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Randomized Controlled Trial for Retractor SPONGE Evaluation in Laparoscopic Colorectal Surgery (SPONGE)

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ClinicalTrials.gov Identifier: NCT02574013
Recruitment Status : Recruiting
First Posted : October 12, 2015
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
dr. A.B. Smits, St. Antonius Hospital

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Surgery Device: Endoractor® Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: sponge-assisted surgery group
Patients offered surgery with use of the retractor sponge
Device: Endoractor®
Endoscopic sponge for retraction of small intestine

No Intervention: Control group
Patients receiving standard care, i.e. surgery in Trendelenburg position



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Operation time (minutes) [ Time Frame: Intraoperative ]
  2. Blood-loss (ml) [ Time Frame: Intraoperative ]
  3. Fluid balance (L) [ Time Frame: Intraoperative ]
  4. Postoperative body temperature [ Time Frame: Baseline ]
  5. Postoperative oxygen therapy [ Time Frame: Baseline ]
    Number of participants in need for oxygen therapy leaving the recovery room.

  6. Postoperative complications [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week ]
    Including cardiac, pulmonary, surgical, infectious and thrombovascular events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. histologically confirmed distal colon (sigmoid) or rectal cancer,
  2. planned for elective laparoscopic colorectal surgery,
  3. performance status WHO 0-2
  4. broad consent for randomization within ProspectIve data coLlection initiative on ColoRectal Cancer (PLCRC) cohort

Exclusion Criteria:

  1. patients planned for open colorectal surgery or emergency colorectal surgery
  2. patients with 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): NCT02574013


Contacts
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Contact: Anke B Smits, MD PhD 0031883201919 a.smits@antoniusziekenhuis.nl
Contact: Helena M Verkooijen, MD PhD 0031887559575 h.m.verkooijen@umcutrecht.nl

Locations
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Netherlands
St. Antonius Hospital Recruiting
Nieuwegein, Utrecht, Netherlands, 3430 EM
Contact: Anke B Smits, MD PhD    0031883201919    a.smits@antoniusziekenhuis.nl   
Contact: Alice M Couwenberg, MD    0031887567692    a.m.couwenberg-2@umcutrecht.nl   
Sponsors and Collaborators
St. Antonius Hospital
Investigators
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Principal Investigator: Anke B Smits, MD PhD St. Antonius Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: dr. A.B. Smits, MD PhD, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT02574013    
Other Study ID Numbers: NL49877.100.14
First Posted: October 12, 2015    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases