Condition category
Injury, Occupational Diseases, Poisoning
Date applied
07/08/2017
Date assigned
17/08/2017
Last edited
17/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An inguinal hernia usually occurs when fatty tissue or a part of the bowel pokes through into the groin at the top of the inner thigh. Multitrocar laparoscopy (MTL) is a popular surgical treatment for inguinal hernia repair. Compared to open techniques, laparoscopic (keyhole surgery) treatment results in less pain, faster recovery, early return to daily activities and better cosmetic results. The next step for inguinal hernia repair is single-incision laparoscopy (SIL), where only a single small incision (cut) is used. SIL totally extraperitoneal repair (SILTEP) has been found to be feasible and safe. Early reports are promising, but the advantages of SILTEP over conventional multitrocar laparoscopic TEP (MTLTEP) have not been clearly defined. The aim of this study is to compare the short and mid-term outcomes of SILTEP and MTLTEP inguinal hernia repair.

Who can participate?
Patients aged over 18 undergoing laparoscopic surgery for inguinal hernia


What does the study involve?
Participants are randomly allocated into two groups to undergo SILTEP or MTLTEP. Complications during surgery and pain after surgery are recorded. All participants are assessed for complications, inguinal hernia recurrence and days needed to return to daily activities at 7 and 30 days after surgery. During follow-up the participants are contacted by phone to assess their surgical and cosmetic satisfaction.

What are the possible benefits and risks of participating?
SILTEP and MTLTEP inguinal hernia repairs are feasible and safe. Both techniques are commonly performed. SILTEP could reduce complications and improve cosmetic results.

Where is the study run from?
Department of Gastrointestinal Surgery, European School of Laparoscopic Surgery, Saint-Pierre University Hospital, Université Libre de Bruxelles (Belgium)

When is the study starting and how long is it expected to run for?
January 2013 to July 2016

Who is funding the study?
Université Libre de Bruxelles (Belgium)

Who is the main contact?
Prof. Giovanni Dapri
giovanni@dapri.net

Trial website

Contact information

Type

Scientific

Primary contact

Prof Giovanni Dapri

ORCID ID

http://orcid.org/0000-0001-7982-283X

Contact details

Saint-Pierre University Hospital Université Libre de Bruxelles
Department of Gastrointestinal Surgery
European School of Laparoscopic Surgery
322
Rue Haute
Brussels
1000
Belgium
+32 (0)2 535 41 15
giovanni@dapri.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SIL/MTL-TEP:210

Study information

Scientific title

Prospective randomised study comparing single-incision laparoscopy versus multitrocar laparoscopy totally extraperitoneal inguinal hernia repair (TEP) at 2 years

Acronym

Study hypothesis

Single-incision laparoscopy totally extraperitoneal (SILTEP) inguinal hernia repair can reduce the postoperative pain and improve the cosmetic results.

Ethics approval

This study does not require ethics approval. Both surgical procedures are frequently used in inguinal hernia repair and have been reported as feasible and safe.

Study design

Single-centre randomized prospective interventional clinical trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Unilateral or bilateral inguinal hernia requiring surgical treatment

Intervention

Participants are randomised using computer-generated randomized numbers in sealed envelopes to either:

Single-incision laparoscopy totally extraperitoneal (SILTEP) inguinal hernia repair:
A 1.5 cm umbilical scar is created in the opposite region of the hernia to treat and the anterior rectus fascia is opened. A fascial purse-string suture using Vicryl 1 is placed starting at 9 o’clock position. An 11-mm reusable rigid trocar is introduced behind the rectus muscle into the preperitoneal space. The 0° regular scope is advanced into the 11-mm trocar and the preperitoneal space is insufflated. The space is dissected using the optical system from medial to lateral side. At the time of hernia sac retraction, a reusable monocurved grasping forceps is introduced inside the purse-string suture, at 9 o’clock position and parallel to the 11-mm trocar. The hernia sac is reduced, the peritoneal sheet is retracted and the spermatic elements are skeletonized. A 15 cm x 10 cm polypropylene mesh is introduced through the 11-mm trocar. The mesh is adequately positioned using the monocurved umbilical grasper, placing the lateral corner anteriorly to the peritoneal sheet and the medial corner under the pubic bone.

Multitrocar laparoscopy totally extraperitoneal (MTLTEP) inguinal hernia repair:
The operation start with an infraumbilical vertical incision approximately 1.5-2 cm long and the rectus fascia on the opposite side of hernia is opened. A space is created slightly off the midline behind the rectus muscle and in front of the posterior rectus sheath. Subsequently, a 11-mm reusable rigid trocar is introduced behind the rectus muscle into the preperitoneal space. The 0° regular scope is advanced into the 11-mm trocar and used for blunt dissection of the areolar tissue in the preperitoneal space using a gentle sweeping motion. Under direct visualization, two other 6-mm trocars are placed. In unilateral hernias, the first 6-mm trocar is placed through the midline between the umbilicus and the pubis, while the second 6-mm trocar through the horizontal umbilical line 3 cm internal to the ipsilateral anterior superior iliac spine. In bilateral hernias, two 6-mm trocars are inserted through the horizontal umbilical line, 2-3 cm internal to anterior superior iliac spines. Two atraumatic grasping forceps are used to isolate and reduce the hernia sac, to retract the peritoneal sheet and to skeletonize and accurately identify all spermatic cord structures. A 15 cm x 10 cm polypropylene mesh is appropriately placed.

All patients were assessed for early postoperative complications at office consultation on 7 and 30 day from surgery. Late postoperative complications (after 30 days), inguinal hernia recurrences and days to return to ADL were recorded too. The mean follow-up was 27 ± 8 months (SILTEP: 28.37 ± 7.29 months; MTLTEP: 26.42 ± 9.04 months). During follow-up the patients were contacted and consulted by phone call questionnaire. The interview was performed on 30/06/2016. Surgical and cosmetic satisfaction were evaluated.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Mid-term outcomes:
1. Late postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma (no case reported), umbilical infection (no case reported), testicular atrophy and chronic pain reported by each patient at follow-up (after 30 days from surgery and during interview)
2. Late inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at follow-up (after 30 days from surgery and during interview)
3. Surgical satisfaction, measured using a numerical rating scale (NRS) at follow-up (during interview)
4. Cosmetic satisfaction, measured using a score questionnaire at follow-up (during interview)

Secondary outcome measures

1. Perioperative outcomes:
1.1. Operative time, calculated using the time from the skin incision until fascia closure at the end of surgical procedure
1.2. Mesh fixation, measured using the number of tack devices used to fix the mesh (if it was necessary) at the end of surgical procedure. (one tack device was used for each mesh fixed)
1.3. Operative complications, measured using the number of peritoneal tear repair, epigastric vessels injury, corona mortis bleeding and conversion to TAPP (transabdominal preperitoneal) repair during surgical procedure
1.4. Postoperative pain, assessed using a visual analogue scale (VAS) at 6, 12, 18 and 24 hours after surgery
1.5. Hospital stay, measured using the number of days of patient’s hospitalization
2. Short-term outcomes:
2.1. Early postoperative complications, measured using the number of umbilical hematoma, inguinal hematoma, inguinal seroma, umbilical infection (abscess), urinary retention and testicular atrophy at office consultation on 7 and 30 days from surgery
2.2. Early inguinal hernia recurrence, measured using the number of inguinal hernia recurrence reported by each patient at office consultation on 7 and 30 days from surgery
2.3. Days to return to activity daily living (ADL), measured using the number of days necessary to return to ADL for each patient evaluated at consultation on 7 and 30 days from surgery or during the interview

Overall trial start date

01/01/2013

Overall trial end date

31/07/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (aged 18 years or over)
2. Unilateral or bilateral inguinal hernia
3. Patient’s approval

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

210 (SILTEP group: 113; MTLTEP group: 97)

Participant exclusion criteria

1. Age <18 years
2. Patient refusal to partecipate in the study
3. Inability to receive general anesthesia
4. Concomitant surgical procedures out of hernia repair

Recruitment start date

14/01/2013

Recruitment end date

28/05/2015

Locations

Countries of recruitment

Belgium

Trial participating centre

Saint-Pierre University Hospital
Université Libre de Bruxelles Department of Gastrointestinal Surgery European School of Laparoscopic Surgery 322, Rue Haute
Brussels
1000
Belgium

Sponsor information

Organisation

Saint-Pierre University Hospital

Sponsor details

Université Libre de Bruxelles
Department of Gastrointestinal Surgery
European School of Laparoscopic Surgery
322
Rue Haute
Brussels
1000
Belgium
+32 (0)2 535 41 15
giovanni@dapri.net

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

University/education

Funder name

Université Libre de Bruxelles

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Trial results will be communicated in conference presentations and peer-reviewed journal publications.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Giovanni Dapri (giovanni@dapri.net).

Intention to publish date

01/11/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes