NCT02574013

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.

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 P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Nov 2015

Longer than P75 for not_applicable colorectal-cancer

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

First Submitted

Initial submission to the registry

September 27, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

4.8 years

First QC Date

September 27, 2015

Last Update Submit

May 29, 2019

Conditions

Colorectal CancerSurgery

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Discharge is based on a checklist

    Participants will be followed for the duration of hospital stay, an expected average of 1 week

Secondary Outcomes (6)

  • Operation time (minutes)

    Intraoperative

  • Blood-loss (ml)

    Intraoperative

  • Fluid balance (L)

    Intraoperative

  • Postoperative body temperature

    Baseline

  • Postoperative oxygen therapy

    Baseline

  • +1 more secondary outcomes

Study Arms (2)

sponge-assisted surgery group

EXPERIMENTAL

Patients offered surgery with use of the retractor sponge

Device: Endoractor®

Control group

NO INTERVENTION

Patients receiving standard care, i.e. surgery in Trendelenburg position

Interventions

Endoractor®DEVICE

Endoscopic sponge for retraction of small intestine

sponge-assisted surgery group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • patients planned for open colorectal surgery or emergency colorectal surgery
  • patients with 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, 3430 EM, Netherlands

RECRUITING

Related Publications (2)

  • Fahim M, Couwenberg A, Verweij ME, Dijksman LM, Verkooijen HM, Smits AB. SPONGE-assisted versus Trendelenburg position surgery in laparoscopic sigmoid and rectal cancer surgery (SPONGE trial): randomized clinical trial. Br J Surg. 2022 Oct 14;109(11):1081-1086. doi: 10.1093/bjs/znac249.

    PMID: 35909251DERIVED

  • Couwenberg AM, Burbach MJ, Smits AB, Van Vulpen M, Van Grevenstein WM, Noordzij PG, Verkooijen HM. The impact of retractor SPONGE-assisted laparoscopic surgery on duration of hospital stay and postoperative complications in patients with colorectal cancer (SPONGE trial): study protocol for a randomized controlled trial. Trials. 2016 Mar 10;17(1):132. doi: 10.1186/s13063-016-1256-x.

    PMID: 26964861DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Anke B Smits, MD PhD

    St. Antonius Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anke B Smits, MD PhD

CONTACT

0031883201919a.smits@antoniusziekenhuis.nl

Helena M Verkooijen, MD PhD

CONTACT

0031887559575h.m.verkooijen@umcutrecht.nl

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
MD PhD

Study Record Dates

First Submitted

September 27, 2015

First Posted

October 12, 2015

Study Start

November 1, 2015

Primary Completion

August 1, 2020

Study Completion

December 1, 2020

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

NL(1)