Stapled or endloop closure of the appendiceal stump in laparoscopic appendectomy. A multicenter blinded randomised trial

Stapled or endloop closure of the appendiceal stump in laparoscopic appendectomy. A multicenter blinded randomised trial - STELLA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON34175

Enrollment

1200

Registered

2010-10-18

Start date

2010-10-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

appendicitis

Interventions

Laparoscopic appendectomy with either stomp closure with use of the endostapler or with the use of endoloops. The procedure is performed according to the Best Practice Guidelines of the Working Grou

Eligibility

Age

12 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patient eligible for laparoscopy Clinical suspicion for acute appendicitis Appendicitis on ultrasound, CT or MRI

Exclusion criteria

Exclusion criteria: Perforation of the appendiceal base Inflammation of the caecum

Design outcomes

Primary

Measure	Time frame
The primary outcome parameters are superficial and intra-abdominal infections. Superficial trocar wound infections demand opening of the wound and additional wound care. After discharge, patients will visit the outpatient department more frequently and return to daily activities is delayed until sepsis has resolved. Intra-abdominal abscesses will require percutaneous drainage or surgery resulting in prolonged hospital stay or readmission after discharge.	—

Measure

Time frame

The primary outcome parameters are superficial and intra-abdominal infections. Superficial trocar wound infections demand opening of the wound and additional wound care. After discharge, patients will visit the outpatient department more frequently and return to daily activities is delayed until sepsis has resolved. Intra-abdominal abscesses will require percutaneous drainage or surgery resulting in prolonged hospital stay or readmission after discharge.

—

Secondary

Measure	Time frame
Postoperative quality of life at two, four and twelve weeks (SF-36, EQ-5D) operating time, conversion rate, overall morbidity, hospital stay, return to work or school, direct and indirect medical costs (direct: equipment, operating time, infectious complications and indirect: return to work, daily activity) .	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)