Colorectal CancerSPONGENCT02574013
Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery
A study testing Endoractor® in people with Colorectal Cancer and Surgery, run by St. Antonius Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Surgery
- What is being tested?
- Endoractor®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2015to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients planned for open colorectal surgery or emergency colorectal surgery
- patients with inadequate understanding of the Dutch language in speech and/or writing.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
St. Antonius Hospital
Nieuwegein, Utrecht, 3430 EM
Anke B Smits, MD PhD, 0031883201919, a.smits@antoniusziekenhuis.nl
Alice M Couwenberg, MD, 0031887567692, a.m.couwenberg-2@umcutrecht.nl
About this study
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
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.
Read the 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.
- Conditions
- Colorectal Cancer, Surgery
- Being tested
- Endoractor®
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoractor®Device
Endoscopic sponge for retraction of small intestine
| Study group | Role | What they receive |
|---|---|---|
| sponge-assisted surgery group | Experimental | Patients offered surgery with use of the retractor sponge Receives: Device: Endoractor® |
| Control group | No intervention | Patients receiving standard care, i.e. surgery in Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Discharge is based on a checklist
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Secondary outcomes (6)
Operation time (minutes)
Measured: Intraoperative
Blood-loss (ml)
Measured: Intraoperative
Fluid balance (L)
Measured: Intraoperative
Postoperative body temperature
Measured: Baseline
Postoperative oxygen therapy
Number of participants in need for oxygen therapy leaving the recovery room.
Measured: Baseline
Postoperative complications
Including cardiac, pulmonary, surgical, infectious and thrombovascular events
Measured: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionAug 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. A.B. Smits, St. Antonius Hospital
- Investigators
- Anke B Smits, MD PhD, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02574013
- Sponsor's protocol ID
- NL49877.100.14
- Acronym
- SPONGE
- Status last verified
- May 2019
- First submitted
- 27 Sep 2015
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35909251Couwenberg 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.
PubMed 26964861
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02574013
- Acronym / sponsor ID
- SPONGE / NL49877.100.14
- Conditions
- Colorectal Cancer, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sponge-assisted surgery group | Experimental | Device: Endoractor®Patients offered surgery with use of the retractor sponge |
| Control group | No intervention | –Patients receiving standard care, i.e. surgery in Trendelenburg position |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- patients planned for open colorectal surgery or emergency colorectal surgery
- patients with inadequate understanding of the Dutch language in speech and/or writing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoractor®Endoscopic sponge for retraction of small intestine | Device | sponge-assisted surgery group |
Primary outcome
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
6 secondary outcomes
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
Postoperative complications
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Derived from this study: PubMed 35909251Fahim 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.
- Derived from this study: PubMed 26964861Couwenberg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anke B Smits, MD PhD principal investigator
St. Antonius Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoractor® in people with Colorectal Cancer and Surgery, run by St. Antonius Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anke B Smits, MD PhD (0031883201919, a.smits@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02574013, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.