Recover@Home Postoperative Follow-up Study

NCT07714343 | Not Yet Recruiting DMC

• 2 other identifiers: GCO 24-0542R21TW012963
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

Hernia, Inguinal; Hernia, Femoral; Hernia, Umbilical; Hernia, Ventral; Thyroidectomy; Appendectomy; Testicular Hydrocele; Varicocele

Keywords

ambulatory surgery; nurse-led mobile health; postoperative care delivery; rural surgical facility; recovery at home; implementation science

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  end of study, at one month

• Facility cost

  end of study, at one month

Study Arms (2)

Intervention arm: Recovery@Home pathway

EXPERIMENTAL

Discharged early and followed through a structured, nurse-led home-based care pathway supported by mobile health tools.

Other: Recovery@home

Traditional inpatient postoperative care

NO INTERVENTION

Remain admitted for routine postoperative monitoring.

Interventions

Recovery@home OTHER

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.

Intervention arm: Recovery@Home pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• ASA 3 or higher

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• University of Pittsburgh: collaborator
• Global Surgical Initiatives Kyabirwa Surgical Center: collaborator
• Fogarty International Center of the National Institute of Health: collaborator

Study Sites (4)

Kyabirwa Surgical Center

Jinja, Uganda, Uganda

Location

Hope and Healing Center

Iganga, Uganda

Location

Lubaga Hospital

Kampala, Uganda

Location

Mengo Hospital

Kampala, Uganda

Location

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Femoral; Hernia, Umbilical; Hernia, Ventral; Testicular Hydrocele; Varicocele

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Testicular Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Gonadal Disorders; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Linda P Zhang, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda P Zhang, MD

CONTACT

(212) 241-0134; linda.zhang@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to linda.zhang@mountsinai.org. To gain access, data requestors will need to sign a data access agreement. Data are available for 5 years at a third party website (Link tbd.)

Locations

UG (4)