NCT05516056

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 25, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

September 6, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

August 18, 2022

Last Update Submit

August 31, 2022

Conditions

ERASGall Bladder Disease

Keywords

laparoscopysurgeryPatient oriented outcomespaincomplicationcholecystectomyanesthesiology

Outcome Measures

Primary Outcomes (2)

  • Length of hospital stay

    Number of days of hospitalization after laparoscopic cholecystectomy (in days)

    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.

    From the day of the laparoscopic cholecystectomy to postoperative day 90

Secondary Outcomes (2)

  • Cost of laparoscopic cholecystectomy

    From the day of the laparoscopic cholecystectomy to postoperative day 90

  • Patient satisfaction measured with the Satisfaction Likert Scale (SLS)

    From the day of the laparoscopic cholecystectomy to postoperative day 90

Study Arms (1)

ERAS group

EXPERIMENTAL

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

Other: ERAS clinical pathway

Interventions

ERAS clinical pathwayOTHER

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

ERAS group

Eligibility Criteria

Age16 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • acute cholecystitis
  • ASA IV patients
  • absence of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Kigali

Kigali, 00250, Rwanda

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39390308DERIVED

MeSH Terms

Conditions

Gallbladder DiseasesPain

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Olivier Detry, MD PhD

    University of Liege

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Nyundo, MD

CONTACT

+250788418727nyundomartin@gmail.com

Miguel Gasakure, MD

CONTACT

+250786170350gasakure.as.miguel@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective and cross sectional study
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chargé de Cours (Associate Professor)

Study Record Dates

First Submitted

August 18, 2022

First Posted

August 25, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2022

Study Completion

March 31, 2023

Last Updated

September 6, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

RW(1)