Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair

Pain, Acute Clinical Trial

Official title:

Is it Necessary to Fix Mesh in Laparoscopic Hernia Repair; Prospective Randomized Double-blinded Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05152654
• Other study ID #: Mesh fixation
• Status: Completed
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: December 2021
• Source: Hitit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inguinal hernias are one of the most common diseases in general surgery practice. In a multicenter study conducted in Germany, inguinal hernia repair is one of the most common operations. Until the last 20 years, after Lichtenstein described tension-free mesh hernia repair, this method was the gold standard in inguinal hernia surgery. This method was advantageous in terms of both less recurrence and less postoperative pain compared to tension methods. With the development of minimally invasive surgery, laparoscopic hernia surgery was first described by Dr. Ger in 1992. Laparoscopic inguinal hernia repair is based on the principles of preperitoneal repair described by Stoppa in open surgery. Its advantages over laparoscopic surgery are; Less post-operative pain, rapid recovery, reduction in nerve damage and chronic pain, and reduced recurrence rate. However, the disadvantage is that the learning curve is longer and higher cost. Two commonly used laparoscopic inguinal hernia surgeries are Trans Abdominal Pre-Peritoneal (TAPP) and totally extraperitoneal (TEP) methods. Although both are preperitoneal repair methods, less intraperitoneal organ damage, less intra-abdominal adhesion formation, and no need for peritoneal sheath repair are the advantages of the TEP method. For this reason, TEP method has been the preferred method today. Various methods have been tried in order not to change the location of the mesh placed in the TEP method. Laparoscopic inguinal hernia is one of the most debated issues. The most common methods for fixation are tacker, tissue adhesive, or suturing the mesh. However, fixing the mesh using a tacker can cause chronic pain. Tissue adhesives are not preferred because tissue adhesives have high costs and sometimes cause allergic reactions. The method in which the mesh is sewn to the pubic bone is avoided by surgeons because it prolongs the operation time. To avoid chronic pain after surgery, the idea was not to fix the mesh. The major drawback of this method is that the mesh may slip and cause recurrence.This study aimed to reveal the difference between the amount of migration and the amount of post-operative pain between detecting the mesh and not detecting it

Description:

The study will be conducted as a prospective, double-blind, randomized controlled study in the general surgery clinic of a university hospital. As a result of the power analysis calculated under Cohen's expert opinion, it was decided to include a total of 100 patients, 50 patients in order to reach 80% power with 0.50 effect size (medium effect) and 5% error (alpha=0.05). in each group. The study will continue by taking the consent of the patients and choosing from among the volunteer patients. The method by which the patients will be operated will be determined by choosing from a total of 100 (50 per group) sealed envelopes containing the group names. In the first (Fixation Group) group, inguinal hernia repair with the TEP method will be fixed with a mesh stapler. While inguinal hernia repair is performed with TEP method in the second (Non-Fixation Group) group, the mesh will not be fixed by any method. Exclusion criteria; It was determined as being younger than 18 years of age, having a comorbidity that prevented him from receiving general anesthesia, having had a previous lower abdominal surgery, having undergone previous inguinal hernia surgery, having bilateral inguinal hernia, scrotal hernia or strangulated hernia.

Creation of double blind; Patients will not be told which study group participants are in as a result of the envelope participants choose. In the postoperative follow-up of the patients, the researcher who recorded the parameters related to the study and provided the measurements will not know which group the patients are in.

Age, gender, comorbidity, smoking history and body mass index of the patients will be recorded on the preoperative forms. The surgery will be performed by a single surgeon according to the group chosen by the patients. The performing surgeon was a general surgeon with 5 years of active experience in laparoscopic hernia surgery and had performed both methods more than 200 times. Until the end of the study, only the surgeon will know which group the patients are in. The investigator evaluating the results of the study and the performing surgeon will not communicate about the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• being over 18 years old

• having a unilateral inguinal hernia

Exclusion Criteria:

• being under18 years old

• having comorbidity that prevents him from receiving general anesthesia

• having undergone previous lower abdominal surgery

• having previous surgery for inguinal hernia

• having bilateral inguinal hernia, scrotal hernia or strangulated hernia

Related Conditions & MeSH terms

• Acute Pain
• Chronic Pain
• Hernia
• Hernia, Inguinal
• Inguinal Hernia
• Pain, Acute
• Pain, Chronic

Intervention

Device:
• Tacker
metallic staples used to fix the mesh

Locations

Country	Name	City	State
Turkey	Hitit University	Çorum

Sponsors (1)

Lead Sponsor	Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Buyukasik K, Ari A, Akce B, Tatar C, Segmen O, Bektas H. Comparison of mesh fixation and non-fixation in laparoscopic totally extraperitoneal inguinal hernia repair. Hernia. 2017 Aug;21(4):543-548. doi: 10.1007/s10029-017-1590-2. Epub 2017 Feb 18. — View Citation

Darwish A. A, Hegab A. A . Tack fixation versus nonfixation of mesh in laparoscopic transabdominal preperitonaeal hernia repair. Egyptian Journal of Surgery. 2016;35(4): 327-331. DOI: 10.4103/1110-1121.194729

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	displacement of the mesh one day after surgery	It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one day after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.	one day after surgery
Primary	displacement of the mesh one week after surgery	It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken one week after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.	first week after surgery and 6th month after surgery
Primary	displacement of the mesh six month after surgery	It is the process of measuring how much the mesh placed in the surgery is displaced. Determining the distance of the titanium clips placed at the four corners of the mesh to the symphysis pubis and measuring the change in time intervals. Abdominal radiographs of the patients in both study arms will be taken 6 months after the operation, and the distance between the symphysis pubis and the titanium clips placed on the mesh will be recorded in millimeters.	first week after surgery and 6th month after surgery
Primary	Postoperative 24th hours pain	Patients will be asked about their visual pain score at the postoperative 24th hour. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)	24th hours after surgery
Primary	Postoperative 6th months pain	Patients will be asked about their visual pain score at 6 months postoperatively. In this scoring system, 0 represents the least pain and 10 represents the most pain. Visual Analogue Scale(VAS) :min 0 max:10 (0 is better)	6th month after surgery