Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Trial for Retractor Sponge Evaluation in Laparoscopic Colorectal Surgery (SPONGE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03334383
Recruitment Status : Recruiting
First Posted : November 7, 2017
Last Update Posted : May 31, 2019
Sponsor:
Information provided by (Responsible Party):
dr. A.B. Smits, St. Antonius Hospital

Brief 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 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.

Condition or disease Intervention/treatment Phase
Colon Carcinoma Rectum Carcinoma Device: Sponge Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sponge group
Patients offered surgery with the retractor sponge
Device: 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



Primary Outcome Measures :
  1. Postoperative hospital stay (days) [ Time Frame: Up to 4 weeks ]
    Based on a discharge checklist


Secondary Outcome Measures :
  1. Operation time [ Time Frame: Up to 4 hours ]
    minutes

  2. Blood-loss peroperative [ Time Frame: During surgery time ]
    ml

  3. Diuretics peroperative and postoperative [ Time Frame: Up to 4 weeks (during hospital stay) ]
    mg

  4. Postoperative hypoxemia [ Time Frame: Up to 1 week ]
    O2 saturation

  5. Peri- and postoperative surgical complications [ Time Frame: Up to 4 weeks ]
    number

  6. Pulmonary complications. [ Time Frame: Up to 4 weeks ]
    number

  7. Cardiac complications [ Time Frame: Up to 4 weeks ]
    number



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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

Exclusion Criteria:

  • Planned for open colorectal surgery
  • Surgery for benign colorectal diseases
  • Emergency colorectal surgery
  • Inadequate understanding of the Dutch language in speech and/or writing

Information from the National Library of Medicine

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): NCT03334383


Contacts
Layout table for location contacts
Contact: Anke B Smits, MD 0031883201919 absmits@antoniusziekenhuis.nl
Contact: Alice M Couwenberg, BSc 0031640904560 alice.couwenberg@gmail.com

Locations
Layout table for location information
Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3430EM
Contact: Anke B Smits, MD    088 3201919    absmits@antoniusziekenhuis.nl   
Contact: Alice M Couwenberg, BSc    0031640904560    alice.couwenberg@gmail.com   
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         
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Layout table for investigator information
Principal Investigator: Anke B Smits, MD St. Antonius Hospital
Layout table for additonal information
Responsible Party: dr. A.B. Smits, Dr. A.M. Smits, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT03334383    
Other Study ID Numbers: 49877
49877 ( Registry Identifier: CCMO (toetsingonline.nl): ABR form )
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Keywords provided by dr. A.B. Smits, St. Antonius Hospital:
Laparoscopic colorectal surgery
Retractor sponge
Trendelenburg position
Postoperative complications
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms