Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery (SPONGE)
Primary Purpose
Colorectal Cancer, Surgery
Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Endoractor®
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
- histologically confirmed distal colon (sigmoid) or rectal cancer,
- planned for elective laparoscopic colorectal surgery,
- performance status WHO 0-2
- broad consent for randomization within ProspectIve data coLlection initiative on ColoRectal Cancer (PLCRC) cohort
Exclusion Criteria:
- patients planned for open colorectal surgery or emergency colorectal surgery
- patients with inadequate understanding of the Dutch language in speech and/or writing.
Sites / Locations
- St. Antonius HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
sponge-assisted surgery group
Control group
Arm Description
Patients offered surgery with use of the retractor sponge
Patients receiving standard care, i.e. surgery in Trendelenburg position
Outcomes
Primary Outcome Measures
Length of hospital stay
Discharge is based on a checklist
Secondary Outcome Measures
Operation time (minutes)
Blood-loss (ml)
Fluid balance (L)
Postoperative body temperature
Postoperative oxygen therapy
Number of participants in need for oxygen therapy leaving the recovery room.
Postoperative complications
Including cardiac, pulmonary, surgical, infectious and thrombovascular events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02574013
Brief Title
Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 2015 (undefined)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
sponge-assisted surgery group
Arm Type
Experimental
Arm Description
Patients offered surgery with use of the retractor sponge
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients receiving standard care, i.e. surgery in Trendelenburg position
Intervention Type
Device
Intervention Name(s)
Endoractor®
Intervention Description
Endoscopic sponge for retraction of small intestine
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Discharge is based on a checklist
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary Outcome Measure Information:
Title
Operation time (minutes)
Time Frame
Intraoperative
Title
Blood-loss (ml)
Time Frame
Intraoperative
Title
Fluid balance (L)
Time Frame
Intraoperative
Title
Postoperative body temperature
Time Frame
Baseline
Title
Postoperative oxygen therapy
Description
Number of participants in need for oxygen therapy leaving the recovery room.
Time Frame
Baseline
Title
Postoperative complications
Description
Including cardiac, pulmonary, surgical, infectious and thrombovascular events
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically confirmed distal colon (sigmoid) or rectal cancer,
planned for elective laparoscopic colorectal surgery,
performance status WHO 0-2
broad consent for randomization within ProspectIve data coLlection initiative on ColoRectal Cancer (PLCRC) cohort
Exclusion Criteria:
patients planned for open colorectal surgery or emergency colorectal surgery
patients with inadequate understanding of the Dutch language in speech and/or writing.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anke B Smits, MD PhD
Phone
0031883201919
Email
a.smits@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Helena M Verkooijen, MD PhD
Phone
0031887559575
Email
h.m.verkooijen@umcutrecht.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anke B Smits, MD PhD
Organizational Affiliation
St. Antonius Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3430 EM
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anke B Smits, MD PhD
Phone
0031883201919
Email
a.smits@antoniusziekenhuis.nl
First Name & Middle Initial & Last Name & Degree
Alice M Couwenberg, MD
Phone
0031887567692
Email
a.m.couwenberg-2@umcutrecht.nl
12. IPD Sharing Statement
Citations:
PubMed Identifier
35909251
Citation
Fahim M, Couwenberg A, Verweij ME, Dijksman LM, Verkooijen HM, Smits AB. SPONGE-assisted versus Trendelenburg position surgery in laparoscopic sigmoid and rectal cancer surgery (SPONGE trial): randomized clinical trial. Br J Surg. 2022 Oct 14;109(11):1081-1086. doi: 10.1093/bjs/znac249.
Results Reference
derived
PubMed Identifier
26964861
Citation
Couwenberg AM, Burbach MJ, Smits AB, Van Vulpen M, Van Grevenstein WM, Noordzij PG, Verkooijen HM. The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 10;17(1):132. doi: 10.1186/s13063-016-1256-x.
Results Reference
derived
Learn more about this trial
Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery
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