Endostomal Three-dimensional Ultrasonography for Parastomal Hernia

NCT04311333 | Unknown

• 1 other identifier: CTULOP
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

The intention is to examine the role of ultrasonographic examination inside intestinal stomas in diagnosing parastomal hernia. Patients with a stoma since at least one year back who are being scheduled for abdominal surgery will be examined for eligibility according to the selection criteria. Included patients will undergo routine clinical examination, endostomal ultrasonography and computerized tomography scan of the abdomen. Findings will be correlated to findings during surgery (gold standard). Values for sensitivity, specificity, predictive values and likelihood ratio will be calculated.

Conditions

Parastomal Hernia

Keywords

Parastomal hernia; Ultrasound; Ultrasonography; Endostomal; Intrastomal; Colostomy; Ileostomy

Outcome Measures

Primary Outcomes (1)

• Test characteristics

  Sensitivity, specificity, predictive values, likelihood ratio

  ≥ 1 year since stoma creation

Study Arms (1)

All patients

EXPERIMENTAL

All patients undergo endostomal three-dimensional ultrasonography, computerized tomography, clinical examination and laparotomy/laparoscopy. At all the respective examinations, the presence of a parastomal hernia as well as hernia location and size is evaluated.

Diagnostic Test: Endostomal three-dimensional ultrasonography; Diagnostic Test: Computerized tomography of the abdomen; Diagnostic Test: Clinical examination; Diagnostic Test: Evaluation at laparotomy/laparoscopy

Interventions

Endostomal three-dimensional ultrasonography DIAGNOSTIC_TEST

Examination with rectal probe enclosed by water-filled balloon. Rectal mode. Dynamic examination in different positions with and without increased intra-abdominal pressure.

All patients

Computerized tomography of the abdomen DIAGNOSTIC_TEST

Supine position, without increased intra-abdominal pressure. Experienced radiologist interprets the examination. If adequate examination has already been performed within the last 10 months, these images will be used and the patient will thus not undergo computerized tomography within the study.

All patients

Clinical examination DIAGNOSTIC_TEST

Patients will be clinically examined with inspection and palpation in supine and erect position with and without increased intra-abdominal pressure.

All patients

Evaluation at laparotomy/laparoscopy DIAGNOSTIC_TEST

During laparotomy or laparoscopy, inspection and/or palpation of the stoma at the abdominal wall orifice is performed.

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• End colostomy or end ileostomy since ≥ 1 year
• Planned for laparotomy or laparoscopy
• Age ≥ 18
• Speaks and reads Swedish language
• Informed consent

You may not qualify if:

• Known parastomal hernia only indication for laparotomy or laparoscopy

Sponsors & Collaborators

• Umeå University: lead

Study Sites (3)

Sunderby Hospital

Luleå, Norrbotten County, 971 80, Sweden

RECRUITING

Södertälje Hospital

Södertälje, Stockholm County, 152 86, Sweden

NOT YET RECRUITING

University Hospital of Umeå

Umeå, Västerbotten County, 907 37, Sweden

RECRUITING

Related Publications (4)

• Gurmu A, Matthiessen P, Nilsson S, Pahlman L, Rutegard J, Gunnarsson U. The inter-observer reliability is very low at clinical examination of parastomal hernia. Int J Colorectal Dis. 2011 Jan;26(1):89-95. doi: 10.1007/s00384-010-1050-2. Epub 2010 Sep 7.

  PMID: 20821218 BACKGROUND

• Gurmu A, Gunnarsson U, Strigard K. Imaging of parastomal hernia using three-dimensional intrastomal ultrasonography. Br J Surg. 2011 Jul;98(7):1026-9. doi: 10.1002/bjs.7505. Epub 2011 Apr 20.

  PMID: 21509751 BACKGROUND

• Strigard K, Gurmu A, Nasvall P, Pahlman P, Gunnarsson U. Intrastomal 3D ultrasound; an inter- and intra-observer evaluation. Int J Colorectal Dis. 2013 Jan;28(1):43-7. doi: 10.1007/s00384-012-1526-3. Epub 2012 Jul 7.

  PMID: 22772711 BACKGROUND

• Nasvall P, Wikner F, Gunnarsson U, Rutegard J, Strigard K. A comparison between intrastomal 3D ultrasonography, CT scanning and findings at surgery in patients with stomal complaints. Int J Colorectal Dis. 2014 Oct;29(10):1263-6. doi: 10.1007/s00384-014-1944-5. Epub 2014 Jul 2.

  PMID: 24986139 BACKGROUND

MeSH Terms

Interventions

Physical Examination; Laparoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Karin Strigård

  Department of Surgical and Perioperative Sciences, Umeå University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan Nyman, M.D.

CONTACT

(+46)90 786 46 87; johan.nyman@umu.se

Karin Strigård, M.D., Ph.D.

CONTACT

(+46)90 786 46 87; karin.strigård@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients will be examined with endostomal three-dimensional ultrasonography, clinical examination and computerized tomography before undergoing laparotomy or laparoscopy

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 17, 2020
• Study Start: September 27, 2016
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (3)