Modified vs. Conventional Laparoscopic TAPP for Inguinal Hernia

Official title

A Randomized Controlled Trial Comparing Modified Tumescent vs. Conventional Laparoscopic TAPP for Inguinal Hernia Repair

Overview

This study aims to compare the outcomes of two laparoscopic techniques for repairing inguinal hernias: the modified tumescent technique (MT-TAPP) and the conventional laparoscopic transabdominal preperitoneal technique (CL-TAPP). The primary goal is to determine which technique provides better outcomes in terms of operative time, ease of pre-peritoneal space dissection, postoperative pain, and the formation of seromas. The study will involve 60 patients diagnosed with unilateral inguinal hernias, randomly assigned to either group. Participants in Group A will undergo the MT-TAPP procedure, which involves pre-peritoneal infiltration of a local anesthetic solution to improve dissection and reduce pain. Group B will undergo the standard CL-TAPP procedure. Data will be collected on various outcome measures and analyzed to identify which technique leads to quicker recovery, less postoperative pain, and fewer complications. The results of this study will help guide surgical decisions and improve patient outcomes in inguinal hernia repair.

Interventions

• Other Modified Tumescent Laparoscopic TAPP (MT-TAPP) for the first group.
  In this intervention, participants will undergo laparoscopic inguinal hernia repair using the modified tumescent technique. This technique involves pre-peritoneal infiltration of a solution containing lidocaine, epinephrine, and saline. The tumescent solution is injected into the peritoneum to create a "tumescent" effect, making the tissues easier to dissect and reducing bleeding. This approach aims to improve surgical visibility, reduce operative time, minimize postoperative pain, and shorten t
• Other Conventional Laparoscopic TAPP (CL-TAPP)
  In this intervention, participants will undergo the conventional laparoscopic transabdominal preperitoneal (TAPP) hernia repair. This standard technique involves placing three ports to access the inguinal region, followed by dissection of the pre-peritoneal space and placement of a mesh to repair the hernia. The conventional method does not use tumescent infiltration and relies solely on the surgeon's skill to navigate the anatomical structures. This approach is well-established and commonly use

Primary outcome measures

• Pain Score [Time frame: Recorded 24 hours post-surgery.]
• Seroma Formation: [Time frame: Presence or absence of seroma, assessed during the 7-day postoperative follow-up.]

Eligibility criteria

Inclusion criteria

• Age: 18 to 50 years.
• Gender: Both male and female participants.
• Condition: Diagnosed with unilateral inguinal hernia (as per operational definition).
• Health Status: ASA I-III (American Society of Anesthesiologists physical status classification), indicating that the patient is fit for surgery.
• Consent: Participants must be able to provide informed consent to participate in the study.

Exclusion criteria

• Femoral Hernias.
• Incarcerated or Strangulated Hernia.
• Recurrent Hernias (as per medical record).
• Serious Systemic Diseases:
• Conditions such as heart failure or coagulation problems (e.g., PT > 15 sec).
• ASA III-V classification, indicating a higher risk for surgery.
• Pregnancy (if applicable).
• Allergy to Anesthesia or the substances used in the tumescent solution (lidocaine, epinephrine, saline).
• Uncontrolled Diabetes or other medical conditions that might interfere with the healing process.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07373314 · Exp132

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗