Predictive Factors for Roux Stasis Syndrome

NCT04919577 | Completed

• 1 other identifier: PekingUTH M2019173
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 were retrospectively analyzed. The occurrence of RSS was evaluated and examined for correlations with demographic and clinicopathological data. "R" package was used to build a nomogram.

Conditions

Gastrostomy

Keywords

Roux stasis syndrome Gastric cancer

Outcome Measures

Primary Outcomes (1)

• Roux stasis syndrome

  Yes or No. We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. If all three conditions meet at the same time and occur within 30 days after operation, we choose Yes, otherwise, we choose No.

  2014.03.01 to 2021.03.01

Secondary Outcomes (14)

• Age

  2014.03.01 to 2021.03.01

• body mass index (BMI)

  2014.03.01 to 2021.03.01

• smoking, diabetes

  2014.03.01 to 2021.03.01

• operation approach

  2014.03.01 to 2021.03.01

• operation time

  2014.03.01 to 2021.03.01

Study Arms (2)

RSS- Group

Patients without RSS after distal gastrectomy.

Diagnostic Test: X-ray

RSS+ Group

Patients with RSS after distal gastrectomy.

Diagnostic Test: X-ray

Interventions

X-ray DIAGNOSTIC_TEST

We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. All three conditions must be met at the same time and should occur within 30 days after operation.

Also known as: CT and Upper Gastroenterography

RSS+ Group; RSS- Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients who were pathologically diagnosed with gastric cancer and underwent distal gastrectomy with R-Y reconstruction between March 2014 and March 2021 at Peking University Third Hospital were retrospectively selected

You may qualify if:

• pathologically diagnosed with gastric cancer
• underwent distal gastrectomy with R-Y reconstruction
• the date of admission is between March 2014 and March 2021
• the admission place is Peking University Third Hospital.

You may not qualify if:

• patients with distant metastasis
• patients with palliative surgery
• death occurred within 14 days after operation
• patients with primary malignant disease in other organs besides stomach.

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

General Surgery Department, Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Wei Fu, MD

  General Surgery Department, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

• Xin Zhou, MD

  eneral Surgery Department, Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: March 1, 2014
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 9, 2021

Record last verified: 2021-06

Locations

CN (1)