ERAS After Cholecystectomy in Kigali, Rwanda

Sponsor

Olivier Detry MD PhD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05516056

Collaborator

University of Rwanda (Other)

Enrollment

Location

Arm

14.9

Anticipated Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Enhanced Recovery After Surgery (ERAS) pathway represents a peri-operative multimodal management aiming at a decrease in surgical aggression and an improved patient rehabilitation, in order to reduce postoperative morbidity, length of hospital stay and, as an important secondary consequence, overall costs. ERAS pathways have been successfully implemented in many surgical managements in the Western world, but very few data exist on ERAS in developing countries. This project aims at the prospective evaluation of ERAS pathway implementation in cholecystectomies in CHUK, Rwanda. The first 50 patients will be prospectively evaluated and compared to the last 50 patients who underwent cholecystectomy before ERAS pathway implementation.

Condition or Disease	Intervention/Treatment	Phase
ERAS Gall Bladder Disease	Other: ERAS clinical pathway	N/A

Detailed Description

Preoperative evaluation All patients included in the ERAS protocol will undergo a preoperative multidisciplinary evaluation performed by the ERAS team. During this evaluation, all informations regarding all steps of the ERAS protocol will be given to the patients including the preoperative steps to follow, such as smoking or alcohol use avoidance. Moreover, informations about the entire postoperative ERAS steps that the patients needed to follow during the hospitalization, will be given. Education and discharge plan will be discussed.

Preoperative fasting All patients will be allowed to take a regular diet until 6 h preop and carbohydrate loading or clear fluids until 2 h before surgery. Thromboembolism prophylaxis with low molecular weight heparins will be administered according to patient's comorbidities.

Anaesthesia protocol No premedication will be administered. Two different types of anesthesia technique will be used: general anesthesia added to local infiltration of the surgical incision. In all cases restricted intra-operative fluid administration (6-8 ml/kg/h) and prevention of hypothermia will be used during the procedure. Moreover, no opioids will be used during all the perioperative period. Antibiotic prophylaxis will be given in agreement with the hospital protocol. Analgesia and prevention of nausea will be given. Immediate postoperative monitoring will be performed in the recovery room where the pain numeric rating scale (NRS) will be routinely evaluated by the anesthesiologist or the NPA.

Surgical technique Laparoscopic approach with a 4-trocar technique will be the first choice when not contraindicated. No abdominal drainage, no nasogastric tube will be used, but if necessary it will be placed immediately during or after anesthesia and removed upon awakening. A bladder catheter will be placed if indicated and removed immediately after surgery.

Postoperative care

Analgesia: IV paracetamol or ketamine administration when necessary.
No opioids
Treatment of nausea and vomiting when necessary
Pain assessment every 4 h using NRS pain scale by nursing staff
If pain not severe: paracetamol + ibuprofen or diclofenac Re-feeding
2h to 4h after surgery: liquid diet and mobilization.
Withdrawal of intravenous infusions (0.7-1 ml/ kg/h) at 6h post-op
From 8h: light semiliquid meal
From the 12h after surgery: a free diet and patient mobilization will be further encouraged and increased gradually. All meals have to be consumed sitting at the table.
From 24h after surgery: Blood works (FBC and CRP) and discharge

Discharge & post discharge The important criteria for the patient's discharge from the hospital will be: normal vital signs and blood tests, absence of complications or symptoms, digestive function enabling the patient to eat without nausea or vomiting, return of intestinal transit with emission of gas (stool not required), autonomy to move and post-operative pain relief with oral analgesics. The patient will be given oral analgesia for at least 48 hour.

After discharge, the surgical team will make follow-up controls by phone on day 3, 5, and 7, to detect any sign of complications during the first week. If no complaint, the outpatient clinic evaluation will be planned at postoperative 15 and 30.

Data collection and analysis A baseline survey will be conducted to assess the awareness and knowledge of health care professional in charge of perioperative care. From November 2021, the investigators will put in place an ERAS protocol for laparoscopic cholecystectomies. Patients living in Kigali and near Kigali having an easy communication means will be sensitized to adhere to the program.

A multidisciplinary team (surgeons, anesthesiologists, nurses, anesthetists and psychologists) will be motivated to be part of the team. A google sheet questionnaire will be designed to collect informations about the awareness and knowledge of perioperative health care professionals on ERAS programme, and then a modified ERAS protocol will be put in place. Data collection will be done using a coded checklist form and consecutive selection of patients will be done during the study period until inclusion of least 50 patients. The operative procedures and instrumentation will be standardized for laparoscopic cholecystectomy, and surgeons with experience in laparoscopic cholecystectomy will perform the procedures. Reasons for conversion from laparoscopic to open cholecystectomy will be recorded and documented.

Exclusion criteria: emergency procedures; patients defined as ASA IV; pediatric patients aged below 16 years of age.

Data will be collected for age, gender, indications for surgery, American Society of Anesthesiology (ASA) class, operative time, adverse events (pain, nausea and vomiting), length of hospitalization, and intra- and post-operative complications. The expenses of surgery and in-hospital care will be calculated and analyzed. After discharge, on days 3, 10, 15 and 30, patients will report outcomes that will be recorded by Surgical Recovery Scale (SRS). After discharge, the patients will be called or texted on phone to know about their status and collect information.

Data will be recorded using EXCEL. Statistical analysis will be done using SPSS software and the one-way analysis of variance (ANOVA) test, the Chi-square test, and the t Student's test will be used when appropriate for comparisons. A Univariate analysis will be done to determine variables associated with the length of hospital stay. Pearson's chi square will be calculated to compare variables. Continuous variables will be presented as mean ± standard deviation or median (range) when appropriate and categorical variables will be presented as frequency (percentage). A Univariate analysis will be performed through a stepwise linear regression model using length of hospital stay as dependent variable and age, BMI, gender, ASA score, intraoperative infusions, pain, analgesia, nausea, vomiting, 30 days-readmission rates, complications and mortality as independent factors. Variables with significant link will be crossed with outcome variables to draw their correlation overnight, using Multivariate logistic regression. A p value < 0.05 will be considered statistically significant.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

prospective and cross sectional studyprospective and cross sectional study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Enhanced Recovery After Surgery Program in a Low and Middle-income Country: Feasibility, Safety, Patient's Acceptance, Reduction of the Length of Hospital Stay, Bed Turnover and Cost Benefits for Laparoscopic Cholecystectomy at CHUK

Actual Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ERAS group First 50 patients included in the ERAS pathway for cholecystectomy in CHUK, Rwanda	Other: ERAS clinical pathway Prospective evaluation of the clinical results of ERAS implementation in the first 50 patients undergoing ERAS for cholecystectomy in CHUK, Rwanda

Arm

Intervention/Treatment

Experimental: ERAS group

First 50 patients included in the ERAS pathway for cholecystectomy in CHUK, Rwanda

Other: ERAS clinical pathway

Prospective evaluation of the clinical results of ERAS implementation in the first 50 patients undergoing ERAS for cholecystectomy in CHUK, Rwanda

Outcome Measures

Primary Outcome Measures

Length of hospital stay in days [1 week]
Number of days of hospitalization after laparoscopic cholecystectomy
Postoperative complications according to Clavien grading [3 months]
All complications graded according to Clavien - Dindo grading of surgical complications
Patient satisfaction measured with the Satisfaction Likert Scale [3 months]
Patient oriented outcome