NCT07369219

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress44%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

May 16, 2025

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

June 9, 2026

Status Verified

June 1, 2026

Enrollment Period

3 months

First QC Date

May 16, 2025

Last Update Submit

June 6, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • KATZ Activities of Daily Living (ADL) Scale

    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

  • Readiness for Discharge Scale

    If the scale dimensions score was ≥7, the patient was considered ready for discharge, and if it was \<7, it was considered not ready.

    Up to 30 days after the patient's hospitalization date.

  • Gastrointestinal Quality of Life Index (GIQLI)

    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 Outcomes (3)

  • Day of hospital stay

    Up to 30 days after the patient's hospitalization date.

  • complications

    Up to postoperative day 30

  • Readmisson

    Within 30 days after discharge

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Routine information, standard care, and follow-up after hospital discharge.

Other: Standard maintenance therapy

intervention group

EXPERIMENTAL

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.

Behavioral: Educational intervention

Interventions

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.

intervention group

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.

Control Group

Eligibility Criteria

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Maslak Hospital

Istanbul, Istanbul, 34050, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 25047143BACKGROUND
  • 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.

    PMID: 40142717BACKGROUND
  • 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.

    PMID: 40740930BACKGROUND
  • 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.

    PMID: 34091514BACKGROUND
  • 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.

    PMID: 32077415BACKGROUND
  • 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.

    PMID: 40783294BACKGROUND
  • 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.

    PMID: 30426190BACKGROUND
  • 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.

    PMID: 38178097BACKGROUND
  • 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.

    PMID: 38572751BACKGROUND
  • 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.

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student

Study Record Dates

First Submitted

May 16, 2025

First Posted

January 27, 2026

Study Start

April 10, 2026

Primary Completion

June 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

June 9, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Data is patient specific, therefore, other data will not be shared except for the research results.

Locations