With Low Anteriresection for Rectal Cancer N/A
Recruiting NCT03560180 - Early Diagnosis of Anastomotic Leakage After Colorectal Surgery: Italian ColoRectal Anastomotic Leakage Study Group.
Completed NCT03357497 - Very Early Mobilization of Colorectal Surgery Patients N/A
Recruiting NCT02143336 - Subcuticular Continuous Suture Versus Skin Staples to Reduce Surgical Site Infections in Colorectal Surgery Patients N/A
Completed NCT02846285 - Causes of Low Digestive Bleeding in Proctology N/A
Completed NCT01547572 - Psychological Preparation for Colorectal Surgery: Impact of Video Education N/A
Completed NCT00731978 - NIRF Trial: Near-Infrared Spectroscopy for Intraoperative Restriction of Fluids Trial N/A
Completed NCT00867958 - Compression Anastomosis Using the CAR™ 27 N/A
Terminated NCT00413127 - Perioperative Protective Effects of Lidocaine Phase 2/Phase 3
Recruiting NCT00498290 - The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery N/A
Not yet recruiting NCT03814681 - Postopoperarive Outcomes After Colorectal Surgery in Europe (euroPOWER)
Completed NCT04040647 - Tolerance of Early Postoperative Mobilization and Ambulation
Completed NCT03012802 - Postoperative Outcomes Within an Enhanced Recovery After Surgery Protocol
Completed NCT03620851 - Enhanced Recovery Program After Colorectal Surgery in Elderly (ERPOLD)
Completed NCT03922113 - Muscle Function After Intensive Care
Completed NCT02947269 - Prucalopride in Postoperative Ileus Phase 3
Recruiting NCT02999217 - Intravenous Iron for Correction of Anaemia After Colorectal Surgery Phase 4
Completed NCT02543190 - System-Wide Improvement for Transitions After Surgery: The SWIFT Post op Program N/A
Completed NCT01220661 - Safety and Efficacy of One Dose Prophylactic Antibiotic in Laparoscopic Colorectal Surgery Phase 2
Recruiting NCT00773981 - Transrectal Vacuum Assisted Drainage: A New Method of Treating Anastomotic Leakage After Rectal Resection Phase 3