Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair

NCT07891845 | Recruiting

• 1 other identifier: HITIT-TAPP-PAS-2026
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare two ways of managing the hernia sac during laparoscopic surgery for an indirect inguinal hernia, a type of groin hernia. A hernia sac is a pouch of tissue that extends through the hernia opening. In the standard technique, the sac is fully separated from nearby structures and returned to the abdomen. In the alternative technique, called Primary Abandon of the Sac (PAS), the lower part of the sac is left in place to reduce the amount of tissue dissection. Both techniques use mesh to repair the hernia. The main question is whether leaving the lower part of the sac in place results in an acceptably similar rate of seroma compared with the standard technique. A seroma is a collection of fluid near the area where surgery was performed. The study will also compare operation time, pain, quality of life, complications, return to daily activities, and whether the hernia comes back. The study plans to enroll 90 adults with a primary indirect inguinal hernia on one side who are scheduled for elective laparoscopic repair. Participants will be assigned by chance to one of the two surgical techniques, with an equal chance of receiving either technique. Participants and the researchers assessing their recovery will not know which technique was used; the operating surgeon will know. Participants will have follow-up assessments at 1 day, 7 days, 1 month, 6 months, and 12 months after surgery. The main assessment of seroma will take place 30 days after surgery.

Conditions

Indirect Inguinal Hernia

Keywords

Laparoscopic Inguinal Hernia Repair; Transabdominal Preperitoneal Repair; TAPP; Primary Abandon of the Sac; PAS; Hernia Sac Management; Postoperative Seroma; Inguinoscrotal Hernia; Non-Inferiority Trial; Hernia-Related Quality of Life

Outcome Measures

Primary Outcomes (1)

• Proportion of Participants With Seroma at Postoperative Day 30

  Percentage of participants with a seroma in the operated inguinal or scrotal region at postoperative day 30. Seroma is defined as a fluctuant fluid collection detected on physical examination and/or a fluid collection demonstrated by ultrasonography. Ultrasonography will be performed when examination findings are uncertain or a seroma is clinically suspected. Seroma rates will be compared between groups to assess non-inferiority of PAS using an absolute margin of 15 percentage points.

  Postoperative Day 30

Other Outcomes (16)

• Operative Time

  Intraoperative period, from skin incision to skin closure

• Postoperative Pain Score

  Postoperative Days 1 and 7, and Months 1, 6, and 12

• Hernia-Related Quality of Life

  Baseline and Postoperative Months 1, 6, and 12

Study Arms (2)

Standard TAPP Repair

ACTIVE COMPARATOR

Participants will undergo laparoscopic transabdominal preperitoneal repair with complete dissection and reduction of the distal hernia sac. Mesh will be placed in the preperitoneal space, followed by peritoneal closure. Mesh fixation and perioperative care will follow standardized procedures.

Procedure: Standard TAPP Repair With Complete Hernia Sac Dissection

Primary Abandon of the Sac (PAS)

EXPERIMENTAL

Participants will undergo laparoscopic transabdominal preperitoneal repair using the Primary Abandon of the Sac technique. Extensive distal sac dissection will be avoided, and the distal hernia sac will be left in the inguinal canal or scrotum. Repair will be completed with preperitoneal mesh placement and peritoneal closure. Mesh fixation and perioperative care will follow standardized procedures.

Procedure: TAPP Repair With Primary Abandon of the Sac

Interventions

Standard TAPP Repair With Complete Hernia Sac Dissection PROCEDURE

Laparoscopic transabdominal preperitoneal mesh repair involving complete dissection of the distal hernia sac from adjacent cord structures and reduction of the sac into the abdomen.

Standard TAPP Repair

TAPP Repair With Primary Abandon of the Sac PROCEDURE

Laparoscopic transabdominal preperitoneal mesh repair in which the distal hernia sac is left in the inguinal canal or scrotum to avoid extensive distal sac dissection.

Primary Abandon of the Sac (PAS)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older.
• Primary unilateral indirect inguinal hernia.
• Scheduled for elective laparoscopic inguinal hernia repair.
• Suitable for general anesthesia and laparoscopic surgery.
• Provision of written informed consent.

You may not qualify if:

• Bilateral inguinal hernia.
• Recurrent inguinal hernia.
• Direct inguinal or femoral hernia without a qualifying indirect inguinal hernia.
• Incarcerated or strangulated hernia requiring emergency surgery.
• Sliding hernia.
• Large spermatic cord lipoma.
• Previous preperitoneal surgery.
• Contraindication to general anesthesia or laparoscopic surgery.

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University Faculty of Medicine

Çorum, 19000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Veysel Barış TURHAN, MD

CONTACT

+905079945141; drbaristurhan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative outcomes assessors will be masked to treatment allocation. Operating surgeons will not be masked because of the nature of the surgical interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of General Surgery

Model Details: Participants will be randomly assigned in a 1:1 ratio to standard transabdominal preperitoneal repair with complete distal hernia sac dissection and reduction or repair using the Primary Abandon of the Sac technique. This two-arm, parallel-group, non-inferiority trial plans to enroll 90 participants, with 45 in each group.

Study Record Dates

• First Submitted: October 12, 2026
• First Posted: October 23, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)