Hirschsprung's Disease: Surgical Techniques and Quality of Life

Quality of Life in Patients With Hirschsprung's Disease in Relation to Surgical Technique: a Study of a Danish Population

This is an observational study examining the long-term quality of life in patients with Hirschsprung's Disease in relation to the choice of surgical technique.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life

Detailed Description

Hirschsprung's Disease (HD) is a developmental defect causing functional obstruction of bowel. It is a condition that almost always requires surgical intervention. This study aims to examine the relation between quality of life and surgical technique in patients with Hirschsprung's disease in hopes of providing insight into advantages and disadvantages of different surgical techniques employed at OUH, department for general surgery in the time between 1985 and 2012. This will be done based on answers given on a set of validated questionnaires that has been sent to all patients diagnosed with HD in the years 1985 to 2012 at OUH, department for general surgery.

• Study Type: Observational
• Enrollment (Actual): 207

Contacts and Locations

Study Locations

• Denmark
  • Fyn
    • Odense, Fyn, Denmark, 5000
      • University of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with HD at OUH, department for general surgery between 1985 and 2012.

Description

Inclusion Criteria:

• All patients diagnosed with HD at the Surgical Department at Odense University Hospital from 1985 to 2012 will be invited to enroll in the study.

Exclusion Criteria:

• lack of informed consent, pregnancy, wrong diagnosis and inability to understand or answer the questionnaires.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hirschsprung Quality of life Questionnaire sub scales and total score	Disease specific questionnaire including sub scales for laxative and constipating diet, presence of diarrhoea and constipation, faecal and urinary incontinence, social and emotional functioning, body image, physical symptoms and sexual functioning. Each item is phrased as a multiple-choice question with four response options; never, once in a while, often and very often. Responses are linearly transformed on a 0-100 scale with a higher score indicating better QOL.	Day 1
General Quality of Life	Based on a generic SF-36 questionnaire subscaled into perception of health, physical functioning, physical role functioning, emotional functioning and emotional role functioning. Each question is phrased as a multiple-choice question with varying options depending on the type of question.	Day 1
Type of Surgical Intervention	At our centre three different types of surgical approaches have been employed: Soave operation, Low anterior resection (Rehbeins operation) and trans-anal pullthrough. These outcomes will be correlated to outcomes of quality of life in other to compare the resulting quality of life between the different surgical approaches.	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Complications	Data will be retrieved through electronic medical journals. Data such as short term and long term major postoperative complications will be gathered in order to compare prevalence of surgical complications to type of surgical approach.	Day 1

Collaborators and Investigators

• Sponsor: University of Southern Denmark

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): January 14, 2022
• Study Completion (Anticipated): January 14, 2022

Study Registration Dates

• First Submitted: July 21, 2021
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2021
• Last Update Submitted That Met QC Criteria: July 21, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Congenital Abnormalities; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Digestive System Abnormalities; Megacolon; Hirschsprung Disease
• Other Study ID Numbers: 232-2021-NQ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No