- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07855328
Enhanced Recovery After Surgery (ERAS) Protocols on Postoperative Outcomes in Patients Undergoing Major Abdominal Procedures
Impact of Enhanced Recovery After Surgery (ERAS) Protocols on Postoperative Outcomes in Patients Undergoing Major Abdominal Procedures
ERAS protocols are still only partially and unevenly implemented in many hospitals in developing nations, despite substantial worldwide evidence to the contrary. Because of institutional regulations, lack of understanding, or budget constraints, local surgical units frequently stick to traditional perioperative care approaches. Furthermore, there is a dearth of local data assessing the viability and efficacy of ERAS protocols in patients undergoing significant abdominal surgeries in our healthcare settings. Thus, the purpose of this study is to evaluate how ERAS protocols affect the postoperative results of patients having major abdominal surgery at our facility. The study's findings will be useful in determining whether ERAS pathways will assist our patient population heal more quickly, experience fewer issues, and spend less time in the hospital. The results might potentially encourage the use of standardized ERAS procedures in surgical practice, which would enhance patient care and maximize the use of medical resources
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Significant postoperative morbidity, extended hospital stays, delayed recovery, and higher healthcare expenditures are linked to major abdominal surgeries, including colorectal, hepatobiliary, and gastric procedures. Prolonged fasting, copious IV fluids, delayed mobilization, and delayed oral meals are common components of traditional perioperative care, which may raise physiological stress and hinder surgical recovery. Enhanced Recovery After Surgery (ERAS) guidelines have become a contemporary perioperative care strategy in recent years, with the goal of improving surgical outcomes and speeding recovery after major procedures.
In order to reduce surgical stress, maintain physiological function, and encourage early postoperative recovery, ERAS is a multidisciplinary, evidence-based treatment route that incorporates a number of perioperative techniques. Preoperative counseling, reduced fasting with carbohydrate loading, less invasive surgical procedures, multimodal analgesia, early mobilization, early oral feeding introduction, and other coordinated preoperative, intraoperative, and postoperative therapies are all part of these protocols. ERAS protocols have been extensively used in various surgical specialties over the last ten years, especially in colorectal and other significant abdominal procedures. When compared to traditional perioperative treatment, a number of recent research and systematic reviews have shown that ERAS approaches considerably improve postoperative outcomes. Without raising readmission or death rates, ERAS implementation has been linked to fewer postoperative complications, an earlier recovery of bowel function, a shorter hospital stay, and lower healthcare costs
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Muhammad Ali Armughan, MBBS
- Numero di telefono: 03337950197
- Email: armughan915@gmail.com
Backup dei contatti dello studio
- Nome: mudassar saeed pansota, MS urology
- Numero di telefono: 03223044443
- Email: netygeulis749@hotmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Patients of either gender between the ages of 18 and 70 years.
- Individuals having elective major abdominal surgery (such as small bowel resection, right hemicolectomy, left hemicolectomy, sigmoid colectomy, anterior resection, or similar colorectal resection).
- ASA class I-III patients
Exclusion Criteria:
- Patients who need to stay in the intensive care unit (ICU) after surgery for more than twenty-four hours.
- Individuals suffering from significant organ malfunction, such as advanced heart, liver, or kidney failure.
- Individuals who have had significant abdominal surgery within the recent three months.
- Patients who withdraw their consent or decline to participate in the study
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: ERA
|
Patients managed by the surgical team according to the ERAS pathway will be included in Group A (ERAS group) |
|
Comparatore placebo: Cura standard
|
Patients managed according to routine conventional perioperative care during the study period will be included in Group B (conventional care group) |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Rate of Postoperative Complications
Lasso di tempo: 30 days
|
Surgical site infection: superficial, deep, or organ-space infection diagnosed clinically by the treating surgeon or supported by wound findings, culture results, imaging, or the need for antibiotics or drainage. Anastomotic leak: clinical or radiological evidence of leakage from a surgical anastomosis, including feculent discharge from drain or wound, intra-abdominal collection related to anastomosis, or leak confirmed on imaging or reoperation. Ileus: failure of return of bowel function requiring continued nil per oral status, nasogastric decompression, or delayed oral intake beyond routine postoperative recovery as documented by the surgical team). As recorded in the patient's medical file, complications will be found by radiological results, laboratory tests, and clinical examinations |
30 days
|
|
Mean hospital stay
Lasso di tempo: 1 week
|
described as the total number of days between the day of surgery and the day of hospital discharge. For every patient, it will be computed in days and documented |
1 week
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: muhammad ali armughan, MBBS, Allama Iqbal Teaching Hospital, DG Khan
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Allama Iqbal Teaching Hospital
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