Incidence of parastomal hernias after lateral pararectal versus transrectal stoma placement

Not Applicable

• Conditions: high-output stoma (> 2000 ml/day), ileus, stenosis, obstruction, prolapse, necrosis, retraction, fistulization, skin complications; K43.9; Z93; Other and unspecified ventral hernia without obstruction or gangrene; Artificial opening status

• Registration Number: DRKS00003534
• Lead Sponsor: Medizinische Fakultät Mannheim, Universität HeidelbergUniversitätsmedizin Mannheim, Chirurgische Klinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-14
• Study Completion: 2014-09-15
• Results First Posted: 2015-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• patient (age >18y) with indication for planned temporary loop ileostomy, i.e. patient with rectal cancer undergoing elective low anterior resection with placement of a temporary protective loop ileostomy
• written informed consent

Exclusion Criteria

• emergency operations
• ostomies which are not definitely planned to be taken down/permanent ostomies
• age <18

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoint is the incidence of parastomal hernias defined by any of the following events:<br><br>a) clinically manifest parastomal hernia as any palpable bulge or defect that appears after removal of the appliance while the patient is erect or coughing (photodocumentation)<br>b) sonographically diagnosed parastomal hernia (definition: protrusion of intraabdominal contents adjacent to the stoma)<br>c) intraoperative finding when the ileostomy is taken down (questionnaire for the surgeon)<br><br>Standardized approach to detect the primary endpoint:<br>All patients are screened for parastomal hernia clinically and sonographically. The surgeon who performs the ileostomy take-down documents the intraoperative finding using a standardized questionnaire.<br>The follow-up duration is about 3-6 months. This observation period corresponds to the time period between stoma placement and ileostomy takedown.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoint(s):<br>• Stoma-related morbidity (according to Clavien): high-output stoma (> 2000 ml/day), ileus, stenosis, obstruction, prolapse, necrosis, retraction, fistulization, skin complications<br>Stratification into complications which can be managed in the ambulatory setting (clinic, outpatient wound therapy, outpatient stoma therapy) vs. complications which require hospitalisation and perhaps even surgical intervention/revision<br>• appliance aspects (patient perspective)<br>• Quality of Life (assessed by the EORTC questionnaires QLQ-CR29 and QLQ-C30)<br><br>Quality of Life (QoL) is assessed twice using the two EORTC questionnaires:<br>1. during the screening visit (preoperative baseline quality of life)<br>2. during the follow-up visit 10 +/- 2 weeks after hospital discharge from UMM (postoperative QoL with stoma)