Randomized Controlled Trial to evaluate the effect of a retractor sponge in postoperative hospital stay in laparoscopic colorectal surgery in patients with malignancy.

Randomized Controlled Trial to evaluate the effect of a retractor sponge in postoperative hospital stay in laparoscopic colorectal surgery in patients with malignancy. - SPONGE trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42300

Enrollment

188

Registered

2014-12-05

Start date

2015-12-09

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

colon cancer colorectal cancer rectal cancer

Interventions

Intraoperative use of the retractor sponge versus usual care, i.e. the steep Trendelenburg position.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Participant in the PICNIC project (METC 12-510) - Informed consent obtained for being offered experimental interventions within the PICNIC project - Planned for laparoscopic surgery of distal colorectal cancer in St. Antonius Hospital - WHO perfomance status 0-2

Exclusion criteria

Exclusion criteria: - Planned for open colorectal surgery - Surgery for benign colorectal diseases - Emergency colorectal surgery - Inadequate understanding of the Dutch language in speech and/or writing

Design outcomes

Primary

Measure	Time frame
Length of hospital stay (days).	—

Secondary

Measure	Time frame
Secondary endpoints are duration of surgery, perioperative blood-loss and fluid balance, postoperative oxygenation and peri- and postoperative surgical, pulmonary and cardiac complications.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)