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

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.

Study Overview

• Status: Unknown
• Conditions: Colon Carcinoma; Rectum Carcinoma
• Intervention / Treatment: Device: Sponge

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 Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anke B Smits, MD; Phone Number: 0031883201919; Email: absmits@antoniusziekenhuis.nl
• Study Contact Backup: Name: Alice M Couwenberg, BSc; Phone Number: 0031640904560; Email: alice.couwenberg@gmail.com

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3430EM
      • Recruiting
      • St. Antonius Hospital
      • Contact: Alice M Couwenberg, BSc; Phone Number: 0031640904560; Email: alice.couwenberg@gmail.com
      • Contact: Anke B Smits, MD; Phone Number: 088 3201919; Email: absmits@antoniusziekenhuis.nl
      • 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Endoractor, Kawamoto corporation (Osaka, Japan)
No Intervention: Control group; Patients receiving standard care: surgery in Trendelenburg position

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative hospital stay (days)	Based on a discharge checklist	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	minutes	Up to 4 hours
Blood-loss peroperative	ml	During surgery time
Diuretics peroperative and postoperative	mg	Up to 4 weeks (during hospital stay)
Postoperative hypoxemia	O2 saturation	Up to 1 week
Peri- and postoperative surgical complications	number	Up to 4 weeks
Pulmonary complications.	number	Up to 4 weeks
Cardiac complications	number	Up to 4 weeks

Collaborators and Investigators

• Sponsor: St. Antonius Hospital
• Investigators: Principal Investigator: Anke B Smits, MD, St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): October 1, 2020

Study Registration Dates

• First Submitted: May 4, 2017
• First Submitted That Met QC Criteria: November 2, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2019
• Last Update Submitted That Met QC Criteria: May 29, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Postoperative complications; Trendelenburg position; Laparoscopic colorectal surgery; Retractor sponge
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 49877 (Registry Identifier: CCMO (toetsingonline.nl): ABR form)