Modified vs. Conventional Laparoscopic TAPP for Inguinal Hernia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Health Sciences Lahore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Femoral Hernias.

Incarcerated or Strangulated Hernia.

Recurrent Hernias (as per medical record).

Conditions such as heart failure or coagulation problems (e.g., PT > 15 sec).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Tumescent Laparoscopic TAPP (MT-TAPP) for the first group.

    Other intervention

    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 the learning curve for less experienced surgeons. The rest of the procedure follows the standard laparoscopic TAPP repair, with mesh placement and peritoneal closure.

  • Conventional Laparoscopic TAPP (CL-TAPP)

    Other intervention

    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 used in inguinal hernia repairs, but it may be associated with longer operative times and more postoperative pain compared to the modified technique.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Modified Tumescent Laparoscopic TAPP (MT-TAPP)Experimental treatment 1 intervention
Group B: Conventional Laparoscopic TAPP (CL-TAPP)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Score

A score of 0 represents no pain, while a score of 10 represents the worst pain.

Time frame
Recorded 24 hours post-surgery.
2

Seroma Formation:

Time frame
Presence or absence of seroma, assessed during the 7-day postoperative follow-up.

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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