NCT00530322

Brief Summary

To ascertain whether there are fewer adhesions (internal scars) formed following laparoscopic (key-hole) surgery for colorectal diseases than traditional open surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
Last Updated

September 17, 2007

Status Verified

September 1, 2007

First QC Date

September 13, 2007

Last Update Submit

September 13, 2007

Conditions

Adhesions

Keywords

AdhesionsLaparoscopyColorectal surgeryColorectal disease

Study Arms (2)

A

Patients who have had previous open colorectal surgery and are referred for a further operative procedure, at which time a "second-look" laparoscopy can be performed.

Procedure: Laparoscopy

B

Patients who have had a previous laparoscopic colorectal procedure and are having a "second-look" procedure

Procedure: Laparoscopy

Interventions

LaparoscopyPROCEDURE

A "second-look" laparoscopy, in patients who require further surgery (for example a liver resection or closure of ileostomy).

AB

Eligibility Criteria

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

You may qualify if:

  • Previous elective colonic or rectal resection
  • Having a further operative intervention at which time a laparoscopy can be performed

You may not qualify if:

  • Children \<18
  • Further surgery not relating to the primary colorectal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Surrey County Hospital

Guildford, Surrey, GU2 4JX, United Kingdom

Location

MeSH Terms

Conditions

Tissue Adhesions

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

CicatrixFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Timothy A Rockall, FRCS

    The Royal Surrey County Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 17, 2007

Study Start

June 1, 2006

Study Completion

September 1, 2007

Last Updated

September 17, 2007

Record last verified: 2007-09

Locations

GB(1)