New scoring system to help predict risk of digestive complications after stomach surgery

A multicenter retrospective study on the development and validation of the f-index scoring system for predicting the risk of gastrointestinal fistula after gastrectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN47338250

Enrollment

Registered

2024-10-24

Start date

2023-08-01

Completion date

Unknown

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal fistula after gastrectomy Digestive System

Interventions

This study is a retrospective cohort analysis aimed at developing and validating the F-index scoring system for predicting gastrointestinal fistula risk after gastrectomy. The participants of this stu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who underwent gastrectomy between August 2021 and December 2023. 2. Patients diagnosed with gastrointestinal fistula postoperatively, confirmed by clinical symptoms and imaging or endoscopic examination. 3. Patients who underwent laparoscopic surgery for benign or malignant gastric diseases. 4. Patients with postoperative clinical manifestations of gastrointestinal fistula, including signs of inflammation (heartbeat >100/min, hyperthermia >38?), peritonitis (diffuse abdominal tenderness), respiratory symptoms (cough, expectoration), or elevated white blood cell count (WBC > 11 x 10^9/L). 5. Patients able to provide informed consent or whose consent was provided by a legal representative.

Exclusion criteria

Exclusion criteria: 1. Patients with a history of gastrointestinal fistula prior to laparoscopic surgery. 2. Patients who did not complete follow-up. 3. Patients who died during surgery or due to other major complications that prevented a clear diagnosis of postoperative fistula. 4. Patients who underwent non-laparoscopic surgical procedures for gastric diseases.

Design outcomes

Primary

Measure	Time frame
Risk of developing gastrointestinal fistula after gastrectomy, assessed by the F-index scoring system (measured as high-risk or low-risk classification) measured using patient records at a single time point	—

Secondary

Measure	Time frame
Predictive accuracy of the F-index scoring system, including AUC of the ROC curve, sensitivity, specificity, and calibration plot measured using patient records at a single time point	—

Countries

China

Contacts

Public ContactYongsheng Yang

qdjnmm@163.com+86 15043033136

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 30, 2026