LESS TEP vs. Three Port TEP for Inguinal Hernia Repair

Sponsor
Sofia Med Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04303182
Collaborator
(none)
200
1
2
18.9
10.6

Study Details

Study Description

Brief Summary

This study aim to compare efficacy and safety of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Standard 3 port TEP
  • Procedure: LESS TEP
N/A

Detailed Description

This is a prospective, double blinded, randomized trial. It compared of Laparoendoscopic single site total extraperitoneal inguinal hernia repair /LESS TEP/ and traditional total extraperitoneal hernia repair with 3 ports /TEP/.

Inguinal hernia is one of the most common surgical diseases. Laparoscopic hernia repairs include two types, TEP and TAPP. Laparoscopic inguinal hernia repair was associated with less post operative pain, a shorter recovery period and better cosmetic results. Efforts are continuing to further reduce the port related morbidities and improve the cosmetic outcomes of laparoscopic surgery, including reduction of the size and number of ports. This has led to the evolution of a novel surgical approach now collectively known as laparoendoscopic single-site surgery.

200 patients will undergo TEP inguinal hernia repair. They will be randomized in two groups by sealed envelope method.

Group A: Standard TEP with 3 ports (10mm. and 2 ports of 5mm.). In case of difficulty in Standard 3 port TEP inguinal hernia repair, the procedure will be converted to TAPP.

Group B: LESS TEP with single skin incision 2-3cm. In case of difficulty in LESS TEP inguinal hernia repair, the procedure will be converted to standard 3 port repair or TAPP.

Patient will be informed at consenting that 3 wound plasters will be applied to their abdomen regardless of whether they are in the single port or 3- ports group so that they would not know which group they have been randomized to. The blind will only be lifted after pain score and area of pain has been recorded before discharge.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Double blinded
Primary Purpose:
Treatment
Official Title:
Laparoendoscopic Single-site Versus Three Port Totally Extraperitoneal Hernia Repair: A Prospective Double Blinded Randomized Clinical Trial
Actual Study Start Date :
Jan 2, 2020
Actual Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jul 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard 3 port TEP

Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).

Procedure: Standard 3 port TEP
3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port

Active Comparator: LESS TEP

Group B will undergo laparoscopic TEP inguinal hernia repair with a single skin incision 2-3cm.

Procedure: LESS TEP
TEP inguinal hernia repair with one vertical skin incision under the umbilicus

Outcome Measures

Primary Outcome Measures

  1. Postoperative Pain [24hours]

    Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.

  2. Postoperative Pain [1 week]

    Assessment of post-operative pain according to the visual analog scale pain score - From 0 to 10 - 0 is no pain and 10 is severe pain.

Secondary Outcome Measures

  1. Operating time [During operation]

  2. Intraoperative complications [During operation]

    Assessment of interoperation procedure of the incident of spermaduct, vessel and other organ damage

  3. Length of hospital stay [24 hours]

  4. Postoperative complications [1 week; 4 weeks]

    Urinary infections; Seroma; Hematoma

  5. Recurrence of hernia [4 weeks; 3 months; 1 year]

  6. Cosmetic scar score [4 weeks]

    Scar evaluation using Patient and Observer Scar Assessment Scale (POSAS) 4 week after the surgery

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age between 18 and 90 years

  • Willing to participate in this study and signed an informed consent.

  • Diagnosed inguinal hernia - primary or recurrence

  • ASA class I, II and III

Exclusion Criteria:
  • Age under 18 years and above 90 years

  • Strangulated hernia

  • Patients with severe chronic diseases or cardiopulmonary dysfunction, who can't undergo general anesthesia

  • Patients who prefer a certain surgical approach

  • Patients who undergo surgery procedures for chronic pain after inguinal hernia repair

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sofiamed Hospital Sofia Bulgaria

Sponsors and Collaborators

  • Sofia Med Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sofia Med Hospital
ClinicalTrials.gov Identifier:
NCT04303182
Other Study ID Numbers:
  • 204
First Posted:
Mar 10, 2020
Last Update Posted:
Jun 21, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sofia Med Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 21, 2021