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

NCT03052023 | Completed

• 1 other identifier: IHPP3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Inguinal Hernioplasty

Keywords

dual approach; laparoscopic hernioplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• intraoperative injuries

  intra operative

• intra operative bleeding

  intraoperative

• post operative pain

  immediately post operative and 6 ,12, 24 hours and two weeks post operative

• post operative wound complication

  2 weeks post operative ,3 ,6 and 12 months postoperative

• post operative chronic pain

  follow up at 3 months , 6 months and one year for pain assessment by VAS

Study Arms (3)

group A (dual approach lap hernioplasty)

EXPERIMENTAL

dual approach laparoscopic inguinal hernioplasty by combination of TAPP (group B) and pneumo-dissection preperitoneal instead of sharp dissection

Procedure: dual approach laparoscopic inguinal hernioplasty

group B (TAPP)

ACTIVE COMPARATOR

trans-abdominal preperitoneal hernioplasty (TAPP) after induction of pneumoperitoneum through peritoneal approach peritoneal incision and preperitoneal dissection then mesh fixation done

Procedure: TAPP

group C (Lichtenstein hernioplasty)

ACTIVE COMPARATOR

open inguinal hernioplasty (lichtenstein) repair through inguinal incision and dissection of the sac anteriorly , excision of the sac and then mesh fixation in the posterior wall of inguinal canal

Procedure: (lichtenstein) repair

Interventions

dual approach laparoscopic inguinal hernioplasty PROCEDURE

after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached

group A (dual approach lap hernioplasty)

TAPP PROCEDURE

pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation

group B (TAPP)

(lichtenstein) repair PROCEDURE

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

group C (Lichtenstein hernioplasty)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut university hospital

Asyut, 71515, Egypt

Location

Related 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.

  PMID: 26099622 RESULT

MeSH Terms

Interventions

tetra-4-amidinophenoxypropane; Wound Healing

Intervention Hierarchy (Ancestors)

Regeneration; Biological Phenomena

Study Officials

• mostafa A. hamad, professor

  Assiut university hospital faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: this is a randomized trial where the participants are selected randomly to each of the previous three groups , and the post operative assessment of complication and pain done by different surgical residents whom are not informed about the groups of study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: general surgeon

Model Details: comparative study between three procedures of inguinal hernioplasty; open (LICHTENSTEIN), TAPP, and laparoscopic DUAL APPROACH (modified TAPP)

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 14, 2017
• Study Start: November 1, 2016
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 9, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)