NCT07258017

Brief Summary

Objective: To investigate the multidimensional effects of an interactive video health intervention on the quality of life and clinical rehabilitation indicators of patients with early postoperative bowel obstruction. Methods: The study consists of two phases. Phase 1 (January 2019-December 2020) involves the development and psychometric validation of a Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction, with approximately 150 patients. Phase 2 (January 2021-January 2025) is a randomized controlled trial enrolling about 310 eligible patients (aged 18-75 years, with basic cognitive ability, diagnosed with early postoperative bowel obstruction after abdominal surgery). Participants are randomly assigned to either a control group (conventional care, including condition monitoring, basic treatment, and non-structured health education) or a study group (conventional care plus an interactive video health intervention consisting of five modular videos covering disease knowledge, rehabilitation, and diet, initiated 24 hours post-surgery). Primary and secondary outcomes will include quality of life (assessed with the validated scale), clinical rehabilitation indicators (such as obstruction relief time and hospitalization duration), electrogastrogram parameters, and gut microbiota diversity (16S rRNA sequencing).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
462

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 10, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 13, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 24, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 2, 2025

Completed
Last Updated

December 2, 2025

Status Verified

January 1, 2025

Enrollment Period

6 years

First QC Date

September 24, 2025

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of Life (QoL) Score

    Scale consists of multiple domains assessing physical, psychological, and social functioning. Scores range from 0 to 100, with higher scores indicating better quality of life.

    Baseline (pre-intervention, within 24 hours after surgery) and at hospital discharge (average 8-10 days after randomization).

Secondary Outcomes (5)

  • Time to Relief of Intestinal Obstruction

    From randomization to hospital discharge (daily assessment, average 8-10 days)

  • Duration of Hospitalization

    From the day of surgery through hospital discharge (an average of 7-10 days)

  • Electrogastrogram (EGG) Parameters - Gastric Antrum Slow-Wave Amplitude

    24 hours post-intervention initiati

  • Electrogastrogram (EGG) Parameters - Gastric Slow-Wave Frequency

    24 hours post-intervention initiation and

  • Title: Gut Microbiota Diversity (Shannon Index)

    First postoperative defecation (typically 3-5 days post-surgery)

Other Outcomes (3)

  • Postoperative Quality of Life Assessment Scale Validation - Reliability Metrics

    At postoperative day 7 (single assessment after intervention)

  • Postoperative Quality of Life Assessment Scale Validation - Construct Validity Metrics

    At postoperative day 7 (single assessment after intervention)

  • Expert Consensus Agreement on Questionnaire Items

    During the pre-intervention development phase (single assessment prior to participant enrollment)

Study Arms (2)

Conventional Care Control Group

ACTIVE COMPARATOR
Behavioral: Conventional care

Interactive Video Health Intervention Group

EXPERIMENTAL
Behavioral: Interactive Video Health Intervention

Interventions

Standard conventional care including condition monitoring, basic medical treatment (gastrointestinal decompression, fluid replacement, correction of water-electrolyte disorders), and non-structured health education. Represents the current standard of care for postoperative bowel obstruction patients without the additional video-based intervention component.

Conventional Care Control Group

A structured interactive video intervention consisting of 5 modular videos covering disease knowledge, rehabilitation exercises, and dietary guidance. The videos use animation demonstrations, case analyses, and expert explanations, with interactive elements such as Q\&A sessions and polls. Initiated 24 hours post-surgery, patients can self-paced viewing using tablet devices with researcher support.

Interactive Video Health Intervention Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with early postoperative intestinal obstruction after abdominal surgery based on clinical symptoms, physical examination and imaging
  • Aged between 18 and 75 years
  • With basic cognitive ability and comprehension
  • Informed consent obtained directly from patients; family members provided supplementary consent

You may not qualify if:

  • Serious underlying diseases
  • Serious mental diseases
  • Audio-visual impairment that prevents normal reception of interactive video information
  • Poor compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Fourth Hospital of Changsha

Changsha, Hunan, 410006, China

Location

Related Publications (1)

  • Yao L, Wu D, Liu J, Zhang X, Zhang L. Multidimensional impact analysis of interactive video health intervention on quality of life and clinical rehabilitation indicators in patients with early postoperative bowel obstruction: a randomized controlled trial. Int J Colorectal Dis. 2026 Jan 8;41(1):19. doi: 10.1007/s00384-025-05051-0.

MeSH Terms

Conditions

Intestinal ObstructionPostoperative Complications

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 24, 2025

First Posted

December 2, 2025

Study Start

January 10, 2019

Primary Completion

January 13, 2025

Study Completion

January 24, 2025

Last Updated

December 2, 2025

Record last verified: 2025-01

Locations