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A prospective non randomized controlled study of Da Vinci robot assisted surgery and traditional open surgery in the treatment of nodular goiter

A prospective non randomized controlled study of Da Vinci robot assisted surgery and traditional open surgery in the treatment of nodular goiter

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONN-17013723
Enrollment
Unknown
Registered
2017-12-06
Start date
2017-12-15
Completion date
Unknown
Last updated
2017-12-11

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

Conditions

nodular goiter

Interventions

Open Group:Traditional open surgery

Sponsors

Lanzhou General Hospital of The Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
25 Years to 80 Years

Inclusion criteria

Inclusion criteria: Robots Group: (1) Aged between 18-70 years old, male or female;Patients conforming to surgical indications of nodular goiter; (2) Patients without a history of neck surgery; (3) Women are not in pregnancy or lactation; (4) The neck and chest are well developed, and the operation space of the robot thyroid operation can be established well; (5) The diameter of the largest lump < 5cm; (6) Parathyroid hyperparathyroidism and parathyroid gland development were normal, and there was no significant variation in the position; (7) patients be able to tolerate surgery; (8) Struma without sternum; (9) Patients who signed the study's informed consent book. Open Group: (1) Aged between 18-70 years old, male or female;Patients conforming to surgical indications of nodular goiter; (2) Retrosternal struma; (3) A clinical symptom caused by pressure of the trachea, esophagus, or recurrent laryngeal nerve. (4) The patients with great goiter affects work and life; (5) Patients with hyperthyroidism secondary to nodular goiter, followed by strict preparation before hyperthyroidism; (6) A patient with a suspected malignant nodular goiter; (7) Patients with nodular goiter requiring traditional open surgery; (8) Patients who signed the study's informed consent book.

Exclusion criteria

Exclusion criteria: Robot Group: (1) Patients younger than 25 years old or more than 80 years old and refuse to perform surgical treatment and sign informed consent or informed consent; (2) Patients who do not meet the indications of nodular goiter; (3) Patients with a history of neck surgery or cervical radiotherapy; (4) Patients who refused to perform robotic thyroid surgery; (5) Women in pregnancy or lactation; (6) Patients with a short flat neck and a deformity of the thoracic cavity; (7) Substernal struma; (8) The diameter of the largest lump is >5 cm; (9) A patient with primary hyperparathyroidism; Location of the parathyroid gland outside the neck; (10) Patients who are intolerant of general anesthesia and surgery; (11) Diagnosis of other diseases of non nodular goiter by thyroid color Doppler ultrasound or diagnostic fine needle aspiration biopsy. Open Group: (1) Patients younger than 25 years old or more than 80 years old; patients who do not meet the indications of nodular goiter surgery; (2) A patient who refuses to undergo surgical treatment and refuses to sign an informed consent form or an informed consent; (3) A patient with a physiological goiter; (4) Patients who are intolerant of general anesthesia and surgery; (5) Patients with non nodular goiter with thyroid color Doppler ultrasound or diagnostic fine needle biopsy.

Design outcomes

Primary

MeasureTime frame
Postoperatively clinical outcome indicators;Postoperative complications;Markers of inflammat;Immunologic function indicators;

Secondary

MeasureTime frame
Visual analogue score of postoperative incision pain;NSS;

Countries

China

Contacts

Public ContactHongbin Liu

Lanzhou General Hospital of The Chinese People's Liberation Army

liuhongbin999@163.com+86 13609936150

Outcome results

None listed

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