NCT07373314

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 13, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
13 days until next milestone

Study Start

First participant enrolled

February 10, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6 months

First QC Date

January 13, 2026

Last Update Submit

January 19, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain Score

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

    Recorded 24 hours post-surgery.

  • Seroma Formation:

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

Study Arms (2)

Modified Tumescent Laparoscopic TAPP (MT-TAPP)

EXPERIMENTAL
Other: Modified Tumescent Laparoscopic TAPP (MT-TAPP) for the first group.

Conventional Laparoscopic TAPP (CL-TAPP)

ACTIVE COMPARATOR
Other: Conventional Laparoscopic TAPP (CL-TAPP)

Interventions

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.

Conventional Laparoscopic TAPP (CL-TAPP)

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.

Modified Tumescent Laparoscopic TAPP (MT-TAPP)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Dr. Taseen Imran

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2026

First Posted

January 28, 2026

Study Start

February 10, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share