NCT00591695

Brief Summary

The purpose of this study is to verify whether stent positioning for malignant obstruction of the colon and rectum followed by elective surgery allows reduction of postoperative complications and hospital stay without worsening of evolution of the neoplastic illness, compared to emergency surgery. Primary endpoint will be 60 days postoperative morbidity. Others endpoints will be postoperative mortality, length of hospital stay, need for analgesia.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2008

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

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

December 29, 2007

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

7.8 years

First QC Date

December 29, 2007

Last Update Submit

July 24, 2018

Conditions

Malignant Colorectal Obstruction

Keywords

Malignant Colorectal ObstructionStent Bridge to Surgery

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative complications

    60 days

Secondary Outcomes (7)

  • postoperative mortality

    30 days

  • success percentage of stent positioning in emergency

    at stent positioning

  • percentage of complications related to stent positioning

    at stent positioning

  • length of hospital stay

    3 months

  • quality of life and survival

    3 years

  • +2 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

positioning in emergency of a prosthetic metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour

Procedure: Stent bridge to surgery + elective surgery

B

ACTIVE COMPARATOR

emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy

Procedure: Emergency Surgery

Interventions

Stent bridge to surgery + elective surgeryPROCEDURE

positioning in emergency of a metallic self-expanding stent followed, in case of successful colic decompression, by an elective surgical (laparoscopic or open) resection of the tumour

Also known as: Colorectal stenting with metallic self-expanding stent + elective surgery
A
Emergency SurgeryPROCEDURE

Emergency surgery performed in these ways: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy

Also known as: Resection followed by enterostomy (Hartmann procedure), 'On table' washing and primary anastomoses, Subtotal colectomy
B

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • malignant colonic obstruction localized between splenic flexure and 15 cm from anal margin diagnosed by CTScan.
  • Possibility of endoscopy and stent location during next 24 h after diagnostic.
  • Clinical occlusion to gas and faeces.
  • Informed consent obtained from the patient or from a relative in case of inability.

You may not qualify if:

  • Bowel perforation diagnosed by clinical exploration and complementary studies.
  • Associated pathologies contraindicating general anaesthesia and/or haemodynamic instability.
  • Impossibility to gain a valid informed consent or refusal from the patient.
  • Patients with multiple liver metastases diagnosed by CTScan at the moment of diagnostic and not considered operable with curative intention following the standards of every center.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Surgery, Minimally Invasive Surgery Center, University of Torino

Torino, 10126, Italy

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (1)

  • Arezzo A, Forcignano E, Bonino MA, Balague C, Targarona E, Borghi F, Giraudo G, Ghezzo L, Passera R, Morino M; collaborative ESCO study group. Long-term Oncologic Results After Stenting as a Bridge to Surgery Versus Emergency Surgery for Malignant Left-sided Colonic Obstruction: A Multicenter Randomized Controlled Trial (ESCO Trial). Ann Surg. 2020 Nov;272(5):703-708. doi: 10.1097/SLA.0000000000004324.

    PMID: 32833762DERIVED

MeSH Terms

Interventions

Elective Surgical Procedures

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Mario Morino, Professor of Surgery

    University of TORINO - European Association for Endoscopic Surgery

    PRINCIPAL INVESTIGATOR

  • Eduardo M Targarona, Professor of Surgery

    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgery

Study Record Dates

First Submitted

December 29, 2007

First Posted

January 11, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

IT(1)ES(1)