Clinical trial NCT05516056: ERAS After Cholecystectomy in Kigali, Rwanda
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ERAS
Gall Bladder Disease
Keywords: laparoscopy
surgery
Patient oriented outcomes
pain
complication
cholecystectomy
anesthesiology
Lead sponsor: University of Liege
Sponsor class: OTHER
Collaborators: name: University of Rwanda
First posted: 2022-08-25
Enrollment: 50
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: prospective and cross sectional study
Primary purpose: TREATMENT

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.

Detailed description: All adult patients scheduled for laparoscopic cholecystectomy at the CHUK and accepting to be included in the study and the ERAS protocol, will be informed of all steps of the ERAS pathway. Education and discharge plan will be discussed.

A regular ERAS pathway will be proposed. All patients will be allowed to take a regular diet until 6h and carbohydrate loading or clear fluids until 2h before surgery. Thromboembolism prophylaxis with low molecular weight heparins will be administered according to patient's comorbidities. No premedication will be administered. Combined 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 the whole 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.

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.

The ERAS anesthesia postoperative care will include: intravenous paracetamol or ketamine administration when necessary, avoidance of opioids, treatment of nausea and vomiting when necessary. Pain will be assessed every 4 h using NRS pain scale by nursing staff, and paracetamol + NSAID will be given if needed.

Re-feeding will be authorized 2h to 4h after surgery with liquid diet and mobilization. Withdrawal of intravenous infusions will be performed at 6h post-operatively. Patient mobilization will be further encouraged and increased gradually. All meals will be consumed sitting at the table. At 24h after surgery, blood tests (FBC and CRP) will be performed and discharge authorized in case of 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 hours. 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. A last follow-up control will be performed by phone at day 90.

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, 30, and 90, patients will report outcomes that will be recorded by Surgical Recovery Scale (SRS).

Eligibility criteria: Inclusion Criteria:

* All adult patients undergoing scheduled elective laparoscopic cholecystectomy in CHUK, Rwanda
* Signed informed consent

Exclusion Criteria:

* acute cholecystitis
* ASA IV patients
* absence of consent

Primary outcomes:
measure: Length of hospital stay
timeFrame: From the day of the laparoscopic cholecystectomy to postoperative day 90
measure: Rate of Postoperative complications
timeFrame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Secondary outcomes:
measure: Cost of laparoscopic cholecystectomy
timeFrame: From the day of the laparoscopic cholecystectomy to postoperative day 90
measure: Patient satisfaction measured with the Satisfaction Likert Scale (SLS)
timeFrame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Centre Hospitalier Universitaire de Kigali
Study officials:
affiliation: University of Liege
name: Olivier Detry, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: