Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery

Colorectal Cancer Clinical Trial

— SPONGE  

Official title:

The Impact of Use of a Retractor Sponge on Duration of Hospital Stay and Perioperative Complications in Patients With Colorectal Cancer Undergoing Laparoscopic Colorectal Surgery: the SPONGE Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02574013
• Other study ID #: NL49877.100.14
• Status: Recruiting
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 2020

Study information

• Verified date: May 2019
• Source: St. Antonius Hospital
• Contact: Anke B Smits, MD PhD
• Phone: 0031883201919
• Email: a.smits[@]antoniusziekenhuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To achieve an adequate visual working field during laparoscopic colorectal surgery without disturbance of the small intestine, patients are positioned in Trendelenburg position. This position results in hemodynamic changes which may increase the risk of cardiopulmonary complications and prolonged hospital stay. Recently, an intraoperative retractor sponge was introduced as alternative for the Trendelenburg position during laparoscopic surgery.

Description:

Objective: To study the impact of use of an intraoperative retractor sponge on duration of hospital stay and risk of perioperative complications in patients undergoing laparoscopic surgery for colorectal cancer.

Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design (clinicaltrials.gov NCT02070146).

Study population: Patients with colorectal cancer who undergo laparoscopic sigmoid of rectal resection, and who have given informed consent to be offered experimental interventions within the prospective cohort. Patient who require open surgery or patients with benign colorectal diseases are excluded for this study.

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

Main study parameters/endpoints: The primary endpoint is hospital stay. Secondary objectives are operation time, blood-loss, fluid balance, body temperature, oxygen therapy and postoperative complications.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The study will be conducted according to the cohort multiple Randomized Controlled Trial (cmRCT) design. Within the PLCRC cohort, we will identify all patients who are eligible for the experimental intervention and who have given informed consent to be invited for future experimental interventions. From this sub cohort, we will randomly select a group of patients to whom we will offer surgery with use of the retractor sponge, which they can accept or decline. Eligible patients from the sub cohort who were not randomly selected will undergo standard treatment, i.e. surgery in Trendelenburg position. We do not expect adverse events in patients in the intervention arm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 188
• Est. completion date: December 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. histologically confirmed distal colon (sigmoid) or rectal cancer,

2. planned for elective laparoscopic colorectal surgery,

3. performance status WHO 0-2

4. broad consent for randomization within ProspectIve data coLlection initiative on ColoRectal Cancer (PLCRC) cohort

Exclusion Criteria:

1. patients planned for open colorectal surgery or emergency colorectal surgery

2. patients with inadequate understanding of the Dutch language in speech and/or writing.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Surgery

Intervention

Device:
• Endoractor®
Endoscopic sponge for retraction of small intestine

Locations

Country	Name	City	State
Netherlands	St. Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of hospital stay	Discharge is based on a checklist	Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary	Operation time (minutes)		Intraoperative
Secondary	Blood-loss (ml)		Intraoperative
Secondary	Fluid balance (L)		Intraoperative
Secondary	Postoperative body temperature		Baseline
Secondary	Postoperative oxygen therapy	Number of participants in need for oxygen therapy leaving the recovery room.	Baseline
Secondary	Postoperative complications	Including cardiac, pulmonary, surgical, infectious and thrombovascular events	Participants will be followed for the duration of hospital stay, an expected average of 1 week

External Links

•   PLCRC - ProspectIve data coLlection initiative on ColoRectal Cancer - a multicenter prospective observational cohort study