NCT07587190

Brief Summary

The study aims 1) to adapt, 2) to develop implementation strategies for and 3) to evaluate the effect of implementing a practice guideline for acute abdomen at primary care level in Zambia. We employ a sequential exploratory mixed method study design. Qualitative and quantitative data from health care workers will be used to adapt a practice guideline developed in a high-income into a low- and middle-income (LMIC) context and to develop strategies for successful implementation. The primary outcome of interest is the prospective change in length of stay in hospital among patients presenting with acute abdomen in the intervention site compared to the control site. The study will address the scarcity of literature on practice guidelines for acute abdomen in the LMIC context. The implementation of an adapted guideline may contribute to a reduction of the morbidity and mortality rates associated with acute abdomen in this setting by increasing management capacity at the primary care level.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
30mo left

Started Sep 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Sep 2025Dec 2028

Study Start

First participant enrolled

September 1, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

May 14, 2026

Status Verified

August 1, 2025

Enrollment Period

12 months

First QC Date

May 8, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Acute Abdomen, Practice guidelines, Primary Health Care, Adaptation, Implementation Strategies, Effectiveness-Implementation Hybrid Type 2 Study Design

Outcome Measures

Primary Outcomes (1)

  • Length of Hospital Stay

    The duration of time in days that a patient with acute abdomen stays in the hospital from the day of admission to discharge

    7 days

Study Arms (2)

Intervention site

EXPERIMENTAL

The intervention site will have the guidelines for acute abdomen implemented

Other: Practice guidelines for primary care of acute abdomen

Control site

ACTIVE COMPARATOR

The control site will not have the guidelines implemented

Other: No intervention

Interventions

Adjusted practice guidelines for primary care of acute abdomen will be implemented at the intervention site.

Intervention site

The control site will receive no intervention.

Control site

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Data from all patients 18 year and older with acute abdomen including surgical, gynecological and medical acute abdomen managed at the intervention site and control site will be collected during the study period.

You may not qualify if:

  • All cases of acute abdomen secondary to trauma will be excluded from the study. All patients in the immediate postoperative phase operated from other facilities presenting with acute abdomen.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanyama First Level Hospital and Matero First Level Hospital

Lusaka, Lusaka Province, 10101, Zambia

RECRUITING

MeSH Terms

Conditions

Abdomen, Acute

Interventions

Practice Guidelines as Topic

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Guidelines as TopicQuality Assurance, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Elisabeth Marie Strømme, MD, PhD

    University of Bergen

    STUDY DIRECTOR
  • Thomas Mildestvedt, MD, PhD

    University of Bergen

    STUDY DIRECTOR
  • Eivind Meland

    University of Bergen

    STUDY DIRECTOR
  • Mpundu Makasa

    University of Zambia

    STUDY DIRECTOR

Central Study Contacts

Wilson Mbewe, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 8, 2026

First Posted

May 14, 2026

Study Start

September 1, 2025

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 31, 2028

Last Updated

May 14, 2026

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations