Laparoscopic & Non-Laparoscopic

Laparoscopic and Non-Laparoscopic Surgeries –

Lotus Clinical Research has extensive experience both as a site and CRO in the following soft tissue surgical models:

• Herniorrhaphy (open and laparoscopic)
• Hysterectomy (open and laparoscopic)
• Colon surgery (open and laparoscopic)
• Bariatric surgery
• Laparoscopic cholecystectomy

Abdominoplasty is generally a superior soft tissue model to all the model choices listed above. However, there are circumstances in which abdominoplasty is either not appropriate or not feasible. In these situations, Lotus Clinical Research recommends that sponsors explore one of the models listed above.

Lotus Clinical Research has implemented the following key success factors in previous soft tissue surgery trials:

• Selection of sites with a history of reliable enrollment
• Consensus building among surgeons and anesthesiologists regarding an acceptable regimen of preoperative medications
• Standardization of ancillary hospital services that tend to confound analgesic results (physical therapy, nerve block, local anesthetic wound infiltration, and incentive spirometry)
• Subject training regarding differentiation of bloating and cramping (visceral discomfort) versus incisional pain (somatic discomfort)
• Placebo response training for study subjects and research staff

Enrollment

Lotus Clinical Research is located inside of Huntington Hospital, which is a large tertiary care center with a high volume of abdominal soft tissue surgeries. As such, Lotus Clinical Research has long standing relationships with multiple general surgeons and anesthesiologists within the hospital. This facilitates rapid enrollment into soft tissue surgical research studies.