Hernia Repair With or Without Sutures

NCT ID: NCT00905320

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2018-11-21

Brief Summary

This is a randomized study between two accepted techniques of mesh fixation for laparoscopic hernia repair.

Detailed Description

This is a randomized study in which subjects will undergo one or two currently accepted techniques of mesh fixation during laparoscopic ventral hernia repair. Subject will undergo mesh fixation with either trans-abdominal sutures and metallic tacks or metallic tacks only.

Pain will be assessed through week 12, and hernia recurrence will be assessed for 2 years after surgery. Subjects will complete pain questionnaires at baseline, each day during hospital stay, and at follow-up visits at 2, 6, and 12 weeks after discharge. Quality of life questionnaires will be completed at baseline, at discharge from hospital, and during follow-up visits at 2, 6, and 12 weeks after discharge.

Conditions

Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Metallic Fasteners and Sutures

Laparoscopic ventral hernia repair with mesh fixation using both metallic fasteners and transabdominal sutures

Group Type: ACTIVE_COMPARATOR

Metallic Fasteners and Sutures

Intervention Type: PROCEDURE

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.

Metallic Fasteners Alone

Laparoscopic ventral hernia repair with mesh fixation using metallic fasteners alone

Group Type: EXPERIMENTAL

Metallic Fasteners Alone

Intervention Type: PROCEDURE

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.

Interventions

Metallic Fasteners and Sutures

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners and sutures.

Intervention Type: PROCEDURE

Metallic Fasteners Alone

Subjects will undergo hernia repair with mesh fixation. Fixation involves using metallic fasteners alone.

Intervention Type: PROCEDURE

Other Intervention Names

Metallic fasteners and sutures.; Metallic fasteners alone for mesh fixation

Eligibility Criteria

Inclusion Criteria

Demographics:

• Age ≥ 18 years old
• If female, negative pregnancy test

Pre-Operative Findings:

• Presence of an abdominal hernia associated with previous surgical incision
• Midline ventral\incisional hernia demonstrated either on physical examination by investigators or radiologic imaging tests.
• CT scan, MRI, Ultrasound
• No evidence of incarceration, strangulation
• Size of hernia ≥ 4 centimeters or ≤ 20 centimeters (cross-sectional diameter)
• Multiple hernias cumulative size ≤ 20 centimeters in cross-sectional diameter

Exclusion Criteria

Pre-Operative History:

• Severe medical co-morbidities that prevent safe performance of laparoscopic surgery including coronary artery disease, obstructive pulmonary disease, etc.
• History of the following:

• Connective tissue or wound healing disorder (e.g. Ehlers-Danlos syndrome)
• Chronic use (defined as greater than 3 months) of narcotic analgesic for pain other than from the hernia that is intended to be repaired
• Allergy to products used in hernia repair including surgical mesh
• Any abdominal ventral incisional hernia previously repaired with permanent synthetic mesh placed inside the peritoneal cavity
• Loss of abdominal domain (i.e. majority of abdominal organs lie outside confines of the abdominal musculature and fascia)
• Presence of simultaneous intra-abdominal infection
• Simultaneous presence of a bowel obstruction
• History of suspected or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
• Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, may interfere with study assessments or compliance.

Intra-operative Findings:

• Simultaneous performance of another surgical procedure during hernia repair other than acts necessary to complete hernia repair (e.g. cutting of abdominal adhesions)
• Intra-operative identification of full thickness injury to intestine (i.e. enterotomy), liver, bladder, etc.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Don Selzer

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Don Selzer, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University Department of Surgery

Locations

Indiana University

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0803-15

Identifier Type: -

Identifier Source: org_study_id