Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery (SPONGE)
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|ClinicalTrials.gov Identifier: NCT02574013|
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Surgery||Device: Endoractor®||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2015|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: sponge-assisted surgery group
Patients offered surgery with use of the retractor sponge
Endoscopic sponge for retraction of small intestine
No Intervention: Control group
Patients receiving standard care, i.e. surgery in Trendelenburg position
- Length of hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]Discharge is based on a checklist
- Operation time (minutes) [ Time Frame: Intraoperative ]
- Blood-loss (ml) [ Time Frame: Intraoperative ]
- Fluid balance (L) [ Time Frame: Intraoperative ]
- Postoperative body temperature [ Time Frame: Baseline ]
- Postoperative oxygen therapy [ Time Frame: Baseline ]Number of participants in need for oxygen therapy leaving the recovery room.
- Postoperative complications [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]Including cardiac, pulmonary, surgical, infectious and thrombovascular events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02574013
|Contact: Anke B Smits, MD PhDfirstname.lastname@example.org|
|Contact: Helena M Verkooijen, MD PhDemail@example.com|
|Principal Investigator:||Anke B Smits, MD PhD||St. Antonius Hospital|