NCT03334383

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 4, 2017

Completed
6 months until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

May 31, 2019

Status Verified

May 1, 2019

Enrollment Period

5.4 years

First QC Date

May 4, 2017

Last Update Submit

May 29, 2019

Conditions

Colon CarcinomaRectum Carcinoma

Keywords

Laparoscopic colorectal surgeryRetractor spongeTrendelenburg positionPostoperative complications

Outcome Measures

Primary Outcomes (1)

  • Postoperative hospital stay (days)

    Based on a discharge checklist

    Up to 4 weeks

Secondary Outcomes (7)

  • Operation time

    Up to 4 hours

  • Blood-loss peroperative

    During surgery time

  • Diuretics peroperative and postoperative

    Up to 4 weeks (during hospital stay)

  • Postoperative hypoxemia

    Up to 1 week

  • Peri- and postoperative surgical complications

    Up to 4 weeks

  • +2 more secondary outcomes

Study Arms (2)

Sponge group

EXPERIMENTAL

Patients offered surgery with the retractor sponge

Device: Sponge

Control group

NO INTERVENTION

Patients receiving standard care: surgery in Trendelenburg position

Interventions

SpongeDEVICE

Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.

Also known as: Endoractor, Kawamoto corporation (Osaka, Japan)
Sponge group

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Antonius Hospital

Nieuwegein, Utrecht, 3430EM, Netherlands

RECRUITING

MeSH Terms

Conditions

Colonic NeoplasmsRectal NeoplasmsPostoperative Complications

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Anke B Smits, MD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke B Smits, MD

CONTACT

0031883201919absmits@antoniusziekenhuis.nl

Alice M Couwenberg, BSc

CONTACT

0031640904560alice.couwenberg@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. A.M. Smits

Study Record Dates

First Submitted

May 4, 2017

First Posted

November 7, 2017

Study Start

January 1, 2015

Primary Completion

June 1, 2020

Study Completion

October 1, 2020

Last Updated

May 31, 2019

Record last verified: 2019-05

Locations

NL(1)