Tactile sensor for laparoscopic surgery

JRCT ID: jRCTs042180117

Registered date:19/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: gastric cancer, gastric GIST
• Date of first enrollment: 22/03/2017
• Target sample size: 20
• Study type: Interventional
• Intervention(s): Identify the location of the lesion by this laparoscopic tactile sensing system.

Outcome(s)

• Primary Outcome: Determine whether lesion or marker clip position can be detected.

Secondary Outcome

- Investigate whether the display attached to the operator interferes with the operation.
- Investigate whether the display attached to the operator interferes with other surgical instruments

Key inclusion & exclusion criteria

• Age minimum: 20age
• Age maximum: 80age
• Gender: Both

Include criteria

1) Histologically proven gastric adenocarcinoma.
2) cStage IA(T1N0) or IB(T1N1, T2[MP]N0) or IIA(T3[SS]N0).
3) PS(ECOG) of 0 or 1.
4) No history of upper abdominal surgery.

Exclude criteria

1) Infectious disease with systemic therapy indicated.
2) Body temperature of 38 or more degrees Celsius.
3) Women during pregnancy or breast-feeding.
4) Severe mental disease.
5) Continuous systemic steroid therapy.
6) Unstable angina pectoris, or history of myocardial infarction within six months.
7) Uncontrollable hypertension.
8) Uncontrollable diabetes millutus.
9) Severe respiratory disease requiring continuous oxygen therapy.

Related Information

• Primary Sponsor: Fujiwara Michitaka