Incidence of parastomal hernias after lateral pararectal versus transrectal stoma placement

Incidence of parastomal hernias after lateral pararectal versus transrectal stoma placement - PATRASTOM

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003534

Enrollment

Registered

2012-02-14

Start date

2012-04-16

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

high-output stoma (> 2000 ml/day), ileus, stenosis, obstruction, prolapse, necrosis, retraction, fistulization, skin complications K43.9 Z93

Interventions

Group 1: lateral pararectal stoma placement Group 2: transrectal stoma placement

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the incidence of parastomal hernias defined by any of the following events: 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) b) sonographically diagnosed parastomal hernia (definition: protrusion of intraabdominal contents adjacent to the stoma) c) intraoperative finding when the ileostomy is taken down (questionnaire for the surgeon) Standardized approach to detect the primary endpoint: 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. The follow-up duration is about 3-6 months. This observation period corresponds to the time period between stoma placement and ileostomy takedown.	—

Measure

Time frame

Primary endpoint is the incidence of parastomal hernias defined by any of the following events: 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) b) sonographically diagnosed parastomal hernia (definition: protrusion of intraabdominal contents adjacent to the stoma) c) intraoperative finding when the ileostomy is taken down (questionnaire for the surgeon) Standardized approach to detect the primary endpoint: 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. The follow-up duration is about 3-6 months. This observation period corresponds to the time period between stoma placement and ileostomy takedown.

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Secondary

Measure	Time frame
Secondary endpoint(s): • Stoma-related morbidity (according to Clavien): high-output stoma (> 2000 ml/day), ileus, stenosis, obstruction, prolapse, necrosis, retraction, fistulization, skin complications 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 • appliance aspects (patient perspective) • Quality of Life (assessed by the EORTC questionnaires QLQ-CR29 and QLQ-C30) Quality of Life (QoL) is assessed twice using the two EORTC questionnaires: 1. during the screening visit (preoperative "baseline" quality of life) 2. during the follow-up visit 10 +/- 2 weeks after hospital discharge from UMM (postoperative QoL with stoma)	—

Measure

Time frame

Secondary endpoint(s): • Stoma-related morbidity (according to Clavien): high-output stoma (> 2000 ml/day), ileus, stenosis, obstruction, prolapse, necrosis, retraction, fistulization, skin complications 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 • appliance aspects (patient perspective) • Quality of Life (assessed by the EORTC questionnaires QLQ-CR29 and QLQ-C30) Quality of Life (QoL) is assessed twice using the two EORTC questionnaires: 1. during the screening visit (preoperative "baseline" quality of life) 2. during the follow-up visit 10 +/- 2 weeks after hospital discharge from UMM (postoperative QoL with stoma)

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Countries

Germany

Contacts

Public ContactJulia Hardt

Universitätsmedizin Mannheim, Chirurgische Klinik

julia.hardt@umm.de0621-383-2225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026