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ERAS After Cholecystectomy in Kigali, Rwanda

Primary Purpose

ERAS, Gall Bladder Disease

Status
Recruiting
Phase
Not Applicable
Locations
Rwanda
Study Type
Interventional
Intervention
ERAS clinical pathway
Sponsored by
Olivier Detry MD PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ERAS focused on measuring laparoscopy, surgery, Patient oriented outcomes, pain, complication, cholecystectomy, anesthesiology

Eligibility Criteria

16 Years - 100 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de KigaliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ERAS group

Arm Description

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

Outcomes

Primary Outcome Measures

Length of hospital stay
Number of days of hospitalization after laparoscopic cholecystectomy (in days)
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.

Secondary Outcome Measures

Cost of laparoscopic cholecystectomy
Total cost of hospitalization and readmission (in Rwandese francs and US $)
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.

Full Information

First Posted
August 18, 2022
Last Updated
August 31, 2022
Sponsor
Olivier Detry MD PhD
Collaborators
University of Rwanda
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1. Study Identification

Unique Protocol Identification Number
NCT05516056
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Olivier Detry MD PhD
Collaborators
University of Rwanda

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ERAS, Gall Bladder Disease
Keywords
laparoscopy, surgery, Patient oriented outcomes, pain, complication, cholecystectomy, anesthesiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
prospective and cross sectional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ERAS group
Arm Type
Experimental
Arm Description
First 50 patients included in the ERAS pathway for cholecystectomy in CHUK, Rwanda
Intervention Type
Other
Intervention Name(s)
ERAS clinical pathway
Intervention Description
Prospective evaluation of the clinical results of ERAS implementation in the first 50 patients undergoing ERAS for cholecystectomy in CHUK, Rwanda
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Number of days of hospitalization after laparoscopic cholecystectomy (in days)
Time Frame
From the day of the laparoscopic cholecystectomy to postoperative day 90
Title
Rate of Postoperative complications
Description
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
Secondary Outcome Measure Information:
Title
Cost of laparoscopic cholecystectomy
Description
Total cost of hospitalization and readmission (in Rwandese francs and US $)
Time Frame
From the day of the laparoscopic cholecystectomy to postoperative day 90
Title
Patient satisfaction measured with the Satisfaction Likert Scale (SLS)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martin Nyundo, MD
Phone
+250788418727
Email
nyundomartin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Gasakure, MD
Phone
+250786170350
Email
gasakure.as.miguel@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Detry, MD PhD
Organizational Affiliation
University of Liege
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Kigali
City
Kigali
ZIP/Postal Code
00250
Country
Rwanda
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Nyundo, MD
Phone
+250788418727
Email
nyundomartin@gmail.com
First Name & Middle Initial & Last Name & Degree
Miguel Gasakure, MD
Phone
+250786170350
Email
gasakure.as.miguel@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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ERAS After Cholecystectomy in Kigali, Rwanda

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