Trial on Postoperative Outcomes According to the Number of Trocar During Laparoscopic Appendectomy

The Catholic University of Korea

Status and phase: Unknown; Phase 1

Conditions: Appendicitis; Complications; Pain

Treatments: Procedure: appendectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00816933

HFHAPPE 01

Details and patient eligibility

About

Appendicitis is the most common benign inflammatory disease that requires an operation.

Laparoscopic appendectomy using three trocar is generally performed, and reveals good surgical outcomes incluing less pain, early recovey, cosmetic effect et al. However, with using three trocar, there are some problems including pain around trocar insertion sites(three portions), wound infecton and scar at trocar insertion sites. For these reasons, more minimal invasive appendectomy is required, with development of laparoscopic instrument,eventually one port sppectomy is developed. So, the investigators assess post-operative Outcomes according to the Number of Trocar.

Enrollment: 140 estimated patients

Sex: All

Ages: 8 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Appendicitis (clinical or radilogical diagnosis)
• ASA < 4

Exclusion criteria

• Appendicitis with palpable mass( clinical or radilogical diagnosis)
• Patient has bleeding tendency
• Pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups

one port

Experimental group

Description:

Patients undergo one port appectomy. Skin incision about 2cm size is made upon umbilicus and dissection is performed to make opening. Then, wound retractcor(Alexis) is iserted on opening site and wound is extended. Rubber glove built-in three 5mm trocars is applied over wound retractor. Pneumoperitoneum is achieved via trocar and appendectomy is performed. After appendectomy, wound is repaired.

Treatment:

Procedure: appendectomy

Three ports

Active Comparator group

Description:

Paitents will undergo three port appendectomy. 10 mm trocar is inserted on umbilicus, and two 5mm trocas is inserted low abdomen, left flank respectively. Appendectomy is performed vis these trocas. After operation, wounds are repaired.

Treatment:

Procedure: appendectomy