Hernia, InguinalNCT07714343
Recover@Home Postoperative Follow-up Study
A study testing Recovery@home in people with Hernia, Inguinal and Hernia, Femoral, run by Icahn School of Medicine at Mount Sinai at 4 sites in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hernia, Inguinal, Hernia, Femoral, Hernia, Umbilical
- What is being tested?
- Recovery@home
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 4 sitesUganda
- Study dates
- 1 Mar 2027to 30 Nov 2029
- Phase
- Interventional
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda4 sites
Hope and Healing Center
Iganga
Isaac Mubezi
Kyabirwa Surgical Center
Jinja, Uganda
Anna Kalumuna, +25639323686, Anna.Kalumuna@kyabirwasc.org
Joseph Okello Damoi
Lubaga Hospital
Kampala
Julius Luyimbaazi
Mengo Hospital
Kampala
About this study
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
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.
Read the 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.
- Conditions
- Hernia, Inguinal, Hernia, Femoral, Hernia, Umbilical, Hernia, Ventral, Thyroidectomy, Appendectomy
- Being tested
- Recovery@home
- Keywords
- ambulatory surgery, nurse-led mobile health, postoperative care delivery, rural surgical facility, recovery at home, implementation science
- Medical subject headings
- Hernia, Inguinal, Hernia, Femoral, Hernia, Umbilical, Hernia, Ventral, Testicular Hydrocele, Varicocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recovery@homeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm: Recovery@Home pathway | Experimental | Discharged early and followed through a structured, nurse-led home-based care pathway supported by mobile health tools. Receives: Other: Recovery@home |
| Traditional inpatient postoperative care | No intervention | Remain admitted for routine postoperative monitoring. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of any postoperative complication within 30 days
Occurrence of any postoperative complication within 30 days-will be treated as a binary variable (1 = complication, 0 = no complication).
Measured: postoperative day 1, postoperative day 3, postoperative day 7, postoperative day 10, postoperative day 14, postoperative day 30
Secondary outcomes (2)
Financial cost to the patient
Indirect and direct costs to the patient
Measured: end of study, at one month
Facility cost
facility costs includes building maintenance cost, personnel cost, material/equipment cost
Measured: end of study, at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Mar 2027 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, Global Surgical Initiatives Kyabirwa Surgical Center, Fogarty International Center of the National Institute of Health
- Responsible party
- Principal investigator, Linda P Zhang, Icahn School of Medicine at Mount Sinai
- Investigators
- Linda P Zhang, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714343
- Sponsor's protocol ID
- GCO 24-0542
- Other IDs
- R21TW012963
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).