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Trial · NCT07893938

Registered outcomes37

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryLength of postoperative hospital stayFrom surgery to hospital discharge during the index hospitalization, up to 17 days after surgery.Number of days from surgery to hospital discharge during the index hospitalization.
SecondaryTime to first postoperative flatusFrom returning to the ward after surgery until the first passage of flatus, up to 29 hours after surgery.Time from the end of surgery to the first passage of flatus, measured in hours.
SecondaryTime to first postoperative bowel movementFrom returning to the ward after surgery until the first bowel movement, up to 126 hours after surgery.Time from the end of surgery to the first bowel movement, measured in hours.
SecondaryTotal postoperative drainage volumeAfter surgery until drain removal, up to postoperative day 7.Cumulative postoperative drainage volume collected until drain removal, measured in milliliters.
SecondaryPostoperative drainage durationFrom postoperative day 1 until drain removal, up to postoperative day 7.Duration from postoperative day 1 to drain removal, measured in days.
SecondaryTime to first postoperative out-of-bed mobilizationFrom the end of surgery until the first mobilization out of bed, up to postoperative day 8.Timing of the first postoperative mobilization out of bed after the end of surgery, recorded as the postoperative day number. Postoperative day 1 is the calendar day after surgery.
SecondaryPercentage of participants with impaired surgical wound healingDuring the index postoperative hospitalization (up to 17 days after surgery) and at 1 month after surgery.
Percentage of participants with impaired healing of the surgical incision, based on clinical observation during the index hospitalization and reassessment at the outpatient follow-up visit 1 month after surgery. Each participant with impaired wound healing is counted once.
SecondaryPercentage of participants with postoperative infectionsDuring the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Percentage of participants who experienced at least one postoperative infection by 1 month after surgery. Infections include surgical incision infections, pulmonary infections (including pneumonia), urinary tract infections, and deep tissue infections. Events are ascertained during hospitalization and at the 1-month outpatient follow-up visit. Each participant is counted once, regardless of the number or sites of infection.
SecondaryPercentage of participants with postoperative complicationsDuring the index postoperative hospitalization (up to 17 days after surgery) and at the outpatient follow-up visit 1 month after surgery.
Percentage of participants who experienced at least one postoperative complication by 1 month after surgery. Complications include postoperative infections, gastrointestinal reactions (abdominal distension, constipation, or diarrhea), impaired surgical wound healing, lower-limb deep vein thrombosis, renal insufficiency, and pressure ulcers. Events are ascertained during hospitalization and at the 1-month outpatient follow-up visit. Each participant is counted once, regardless of the number or types of complication.
SecondaryBody mass indexAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Body mass index calculated as body weight in kilograms divided by height in meters squared, reported in kg/m\^2.
SecondaryTriceps skinfold thicknessAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Triceps skinfold thickness, measured in millimeters.
SecondaryMid-upper arm circumferenceAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Mid-upper arm circumference, measured in centimeters.
SecondaryMid-upper arm muscle circumferenceAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Mid-upper arm muscle circumference, reported in centimeters.
SecondaryMean bilateral handgrip strengthAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Arithmetic mean of the left- and right-hand grip strength measurements, reported in kilograms.
SecondaryWaist circumferenceAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Waist circumference, measured in centimeters.
SecondaryHip circumferenceAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Hip circumference, measured in centimeters.
SecondaryWaist-to-hip ratioAt hospital admission and at the pre-discharge assessment (the latter performed up to 17 days after surgery).Waist circumference divided by hip circumference, with both measurements expressed in centimeters. The ratio is dimensionless.
SecondaryVisual Analog Scale score for overall painAt hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.Overall pain intensity assessed using a Visual Analog Scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain. Higher scores indicate greater pain intensity.
SecondaryJapanese Orthopaedic Association low back pain scoreAt hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Low back symptoms and function assessed using the Japanese Orthopaedic Association (JOA) low back pain score. The score includes subjective symptoms (0 to 9 points), clinical signs (0 to 6 points), activities of daily living (0 to 14 points), and urinary bladder function (-6 to 0 points). The total score ranges from -6 to 29 points, with higher scores indicating better clinical status and function.
SecondaryNutritional Risk Screening 2002 scoreAt hospital admission; on postoperative day 3; at the pre-discharge assessment (up to 17 days after surgery); and at 1 month after surgery.
Nutritional risk assessed using Nutritional Risk Screening 2002 (NRS-2002). The total score is the sum of the impaired nutritional status score (0 to 3) and the disease severity score (0 to 3), with 1 additional point for participants aged 70 years or older. The total score ranges from 0 to 7, with higher scores indicating greater nutritional risk.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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