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Laparoscopic-assisted ileostomy reversal versus conventional open surgery for efficacy, safety, and postoperative recovery: a prospective, randomized, assessor-blinded, parallel-group clinical trial

Laparoscopic-assisted ileostomy reversal versus conventional open surgery for efficacy, safety, and postoperative recovery: a prospective, randomized, assessor-blinded, parallel-group clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127406
Enrollment
Unknown
Registered
2026-06-30
Start date
2026-07-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Postoperative ileus

Interventions

Conventional open ileostomy reversal group:Conventional open ileostomy reversal
Laparoscopic-assisted ileostomy reversal group:Laparoscopic-assisted ileostomy reversal

Sponsors

Huai He Hospital of Henan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75 years, both genders; 2. Previous temporary ileostomy for benign or malignant colorectal disease, now scheduled for reversal; 3. Stoma duration >=3 months with normal stoma function; 4. Preoperative imaging (CT/MRI) showing no tumor recurrence/metastasis; 5. Preoperative colonoscopy or contrast study confirming distal bowel patency; 6. ASA grade I-III; 7. Voluntary participation with signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Emergency surgery or acute abdomen such as intestinal obstruction or peritonitis; 2. Previous major abdominal surgery other than colorectal procedure, with expected extensive adhesions; 3. Distal bowel stenosis, ischemia, or anastomotic leak; 4. Severe cardiopulmonary insufficiency unable to tolerate pneumoperitoneum; 5. Hepatic or renal failure (Child-Pugh C or requiring dialysis); 6. Coagulation disorders or long-term anticoagulation therapy; 7. Pregnant or lactating women; 8. Mental illness or cognitive impairment; 9. Extensive peritoneal metastasis or locally advanced tumor; 10. Obesity (BMI>=35 kg/m^²); 11. Intraoperative conversion to open surgery due to extensive adhesions (laparoscopic group).

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative ileus within 30 days;

Secondary

MeasureTime frame
30-day readmission rate;Overall postoperative complication rate within 30 days;Length of postoperative hospital stay;Quality of life score;Intraoperative blood loss;Reoperation rate;Time to first flatus and defecation;Total operative time;

Countries

China

Contacts

Public ContactLi Xingwang

Huai He Hospital of Henan University

kflxwang@163.com+86 371 23906598

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026