ERASNCT05516056
ERAS After Cholecystectomy in Kigali, Rwanda
A study testing ERAS clinical pathway in people with ERAS and Gall Bladder Disease, run by Olivier Detry MD PhD at 1 site in Rwanda.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- ERAS, Gall Bladder Disease
- What is being tested?
- ERAS clinical pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteRwanda
- Study dates
- 1 Jan 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All adult patients undergoing scheduled elective laparoscopic cholecystectomy in CHUK, Rwanda
- Signed informed consent
Who cannot join
- acute cholecystitis
- ASA IV patients
- absence of consent
Trial locations and contacts
1 site in 1 country.
Rwanda1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire de Kigali
Kigali, 00250
Martin Nyundo, MD, +250788418727, nyundomartin@gmail.com
Miguel Gasakure, MD, +250786170350, gasakure.as.miguel@gmail.com
About this study
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
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.
Read the 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).
- Conditions
- ERAS, Gall Bladder Disease
- Being tested
- ERAS clinical pathway
- Keywords
- laparoscopy, surgery, Patient oriented outcomes, pain, complication, cholecystectomy, anesthesiology
- Medical subject headings
- Gallbladder Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS clinical pathwayOther
Prospective evaluation of the clinical results of ERAS implementation in the first 50 patients undergoing ERAS for cholecystectomy in CHUK, Rwanda
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | Experimental | First 50 patients included in the ERAS pathway for cholecystectomy in CHUK, Rwanda Receives: Other: ERAS clinical pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Number of days of hospitalization after laparoscopic cholecystectomy (in days)
Measured: 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.
Measured: From the day of the laparoscopic cholecystectomy to postoperative day 90
Secondary outcomes (2)
Cost of laparoscopic cholecystectomy
Total cost of hospitalization and readmission (in Rwandese francs and US $)
Measured: 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.
Measured: From the day of the laparoscopic cholecystectomy to postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ERASStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective and cross sectional study
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olivier Detry MD PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rwanda
- Responsible party
- Sponsor-investigator, Olivier Detry MD PhD, University of Liege
- Investigators
- Olivier Detry, MD PhD, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05516056
- Sponsor's protocol ID
- EC/CHUK/074/2021
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 6 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nyundo M, Kayondo K, Gasakure M, Twagirumukiza JD, Gashegu J, Detry O. Implementation and outcomes of an enhanced recovery after surgery pathway for laparoscopic cholecystectomy in East and Central Africa: A prospective non-randomized controlled trial in Rwanda's Tertiary Teaching Hospital. World J Surg. 2025 Mar;49(3):605-614. doi: 10.1002/wjs.12371. Epub 2024 Oct 10.
PubMed 39390308
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05516056
- Acronym / sponsor ID
- EC/CHUK/074/2021
- Conditions
- ERAS, Gall Bladder Disease
- Keywords
- laparoscopy, surgery, Patient oriented outcomes, pain, complication, cholecystectomy, anesthesiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Olivier Detry MD PhDUniversity, hospital or other
- Collaborators
- University of Rwanda
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 25 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective and cross sectional study
| Arm | Type | Receives |
|---|---|---|
| ERAS group | Experimental | Other: ERAS clinical pathwayFirst 50 patients included in the ERAS pathway for cholecystectomy in CHUK, Rwanda |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All adult patients undergoing scheduled elective laparoscopic cholecystectomy in CHUK, Rwanda
- Signed informed consent
Key exclusion criteria (3 listed)
- acute cholecystitis
- ASA IV patients
- absence of consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS clinical pathwayProspective evaluation of the clinical results of ERAS implementation in the first 50 patients undergoing ERAS for cholecystectomy in CHUK, Rwanda | Other | ERAS group |
Primary outcome
Length of hospital stay
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Number of days of hospitalization after laparoscopic cholecystectomy (in days)
Rate of Postoperative complications
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
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.
2 secondary outcomes
Cost of laparoscopic cholecystectomy
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Patient satisfaction measured with the Satisfaction Likert Scale (SLS)
Time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- Derived from this study: PubMed 39390308Nyundo M, Kayondo K, Gasakure M, Twagirumukiza JD, Gashegu J, Detry O. Implementation and outcomes of an enhanced recovery after surgery pathway for laparoscopic cholecystectomy in East and Central Africa: A prospective non-randomized controlled trial in Rwanda's Tertiary Teaching Hospital. World J Surg. 2025 Mar;49(3):605-614. doi: 10.1002/wjs.12371. Epub 2024 Oct 10.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Detry, MD PhD principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS clinical pathway in people with ERAS and Gall Bladder Disease, run by Olivier Detry MD PhD at 1 site in Rwanda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Rwanda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Nyundo, MD (+250788418727, nyundomartin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: From the day of the laparoscopic cholecystectomy to postoperative day 90). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05516056, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2022.