An interventional study of Standard TAPP Repair With Complete Hernia Sac Dissection and TAPP Repair With Primary Abandon of the Sac in Indirect Inguinal Hernia, sponsored by Hitit University. Recruiting at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Hitit University · Not applicable, Interventional, and Treatment
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.
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.
561 studies on the registry are indexed under Hernia, Inguinal; 76 are open to participants now.
This study's planned enrollment of 90 is close to the median of 90 across 414 interventional studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Hitit University is the lead sponsor of 84 studies on the registry; 30 are open to participants now.
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Exclusion Criteria:
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
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
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.
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.
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.
Time frame: Postoperative Day 30
Operative Time
Duration of surgery in minutes, measured from the first skin incision to final skin closure.
Time frame: Intraoperative period, from skin incision to skin closure
Postoperative Pain Score
Pain intensity measured on a 0-10 visual analog scale or numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Time frame: Postoperative Days 1 and 7, and Months 1, 6, and 12
Hernia-Related Quality of Life
Hernia-related quality of life assessed using the EuraHS-QoL questionnaire, covering pain, activity restriction, and cosmetic discomfort. Higher scores indicate worse quality of life. Postoperative scores will be compared between groups and with baseline values.
Time frame: Baseline and Postoperative Months 1, 6, and 12
Length of Hospital Stay
Duration of hospitalization in days following hernia repair, measured from surgery to discharge.
Time frame: From surgery to hospital discharge, an average of 1 day
Time to Return to Normal Daily Activities
Number of days from surgery until the participant can independently perform basic daily activities without a marked increase in analgesic requirements.
Time frame: From surgery through postoperative Month 12
Postoperative Complications
Percentage of participants experiencing postoperative complications. Complications will be graded according to the Clavien-Dindo classification.
Time frame: Through postoperative Month 12
Postoperative Hematoma
Percentage of participants with a hematoma in the operated inguinal or scrotal region.
Time frame: Through postoperative Month 12
Postoperative Hydrocele
Percentage of participants with a postoperative hydrocele on the operated side.
Time frame: Through postoperative Month 12
Postoperative Scrotal Edema
Percentage of participants with postoperative scrotal edema.
Time frame: Through postoperative Month 12
Surgical Site Infection
Percentage of participants with a surgical site infection following hernia repair.
Time frame: Through postoperative Month 12
Postoperative Testicular Pain
Percentage of participants reporting testicular pain on the operated side.
Time frame: Postoperative Days 1 and 7, and Months 1, 6, and 12
Postoperative Urinary Retention
Percentage of participants experiencing urinary retention following surgery.
Time frame: Through postoperative Month 12
Chronic Inguinal Pain
Percentage of participants reporting persistent pain in the operated inguinal region at the 6-month and 12-month follow-up assessments.
Time frame: Postoperative Months 6 and 12
Hernia Recurrence
Percentage of participants with a recurrent hernia on the operated side, confirmed by clinical examination and/or ultrasonography.
Time frame: Through postoperative Month 12
Intraoperative Complications
Percentage of participants experiencing intraoperative complications, including injury to the spermatic cord, vas deferens, testicular vessels, inferior epigastric vessels, bladder, or bowel, and peritoneal tears.
Time frame: Intraoperative period, from skin incision to skin closure
Conversion to Open Surgery
Percentage of participants whose planned laparoscopic repair is converted to open surgery.
Time frame: Intraoperative period, from skin incision to skin closure
Plan to share: No — Individual participant data will not be shared with other researchers. Study findings will be disseminated through aggregate results in scientific publications.
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.
Of 181 non-industry interventional studies with no phase under Hernia, Inguinal, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 35. This study's planned 6 months is below that.
Counting every sponsor, half of 190 studies reached it within 17 months; a quarter within 8 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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