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Clinical study on the safety and efficacy of single port robot-assisted laparoscopic surgery for children digestive tract malformations and retroperitoneal/pelvic tumor

Clinical study on the safety and efficacy of single port robot-assisted laparoscopic surgery for children digestive tract malformations and retroperitoneal/pelvic tumor

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070365
Enrollment
Unknown
Registered
2023-04-11
Start date
2023-04-11
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Digestive tract malformations and retroperitoneal/pelvic tumors in children

Interventions

Treatment group:Single port laparoscopic surgery was performed by the "Shu-rui" robotic surgical system

Sponsors

Shanghai Children’ s Medical Center Affiliated of shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1) Children with digestive tract malformations (including intestinal duplication, congenital megacolon, choledochal cyst, etc.) and retroperitoneal/pelvic tumors who received treatment in the General Surgery Department of Shanghai Children's Medical Center 2) Older than 3 years and younger than 18 years 3) Weigh more than 15kg 4) Preoperative imaging examination (BE\CT\MRI\ ultrasound) to confirm the diagnosis 5) ASA grade I-II 6) Obtain written consent from the guardian.

Exclusion criteria

Exclusion criteria: 1) Patients in need of emergency surgical intervention2) Anesthesia was used to evaluate patients who could not tolerate pneumoperitoneum3) Tumors surrounding important large blood vessels or nerves4) Intraspinal invasion or growth of tumor5) The maximum tumor diameter is greater than 10cm6) General exclusion: refusal to provide written informed consent/consent form, other known organ dysfunction and complicated vital organ malformations

Design outcomes

Primary

MeasureTime frame
Success rate of operation;

Secondary

MeasureTime frame
Surgical time;Anesthesia time;Intraoperative bleeding volume;Intraperitoneal drainage flow rate 24 hours after surgery;Postoperative abdominal drainage time;Postoperative pain FLACC score;Incidence rate of complications within 30 days after operation;Hospitalization time;

Countries

China

Contacts

Public ContactJiang Dapeng

Shanghai Children’ s Medical Center Affiliated of shanghai Jiao Tong University School of Medicine

jdp509@163.com13671785132

Outcome results

None listed

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