Colon CarcinomaSPONGENCT03334383
Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery
A study testing Sponge in people with Colon Carcinoma and Rectum Carcinoma, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract… Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Colon Carcinoma, Rectum Carcinoma
- What is being tested?
- Sponge
- 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
- Jan 2015to Oct 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant in the PICNIC project (METC 12-510)
- Informed consent obtained for being offered experimental interventions within the PICNIC project
- Informed consent obtained for questionnaires on patient reported outcomes within the PICNIC project
- Planned for laparoscopic surgery of distal colorectal cancer in St. Antonius Hospital
Who cannot join
- Planned for open colorectal surgery
- Surgery for benign colorectal diseases
- Emergency colorectal surgery
- 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, 3430EM
Anke B Smits, MD, 088 3201919, absmits@antoniusziekenhuis.nl
Alice M Couwenberg, BSc, 0031640904560, alice.couwenberg@gmail.com
About this study
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
Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract the small intestine. This method is associated with haemostatic changes caused by the cranial shift of abdominal organs and blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor, with the aim to keep the small intestines aside while the patient remains in a horizontal position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a clear surgical field and potentially prevents haemostatic instability by avoiding Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that use of the sponge might be associated with shorter hospital stay.
Read the detailed description
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.
- Conditions
- Colon Carcinoma, Rectum Carcinoma
- Being tested
- Sponge
- Keywords
- Laparoscopic colorectal surgery, Retractor sponge, Trendelenburg position, Postoperative complications
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpongeDevice
Also called Endoractor, Kawamoto corporation (Osaka, Japan)
Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.
| Study group | Role | What they receive |
|---|---|---|
| Sponge group | Experimental | Patients offered surgery with the retractor sponge Receives: Device: Sponge |
| Control group | No intervention | Patients receiving standard care: surgery in Trendelenburg position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative hospital stay (days)
Based on a discharge checklist
Measured: Up to 4 weeks
Secondary outcomes (7)
Operation time
minutes
Measured: Up to 4 hours
Blood-loss peroperative
ml
Measured: During surgery time
Diuretics peroperative and postoperative
mg
Measured: Up to 4 weeks (during hospital stay)
Postoperative hypoxemia
O2 saturation
Measured: Up to 1 week
Peri- and postoperative surgical complications
number
Measured: Up to 4 weeks
Pulmonary complications.
number
Measured: Up to 4 weeks
Cardiac complications
number
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study startJan 2015
- Primary completionJun 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CarcinomaStudies 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, Principal investigator, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03334383
- Sponsor's protocol ID
- 49877
- Other IDs
- 49877
- Acronym
- SPONGE
- Status last verified
- May 2019
- First submitted
- 4 May 2017
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03334383
- Acronym / sponsor ID
- SPONGE / 49877
- Conditions
- Colon Carcinoma, Rectum Carcinoma
- Keywords
- Laparoscopic colorectal surgery, Retractor sponge, Trendelenburg position, Postoperative complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 7 Nov 2017 (actual)
- 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.
Laparoscopic surgery of the distal colon and rectum requires surgery with an appropriate field of view. A commonly used technique to create a clear exposure is the steep Trendelenburg position in which the patient is positioned in an angle of 15 to 40 degrees with the head down using the effect of gravity to retract the small intestine. This method is associated with haemostatic changes caused by the cranial shift of abdominal organs and blood. Recently, a cellulose compressed sponge was developed as intraoperative retractor, with the aim to keep the small intestines aside while the patient remains in a horizontal position. The safety of the sponge is secured with CE marking. The retractor sponge ensures a clear surgical field and potentially prevents haemostatic instability by avoiding Trendelenburg position. A pilot study in the St Antonius Hospital Nieuwegein has shown that use of the sponge might be associated with shorter hospital stay.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sponge group | Experimental | Device: SpongePatients offered surgery with the retractor sponge |
| Control group | No intervention | –Patients receiving standard care: surgery in Trendelenburg position |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant in the PICNIC project (METC 12-510)
- Informed consent obtained for being offered experimental interventions within the PICNIC project
- Informed consent obtained for questionnaires on patient reported outcomes within the PICNIC project
- Planned for laparoscopic surgery of distal colorectal cancer in St. Antonius Hospital
Key exclusion criteria (4 listed)
- Planned for open colorectal surgery
- Surgery for benign colorectal diseases
- Emergency colorectal surgery
- 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 |
|---|---|---|
| SpongeAlso: Endoractor, Kawamoto corporation (Osaka, Japan)Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field. | Device | Sponge group |
Primary outcome
Postoperative hospital stay (days)
Time frame: Up to 4 weeks
Based on a discharge checklist
7 secondary outcomes
Operation time
Time frame: Up to 4 hours
Blood-loss peroperative
Time frame: During surgery time
Diuretics peroperative and postoperative
Time frame: Up to 4 weeks (during hospital stay)
Postoperative hypoxemia
Time frame: Up to 1 week
Peri- and postoperative surgical complications
Time frame: Up to 4 weeks
Pulmonary complications.
Time frame: Up to 4 weeks
Cardiac complications
Time frame: Up to 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
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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 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 Sponge in people with Colon Carcinoma and Rectum Carcinoma, 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 4 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 31 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 (0031883201919, absmits@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative hospital stay (days) (time frame: Up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 May 2019.