Comparison of Two Surgical Techniques for Indirect Inguinal Hernia Repair

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.

Detailed Description Management of the distal hernia sac can be technically challenging during laparoscopic repair of indirect inguinal hernias, particularly in large hernias or those extending into the scrotum. Complete dissection may increase manipulation of the spermatic cord, vas deferens, and testicular vessels. The Primary Abandon of the Sac (PAS) technique avoids extensive distal sac dissection by leaving the distal portion in the inguinal canal or scrotum while completing preperitoneal mesh repair. The potential reduction in dissection must be evaluated alongside the risk of postoperative fluid collections.

This single-center, prospective randomized trial uses a non-inferiority design to evaluate PAS against standard transabdominal preperitoneal repair with complete distal sac dissection and reduction. Non-inferiority will be assessed using an absolute margin of 15 percentage points for the difference in seroma rates, defined as the PAS rate minus the standard repair rate, at postoperative day 30.

Allocation will use a computer-generated block randomization sequence with a 1:1 ratio. Allocation concealment will be maintained using sequentially numbered, opaque, sealed envelopes opened after enrollment and written informed consent. Participants and postoperative outcome assessors will be masked to allocation. Operating surgeons cannot be masked because of the nature of the procedures.

Operations will be performed by surgeons experienced in laparoscopic inguinal hernia repair who have completed their learning curve. Mesh use, fixation, and perioperative care will follow standardized surgical principles to limit differences between groups other than distal sac management.

Seroma will be identified by a fluctuant fluid collection on physical examination of the operated inguinal or scrotal region and/or a fluid collection demonstrated by ultrasonography. Ultrasonography will be used when examination findings are uncertain or a fluid collection is clinically suspected.

Pain will be assessed using a 0-10 visual analog scale or numeric rating scale. Hernia-related quality of life will be assessed with the EuraHS-QoL questionnaire before surgery and at postoperative months 1, 6, and 12. Postoperative complications will be graded using the Clavien-Dindo classification. Return to normal daily activities will be recorded as the first day on which the participant can independently perform basic daily activities without a marked increase in analgesic requirements. Recurrence will be defined as a same-side hernia confirmed by clinical examination and/or ultrasonography during the 12-month follow-up period.

Analyses will be performed in both intention-to-treat and per-protocol populations. Continuous variables will be compared using an independent-samples t-test or Mann-Whitney U test, as appropriate for their distribution. Categorical variables will be compared using the chi-square test or Fisher's exact test, as appropriate.