An interventional study of ERAS clinical pathway in ERAS and Gall Bladder Disease, sponsored by Olivier Detry MD PhD. Status unknown at 1 site in Rwanda. Open to participants aged 16 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-09-06.
Sponsored by Olivier Detry MD PhD · Not applicable, Interventional, and Treatment
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.
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).
92 studies on the registry are indexed under Gallbladder Diseases; 19 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 59 interventional studies indexed under Gallbladder Diseases.
Browse Gallbladder Diseases studies →This is the only study on the registry with Olivier Detry MD PhD as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Length of hospital stay
Number of days of hospitalization after laparoscopic cholecystectomy (in days)
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Rate of Postoperative complications
All postoperative complications reported according to the Dindo-Clavien grading of surgical complications, graded from grade 0 (no complication) to death (worst outcome) as grade V. This is the standard grading of surgical complication.
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Cost of laparoscopic cholecystectomy
Total cost of hospitalization and readmission (in Rwandese francs and US $)
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Patient satisfaction measured with the Satisfaction Likert Scale (SLS)
Patient satisfaction measured with the 5-point Satisfaction Likert Scale (1: very dissatisfied; 2: dissatisfied; 3: neutral; 4: satisfied; 5: very satisfied.
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Jan 2022 (actual). Primary completion is estimated for Dec 2022, 11 months after the start.
Of 32 non-industry interventional studies with no phase under Gallbladder Diseases, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 26. This study's planned 11 months is below that.
Counting every sponsor, half of 34 studies reached it within 14 months; a quarter within 8 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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