Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery (SPONGE)
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|ClinicalTrials.gov Identifier: NCT03334383|
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : May 31, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colon Carcinoma Rectum Carcinoma||Device: Sponge||Not Applicable|
Objective: We study the efficacy of the retractor sponge in laparoscopic colorectal surgery to reduce hospital stay in patients operated for a malignancy. Secondary objectives are duration of surgery, blood-loss, use of diuretics as volume therapy (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative complications.
Study design: Randomized controlled trial, nested within a prospective cohort according to the 'cohort multiple randomized controlled trial' (cmRCT) design.
Study population: Patients with colorectal cancer who undergo laparoscopic surgery, and who have given informed consent to be offered experimental interventions within the PICNIC project. 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 length of hospital stay. Secondary endpoints are duration of surgery, blood-loss, use of diuretics (during surgery as wells as during total hospital stay), postoperative hypoxemia and peri- and postoperative surgical, pulmonary and cardiac 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 PICNIC cohort, we will identify all patients who are eligible for the experimental intervention (use of the sponge) 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, besides dysfunction of the sponge, after which conversion to standard treatment (Trendelenburg position) needs to take place.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial to Evaluate the Effect of a Retractor Sponge in Postoperative Hospital Stay in Laparoscopic Colorectal Surgery in Patients With Malignancy|
|Actual Study Start Date :||January 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||October 2020|
Experimental: Sponge group
Patients offered surgery with the retractor sponge
Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.
Other Name: Endoractor, Kawamoto corporation (Osaka, Japan)
No Intervention: Control group
Patients receiving standard care: surgery in Trendelenburg position
- Postoperative hospital stay (days) [ Time Frame: Up to 4 weeks ]Based on a discharge checklist
- Operation time [ Time Frame: Up to 4 hours ]minutes
- Blood-loss peroperative [ Time Frame: During surgery time ]ml
- Diuretics peroperative and postoperative [ Time Frame: Up to 4 weeks (during hospital stay) ]mg
- Postoperative hypoxemia [ Time Frame: Up to 1 week ]O2 saturation
- Peri- and postoperative surgical complications [ Time Frame: Up to 4 weeks ]number
- Pulmonary complications. [ Time Frame: Up to 4 weeks ]number
- Cardiac complications [ Time Frame: Up to 4 weeks ]number
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03334383
|Contact: Anke B Smits, MDemail@example.com|
|Contact: Alice M Couwenberg, BScfirstname.lastname@example.org|
|St. Antonius Hospital||Recruiting|
|Nieuwegein, Utrecht, Netherlands, 3430EM|
|Contact: Anke B Smits, MD 088 3201919 email@example.com|
|Contact: Alice M Couwenberg, BSc 0031640904560 firstname.lastname@example.org|
|Principal Investigator: Anke B Smits, MD/PhD|
|Sub-Investigator: Alice M Couwenberg, BSc|
|Sub-Investigator: Johannes PM Burbach, MD|
|Sub-Investigator: Helena M Verkooijen, MD/AssProf|
|Sub-Investigator: Peter G Noordzij, MD/PhD|
|Sub-Investigator: Onne Reerink, MD/PhD|
|Sub-Investigator: Marco van Vulpen, MD/Prof|
|Principal Investigator:||Anke B Smits, MD||St. Antonius Hospital|