An interventional study of Conventional care and Interactive Video Health Intervention in Intestinal Obstruction and Postoperative Complications, sponsored by Changsha Fourth Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-02.
Sponsored by Changsha Fourth Hospital · Not applicable, Interventional, and Treatment
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).
104 studies on the registry are indexed under Intestinal Obstruction; 15 are open to participants now.
This study's enrollment of 462 is above the median of 62 across 54 interventional studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →This is the only study on the registry with Changsha Fourth Hospital as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Behavioral: Conventional care
Behavioral: Interactive Video Health Intervention
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.
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.
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.
Time frame: Baseline (pre-intervention, within 24 hours after surgery) and at hospital discharge (average 8-10 days after randomization).
Time to Relief of Intestinal Obstruction
Time from randomization to relief of intestinal obstruction symptoms (abdominal pain, distension, and resumption of defecation/flatus), measured in hours using daily clinical evaluation and patient report.
Time frame: From randomization to hospital discharge (daily assessment, average 8-10 days)
Duration of Hospitalization
Total number of days from the date of surgery to the date of hospital discharge, as recorded in hospital medical records. This indicator reflects postoperative recovery efficiency and the impact of the interactive video intervention on clinical outcomes.
Time frame: From the day of surgery through hospital discharge (an average of 7-10 days)
Electrogastrogram (EGG) Parameters - Gastric Antrum Slow-Wave Amplitude
Gastric antrum slow-wave amplitude measured in microvolts (μV) using electrogastrogram at specified time points.
Time frame: 24 hours post-intervention initiati
Electrogastrogram (EGG) Parameters - Gastric Slow-Wave Frequency
Gastric slow-wave frequency measured in cycles per minute (cpm) using electrogastrogram at specified time points.
Time frame: 24 hours post-intervention initiation and
Title: Gut Microbiota Diversity (Shannon Index)
Alpha diversity of gut microbiota measured by Shannon index using 16S rRNA sequencing of fecal samples.
Time frame: First postoperative defecation (typically 3-5 days post-surgery)
Postoperative Quality of Life Assessment Scale Validation - Reliability Metrics
Internal consistency of the Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction, assessed using Cronbach's alpha (range 0-1; higher scores indicate better internal consistency).
Time frame: At postoperative day 7 (single assessment after intervention)
Postoperative Quality of Life Assessment Scale Validation - Construct Validity Metrics
Construct validity of the Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction (PQOL-EO), assessed using Average Variance Extracted (AVE) and Composite Reliability (CR). Both are unitless indices (range 0-1), where higher values indicate better construct validity and internal consistency of the scale.
Time frame: At postoperative day 7 (single assessment after intervention)
Expert Consensus Agreement on Questionnaire Items
Percentage of questionnaire items rated as "appropriate" or "highly relevant" by an expert panel using a 5-point Likert scale (1 = not relevant to 5 = highly relevant). Higher scores indicate greater content validity and expert consensus regarding the Postoperative Quality of Life Assessment Scale for Early Intestinal Obstruction (PQOL-EO).
Time frame: During the pre-intervention development phase (single assessment prior to participant enrollment)
Ran from Jan 2019 to primary completion in Jan 2025, 72 months.
Of 24 interventional studies with no phase under Intestinal Obstruction, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 59. This study's 72 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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