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Not yet recruiting NCT07714343

Recover@Home Postoperative Follow-up Study

No phase Interventional Hernia, Inguinal Hernia, Femoral Hernia, Umbilical Hernia, Ventral

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Recovery@home.
Who it may be relevant to
Registry conditions: Hernia, Inguinal, Hernia, Femoral, Hernia, Umbilical, Hernia, Ventral. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Uganda
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Incorporating Mobile Technology Into Postoperative Care: A Randomized-Control Trial on Ambulatory Surgery With Recover@Home Approach Compared to Traditional Postoperative Inpatient Stay

Overview

This proposal describes a human subjects research study evaluating mHealth Ambulatory Surgery with Follow-up Nurse (Recovery@Home), as an alternative postoperative care pathway for selected low-acuity surgical procedures in Uganda. The Recovery@Home model discharges eligible patients home on the day of surgery and provides structured postoperative follow-up through nurse telephone calls, home visits, mobile-app documentation, escalation algorithms, and surgeon teleconsultation when clinically indicated. The proposed research includes a design to evaluate Recovery@Home against traditional postoperative inpatient care in a randomized controlled trial across three participating Ugandan surgical facilities.

Detailed description

Surgeries in high-income countries have progressively transitioned to ambulatory settings, but in low- and middle-income countries, even patients who have low-acuity surgeries still typically stay in the hospital after their surgeries, and these postoperative inpatient stays are costly and inefficient, for both patients and the surgical facilities. We propose an innovative approach of Recover@Home in Uganda, incorporating mobile technology into postoperative care, to ensure safe, cost-effective and efficient care with same-day discharge and reliable follow-up after surgery. Using a multicenter, randomized controlled trial, we will provide the evidence necessary to shift practice towards ambulatory surgery for low-acuity surgical procedures, resulting in more efficient and effective allocation of healthcare resources in LMICs.

Interventions

  • Other Recovery@home
    The Recovery@Home model discharges eligible patients home on the day of surgery and provides structured postoperative follow-up through nurse telephone calls, home visits, mobile-app documentation, escalation algorithms, and surgeon teleconsultation when clinically indicated.

Primary outcome measures

  • Occurrence of any postoperative complication within 30 days [Time frame: postoperative day 1, postoperative day 3, postoperative day 7, postoperative day 10, postoperative day 14, postoperative day 30]
Secondary outcome measures (2)
  • Financial cost to the patient [Time frame: end of study, at one month]
  • Facility cost [Time frame: end of study, at one month]

Eligibility criteria

Inclusion criteria

  • Age 18 years or older.
  • Undergoing one of the eligible surgical procedures: inguinal/femoral hernia repair; umbilical/epigastric hernia repair; excision of soft tissue tumors; thyroidectomy; or appendectomy; varicocelectomy, hydrocelectomy.
  • Able to provide informed consent, with consent read aloud and/or fingerprint signature permitted where approved by local ethics authorities.
  • Available for inpatient interviews, postoperative clinic visit interviews, and postoperative telephone and/or home follow-up during the 30-day postoperative period.

Exclusion criteria

  • Clinical determination by the surgeon or anesthesia team that same-day discharge is unsafe or inappropriate.
  • Inability to provide informed consent or lack of an approved surrogate/alternative consent process if required by the IRB.
  • Any other exclusion required by the final approved protocol or local regulatory authority.
  • ASA 3 or higher

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Uganda · 4 centers
  • Kyabirwa Surgical Center — Jinja
  • Hope and Healing Center — Iganga
  • Lubaga Hospital — Kampala
  • Mengo Hospital — Kampala

Identifiers

NCT: NCT07714343 · GCO 24-0542 · R21TW012963

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗