Comparative Study Between Lap. Dual Approach, Lap. Trans Abdominal Pre-peritoneal and Lichtenstein Procedures

Inguinal Hernioplasty Clinical Trial

Official title:

Inguinal Hernioplasty: Comparative Study Between Laparoscopic Dual Approach, Laparoscopic Trans Abdominal Preperitoneal and Lichtenstein Procedures. A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052023
• Other study ID #: IHPP3
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: April 2019

Study information

• Verified date: January 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study designed to compare the new laparoscopic dual approach to inguinal hernia repair with trans-abdominal preperitoneal (TAPP) and lichtenstein repair (open procedure)

Description:

inguinal hernioplasty is a procedures where synthetic mesh is used to strengthen the inguinal tissues sites for hernia repair different methods used which is either anterior approach (open Lichtenstein) or laparoscopic posterior approach through the abdomen (TAPP) comparing these two methods by new approach which is considered to some extent a modified TAPP by pneumo-dissection of pre-peritoneal space with abdominal approach by lap. repair

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult male patient (older than 18y).

• Not complicated.

• No previous lower abdominal incisions (lower abdominal midline and lower paramedian incision in the same side of hernia).

• No contraindication for general anesthesia.

• Not recurrent.

Exclusion Criteria:

• any one not in fulfill inclusion criteria

Related Conditions & MeSH terms

• Inguinal Hernioplasty

Intervention

Procedure:
• dual approach laparoscopic inguinal hernioplasty
after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached
• TAPP
pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation
• (lichtenstein) repair
inguinal incision is done and inguinal canal approach anteriorly and then sac dissection and excision then mesh fixation to posterior wall and closure the incision in layers

Locations

Country	Name	City	State
Egypt	Assiut university hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Nasr MM. Early results of dual approach hernioplasty (DAH): an innovative laparoscopic inguinal hernioplasty technique. Surg Endosc. 2016 Mar;30(3):1113-8. doi: 10.1007/s00464-015-4308-5. Epub 2015 Jun 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	operative time will be measured in minutes for each procedure.and comparing three groups ( dual approach , TAPP and Lichtenstein ) in operative time which determined as follow: from the inflation of the abdomen till deflation and port closure; for Lichtenstein from skin incision to skin closure	from the inflation of the abdomen till deflation and port closure ---for lichtenstein from skin incision to skin closure.
Secondary	intraoperative injuries	abdominal visceral injuries cord structure injuries	intra operative
Secondary	intra operative bleeding	mild bleeding and oozing controlled by cautery bleeding from inferior epigastric artery or testicular artery major vascular injury	intraoperative
Secondary	post operative pain	pain measured by visual analog scale from 0 no pain to 10 the worst pain ever.	immediately post operative and 6 ,12, 24 hours and two weeks post operative
Secondary	post operative wound complication	wound seroma , hematoma either small with conservative treatment and large need intervention wound infection either superficial skin and S.C. or mesh infection	2 weeks post operative ,3 ,6 and 12 months postoperative
Secondary	post operative chronic pain	post operative paraesthesia , bricking pain, dull-aching pain. measured by visual analog scale (VAS) from 0 no pain to 10 the worst pain ever	follow up at 3 months , 6 months and one year for pain assessment by VAS
Secondary	recurrence	post operative inguinal swelling confirmed clinically as a recurrent hernia	3 months, 6 months and one year