Prospective trial to assess the incidence of trocar-site hernias after laparoscopic bariatric procedures between patients that received closure of the fascia and the skin and patients who received closure of the cutaneous incision

Prospective trial to assess the incidence of trocar-site hernias after laparoscopic bariatric procedures between patients that received closure of the fascia and the skin and patients who received closure of the cutaneous incision - HERBALS (HErnia after BAriatric Laparoscopic Surgery)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00013122

Enrollment

400

Registered

2018-01-17

Start date

2017-08-01

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K43 E66.06

Interventions

Group 1: Patients, where both the skin incision and the underlying fascia were closed during the laparoscopic bariatric surgery. Using sonography scans, we are planing to examine the trocar insertion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients who have undergone bariatric surgery in our department between 2009 and 2016

Exclusion criteria

Exclusion criteria: 1. Patients who are not able of consenting to the Trial 2. Patients with follow-up shorter than 9 months after the bariatric procedure 3. Patients with lalaparoscopic surgery in the upper abdomen before the bariatric procedure 4. Patients with any type of midline or transverse laparotomy in the upper abdomen before or after the bariatric procedure 5. Patients with procedures implementing implantable devices penetrating the fascial layer After completing the recruitment (July 2019) we revised the exclusion criteria. The added ones are presented in number 2-5. The reason for the revision was to enable a more objective evaluation of the primary endpoint and reduce the bias. Furthermore, the preexisting exclusion criterion 'patients after abdominoplasty' was removed because during the study we observed that these patients can be examined using sonography scans without any problems.

Design outcomes

Primary

Measure	Time frame
Primary endpoint is the Incidence of trocar-site hernias after bariatric surgery considering the fascia closure as a possible influence factor. The primary endpoint will be evaluated using sonography scan and a minimum follow- up of one year after the operation.	—

Secondary

Measure	Time frame
Secondary endpoint is to detect how many patients actually have a symptomatic defect of the fascia and how many a symptomatic incisional hernia.	—

Countries

Germany

Contacts

Public ContactMirko Otto

Chirurgische Klinik, Universitätsmedizin Mannheim

mirko.otto@umm.de0049-621-383-2225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026