To compare the clinical effect of laparoscopic single-incision triangulated umbilicus surgery and conventional laparoscopy: a prospective, randomized controlled clinical study

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100049947

Enrollment

Unknown

Registered

2021-08-14

Start date

2021-09-01

Completion date

Unknown

Last updated

2022-04-19

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

Conditions

A modified single incision single-incision triangulated umbilicus

Interventions

SITUS procedure group:SITUS porcedure

Conventional laparoscopy Group:Conventional laparoscopy

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Substantial space-occupying lesions of abdominal, pelvic, or retroperitoneal organs, in line with clinical indications for surgery; 2. Aged 18 to 80 years; 3. BMI<=32Kg/M2; 4. Contraindications to surgery without clinical evaluation.

Exclusion criteria

Exclusion criteria: 1. Height >=190cm; 2. The solid mass in the abdominal and pelvic cavity is accompanied by extensive metastasis and cannot be surgically removed; 3. History of major abdominal surgery within 2 years, clinical evaluation may be severe abdominal organ adhesion; 4. Surgical scar within 2 years around the umbilicus, which affects the incision and the effect of surgery; 5. Accompanied by severe pulmonary infection or systemic infection, and cannot tolerate general anesthesia surgery; 6. Accompanied by hemorrhagic disease or severe bleeding tendency, which seriously affects the operation process and effect; 7. Severe liver and kidney dysfunction, unable to tolerate anesthesia and surgery; 8. Heart failure, new functional class III and IV, clinical assessment can not tolerate anesthesia and surgery; 9. Anemia HGB<60g/L; 10. Severe agranulocytosis, the absolute value of neutrophils is less than 1.5x10^9/L; 11. Thrombocytopenia, PLT<80x10^9/L; 12. Other clinically assessed conditions that cannot tolerate surgery.

Design outcomes

Primary

Measure	Time frame
PSAQ score;	—

Secondary

Measure	Time frame
length of the incision;Nerve sensation near the incision;Drainage tube removal time;Postoperative hospital stay;VAS pain score;Hemoglobin;time of the incision establishment;time of incision close;time of incision close;	—

Countries

China

Contacts

Public ContactWang Yong

Tangdu Hospital of Air Force Medical University

dryongwangfmmu@163.com+86 29 84717465

Outcome results

None listed

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