Gsvm Medical College Kanpur
Kanpur, Uttar Pradesh, 208002, India
NCT Number: NCT07055464
This study aims to compare the outcomes of Enhanced View Totally Extraperitoneal Rives-Stoppa (eTEP-RS) repair and Intraperitoneal Onlay Mesh Plus (IPOM Plus) repair in the management of ventral wall hernias. The comparison includes operative time, post-operative pain, hospital stay, surgical site occurrences, and recurrence rates. Patients will be prospectively enrolled and allocated into two groups based on the surgeon's discretion or patient-specific criteria.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Kanpur, Uttar Pradesh, 208002, India
Abdominal wall hernias are common surgical conditions, and multiple techniques have evolved for their repair. eTEP-RS is a relatively newer, minimally invasive approach that combines the principles of the Rives-Stoppa retromuscular mesh placement with the benefits of laparoscopic surgery. IPOM Plus, on the other hand, is a widely practiced technique involving intraperitoneal mesh placement with defect closure.
This prospective comparative study is designed to evaluate the effectiveness and safety of eTEP-RS versus IPOM Plus in patients undergoing elective repair of ventral or incisional hernias. The study will assess intra-operative parameters (e.g., duration of surgery, blood loss), early post-operative outcomes (pain score, duration of hospital stay), surgical site complications (seroma, infection, mesh-related issues), and long-term outcomes (recurrence, quality of life).
Patients fulfilling inclusion criteria will be assigned to one of the two arms. Standardized protocols will be followed for pre-operative work-up, anesthesia, surgical steps, and post-operative care. Data will be analyzed to determine if one technique offers superior clinical outcomes, better patient satisfaction, or reduced recurrence
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Laparoscopic retromuscular mesh repair using the enhanced view totally extraperitoneal (eTEP-RS) technique for ventral or incisional hernia.
Intraperitoneal onlay mesh (IPOM Plus) repair involving laparoscopic fascial defect closure and mesh placement for abdominal wall hernias.
Time frame: Up to 6 months post-surgery
Clinical or radiological evidence of hernia recurrence during follow-up.
Time frame: 6 months
Postoperative pain will be assessed using the Visual Analogue Scale (VAS) 24 hours, and 7 days, 30 days and 6 months after surgery.
Pain intensity will be assessed using the Visual Analog Scale (VAS). The scale ranges from 0 to 10, where:
0 = No pain
10 = Worst imaginable pain Higher scores indicate a worse outcome.
Time frame: Intraoperative
Time from first incision to final closure, measured in minutes.
Time frame: DAY 1 TO DAY 15
Number of days from surgery to discharge(upto 15 days post- operatively)
Time frame: Within 30 days post-surgery
Includes wound infection, seroma, hematoma, or mesh-related complications occurring within 30 days
Time frame: Within 30 days postoperatively
Number of days taken by the patient to resume routine daily activities, such as walking without support, household tasks, or returning to work, as reported during follow-up.
GSVM Medical College
Other
Comparative Study Between Etep-rs and Ipom Plus for Abdominal Wall Hernias
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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