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Feasibility Study of Enhanced Recovery After Surgery (ERAS) Concept in Endoscopic Submucosal Dissection (ESD) for Upper Gastrointestinal Lesions <= 2 cm: A Prospective, Randomized, Single-Center, Non-Inferiority Study

Feasibility Study of Enhanced Recovery After Surgery (ERAS) Concept in Endoscopic Submucosal Dissection (ESD) for Upper Gastrointestinal Lesions <= 2 cm: A Prospective, Randomized, Single-Center, Non-Inferiority Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104159
Enrollment
Unknown
Registered
2025-06-12
Start date
2025-06-30
Completion date
Unknown
Last updated
2025-06-16

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

Conditions

Upper gastrointestinal lesions <= 2 cm

Interventions

Traditional rehabilitation group:Postoperative fasting: 48-72 hours of fasting in the traditional rehabilitation group
Analgesia: analgesic drugs were applied as needed in the traditional rehabilitation group
Gastrointestinal decompression release time: the third day after surgery in the traditional rehabilitation group
The regular rehabilitation group is carried out by the respective treating doctors.
ERAS group:Postoperative fasting: ERAS group resumed water intake 24 hours after surgery, and then resumed a full liquid diet according to the situation
Analgesia: The ERAS group was routinely treated with parecoxib sodium 40mg intravenously once after surgery
Gastrointestinal decompression release time: ERAS group released on the second day after surgery
One-on-one instruction from a professionally trained mission specialist using the concept of rapid recovery surgery.

Sponsors

General Hospital of Northern Theater Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 65 Years

Inclusion criteria

Inclusion criteria: 1.The initial diagnosis was gastric and esophageal lesions (early cancer, intraepithelial neoplasia, submucosal tumors) with a lesion diameter <=2 cm, all of which were solitary and supported by pathological or endoscopic ultrasound evidence. 2.Patients aged under 65, with a body mass index (BMI) of 18.5 to less than 27.9. 3.Patients with an American Society of Anesthesiologists (ASA) physical status classification of I to III. 4.Patients who have signed an informed consent form, agreeing that their clinical data may be used for future research.

Exclusion criteria

Exclusion criteria: 1.Patients with serum albumin below 35 g/L or hemoglobin below 90 g/L. 2.Patients with bleeding-related risks (taking oral antiplatelet drugs or anticoagulants). 3.Patients who need additional surgical treatment after non-curative ESD. 4.Patients with active gastric ulcers or bleeding, or those who have had gastric bleeding or perforation after using nonsteroidal drugs. 5.Patients with severe heart disease and pulmonary disease. 6.Patients with peripheral vascular or cerebrovascular disease. 7.Patients with moderate to severe liver dysfunction and severe renal dysfunction (creatinine clearance rate less than 30 ml/min). 8.Patients with diabetes. 9.Patients with gastrointestinal motility disorders (constipation) or delayed gastric emptying diseases. 10.Patients with reflux esophagitis or bile reflux gastritis. 11.Patients with inflammatory bowel disease. 12.Pregnant or breastfeeding women. 13.Patients with mental disorders or limited mobility. 14.Patients deemed unsuitable for participation in this study by the investigators.

Design outcomes

Primary

MeasureTime frame
The incidence rates of perforation ;The incidence of bleeding;The incidence of electrocoagulation syndrome;The incidence of postoperative infections ( intraincluding-abdominal infections) ;

Secondary

MeasureTime frame
The incidence of thirst;The incidence of hunger;The incidence of dry mouth;The incidence of postoperative nausea;The incidence of postoperative vomiting;The incidence of abdominal pain;The VAS score for abdominal pain;The time of first flatus;Hospitalization costs;

Countries

China

Contacts

Public ContactZhuo Yang

General Hospital of Northern Theater Command

yangzhuocy@163.com+86 133 0988 8172

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026