- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07369219
The Impact of AI-Assisted Nursing Care Intervention Within the Enhanced Recovery Framework on Outcomes of Colorectal Surgery Patients
The Impact of AI-Powered Video-Based Discharge Education and Follow-up Intervention on Patient Outcomes and Home Care Management in Colorectal Surgery Patients Receiving Care in Line With the Postoperative Accelerated Recovery Protocol: A Mixed Methods Study
Colorectal cancer is one of the most common cancers worldwide, affecting a large number of people each year (Bray et al., 2022). Surgical intervention remains the gold standard in treatment. However, advances in surgical techniques and increased effectiveness of neoadjuvant therapies have brought sphincter-preserving surgeries to the forefront, reducing the need for stoma creation compared to the past (Jo & Wilson, 2025; Wang et al., 2025). Even without stoma creation, these patients face complex care needs in the post-discharge period, including changes in bowel habits, nutritional management, and adaptation to physical activity (Wang et al., 2025). Difficult-to-manage complications carry a high risk of readmission to the hospital. Patients receive limited support during the transition from the hospital to home and at home (Storm et al., 2024). Patients and their families are often left alone to manage home care until routine follow-up appointments. Patients, especially those poorly prepared for discharge, may not know how to perform care practices at home or what to watch out for in case of complications. Situations that are well managed in the hospital can spiral out of control upon inadequate follow-up after the patient returns home, leading to unplanned readmissions. Insufficient postoperative patient follow-up can cause anxiety in patients, leading to readmissions due to the inability to manage the home care process effectively (Storm et al., 2024).
Although accelerated recovery after surgery (ERAS) is known to shorten hospital stays (Gustafsson et al., 2025; Gustafsson et al., 2019), studies show varying results regarding readmissions, re-operations, developing complications, and survival (Coleman et al., 2006; Takchi et al., 2020; Lee et al., 2022). These variable results highlight the need for a structured discharge process and home care management for patients who undergo ERAS and are discharged home earlier. In the study by Takchi et al. (2020), a scheduled phone call was proposed as the final step in advanced recovery recommendations and presented as a pilot study. The study reported that each patient contacted reported at least one symptom and personal care need (Takchi et al., 2020). The scheduled phone calls proposed by Takchi et al. (2020) are an important monitoring mechanism in the recovery process; however, they are insufficient.
Supporting this monitoring process with a structured discharge management and AI-powered digital video accessible to the patient at any time, extends the continuity of care to a digital dimension.
It is reported that AI-powered multimedia tools, whose use is increasing with the transformation in health technologies today, reduce cognitive load by concretizing complex surgical processes with audiovisual materials and improve patients' self-care skills regardless of their health literacy level (Mendoza-Pinto et al., 2025). "Content prepared with generative artificial intelligence algorithms, in particular, increases the retention of information and the patient's digital health literacy compared to traditional educational materials (Zaretsky et al., 2024). This study aims to both structure the discharge and post-discharge follow-up process, which is included in ERAS protocols to a limited extent, and to increase the patient's readiness for discharge, improve patient outcomes, and facilitate home care management using AI-assisted educational videos. Thus, the study significantly points to a fourth step, which is included in ERAS guidelines in the pre-operative, intra-operative, and post-operative phases and is felt to be missing: the discharge and home follow-up process.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
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Istanbul, Istanbul, Turkey (Türkiye), 34050
- Acıbadem Maslak Hospital
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Agreement to participate in the study Being 18 years of age or older Ability to communicate in Turkish No visual or hearing impairment No cognitive impairment Undergoing elective colorectal surgery in accordance with an accelerated postoperative recovery protocol
Exclusion Criteria:
Patients who did not meet the inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Routine information, standard care, and follow-up after hospital discharge.
|
Routine postoperative care and standard hospital discharge education are provided in accordance with institutional protocols.
Routine care includes a general postoperative recovery assessment, complication screening, and standard follow-up visits without AI-assisted video training or a scheduled telephone follow-up program.
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Experimental: intervention group
A structured, AI-powered, video-based discharge education program is supported by scheduled follow-up phone calls on days 3, 7, 10, and 30 post-surgery.
An in-depth qualitative interview is also conducted on day 30.
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A structured discharge education program is supported by video-based training and scheduled follow-up phone calls on days 3, 7, 10, and 30 post-operatively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
KATZ Activities of Daily Living (ADL) Scale
Time Frame: Baseline (pre-discharge) and postoperative day 30
|
If the individual can do their ADL independently, they are given 3 points, if they are partially assisted, they are given 2 points, if they cannot do it at all, they are given 1 point and the evaluation is made accordingly.
In the evaluation made according to this scale, 0-6 points are evaluated as dependent, 7-12 points as partially dependent, and 13-18 points as independent.
Accordingly, as the score obtained from the scale increases, dependency decreases.
|
Baseline (pre-discharge) and postoperative day 30
|
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Readiness for Discharge Scale
Time Frame: Up to 30 days after the patient's hospitalization date.
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If the scale dimensions score was ≥7, the patient was considered ready for discharge, and if it was <7, it was considered not ready.
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Up to 30 days after the patient's hospitalization date.
|
|
Gastrointestinal Quality of Life Index (GIQLI)
Time Frame: Baseline (pre-discharge) and postoperative day 30
|
The scale is a 5-point Likert-type scale consisting of 36 items, scored between 0 and 4. While the original scale included sub-dimensions of symptoms, emotions, physical functions, and social functions, the factor analysis conducted in the Turkish validity study revealed a 7-factor structure (sub-dimensions).
The total score obtainable from the scale ranges from 0 to 144.
A higher total score on the scale indicates an improvement in the patient's quality of life specific to the gastrointestinal system and an improvement in their health status.
|
Baseline (pre-discharge) and postoperative day 30
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Day of hospital stay
Time Frame: Up to 30 days after the patient's hospitalization date.
|
Up to 30 days after the patient's hospitalization date.
|
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complications
Time Frame: Up to postoperative day 30
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Up to postoperative day 30
|
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Readmisson
Time Frame: Within 30 days after discharge
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Within 30 days after discharge
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Gustafsson UO, Scott MJ, Hubner M, Nygren J, Demartines N, Francis N, Rockall TA, Young-Fadok TM, Hill AG, Soop M, de Boer HD, Urman RD, Chang GJ, Fichera A, Kessler H, Grass F, Whang EE, Fawcett WJ, Carli F, Lobo DN, Rollins KE, Balfour A, Baldini G, Riedel B, Ljungqvist O. Guidelines for Perioperative Care in Elective Colorectal Surgery: Enhanced Recovery After Surgery (ERAS(R)) Society Recommendations: 2018. World J Surg. 2019 Mar;43(3):659-695. doi: 10.1007/s00268-018-4844-y.
- Mortensen K, Nilsson M, Slim K, Schafer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; Enhanced Recovery After Surgery (ERAS(R)) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS(R)) Society recommendations. Br J Surg. 2014 Sep;101(10):1209-29. doi: 10.1002/bjs.9582. Epub 2014 Jul 21.
- Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
- Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4.
- Jo A, Wilson MZ. From Diversion to Permanence: Trends in Ostomy Creation in Rectal Cancer Surgery. J Clin Med. 2025 Mar 12;14(6):1913. doi: 10.3390/jcm14061913.
- Wang S, Li AJ, Jiang HH, Lin Y, Ding HB. Sphincter-preserving surgical techniques in low rectal cancer management: A systematic review of contemporary evidence. World J Gastrointest Surg. 2025 Jul 27;17(7):107525. doi: 10.4240/wjgs.v17.i7.107525.
- Lee L, Eustache J, Baldini G, Liberman AS, Charlebois P, Stein B, Fiore JF Jr, Feldman LS. Enhanced Recovery 2.0 - Same Day Discharge With Mobile App Follow-up After Minimally Invasive Colorectal Surgery. Ann Surg. 2022 Dec 1;276(6):e812-e818. doi: 10.1097/SLA.0000000000004962. Epub 2021 Jun 2.
- Takchi R, Williams GA, Brauer D, Stoentcheva T, Wolf C, Van Anne B, Woolsey C, Hawkins WG. Extending Enhanced Recovery after Surgery Protocols to the Post-Discharge Setting: A Phone Call Intervention to Support Patients after Expedited Discharge after Pancreaticoduodenectomy. Am Surg. 2020 Jan 1;86(1):42-48.
- Gustafsson UO, Rockall TA, Wexner S, How KY, Emile S, Marchuk A, Fawcett WJ, Sioson M, Riedel B, Chahal R, Balfour A, Baldini G, de Groof EJ, Romagnoli S, Coca-Martinez M, Grass F, Brindle M, Hubner M. Guidelines for perioperative care in elective colorectal surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations 2025. Surgery. 2025 Aug;184:109397. doi: 10.1016/j.surg.2025.109397. Epub 2025 Jun 29. No abstract available.
- Storm M, Morken IM, Austin RC, Nordfonn O, Wathne HB, Urstad KH, Karlsen B, Dalen I, Gjeilo KH, Richardson A, Elwyn G, Bru E, Soreide JA, Korner H, Mo R, Stromberg A, Luras H, Husebo AML. Evaluation of the nurse-assisted eHealth intervention 'eHealth@Hospital-2-Home' on self-care by patients with heart failure and colorectal cancer post-hospital discharge: protocol for a randomised controlled trial. BMC Health Serv Res. 2024 Jan 4;24(1):18. doi: 10.1186/s12913-023-10508-5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Colonic Diseases
- Colonic Neoplasms
- Health Services
- Health Care Facilities Workforce and Services
- Child Health Services
- Community Health Services
- Preventive Health Services
- Early Intervention, Educational
Other Study ID Numbers
- Approval number 2026-07/290
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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