Incisional Hernia of Midline of Abdomen Clinical Trial
Official title:
Comparison of Laparoscopic Intraperitoneal Onlay Mesh (IPOM Plus) and Extended Totally Extraperitoneal (eTEP) Repair for Incisional Hernia - a Randomized Controlled Trial
NCT number | NCT05528107 |
Other study ID # | 2907-1/22 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 14, 2023 |
Est. completion date | March 2024 |
The survey will compare primary and secondary outcomes of laparoscopic intraperitoneal onlay mesh (IPOM plus) and extended totally extraperitoneal (eTEP) repair for incisional hernia. The research hypothesis is the following: patients who underwent eTEP repair may experience 30% less pain, assessed on the NRS-11 scale by the end of postoperative day 1, compared with IPOM plus procedure
Status | Recruiting |
Enrollment | 72 |
Est. completion date | March 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - midline incisional hernia - defect width 2-6 cm - ASA I-II class - Elective hernia repair - Considered eligible for minimally invasive ventral hernia repair - Able to give informed consent - Able to tolerate general anesthesia Exclusion Criteria: - primary ventral herna - lateral hernia with/without midline - defect width more than 6 cm - refuse to give informed consent - prior mesh placement in the retrorectus space |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Clinical City Hospital #1 named after N.I. Pirogov | Moscow |
Lead Sponsor | Collaborator |
---|---|
City Clinical Hospital No.1 named after N.I. Pirogov | Pirogov Russian National Research Medical University |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain on postoperative day 1 | Pain score will be assessed using the Numeric Pain Rating Scale. The mean pain score is calculated between pain values at rest and on coughing.
Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain. |
postoperative day 1 | |
Secondary | pain on postoperative days 7 and 30 | Pain score will be assessed using the Numeric Pain Rating Scale. The mean pain score is calculated between pain values at rest and on physical activity.
Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain. |
postoperative 7 (±1) and 30 (±3) days | |
Secondary | number of participants with chronic pain | Persisted pain in surgical site more than 90 days after surgery. Pain score will be assessed using the Numeric Pain Rating Scale. Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain. | postoperative day 100 (±5 days) | |
Secondary | length of stay | From date of hospital admission until discharge. The length of hospital stay (days) | 30 days after surgery | |
Secondary | postoperative complications | Number of participants with postoperative complications, evaluated by Clavien-Dindo classification of surgical complications from Dindo et al. | 30 days after surgery | |
Secondary | analgetic consumption | Consumption of analgesics during the first 48 hours after surgery | 48 hours after surgery | |
Secondary | pain 6 hours after surgery | Pain score will be assessed using the Numeric Pain Rating Scale. The mean pain score is calculated between pain values at rest and on coughing.
Participants verbally requested to rate their pain : "Rate your pain from 0 (no pain) to 10 (unbearable pain)". 0 point is the minimum and 10 point is the maximum. The higher the score, the more severe the pain. |
6 hours (± 1 hour) after surgery |
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