NCT02116881

Brief Summary

Despite of technological advances in surgery, incisional hernia and bowel obstruction remain frequent surgical complications. To date, the relationship between these two types of surgery and the occurrence of incisional hernia remains unclear. This is an observational study to evaluate outcomes of incisional hernia with respect to the incision site and adhesion-related bowel obstruction after open and laparoscopic colorectal surgery.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
terminated

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

April 11, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
9 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

August 4, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

April 11, 2014

Last Update Submit

August 3, 2017

Conditions

Colorectal DisordersIncisional HerniaBowel Obstruction

Keywords

Incisional herniacolorectal surgerybowel obstruction

Outcome Measures

Primary Outcomes (1)

  • Incisional hernia

    24 month

Secondary Outcomes (2)

  • Cosmesis

    24 month

  • Body image

    24 month

Study Arms (2)

Open colorectal surgery

Patients scheduled to undergo open colorectal surgery from Department of Colorectal Surgery at Cleveland Clinic

Procedure: Colorectal Surgery

Laparoscopic colorectal surgery

Patients scheduled to undergo laparoscopic colorectal surgery from Department of Colorectal Surgery at Cleveland Clinic

Procedure: Colorectal Surgery

Interventions

Colorectal SurgeryPROCEDURE

Application of postoperative questionnaires will be completed by patients. The intervention is the standard of care.

Laparoscopic colorectal surgeryOpen colorectal surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for an elective colorectal operation in the Department of Colorectal Surgery at Cleveland Clinic

You may qualify if:

  • Age equal to or greater than 18 years
  • Informed consent
  • Admissions for any diagnosis that will result in colorectal surgery
  • BMI lower than 50

You may not qualify if:

  • Pregnancy
  • Lack of informed consent
  • Previous abdominal surgery (laparotomy/laparoscopy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic Colorectal Surgery Department

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Incisional HerniaIntestinal Obstruction

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Emre Gorgun, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 11, 2014

First Posted

April 17, 2014

Study Start

January 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

August 4, 2017

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)