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Botox treatment of abdominal wall hernia

Phase 3
Recruiting
Conditions
abdominal wall hernia
Registration Number
JPRN-jRCTs041230054
Lead Sponsor
Saito Takuya
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
30
Inclusion Criteria

1) For this study, patients with abdominal wall hernias with a hernia portal of 5 cm or more.
2) Patients with indications for abdominal wall hernia repair based on the preoperative evaluation.
3) Patients who are willing to comply with the research protocol.
4) Patients have signed a consent document approved by the Clinical Research Review Committee regarding participation in the study.

Exclusion Criteria

1) Patients with active cancer. However, active cancer does not include intraepithelial carcinoma or lesions equivalent to intramucosal carcinoma that is considered curable by local treatment.
2) Patients with systemic muscle disease (myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
3) Women who may be pregnant or are lactating.
4) Patients who are allergic to Botox.
5) Patients with severe psychosis or psychiatric symptoms that make it difficult for them to participate in the study.
6) Patients who are deemed ineligible for surgery.
7) Patients with a serious medical condition that would make it inappropriate for the investigator to participate in the study.
8) Patients with a history of abdominal surgery that is inoperable.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Recurrence rate at 1 year
Secondary Outcome Measures
NameTimeMethod
Operating time, postoperative hospital stay, NRS (Numerical rating scale), SSI (Surgical site infection), seroma, mesh size, hernia portal measurement
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